SAS and Stats

Data Standards and role of Clinical Trial Team

noreply@blogger.com (Anonymous) — Wed, 5 Feb 2014 23:08:00 +0530

I have to agree that the journey of submission was not easy using new data standards - found few obstacles in the way, fixed obstacles without sacrificing the SOPs and guidelines but we learned priceless learnings. And today I am going to discuss one of the learning.

When it comes to data submission to health authorities, most of the internal and external stakeholders consider that this is the responsibility of statistical programmers. As a programmer I will not deny this part because certainly we are the primarily responsible team to develop CRTs as per the HA guidelines.

BIG Questions:

1. Are we only involved in data standards?

2. Is it single line function responsibility to develop FDA approved CDISC format data for submission?

Without any hesitation, I say NO – its entire Clinical Trial Team responsibility to maintain data in standard format from eCRF to eCDT.

Let’s have a roles and responsibility of each line function and where they can contribute to meet new data standards format for clinical drug submission process.

Clinical Team:

Clinical team needs to have clear direction of the data collection as per new the clinical data standards while reviewing the case report forms and third party data transfer specifications. Visit schedule assessments and TV domain design plays vital role while setting up the database for the study.

Data Management:

Should have clear understandings about CDASH and SDTM standards – I know it’s difficult to collect SDTM data in database (most challenges will come from investigators and data cleaning process) – but data must be close to the SDTM standards then Statistical reporting can do the data transformation and can make ease transformation data from SDTM like to Pure SDTM domains.

Statisticians:

Statisticians must provide clean and effective Trail design Domains, TDM domains plays a vital role in the development of Pure SDTM.

Programmers:

Programmer is responsibility person to develop data domains which satisfy the CDISC /FDA standards – and should support CSR and pool analysis and should satisfy the Open CDISC and Janus checks. We will discuss point by point about Statistical programmers role in CDISC data standards submission to Health authorities.

Welcome 2014

noreply@blogger.com (Anonymous) — Wed, 1 Jan 2014 12:15:00 +0530

Hello Friends –

Wish you a happy and prosperous 2014J.

Apologies for not putting new topics in my blog from few months and I don’t to excuse myself by apologizing – because I know “Being Busy is always Good, It shows that I am alive”.

2013 was a great year for me – when I jog my memory – I want to put in Steve’s style “Insanely Great Year” personally and professionally. Since two years, I have been working on new data standards (CDISC), Spent lot of time in connecting the DOTS and try to simplify my JOB easy as a Clinical SAS Programmer. And I certainly believe, Statistical programmer role make a big difference in clinical drug development process.

I decided to bring in upcoming TOPICS about CDISC and Metadata related stuff which helps us to do Programming tryouts to lean the clinical drug development process time.

I welcome you, let’s learn together and make the change by

Venkata Maguluri

Standardised MedDRA Queries (SMQs) Part 1

noreply@blogger.com (Anonymous) — Fri, 1 Jul 2011 14:27:00 +0530

What is Standardised MedDRA Queries (SMQs)?

Standardised MedDRA Queries (SMQs) are groupings of MedDRA terms, ordinarily at the Preferred Term (PT) level that relate to a defined medical condition or area of interest. SMQs are intended to aid in the identification and retrieval of potentially relevant individual case safety reports. The included terms may relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data, etc. The only Lowest Level Terms (LLTs) represented in an SMQ are those that link to a PT used in the SMQ; all others are excluded.

SMQs were developed to facilitate retrieval of MedDRA-coded data as a first step in investigating drug safety issues in pharmacovigilance and clinical development.

What is the Background?

SMQs arose out of a recognized need of the MedDRA user community for standard tools to assist in the identification and retrieval of safety data. The original MedDRA Special Search Categories (SSCs) were intended for a similar purpose, but after several years of MedDRA use, the biopharmaceutical community (regulators and industry) concluded that these tools did not adequately address the need. In response, the MedDRA Maintenance and Support Services Organization (MSSO), in early 2002, began to develop MedDRA Analytical Groupings (MAGs). MAGs were defined as collections of terms from any level of the MedDRA hierarchy (except, in general, LLTs) and from any, several, or all MedDRA SOCs that relate to the medical condition or area of interest defined by the name of the MAG, including signs, symptoms, physical findings, laboratory and other physiologic test data, and associated social circumstances related to the medical condition or area of interest.

At the same time that MAGs were being developed at the MSSO, an independent initiative by the Council for International Organizations of Medical Sciences (CIOMS) was started to address the need for special queries/groupings using MedDRA-coded data; their groupings were called Standardised Search Queries (SSQs). It was clear that the concepts of MAGs and SSQs were quite similar to one another and were both intended to fulfill the perceived need for a retrieval tool to accompany MedDRA. Thus, CIOMS and the MSSO agreed that it was in the user community’s best interest for the CIOMS Working Group and the MSSO to combine their efforts in developing this tool. To recognize the joint effort, the former “MAG” and “SSQ” designations were dropped, and an agreement on a name for these new standard groupings was reached. Since May 2003, the joint efforts of the CIOMS Working Group and MSSO have been designated Standardised MedDRA Queries (SMQs). In November 2003, the ICH MedDRA Management Board endorsed the cooperative effort, and the ICH process was adopted.

The CIOMS Working Group is composed of senior scientists from several drug regulatory authorities, international pharmaceutical companies, the MSSO, the Japanese Maintenance Organization (JMO), the World Health Organization, and other institutions.

Design Concepts for SMQs:

SMQs may have a mixture of very specific terms and less specific terms that are consistent with a description of the overall clinical syndrome associated with particular adverse event and drug exposure.

Narrow Scope SMQ’s:

Instances in which a user may need to identify cases that are highly likely to represent the condition of interest. It yields “specificity”.

Broad Scope SMQ’s:

Instances in which a user seeks to identify all possible cases, including some that may prove to be of little or no interest on closer inspection. It includes both narrow terms and additional broad terms, often of a less-specific in nature. It yields “sensitivity”.