Code of Conduct - Question & Answers

9. Post Registration Clinical Studies

Question 1
In section 9.2.4 of the code it clearly states that representative involvement is limited to the distribution and collection of material pertinent to the study.

9.2.4 The company must ensure that post registration clinical studies are designed/approved and administered by qualified people in the medical/scientific department, using the same kinds of methodology (i.e. the planning, protocol development, monitoring and data interpretation) that apply to pre-marketing trials. Other company representatives' role in the process must be limited to the distribution and collection of materials pertinent to the study, on behalf of the medical/scientific department.

The question is why is this different to what PAAB allows? Our understanding is that PAAB allows sales representatives to discuss study design and proposed outcomes up to the close of the actual study. Also if we look at the FDA (whose lead the TPD is talking of taking) they encourage PMS studies as part of their accelerated approval programme.

Should we be allowing our sales representatives to at least discuss the study design and proposed outcomes?? Is it time that we reviewed section 9 of the Code to cover this as well as prevent companies paying honoraria for physicians to attend PMS investigator meetings?

Response:
This Section of the Rx&D Code of Conduct is currently under review, until further notice the Code as it is currently written applies.