MediciGlobal Industry Blog

Help Expand the Pool of Patients for Clinical Research in the US

2009-10-30T14:26:03-05:00

It’s a little known fact that Americans receiving Supplemental Social Security income are not allowed by law to accept compensation for research. The dilemma is that many people with debilitating illnesses fall into this category. They are ineligible to receive government medical benefits and this in turn prevents them from participating in clinical studies. Patients are already hard to find and denying them access to clinical research over the issue of reimbursement for time and travel is folly. It impedes clinical progress and is counterproductive to the goal of advancing new medicines.

As word gets out, patients, academia and industry groups are working together to support legislation that allows individuals with chronic debilitating and rare diseases to become involved in clinical trials without losing their eligibility for government assisted healthcare benefits. Some of these groups include the Cystic Fibrosis Foundation, the National Health Council, Johns Hopkins University, Yale University Medical College, and Pharmaceutical Research and Manufacturers Association (PhRMA).

The President and CEO of the Cystic Fibrosis Foundation, Robert Beall, PhD., summed the situation up this way: “Clinical trials are critical for developing effective therapies for cystic fibrosis and dozens of other rare diseases.” Dr. Beall is encouraging the US government to quickly pass a law that will support life-saving research for the many people who will benefit from new medical advances. (Medical News Today 9/29/09)

The bill to be voted on was introduced into the US Senate on September 16th. It is called “The Improving Access to Clinical Trials Act.”

Specifically this bill allows patients with a rare disease to disregard up to $2,000 of compensation received for participation in a clinical trial in their Social Security income (SSI) and Medicaid income calculations. Proponents of the bill have pointed out that it will have a negligible impact on the federal budget, and it will make a significant difference to those who will now have access to potentially life-saving treatments via clinical trials, and the output of this research.

It is estimated that 10% of Americans are afflicted with one of the roughly 700 existing diseases described in the bill, and it is estimated two new pathologies are described every week in medical publications.

To track the current status of this bill, click here: http://www.govtrack.us/congress/bill.xpd?bill=h111-2866

To support this bill, contact: http://www.usa.gov/Contact/Elected.shtml

Pfizer to Launch Clinical Trial Network

2009-08-31T18:06:24-05:00

Pfizer must be applauded for its efforts to further raise public awareness for clinical trials through an internet application.

Over the past 20 years, many web-based patient recruitment projects and programs for clinical trials have come and gone. It would be nice to see this one actually succeed and change the course of history.

Patient recruitment initiatives of past have had a bumpy ride. In each case, the venture was company-driven rather than Sponsor-led. So this latest patient recruitment initiative by may result in a different outcome.

Consider that over a decade ago, the Harris Poll was a pioneer in this field; the company matched patients to clinical trials from their database, generated through a search engine called “excite”. While over 4 million patients spanning 47 therapeutic categories opted in through Harris Poll’s daily polling question, the initiative did not succeed. There were many reasons including the fact that the specificity of a clinical trial’s inclusion-exclusion criteria weeds out many patients. Additionally, more patients were excluded because they were not located near a study site. The model did not warrant long term success.

Another company, Veritas Medicine an internet-based patient recruitment firm also entered the online patient recruitment space. Like Harris Poll, it based its business model on building online databases of patients, and matching them to clinical trials. In 2007 however, this company-driven database closed it doors.

Companies driving online initiatives that involve building patient databases for clinical trials have so far shown limited success. A more recent initiative came earlier this year, when in January 2009, Acurian Inc. announced, the release of an internet application aimed at Facebook and MySpace. The company wanted to generate “clinical trial awareness and patient recruitment.” It projected that with Facebook and MySpace having nearly 200 million registered users; it could tap into these online audiences and have them sign up for access to clinical trials. The company even sought to entice people with earning points that would correspond with a donation to one of twenty medical causes. On August 12, 2009, just 8 months after launch, Facebook lists 34 fans, and 97 active users.

With a lack luster history of companies driving patients into databases online, could it be that patients are generally mistrustful when a company is involved? Are patients reticent to leave contact or personal information in the hands of businesses? Do online databases have more success when they are backed by patient groups and disease associations? Just some of the many questions we ask ourselves as patient recruitment specialists, always seeking to harness the power of the web.

Finally, in the examples described above, it is again important to emphasize that each initiative was company-driven not sponsor-led. A major pharmaceutical company stepping into the fray is a new approach. It makes us hopeful that this will yield a more positive outcome.

Yes patient recruitment is challenging. But it is the patient centric approach that requires high touch and well thought out strategies. In 20 years of our specialization in this field, we continue to work through the challenge of successfully finding patients using multiple channels. The Internet is just one of them.

Should Study Patients be Informed about Study Results?

2009-04-14T21:00:56-05:00

In a study retention program that we have designed for a multi year study, patients receive a “score card” with their study results. This is tracked at each visit, then at study conclusion, patients recieve the completed card.

This achieves two results:

It keeps patients interested in tracking their results at each visit.
At the study conclusion the score card transitions these patients back to their primary care provider.

Providing patients with their data as part of a study retention program is an ethically correct and powerful retention tool if handled correctly.

Any thoughts?

Should the life sciences industry reverse course and restrict the use of DTC advertising for its pro

2009-04-07T18:40:18-05:00

Information to patients in accordance with fair balance regulations allows patients to be a part of the decision-making process. It is a natural part of the right-to-know process. America is built on a foundation of “rights”. The right to choose (doctor, HMO, insurance, medication), the right to know (side effects, available clinical trials, treatment options) and the right to decide (which course of treatment to take).

A decade ago, former Surgeon General C. Everett Koop sent a clear message to consumers.“Become empowered about your healthcare and take responsibility.” That is what advertising in general achieves. DTC (a highly regulated advertising approach) plays an important role in increasing patient/consumer awareness, fostering dialogue with healthcare providers and empowering patients in the process.

What are your thoughts?

Reducing Clinical Trials Costs

2009-03-31T17:26:49-05:00

1. Avoid “watchful waiting.” All too often recruitment is seen as an expense rather than an investment to save money in the long run.

Companies may not realize that they will save more money by proactively implementing patient recruitment-retention programs than by “watchful waiting.” Chancing fate when on average 80% of clinical trials miss their timelines is not wise. It results in sunk costs that cannot be recovered.

2. Use forecasts and projections to set realistic budgets to achieve accelerated timelines.

When recruitment budgets are set arbitrarily or too low, delays are encountered and the costs are greater. Don’t set up to fail from the start with unrealistic timelines and budget!

3. When the right advertising recruitment message accounts for ~30% of the response, getting the messages right from the “start” speeds up recruitment and saves costs.

Market research plays an important role of validating assumptions and key decisions before they are made. Online patient surveys allow this to be achieved simply, fast and at low cost. Conducting these at the start avoids costly mistakes and delays.

4. Reduce start-up time to allow sites more time to recruit patients.

On a global study, accelerating the launch of a patient recruitment program by ~4 weeks per country, means that a study involving 20 countries results in 40-80 weeks of additional patient recruitment time—improving the likelihood of recruitment success. MediciGlobal’s proprietary system called ADapt localizes recruitment materials by country/culture, and rapidly deploys them to ethics, streamlining the process, and saving time and money.

5. Quickly weed out non-performing sites using real time performance data.

At least one third of study sites will fail to perform. Weeding out sites within 4 weeks of launch, minimizes money wasted on non-performing sites. When recruitment budgets are limited and time is of the essence, sites that actively recruit are those to be supported.

6. Make study sites accountable for locally placed advertising.

Most sponsors include a standard advertising budget for each study site, yet few sponsors make sites accountable for tracking ad response and reporting metrics. MediciGlobal provides oversight and management of this process, lending their media buying expertise to assist study sites in placing cost effective advertising.

7. Use low cost – high impact communications channels; (like the Internet) to deliver health information to patients, consumers and health care professionals.

When budgets are limited, use lower cost media options before more expensive media ie. radio, print and television in some countries .

8.Proactively manage retention—don’t wait for patients to drop from the study before taking action.

Look at retention like an insurance policy. Initiating a retention program at study start protects sponsors’ investment and the statistical power of the data. Every time a patient drops from the study the value of the remaining participants increase. A sponsor who recently invested in a retention program showed that the program retained over 650 patients, saving an investment of $7 million that would have been otherwise lost.

9. Put your money where the patient recruitment results are.

Burdensome protocols, consenting patients, accurate case report forms, and adhering to timelines are tasks conducted by study coordinators. So increasing Investigator study grants for ailing studies is not the answer when study workload is carried by study coordinators. Consider a performance based program that rewards coordinators for achieving study objectives, quality of data, patient care and responsiveness to queries.

10. Minimize clinical team turnover.
Loss of project leadership can cause ~8 weeks delay and result in increase study costs.

Globalizing human experiments

2009-03-19T12:55:18-05:00

Liz Moench describes the transition of US based to global clinical trials.

Read the transcript here.

Most IRB Rules Don’t Ban Finder’s Fees for Clinical Trials

2009-03-03T17:52:35-05:00

At first I was getting a bit disheartened by this article until I read the line:

But, they said, reimbursing doctors for the extra time and work involved in recruiting patients and monitoring their involvement in a clinical trial is a murkier area.

I guess the trick is to figure out what a fitting reimbursement payment would be… Enough to be an incentive but not enough to draw suspicion. I feel that the range they gave of $2000 - $10,000 dollars was incredibly rich, though given certain indications could be viewed as a worthwhile investment, but at that point I think an ethical dilemma does come into play. I would not want to find out that my doctor received such a payment for getting me involved in a study… Especially if the study involved a placebo arm of which I may be in.

If the reimbursement was more nominal in nature (though more substantial than I originally anticipated for such a program) and tied to a screening system that tracked activity and could be audited to mitigate risks associated with enrollment solely for profit… And its use was widespread, it could be an excellent recruitment channel.

So what is the magic number?

Read the full article

Competition for patients: Participatory Medicine

2009-03-02T18:50:02-05:00

In the 1990s we saw an evolution of “right to know” and “right to choose” and even participation in clinical trial design by AIDS and cancer patients. In the 2000s we saw patient rights expand to include: “right to understand”, “right to blame,” “right to quality of life” and more. I believe that it is important to continue to bring information to patients to assist them in their decision-making process. It is for this reason that 20 years ago we again pioneered to bring clinical trials information directly to patients for a cancer drug, and continue to inform patients about clinical trials opportunities across many diseases today.

Pharmaceuticals and Healthcare recently posted an article regarding the patient and how they are the basis of the pharamaceutical and healthcare industry.

Read the full article

Survival of the Fittest: Patient Recruitment & Retention for Clinical Trials

2009-02-01T21:18:44-05:00

Biopharmaceutical companies must consider three critical steps: how to manage their clinical trials wisely, preserve cash reserves as long as possible, and mitigate risk. These are issues of increasing ramification in today’s economic environment. The risk of failure is great; eighty percent of clinical trials fail due to lack of patient enrolment, yet effective planning can prevent this from occurring, and the financial consequences associated with study delay can be avoided.

Download the Full Article

Senator Pell and Parkinson’s Disease

2009-01-12T21:01:53-05:00

After reading the MSNBC article Former Sen. Pell, creator of Pell Grants, dies I found myself moved by the story of such a determined individual who contributed so much to the welfare of others.

Former Rhode Island Senator Claiborne Pell died Thursday at the age of 90, after suffering from Parkinson’s disease for nearly 15 years. The state of Rhode Island and the American population are better people for having had Pell serve in the United States Senate for 36 years. During his lifetime Pell accomplished more than most dream of.

He is most notably known for his passion and dedication to education. In 1972 Pell’s legislation was passed, and the Basic Educational Opportunity Grants (BEOG) became a staple in lower and middle class families with college bound children. BEOG also known as Pell Grants provided direct aid to more than 54 million college students.

Pell retired the year following his Parkinson’s diagnosis, but upheld that his disease had nothing to do with his retiring from the Senate. Many people are aware that Parkinson’s disease is a degenerative disorder that affects one’s central nervous system and often impairs their motor skills, speech, and other functions. Yet, there is a side to Parkinson’s disease that so many are unaware of.

As Parkinson’s disease progresses, sufferers may experience mental and/or cognitive changes. As well as falsely accusing others, having irrational thoughts and distorted beliefs. Claiborne Pell did not have Parkinson’s Disease Psychosis but 40 percent of Parkinson’s sufferer’s will.

Many patients, families, friends and even doctors are unaware of Parkinson’s Disease Psychosis which often has devastating non-physical symptoms. Sufferers may experience hallucinations, delusions or illusions – making them see and/or hear things that are not really there.

MediciGlobal recently conducted an interview with Carol McLain, a registered nurse and caregiver for her late husband who suffered from Parkinson’s disease. In this interview Carol expressed that she had never been told about Parkinson’s Disease Psychosis. She continued to say that “as a registered nurse, I was prepared for the physical problems with my husband’s Parkinson’s disease but, despite my job as a RN, I was totally unprepared for the psychiatric issues”.

Currently there are no FDA-approved treatments for Parkinson’s Disease Psychosis and the symptoms that accompany it. However, there is a clinical trial currently accepting these unique Parkinson’s Disease patients who are experiencing symptoms related to Parkinson’s Disease Psychosis. To learn more about this clinical research study visit: http://www.ParkinsonsMindStudy.com .