With an overall goal in protecting public health, the objective of pharmacovigilance (PV) is to promote the safe clinical use of medicines and prevent adverse drug reactions from clinical investigation throughout post-marketing of a drug.  While there are multitudes of factors that affect a PV program, the focus of this article is risk management and the associated value of patients’ participating in clinical research, as they are a major resource to clinical drug development and represent important safety information during the clinical trial period and beyond.

What is pharmacovigilance (PV) and how does it relate to clinical research?

PV is an integrated risk management approach/system developed in efforts to assure drug safety from the clinical research stage through post marketing of a drug.1

What are the ramifications of insufficient risk management/PV systems?

The three main consequences are drug failures, drug withdrawals, and new regulations.  In the past decade a significant number of high-profile brands have struggled with safety concerns, either causing such drugs to be withdrawn from the market1 (e.g., Rezulin,Vioxx, Bextra), or those alerting U.S. lawmakers to enforce stricter laws and regulations.  A current example is the FDA recommendations that all antihyperglycemia agents under clinical development demonstrate lack of cardiovascular adversities the basis of which was fueled by concerns raised about the cardiovascular safety of drugs in this field, especially the thiazolidinediones (TZDs), including rosiglitazone (Avandia, GlaxoSmithKline).2

What key issues are involved with drug safety that a successful risk management/PV program can enhance?

*  Risk management from clinical trial participation through post marketing
*  Safety surveillance to detect adverse signals
*  The establishment and continuous monitoring of a drug’s benefit-risk relationship

How can the three key issues be managed more successfully?

One key factor that can favorably affect success is establishing effective patient retention processes from the time of participation in a clinical study throughout the postmarketing period of a drug; patients drop outs or those lost to follow-up (LTFU) represent valuable safety information long-term.

What percentage of patients’ drop out of clinical research or are LTFU that  hinder risk management?

There are various statistics reported depending on the investigational drug being studied. Centerwatch3 in past surveys has reported up to a 30% drop out rate overall and a study investigating arthritis medicine in osteoarthritis patients reported a 45% drop out with 54% of those LTFU. 4

Who is Omnitrace and how can it assist drug manufacturers in risk management/PV approaches?

Omnitrace is a people locate company that has been in operation for 16 years.  Omnitrace has a stellar record of success in locating tens of thousands of people world-wide, servicing several sectors including the pharmaceutical/biotechnological industry in finding clinical trial patients and those who dropout and become LTFU.   As mentioned, as every participant in clinical research is a valuable source of safety information, locating patients LTFU is critical to maintaining a robust risk management system.

What have we learned from drug manufactures that have established an effective PV process?

An integrated approach that takes into account the key stages of drug development including preclinical, clinical and postmarketing is critical.  The sum of several factors are required for success: Prepahase safety considerations + PV safety strategy + clinical trial safety including surveillance + risk management planning, plans, and strategy + postmarketing surveillance + signal detection of adverse events.5

As demonstrated, multifaceted issues affect risk management and PV systems. While the equation of success can be overwhelming, a common dynamic that exists throughout the process is the research participants as they represent important safety information during the clinical trial period and beyond.  Integrating an effective patient retention program so patients don’t drop out or are LTFU will assist in facilitating a successful PV strategy.

References
1. Maennl, U. Pharmacovigilance: A Company-Wide Challenge. (2008) Accessed http://appliedclinicaltrialsonline
2. Food and Drug Administration. FDA announces new recommendations on evaluating cardiovascular risk in drugs intended to treat type 2 diabetes. December 17, 2008. Available at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01928.html
3. Available at http://www.centerwatch.com
4. Wider, F., Barrett, J. The association between medication usage and dropout status among participants of an exercise study for people with osteoarthritis. Physical Therapy (2005) 85; 142-149)
5. P.C. Waller and S.J.W. Evans, “A Model for the Future Conduct of Pharmacovigilance,” Pharmacoepidemiology and Drug Safety, 12, 17-29 (2003).

Please contact our CEO David Betz at 888-965-6696, and he will answer any immediate questions you have and provide you information about our OmniTrace lost to follow-up patient search services.  You can also email David at:  dave@omnitrace.com.

THE CONTENT ON OUR OMNITRACE OWNED WEBSITES IS MERELY GENERAL INFORMATION OBTAINED BY ORDINARY PEOPLE AND NOT LEGAL ADVICE.  ONLY A QUALIFIED LAWYER CAN GIVE LEGAL ADVICE.  WE ARE NOT LAWYERS.

Electronic Medical Records Utility in Clinical Trial Conduct

Patient dropouts and those lost to follow-up (LTFU) pose a major challenge and costly burden in the conduct of clinical trials as each patient represents a valuable source of data.  High patient dropout rates are not only costly but pose a risk to the interpretation and validity of intended research findings.  Therefore, retention and adherence processes are critical so patients don’t dropout and become lost to follow-up (LTFU).

Such procedures require a combination of patient, physician, and coordinator related factors including recruiting patients per protocol inclusion criteria, managing patient expectations, and efficient recording of all relevant documentation.  These are important factors that can favorably influence cost effectiveness.  In this regard, electronic medical records ( EMRs ), considered an asset to the health care industry, offer much advantage to clinical research by assisting in recruiting the correct patients to the appropriate clinical trial, ¹ aiding in cost effective subject recruitment, and rapidly identifying adverse events.^{2, 3} These factors can reduce patient dropout rates and patients LTFU.  Additionally, EMRs facilitate clinical investigators in maintaining adequate and accurate patient case histories and in providing direct access to source data/documentations for trial-related monitoring required by the FDA,⁴ GCP guideline and ICH Guideline for Good Clinical Practice (E6).⁵   Such formation may also provide the necessary information to find a patient LTFU and reintegrate them into the study.

Despite the many advantages of EMRs, there are some potential concerns with their utilization based on data integrity assurance and privacy mandates per the Health Insurance Portability and Private Act (HIPAA) ^6,7 for Sponsors of clinical research due to the necessitation of monitors and quality assurance auditors to inspect study records.  However, as the HIPAA privacy rule requires that an individual participating in research provide signed permission before records may be accessed by researchers and/or due to FDA-required elements, ⁸ these concerns can be easily avoided if the informed consent process is conducted as appropriate, which includes an adequately prepared informed consent form (ICF) that is signed by the patient prior to any research related activity. Therefore, if a valid informed consent process is in place, the monitoring of any medical record, including EMRs, even if the EMR is part of a larger record that includes non-research related health information is considered HIPAA complaint.

Importantly, it must be recognized that while Electronic Medical Records (EMR) can greatly enhance the entire clinical trial process and subsequently increase patient retention, reduce dropout rates and patients LTFU, there must be quality monitoring data and recordkeeping systems and standard operating procedures that sponsors have in place  to assure data integrity and patient privacy per governing mandates.

1. J.W. Goldwein et al., Abstract No. 6626, Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings, Part 1 Vol. 25, No. 18S (June 20 Supplement) 2007: 6626.

2. M. Mowry and D. Constantinou, “Electronic Health Records: A Magic Pill?” Applied Clinical Trials, February 2007.

3. J.C. Crosson et al, “Electronic Medical Records and Diabetes Quality of Care: Results From a Sample of Family Medicine Practices,” Annals of Family Medicine, 5: 209-215 (2007).

4. Code of Federal Regulations, Title 21, Part 312.62(b) (U.S. Government Printing Office, Washington, DC).

5. Food and Drug Administration, “ICH E6 Good Clinical Practice: Consolidated Guidance, Section 4.9.7, Federal Register 62 (90), 25691-25709 (May 1997).

6. U.S. Department of Health & Human Services, Health Insurance Portability and Privacy Act of 1996 (U.S. Government Printing Office, Washington, DC).

7. Code of Federal Regulations, Title 45, Parts 164-168 (U.S. Government Printing Office, Washington, DC).

8. Code of Federal Regulations, Title 21, Part 50 Section 25(a)(5) (U.S. Government Printing Office, Washington, DC).

Please contact our CEO David Betz at 888-965-6696, and he will answer any immediate questions you have and provide you information about our OmniTrace lost to follow-up patient search services.  You can also email David at:  dave@omnitrace.com.

THE CONTENT ON OUR OMNITRACE OWNED WEBSITES IS MERELY GENERAL INFORMATION OBTAINED BY ORDINARY PEOPLE AND NOT LEGAL ADVICE.  ONLY A QUALIFIED LAWYER CAN GIVE LEGAL ADVICE.  WE ARE NOT LAWYERS.

In any clinical trial, issues of patient retention, patient dropouts and patients lost to follow-up ( LTFU ) poses a major challenge.  Each patient represents a significant amount of time, effort and other resources, so that a high rate of patient dropouts are not only costly but pose a risk to the interpretation and validity of the intended research findings.

Patient dropouts / patients not retained of a study can quickly become lost to follow-up ( LTFU ), a critical situation where it is difficult to locate the patient and necessary patient information.  Retention and adherence depend on a combination of patient-, physician- and coordinator-related issues–factors that need to be carefully evaluated to ensure success.  Analyzing rates of patient dropouts and when they occur can give important information about patient characteristics, study design and conduct and respective intervention.  It is also important to assess the inclusion and exclusion criteria’s impact on patient dropout rates and the comparative losses between the control and intervention groups.

Patient dropouts and those lost to follow-up ( LTFU ) after recruitment negatively affects study duration, cost and generalizing the study results, which may result in regulatory approval delay.  In fact, it is widely recognized that high patient dropout and lost to follow-up ( LTFU ) rates in clinical trials are a major threat both to the ability to conduct critical research and to generalize results to broader populations.

Patient dropout and/or LTFU rates are estimated to range from 15-40% of enrolled subjects.  Therefore, while designing a study, an estimate of a potential patient dropout rate must be assumed and then compensated for by increasing the number of enrolled subjects, investigational sites, as well as the supplies and resources for these additions.¹ While this procedure is necessary, if judged incorrectly it becomes a costly burden.  For example, the average subject cost is estimated to be $6,500 per subject for a Phase II trial,  so if the trial design estimates an enrollment of 150 subjects but exceeds its enrollment by 10% to compensate for expected patient dropouts, it will cost an additional $97,500, not including the possible costs associated with delayed trial completion.²

Characteristics and Reasons for Patient Dropouts  and Lost To Follow-Up ( LTFU )

Several studies have investigated demographic characteristics of participants who tend to dropout and/or those LTFU of research protocols.  One characteristic predictive of patient dropout appears to be age, with younger participants (< 50 years old) at significantly higher risk than older participants.³  It has also been reported that minorities represent higher patient dropout and LTFU rates.⁴  In addition to demographic factors, psychological and behavioral characteristics appear to predict higher patient dropout risk and LTFU.⁴          

The causes for patients’ failure to complete the study have also been investigated and the most frequently cited reasons reflect issues related to competing life demands, logistical problems, demands of the study, and lack of motivation/commitment.  The most commonly cited explanations are stress related to family care responsibilities and interference with work^4,5  Lack of time, as well as complicated and cumbersome record-keeping and paperwork associated with a study have also been reported as common reasons.  A logistical barrier frequently cited is difficulty with transportation and inconvenience of study site location, including distance and parking.  Other logistical issues include the timing of appointments with study staff and the need for flexibility in times and dates available for meetings and data collection.^4,6  Positive reinforcement and patient motivation also play a major role in decisions concerning whether to complete or drop out of the study. 

Patient dropouts and LTFU occur when participants’ perceived time and effort invested outweigh the perceived benefits of being in a study.¹  Reasons patients give for completing research protocols also reflect incentive and motivation, and include remuneration, a commitment to finish, and a belief that the study is important.⁴  All of these factors that determine whether patients remain in studies or dropout and become LTFU obviously have implications for developing strategies that enhance the likelihood of study completion. Strategies must use multiple methods to enhance patient retention and include initiatives that address multiple barriers and facilitators of research participation, such as motivation, convenience, and data tracking.

We will discuss strategies that provide logistical approaches and initiatives to improve patient participation in our next post.

 References

• 1. Berger A, Neumark D. Enhancing recruitment and retention in randomized clinical management. Oncology Nursing Forum, 2007, 34, e18.
• 2. Blanton S, Morris D, Prettyman M, McCulloch K, Redond S, Light K, Wolf S. Lessons learned in participant recruitment and retention: The EXCITE trial. Physical Therapy, 2006, 86, 1520-1523.
• 3. Glasgow R, Nelson C, Kearney K, Reid R, Ritzwoller D, Strecher V, Couper M, Green B, Wildenhaus K. Reach, engagement, and retention in an Internet-based weight loss program in a multi-site randomized controlled trial. Journal of Medical Internet Research, 2007, 9, e11.
• 4. Janson S, Alioto M, Boushy H. Attrition and retention of ethnically diverse subjects in a multicenter randomized controlled research trial. Controlled Clinical Trials, 2001, 22, 236S-43S.
• 5. Parra-Medina D, Antonio A, Smith S, et al. Successful recruitment and retention strategies for a randomized weight management trial for people with diabetes living in rural, medically underserved counties of South Carolina: The POWER Study. Journal of the American Dietetic Association, 2004, 104, 70-75.
• 6. Tansey C, Matte A, Needham D, Herridge M. Review of retention strategies in longitudinal studies and application to follow-up of ICU survivors. Intensive Care Medicine, 2007, 33, 2051-2057.

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Please share your thoughts regarding our post on patient dropouts and patients lost to follow-up.  And, please do email or call us with any questions you have about our OmniTrace Corp. patient search and patient retention services:

dave@omnitrace.com (Dave Betz)
888-965-6696

THE CONTENT ON OUR OMNITRACE OWNED WEBSITES IS MERELY GENERAL INFORMATION OBTAINED BY ORDINARY PEOPLE AND NOT LEGAL ADVICE.  ONLY A QUALIFIED LAWYER CAN GIVE LEGAL ADVICE.  WE ARE NOT LAWYERS.

Recent reports have indicated that the Health Insurance Portability and Accountability Act (HIPAA) that went into effect in 2003 has adversely affected clinical trial conduct and patient retention by imposing significant time and cost burden and by impeding clinical trial recruiting and patient retention,¹ which in turn has deterred patient search efforts–locating patients lost-to-follow-up.  This commentary will serve as the third of a series that will discuss strategies to enhance patient retention and finding patients lost to follow-up based on evolving interpretations of the HIPAA regulations.

Challenges of Patient Retention

When conducting a clinical study on a treatment or intervention, it is imperative to retain patients throughout the entire study duration and for a follow-up period, which can be months or even a decade for longitudinal studies.  Patient retention for study duration and follow-up represents a major challenge and we must address this issue to avoid potentially devastating consequences to the clinical trial industry.² 

In fact, estimates reported in 2003, before HIPAA- impact, indicate that 85% of trials do not finish on schedule, 60% to 80% of clinical trials do not meet their chronological endpoints because of challenges in recruitment, and 30% of trial sites fail to recruit even a single participant.²  

Additionally, disappointing statistics show that 26% of patients drop out after providing consent and greater than 94% of studies are delayed due to failed enrollment / patient retention (including patients lost to follow-up).  The situation is worsening in large part due to HIPAA regulations.  In fact from 1997 to 2003, the percentage of studies completed on time decreased from 18% to 6%.^3,4  The costly consequences of trial delay are so staggering  that each day of delay can equate to  $220K, and a 2 month delay can equate to $70 million potential product sales due to postponed launch.

Strategies to Enhance Patient Retention

We can enhance retention of participants by utilizing appointment reminders with the caveat that this process must be cognizant of participant privacy.  Under HIPAA, postcard reminders are discouraged due to the possibility of a patient’s medical diagnosis being inferred by anyone seeing the postcard (by virtue of a study logo or clinic’s name). Therefore, if utilizing mail reminders, enclose in an envelope without a return address that includes the affiliated study group (e.g., the Diabetes Research Group).²   Additionally, a mail reminder should not resemble a medical bill as patients may delay opening.

Utilizing a mail reminder several days in advance, followed by a telephone reminder 24 to 48 hours prior to a follow-up appointment is an effective strategy for patient retention.  Utilizing this method, ensures that the patient’s protected health information (PHI) is not revealed.  For example, if an appointment reminder is recorded on a patient’s answering machine the message should only provide the date and time for the pending appointment, and a contact number if needed by the patient for questions or re-rescheduling.  While, e-mail has become another option for appointment reminders, we must recognize that older adults may not be computer savvy and some minorities may not have e-mail access.²

Reimbursement of patients is also a well-known strategy for effective patient retention.  However, the processes of reimbursement must be consistent with participant privacy.  The standard patient reimbursement process involves the research facility’s accounting department forwarding a check to the patient’s home.  Patients can also be reimbursed with gift cards, books of stamps, and other monetary equivalents.

Lastly, a critical element of patient retention strategies are plans that include patient search initiatives to locate those lost to follow-up quickly and efficiently so they return to the study in a timely manner.  It has been shown that if patients lost to follow-up are contacted expeditiously they will return to the study, either during the ongoing phase or for follow-up evaluations. This is critical because loss of patients equates to loss of data; loss of data causes trial delay; trial delay negatively affects regulatory submission and subsequent product launch; and together this debacle of events leads to an extremely high cost burden.

References:

1. Blanton, B. et al. Lessons learned in participant recruitment and retention: The EXCITE Trial. Physical Therapy. 2006; 86: 1520-1533.

2. Wipke-Tevis, D. Impact of the Health Insurance Portability and Accountability Act on participant recruiting and retention. Western Journal of Nursing. 2008;30: 399-53.

3. 5^th annual patient recruitment and retention conference September 24-25, 2007; Washington DC; Data presented by John Benbrook and Malcolm Bohm of MMG & trialytics, Inc.

4. 101 facts about clinical research (2005) Accessed at www.ciscrp.org 

5. Nature Reviews Drug Discovery 2, 851 (November 2003)

6.  DataMonitor (2004), patient recruitment online

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Please share your thoughts regarding our post on Patient Retention.  And, please do email or call us with any questions you have about our OmniTrace Corp. patient search and patient retention services:

dave@omnitrace.com (Dave Betz)
888-965-6696

THE CONTENT ON OUR OMNITRACE OWNED WEBSITES IS MERELY GENERAL INFORMATION OBTAINED BY ORDINARY PEOPLE AND NOT LEGAL ADVICE.  ONLY A QUALIFIED LAWYER CAN GIVE LEGAL ADVICE.  WE ARE NOT LAWYERS.

How does OmniTrace determine the vital status of a clinical trial patient lost to follow-up?  What a great question! 

Our first efforts are to establish that the clinical trial patient is alive and determine the patient’s current address and phone number.  Each search can be quite different, and our research procedures will vary depending on the makeup of the clinical trial [e.g., age of patients, economic status of patients, health status of patients, geographic information (urban or rural)]. 

When conducting a search for an “alive” patient, we are typically flagged by our proprietary databases if the patient has been deceased for more than thirty days–our databases pull directly from the Social Security Death Index (SSDI).

If we are unable to determine a patient’s current address and the SSDI does not indicate that the patient is deceased, we check available state death indexes which often contain vital status information not in the SSDI.

If we are still unable to determine a patient’s vital status, we search available public records for reported deaths.  These public records consist of possible obituaries and newspaper articles. (Obituaries will vary depending on the state and year of death.)

We also research where the patient was employed and if the patient was a member of any clubs or associations.  We then determine whether any of these entities have posted a notice of death or a memorial.

These are the primary death record resources utilized in HIPAA Compliant Searching.  In a non-HIPAA search, we might simply call family members for patient vital status information.

Additional:

When searching for a patient, we research many database sources such as property deeds and real time phone listings.  These are very current public records and will greatly narrow down the time-frame of a possible death.  We research if anyone new has recently purchased or moved into the patients’s most current listed address.  If not, this is a good sign that the patient still resides there.  We also research whether the patient’s consumer/credit history has had recent changes.  Are there bills going to the patient’s address?  Are there any other addresses?

There are many other nuances involved with searching, and it is difficult to cover all of these. As an example, we know that not everyone is listed in the SSDI.  The SSDI is an index of all persons with Social Security Numbers that have been reported to the Social Security Administration.  These deaths are usually reported by a survivor requesting death benefits or to stop Social Security benefits to the decedent.  Because of this, when we are researching the patient, we look to see if they are married or if they have living children.  If so, and they died, almost certainly they would be listed in the SSDI.  If we see that a patient lived alone, was predeceased by their spouse and/or does not have living children, there is a greater likelihood that the patient is not listed in the SSDI.

Finally the greatest concern in determining patient vital status are very recent deaths which do not allow enough time for the data to appear in our databases and public records (i.e., an updated SSDI and obituaries and notices of death have not yet become available).  Because of this, we err on the side of caution and typically show the patient alive at a conservative earlier date.  We will also continue to rerun our database searches until we determine the vital status of the patient.

For those of you who are curious, OmniTrace may access many proprietary databases, public record resources and genealogical resources resources when we search for patients and determine vital status.  These include:

• Credit header information
• Employment records
• Telephone directory information
• Magazine, newspaper and book club subscriptions
• Motor vehicle and traffic accident records
• Driver’s License Records
• Cell phone users
• Boat owners
• Postal records
• UCC filings
• Corporate information
• Reverse directories
• Internet search engines
• Liens, judgments, civil and criminal records
• Pizza delivery listings
• Bankruptcy records
• Obituary notices
• Property records
• Census records
• State and national birth and death records
• Additional state and county specific databases

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Please share your thoughts regarding our post on Determining Clinical Trial Patient Vital Status.  And, please do email or call us with any questions you have about our OmniTrace Corp. patient search and patient retention services:

dave@omnitrace.com (Dave Betz)
888-965-6696

Recent reports have indicated that the Health Insurance Portability and Accountability Act (HIPAA) that went into effect in 2003 has adversely affected clinical trial conduct by imposing significant time and cost burdens, and by impeding clinical trial recruitment and retention,¹ which in turn has deterred finding patients lost-to-follow-up (LTFU).  This post will serve as the second of several that will discuss strategies to enhance recruitment, retention, and finding patients lost-to-follow-up based on evolving interpretations of the HIPAA regulations and will focus on initial patient contact.

Contacting eligible participants for clinical trial recruitment is a challenge and HIPAA regulations have made this process more complicated.  Pre-HIPAA, patient lists and their contact information were accessible for review, and clinical study personnel were able to identify and subsequently contact eligible participants. 

Conversely, post-HIPAA, the contact information of potential participants cannot be accessed without the participants’ explicit authorization, a clear hindrance to the contact and clinical trial recruitment process.  In this regard, the burden shifted to the health care provider (who now becomes the recruiter), already inundated with patient care responsibilities and time constraints, to introduce the study to the patient and obtain their consent for subsequent contact.² 

As a result, there have been substantial decreases in participant accrual, as well as increases in recruitment costs.  For example:  studies have reported that clinical trial recruitment has decreased from an average of 12.4 participants per week pre-HIPAA to 1.9 participants per week post-HIPAA.^3,4 Additionally, recruitment costs have increased from $49 per participant to $169 per participant post- HIPAA, a situation particularly problematic for studies already in progress at the time of the HIPAA implementation.⁴

Despite the burden the HIPAA privacy rule has placed on contacting patients for clinical trial recruitment, deliberation of the seemingly logical intent of these regulations, along with prior planning can facilitate these efforts.  In response to the HIPAA privacy rule, routine clinic visits by study personnel such as medical directors, nurses, etc., now speak directly to patients about their eligibility and study participant interest vs. identifying their names from lists.  Clinical collaborators and staff liaisons now obtain patient authorizations with their contact information and provide this data to the appropriate persons for study recruitment.  Additionally, clinical collaborators write letters on the clinicians’ letterhead including clinicians’ signature to potential eligible patients of interest, informing them of the study.⁵

Further, a number of other innovative-HIPAA compliant strategies have been implemented to make initial contact with participants, subsequent to local IRB approval.  These include:  flyers, advertisements, and electronic media.  Flyers are posted at health care institutions such as hospitals and clinics, as well as in community locations including pharmacies, public libraries, and senior and community centers.  

Most academic health sciences centers have a web page advertising current clinical trials that are designed to include contact information of the study coordinator, or to include a study sign-up form embedded on the page to be completed by those interested.  An example of this form is located at https://apps.muhealth.org/clinical_research/.²  

Subsequent to receipt of participant information, the study site calls respectively to gain additional eligibility criteria, or PHI per HIPAA.  It’s important to note that no specific HIPAA guidance is available on this last contact approach, therefore logic should prevail and many institutes interpret this contact NOT to require additional HIPAA or alternative authorization because the person is freely volunteering to provide his or her health information.

Because the challenges imposed by HIPAA for clinical trial recruitment, retention, and finding patients lost to follow-up are ambiguous, logical interpretation and processes must guide the clinical trial conduct process until further clarification and guidance are made available.

A future post will focus on processes compliant to patient retention and long-term follow-up.
References:

1. Blanton, B. et al. Lessons learned in participant recruitment and retention: The EXCITE Trial. Physical Therapy. 2006; 86: 1520-1533.

2. Wipke-Tevis, D. Impact of the Health Insurance Portability and Accountability Act on participant recruiting and retention. Western Journal of Nursing. 2008;30: 399-53.

3. Ness, R. B. (2005). A year is a terrible thing to waste: Early experience with HIPAA [Editorial]. Annals of Epidemiology, 15, 85-86.

4. Wolf, M. S., & Bennett, C. L. (2006). Local perspective of the impact of the HIPAA privacy rule on research. Cancer, 106, 474-479.

5. Olsen, D. P. (2003). HIPAA privacy regulations and nursing research. Nursing Research, 52, 344-348.

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Please share your thoughts regarding our post on Addressing Clinical Trial Recruitment and Retention Issues Imposed by HIPAA.  And, please do email or call us with any questions you have about our OmniTrace Corp. patient search and patient retention services:

dave@omnitrace.com (Dave Betz)
888-965-6696

THE CONTENT ON OUR OMNITRACE OWNED WEBSITES IS MERELY GENERAL INFORMATION OBTAINED BY ORDINARY PEOPLE AND NOT LEGAL ADVICE.  ONLY A QUALIFIED LAWYER CAN GIVE LEGAL ADVICE.  WE ARE NOT LAWYERS.

Subsequent to our recent post that focused on these factors that hinder the conduct of clinical trials as a consequence of the HIPAA, this commentary will serve as the first of several that will discuss strategies to enhance recruitment, retention, and finding patients LTFU based on evolving interpretations of the HIPAA regulations.  

The first of these series will focus on initial procedural practices to facilitate participant recruitment–considered the most difficult aspect of the research process¹–and made even more difficult due to HIPPA.  Estimates reported in 2003, before HIPAA- impact, indicated that 85% of trials do not finish as scheduled because:

• There is low participant accrual.
• Sixty to eighty percent of clinical trials do not meet their chronological endpoints because of challenges in recruitment.
• Thirty percent of trial sites fail to recruit even a single participant.²

Despite the burden that the HIPAA privacy rule has placed on participant recruitment, retention and finding patients lost to follow-up (LTFU), deliberation of the seemingly logical intent of these regulations, along with prior planning, can facilitate clinical research efforts.  Consider one initial important process in study planning–preparatory research.  It is a necessity to identify potential sample populations available for recruitment and estimate those who will meet inclusion criteria.³   This task obviously requires the need to review individuals’ health information and the ability to subsequently contact these respective individuals.

Pre-HIPAA, these activities were not regulated by the Investigation Review Board (IRB), however, in the post-HIPAA era accessing this information– protected health information(PHI)–requires IRB or privacy board approval.⁴

Keeping in mind that logic must prevail, the initial fears of HIPAA caused institutes not to allow medical record access without patient consent.  This led to increased interruption in recruiting patients, and following the realization of no patients, no study interpretations, were adjusted to allow HIPAA waivers of authorization to facilitate this process.

Although logical interpretation can reign in situations of HIPAA non-clarification/guidance, abiding to regulatory standards such as completing a Preparatory to Research form and submitting to the local IRB or privacy board has been clearly confirmed.  The form must answer the following questions:   

• What is the purpose of the review?
• What PHI will be used or disclosed?
• Why is the PHI necessary for the research?
• Where is the information located?
• How will the information be assessed and by whom? ³

Only the minimal PHI from the covered entity (i.e., health plan, health care clearinghouse, or health care provider who transmits any health information in connection with a HIPAA transaction) is utilized to answer the questions on the form.  If no treatment relationship exists between the institute and prospective participants, the institute should work with the hospital or clinic staff to contact potential trial participants identified in the preparatory research. ³

Because the challenges imposed by HIPAA for recruitment, retention, and finding patients lost to follow-up (LTFU) are ambiguous, logical interpretation and processes must guide the clinical trial conduct process until further clarification and guidance are made available.

Our next post will focus on processes compliant to initial contact of participants and the consent process.

References:

1. Blanton, B. et al. Lessons learned in participant recruitment and retention: The EXCITE Trial. Physical Therapy. 2006; 86: 1520-1533.

 2. Nitkin R. Patient recruitment strategies. Training workshop conducted by National Institutes of Health, Bethesda, MD, 2003.

 3. Wipke-Tevis, D. Impact of the Health Insurance Portability and Accountability Act on participant recruiting and retention. Western Journal of Nursing. 2008;30: 399-53.

 4. U.S. Department of Health and Human Services. (2004). Protecting personal health information in research: Understanding the HIPAA privacy rule. Retrieved March 15, 2006, from http://privacyruleandresearch.nih.gov/HIPAA_Booklet_4-14-2003.rtf

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Please share your thoughts regarding our post.  Also, please email or call us with any questions you have about our OmniTrace Corp. patient search and patient retention services:

dave@omnitrace.com (Dave Betz)
888-965-6696

THE CONTENT ON OUR OMNITRACE OWNED WEBSITES IS MERELY GENERAL INFORMATION OBTAINED BY ORDINARY PEOPLE AND NOT LEGAL ADVICE.  ONLY A QUALIFIED LAWYER CAN GIVE LEGAL ADVICE.  WE ARE NOT LAWYERS.

Our OmniTrace patient locator division has located well over five thousand patients who were at one point considered lost to follow-up.

Finding missing people is all we do (well almost).  We have located tens of thousands of people including:  clinical trial patients, lost friends, military personnel, lost loves, classmates, debtors, dead beat parents, missing heirs, lost family members and persons in hiding. 

Here are a few reasons why you should consider OmniTrace as your patient locator provider:

• We have a tremendous amount of experience finding people from all walks of life all over the world and have worked with patient recruiters, principal investigators, physicians and study coordinators on a wide variety of clinical research studies.
• We combine state-of-the-art database searching with old world genealogical research methods.
• We will assign an experienced, dedicated researcher to your file to provide the most timely results.
• We have an unsurpassed success rate and we guarantee our patient locator results.
• We are knowledgeable about patient retention and understand why patients become lost, allowing us to customize our patient locator service for each clinical trial. 

Please email or call us with any questions you have about our patient locator service:

dave@omnitrace.com (Dave Betz)
888-965-6696

THE CONTENT ON OUR OMNITRACE OWNED WEBSITES IS MERELY GENERAL INFORMATION OBTAINED BY ORDINARY PEOPLE AND NOT LEGAL ADVICE.  ONLY A QUALIFIED LAWYER CAN GIVE LEGAL ADVICE.  WE ARE NOT LAWYERS.

Assuring full compliance of guidelines mandated by governing authorities is critical to conducting successful clinical trial research and to subsequent product approval.  The federal government’s medical privacy rule, the Health Insurance Portability and Accountability Act (HIPAA), that went into effect in 2003 is such a mandate.  It has greatly impacted the conduct of clinical trials, however, not in a favorable way.  The focus of this post is to highlight various factors that have hindered the conduct of clinical trials as a consequence of rules imposed by HIPAA.

HIPAA of 1996 included a major provision that required covered entities (hospitals, physicians, health plans, and other entities that handle patient information) to obtain confidentiality documentation from researchers before disclosing health data.  This section of the law, which took effect as part of the overall medical privacy law in April 2003, was intended to ensure that patients’ protected health information (PHI) would not be inappropriately disclosed or used during the course of a research trial.¹

In the wake of implementation of this rule, researchers have reported that HIPAA is hindering research by increasing administrative burden so that the additional paperwork required to obtain a patients’ consent to participate in clinical research trials has caused enrollment to plummet by as much as 50% in one research institute alone.  Several different research institutions have report similar situations.¹  In fact, nearly three quarters (72%) of 331 U.S. investigators polled by the Association of American Medical Colleges reported that HIPAA was having an adverse effect on clinical research during the first six months after its implementation.  Negative effects on patient recruitment, data access, and data acquisition were cited by more than 68% of the respondents.¹

Recent reports have indicated that HIPAA has not only adversely affected clinical trial recruiting but also retention, ² which in turn has thwarted finding patients lost to follow-up (LTFU).  As recruiting and retaining an adequate sample is critical to the success of clinical research trials, the fact that HIPAA has adversely affected this research is discouraging.  However, even more daunting is that few resources are available to assist researchers in delineating the challenges imposed by HIPAA for recruitment and retention, and there is a lack of guidance by the U.S. Department of Health and Human Services (HHS) on how to interpret this provision and the resulting variability in approaches by research institutions.²  

Further, it is unclear when and how researchers can access and use data concerning an individual who drops out of a clinical study and becomes LTFU.  This is particularly important for pharmacovigilance initiatives if the withdrawal relates to an adverse event or other development affecting the safety or efficacy of a drug under study.¹

 While these issues have been brought to the attention of the HHS and advisory committees have been put into place, currently there has been no public clarification.  As the aim in clinical research is to protect individual privacy, researchers have urged the HHS to design policies that that will encourage clinical trial investigators to protect confidentiality by educating on how to appropriately record and publish data versus developing so many detailed rules that make critical research excessively costly and burdensome to undertake. ¹

1. Nosowsky, R.et al.  Ann Epidemiol. 2005; 57: 15:85-86

2. Wipke-Tevis, D. Impact of the Health Insurance Portability and Accountability Act on participant recruiting and retention. Western Journal of Nursing. 2008;30: 399-53.

Please share your thoughts regarding our post on The Impact Of HIPAA On Clinical Trial Conduct.  Also, please email or call us with any questions you have about our OmniTrace Corp. patient search and patient retention services:

dave@omnitrace.com (Dave Betz)
888-965-6696

THE CONTENT ON OUR OMNITRACE OWNED WEBSITES IS MERELY GENERAL INFORMATION OBTAINED BY ORDINARY PEOPLE AND NOT LEGAL ADVICE.  ONLY A QUALIFIED LAWYER CAN GIVE LEGAL ADVICE.  WE ARE NOT LAWYERS.

Patient Recruiters, Principal Investigators and Study Coordinators can greatly improve clinical trial retention and reduce patients lost to follow-up by simply obtaining more contact information when the patient is first recruited into a study.  Detailed contact information will allow a search company, such as OmniTrace, many more avenues to find a patient in the event the patient becomes lost. 

We suggest you request the following information when enlisting a new patient for a clinical trial: 

• Full Name
• Current Address
• Maiden Name (if applicable)
• Social Security Number
• Date of Birth
• State of Birth
• Physical Description
• Marital Status
• Employer / Occupation
• Education (high school, college, years attended)
• Military Service (branch, when discharged)
• Religion (where they attend church)
• Hobbies
• Family Member (s) Address and Phone Information
• Best Person To Contact In Event Of Emergency

Having a patient’s Social Security Number (SSN) typically allows us to to use proprietary databases to find a patient fast.  However, in many instances, having a SSN is not enough to find a patient.  This might occur if:

• A patient is not using their SSN to conduct personal transactions.
• A patient is not residing under their own name (e.g. living with relative or friend).
• A patient provides the wrong SSN, it is taken down incorrectly, or it is illegible.
• A patient is using another person’s SSN (e.g. a wife is using her husband’s SSN).
• A patient becomes indigent.
• A patient is in a nursing home.
• A patient has little or no consumer history.

In the above instances and others, OmniTrace will likely need information, besides a SSN, to find a lost patient. 

For your convenience, here is the form we use at OmniTrace when we request information on a missing subject:

Missing Person Search Form (PDF File)

Perhaps you can use it as a guideline to create a new, more detailed, patient intake form. 

Please share your thoughts regarding our post.  Also, please email or call us with any questions you have about our OmniTrace Corp. patient find and patient retention services:

dave@omnitrace.com (Dave Betz)
888-965-6696

THE CONTENT ON OUR OMNITRACE OWNED WEBSITES IS MERELY GENERAL INFORMATION OBTAINED BY ORDINARY PEOPLE AND NOT LEGAL ADVICE.  ONLY A QUALIFIED LAWYER CAN GIVE LEGAL ADVICE.  WE ARE NOT LAWYERS.