# E-DRUG: Risks for patients in clinical trials **URL:** \ **Category:** e-drug\ **Created:** [July 28, 1999, 7:58am UTC](https://talk.edrugplus.org/t/e-drug-risks-for-patients-in-clinical-trials/5653 "1999-07-28T07:58:49Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![Charles\_Medawar](https://avatars.discourse-cdn.com/v4/letter/c/9dc877/32.png) [@Charles\_Medawar](https://talk.edrugplus.org/u/Charles_Medawar)\ **Post date:** [July 28, 1999, 7:58am UTC](https://talk.edrugplus.org/t/e-drug-risks-for-patients-in-clinical-trials/5653/1 "1999-07-28T07:58:49Z")
E-drug: Risks for patients in clinical trials --------------------------------------------- Dear E-Drug readers, Today's entry on the Social Audit website may be of some interest. The source is excellent, and the data impressive: they point to significant risks for patients involved in clinical trials - apart from raising big questions about the reliability of trials' results. See: [http://www.socialaudit.org.uk/5100what.htm](http://www.socialaudit.org.uk/5100what.htm) Abstract of this item as follows: "Seminal new evidence points to systematic and sometimes fundamental inadequacies in the conduct of clinical trials. In this letter to the Secretary of State for Health, Social Audit asks what the MCA/CSM know about standards of compliance with Good Clinical Practice (GCP) guidelines - and what they propose to do to reduce risks for patients and to eliminate sloppy research practice in clinical trials conducted in the UK and elsewhere. This letter was prompted by the findings of some 800 GCP audits conducted by a relatively small commercial consultancy - but with much more experience in this field than the MCA. Patients considering involvement in clinical trials should be aware of the conclusions of one of the directors of this consultancy, Wendy Bohaychuk PhD: "Our database of GCP compliance assessment basically shows that new GCP guidelines and regulations have not yet improved the situation for patients over the last few years and frankly, after 10 years of detailed auditing, I would never go into a clinical study myself and I would certainly try to discourage anyone in my family from doing so." This issue is also the subject of a feature and editorial in The Guardian, 27 July 1999. I hope this is of interest and use Charles Medawar Social Audit Ltd PO Box 111 London NW1 8XG Telephone/FAX: +44 (0)171 586 7771 [http://www.socialaudit.org.uk](http://www.socialaudit.org.uk) Email: charle@socialaudit.org.uk -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.