Drug Evaluation Committee 2013-09 Scope of Non-expert Members of Clinical Trial Review Committees (Part 5)
Related classification: Clinical Trial Review Committee
First published: Jul 2013
Question
If a qualified veterinarian is appointed as a member of a Clinical Trial Review Committee, does the said member fall under the category of a person with expertise in medicine, dentistry, pharmacy or other medical care or clinical trials (so-called "expert member")? I have asked several people for their opinions, and the opinions are varied.
Opinion of the Pharmaceutical Manufacturers Association
Article 28, Paragraph 1, Guidance 1 of the GCP stipulates that "A clinical trial review committee shall consist of an appropriate number of members who have the qualifications and experience necessary to deliberate and evaluate the clinical trial from ethical, scientific, and medical/pharmacological perspectives, and to maintain such qualifications and experience as a committee as a whole.
We believe that it is difficult to uniformly determine that a qualified veterinarian is a specialist in medicine, pharmacology, or other fields. However, there are some veterinarians who are engaged in public health and biomedical fields and play a part in medical care. In addition, some of them may be nominated as committee members because they are expected to have expertise in non-clinical studies (e.g., animal studies) in order to deliberate the appropriateness of conducting clinical trials. Therefore, it is acceptable for the establisher of a clinical trial review committee to determine whether or not a person falls under the category of an expert committee member at the time of nomination of the relevant committee member. In addition to the committee members who are qualified veterinarians, we believe it is necessary to nominate physicians who are actually engaged in medical care as committee members.