forced BE? [Design Issues]

posted by DavidManteigas – Portugal, 2017-08-07 14:42 (2425 d 03:43 ago) – Posting: # 17666
Views: 15,137

Hi Helmut,

From my knowledge, in the portuguese law and other guidances there is not any requirement on the backgroud of the participants other than the ones mentioned in GCP guideline and the portuguese law for health ethics committees, which states:

"1 - As CES têm uma composição multidisciplinar e são constituídas por sete
membros, designados de entre médicos, enfermeiros, farmacêuticos, juristas, teólogos,
psicólogos, sociólogos ou profissionais de outras áreas das ciências sociais e humanas."

Translated as
"1 - The EC have a multidisciplinary composition and are composed by 7 members, designated within physicians, nurses, pharmacists, jurist, theologians, psychologist, sociologists or other health and human sciences professionals"


Portuguese Ethics Committee has a lot of members with an amazing knolwedge (even a priest!), most of them experts in their fields of work. And they usually request the review from another "outside" expert on the therapeutic area when there is none in the permanent members. The only field where there is a lack of expertise (imo, of course) is statistics. IMO, that happens because portugal does not have a strong tradition in clinical trials, and even the SPE (Portuguese Statistics Society) does not have a strong interest in clinical trials, as one may see from their meetings and relevant conferences. Also, I had never found any comment from SPE to relevant guidelines nor have received any e-mail as member to provide insights into any sort of coordinated review. As regards to the portuguese authority, in my experience in the assessment of clinical trial applications (not MA), we never receive any questions from the statistical part of the study (either they don't have experts for this or they rely on the assessment of the EC). As statistician, I usually receive multiple questions regarding sample size and statistical methodology (for instance, missing data imputation method) when the investigators submit an application for financing from pharmaceutical companies, but usually none from either EC or regulators.

I will try, since I intend to use that data to my master thesis in biostatistics. I will hope that the relevance of the theme and the academic part of the job might sensitize them on this :-D

There are still a lot of questions on how to do that, of course, that is why I only have that planned for 2018 :-D Don't know if assuming the same GMR as in the planned sample size calculation and the observed CV might be a solution - still a long way to go from idea to practice. The primary purpose will be to sensitize the regulators/EC to studies that they approve with a justification like "Assuming a GMR of 0.95 and a CV of XX%, a total of XX patients will be included in the study" which after conduct have a result with 99.99% power. And not a single reference or a decent justification is provided on how they've got that CV. Sometimes is the "sponsor in-house data" or "published data, which we don't reference here and for some reason nobody asked for it and the estimated ISCV of 20% was in fact only 6%".

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