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Should a Specialist Physician, who does not have certification in GCP as Certified Investigator be chosen as a PI in clinical trial? . By GCP regulations this is not allowed , but in practice it does not always apply due to many reasons.Should this be continued? Please candidly share your opinion?

  • jmueller Jenny Mueller 5 Apr 2012

    I want to stress what Amina has indicated above. To my knowledge there is no GCP certification for investigators, but the PI and key study personnel must be trained in GCP including ethics.
    ICH GCP requires that investigators are qualified by education, training and experience. The GCP training should be updated from time to time; we suggest every 3 years, but others might require every year.
    Most important seems to be the experience as every trial is different, and we learned a lot from the various monitoring visits and audits.

  • aawasthi amina awasthi 21 Feb 2012

    This is a very important post and raises an important issue. First and foremost an investigator does not need to be a clinician. This is made clear in ICH-GCP where it states that the investigators must be appropriately trained and qualified - but does not set a minimum qualification. It also states that local regulations need to be met. In the most cases these also follow this standard. The FDA clearly states that there are no specific qualifications set and the investigator must have the appropriate experience in the trial intervention. The same is true for the European regulators.

    This is an important point because we need more investigators and the PI role should be taken by the person who is responsible for the idea for the question and resulting trial. Or, if it is a multi-centre study then the local PI should be the person who takes responsibility for the conduct of the trial at that site. That should be the person who understands the intervention being assessed and the setting in which it is being assessed.

    Not all trials are new drug and vaccines - and there are many good examples of scientists who do not have a medical degree who are highly successful PI and co-investigators.

    We need more practical trials that test how we manage health issues and disease. Such studies may well be better designed and led by a nurse or a midwife, for example. Or we need to evaluate new diagnostics in properly designed and conducted clinical trial conditions and these would be well served by having a laboratory scientistic as PI.

    The ICH-GCP matter is an easy one. Investigators should have training and a comply with standards that ensure the rights and well being of the participants are protected and that the trial is conducted in such as way that insures that the data is valid and high quality. ICH-GCP is a get of guiding principals that should be adapted and implements to achieve this in any specific trial. ICH-GCP training is readily available now online - including on this website. There is no excuse for investigators not to have GCP training.

    So in summary all investigators should be appropriately trained in how to conduct ethics, safe and rigorous trials and this is readily achieved. Whether or not they hold a senior clinical position is not relevant. More importance is their familiarity with the intervention, trial design and patient population and this should determine who is best placed to be an investigator.

    Career support and development is really important in research in developing countries. Institutions and sponsors should think about this carefully and their choice of investigator could be a much more realistic reflection on who is based placed and most appropriately 'qualified' and 'experienced' and this will increase the opportunities for a wider range of medical staff and associated roles. This would benefit clinical trial capacity in our regions much more than continuing the habit of nominating 'window dressing' nominal PI's just because they are a senior hospital specialist.

  • deensani Shamsuddeen Sani 20 Feb 2012

    I personally do not feel it should be continued. It is a breach of the provisions of ICH-GCP, the cardinal protection of patients safety and right as well as accuracy and integrity of our clinical trial.

    I agree there are alot of constraints especially in the developing countries, BUT we must strive to ensure having a PI that is 'qualified by education and training and experience....'
    ICH-GCP Section 4.1.3 said: '.the investigator should be aware of, and should comply with, GCP and applicable regulatory requirements'.

    This could easily be solved by ensuring that those specialist physicians get trained on GCP.In many cases, if the specialist physicians are relegated to the position of a sub-investigator in favour of a junior physician but GCP certified, crisis may ensue and at the long run quality may be jeopardised at that particular site.

    By and large my opinion is that we should not go for 'second best'. If it's not GCP compliant then a study is deficient.