Compulsory registration of clinical trials
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《英国医生杂志》
EDITOR—Abbasi discussed the compulsory registration of clinical trials.1 MedicoLegal Investigations is one of the leading bodies concerned with investigating misconduct and fraud in relation to clinical trials, both in the United Kingdom—where currently most of our cases have been—and overseas. The company is a not for profit company financed primarily by subscriptions from numerous (but not all) pharmaceutical companies that share our objective of safeguarding patients through maintaining and enhancing the quality and reputation of clinical research in the United Kingdom and elsewhere.
In our experience two primary causes underlie misconduct and fraud: laziness and greed. However, this tends to be at a personal level. At the corporate level, a desire to protect the image of a company or product, the wish to preserve or enhance a career, and the desire to maintain or enhance the share price also come into play. These factors may have encouraged companies to under-report the results of clinical research, potentially with a disregard for the impact on patients and clinical practice.
MedicoLegal Investigations has the goal of improving patients' safety; we believe that under-reporting cannot be justified in any circumstances. We therefore welcome the recently published statement of the International Committee of Medical Journal Editors, and the good publication practice guidelines.2 3 To date, MedicoLegal Investigations has not been called on to investigate biased under-reporting of research, but we believe it is just a matter of time.
Peter Jay, managing director
MedicoLegal, Nup End Business Centre, Nup End Green, Old Knebworth, Hertfordshire SG3 6QJ mli.fraud@btinternet.com
Mike Wallace, chairman
37 Crescent Road, Burgess Hill, West Sussex RH15 8EH mikewallaceuk@yahoo.co.uk
Competing interests: MW and PJ are directors of MedicoLegal Investigations.
References
Abbasi K. Compulsory registration of clinical trials. BMJ 2004;329: 637-8. (18 September.)
De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004;351: 1250-1.
Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Op 2003;19: 149-54.
In our experience two primary causes underlie misconduct and fraud: laziness and greed. However, this tends to be at a personal level. At the corporate level, a desire to protect the image of a company or product, the wish to preserve or enhance a career, and the desire to maintain or enhance the share price also come into play. These factors may have encouraged companies to under-report the results of clinical research, potentially with a disregard for the impact on patients and clinical practice.
MedicoLegal Investigations has the goal of improving patients' safety; we believe that under-reporting cannot be justified in any circumstances. We therefore welcome the recently published statement of the International Committee of Medical Journal Editors, and the good publication practice guidelines.2 3 To date, MedicoLegal Investigations has not been called on to investigate biased under-reporting of research, but we believe it is just a matter of time.
Peter Jay, managing director
MedicoLegal, Nup End Business Centre, Nup End Green, Old Knebworth, Hertfordshire SG3 6QJ mli.fraud@btinternet.com
Mike Wallace, chairman
37 Crescent Road, Burgess Hill, West Sussex RH15 8EH mikewallaceuk@yahoo.co.uk
Competing interests: MW and PJ are directors of MedicoLegal Investigations.
References
Abbasi K. Compulsory registration of clinical trials. BMJ 2004;329: 637-8. (18 September.)
De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004;351: 1250-1.
Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Op 2003;19: 149-54.