PRIM&R AER 2014: Fundamentals of Clinical Research and Study Design

It was my pleasure to attend one of the pre-conference activity about the Fundamentals of Clinical Research and Study Design. This full day Program was geared toward IRB/HRPP members and research staff without a scientific background.

Research is a systematic investigation aiming to contribute to the body of generalizable knowledge. It is very important to disseminate the knowledge regarding research methodology among non scientific members of IRBs and to academic staff members who may at times need clarification regarding certain types of study design. I was very much interested in attending this program to see how these topics can be told in an easily understandable way to non-scientific members of IRBs.

This program was offered by Susan Fish, PharmD, MPH, who is a Professor of Biostatistics and Epidemiology at the Boston University School of Public Health, as well as Lindsay McNair, MD, MPH, MSB, who is the Chief Medical Officer and President of Consulting Services of the WIRB-Copernicous Group, Inc (WCG).

This six and a half hour program covered the following topics:

  • Basic research design
  • Bias and confounding
  • Research questions
  • Enrollment criteria
  • Outcome measures
  • Sample size and Power
  • Data Safety monitoring boards (DSMBs)
  • Interim Analysis
  • Qualitative research methods.

The workshop combined lecture, individual exercises and case studies. It was a big challenge to cover all of the topics in one day, especially when offered to individuals who have less experience in clinical design and research methodology as non-scientific members. In thinking about offering a similar program to non-scientific members of IRBs/ REC in the Middle East, I still find it to be a challenge to give proper time to these topics in one day.

During the conference, I chose to attend one of the didactic session offered by Professors Fish  and Susan S. Ellenberg, entitled, “Statistics Without Tears”. This session explained the intimidating statistical terms that as many would say, “make the eyes glaze over.” The attendees were split into two groups depending on their level of experience biostatistics. Basic statistical terms were introduced and basic concepts of statistical testing was covered. We reviewed concepts of the different types of errors in clinical research, including type one and type two, followed by discussions of power calculation and assessment. This session introduced topics in a very smooth way that ensured understanding and participation by most of the attendees who overall identified as non-scientific IRB members or had little prior experience with statistics.

Both the pre-conference workshop and didactic program provided great insight. I hope I can use the teaching methods demonstrated by the faculty to deliver this information to IRB/REC members in the Middle East region.

Tamer Hifnawy, MD.Dr.PH, Professor of Public Health and Community Medicine, Faculty of Medicine, Beni Suef University, Egypt and College of Dentistry, Taibah University, Saudi Arabia.

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