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ABPI Phase I Guidelines 2012 Edition 05/09/2012

Posted by Shirley Hallam in Essential Documents, Regulatory.
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The Association of the British Pharmaceutical Industry has published new Guidelines for Phase I Clinical Trials, 2012 edition. At 63 pages, this is an informative and well written document, providing  not only a comprehensive overview of current requirements for phase I trials, but also historical background on the development of clinical research legislation in the UK. The introductory sections would make a good starting point for anyone interested in learning more about the drug development process.

On the whole the guidelines are derivative, referencing UK and European legislative requirements and guidance, and other recently published research. As might be expected post TGN1412 there are detailed sections on Risk Assessment (section 4) and Risk Management (section 5) in phase I research.

Section 8 Contracts goes beyond the definitions of essential documents in ICH E6, including the IMP dossier and CT application among the list if documents which must be supplied by the sponsor to the investigator before the trial begins.

There is clarification in section 9 that general (i.e. non study specific) recruitment advertising and non-invasive screening procedures do not require REC or MHRA approval. There is reference to the TOPS database for the prevention of over-exposure.  There are several mentions of the importance of communicating with the subject’s General Practitioner.  Subject payments should be based on the minimum hourly wage and should be increased for procedures requiring extra care on the part of the subject or involving more discomfort; however, payment must never be related to risk. There is guidance relating to payment for cancelled or prematurely terminated trials.

Phase I units should have a designated pharmacy area, carrying a stock of treatments for common adverse events and an antidote to the IMP, if one exists.

Particularly welcome in the guidelines is the specificity with regard to qualifications which key researchers might be expected to have – a concrete answer to the question “What is appropriate?” in the context of the much quoted ICH E6 principle that those conducting clinical research should be “appropriately qualified by education and experience”.  So Appendix 1 includes a list of possible post-graduate qualifications for medical researchers, while section 21 suggests that laboratory heads would be expected to have “a professional qualification such as FIBMS”