CMAJ • March 1, 2005; 172 (5). doi:10.1503/cmaj.1041671.
© 2005 CMA Media Inc. or its licensors
All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association.
This Article
Right arrow Full Text (PDF)
Right arrow Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Delaney, J.A. C.
Right arrow Articles by Brennan, A. S.P.
Right arrow Search for Related Content
PubMed
Right arrow Articles by Delaney, J.A. C.
Right arrow Articles by Brennan, A. S.P.
Related Collections
Right arrow Clinical research

Letters
Correspondance

Clinical trial budgets

J.A. "Chris" Delaney* and Andrei S.P. Brennan{dagger}

Statistician, Royal Victoria Hospital, McGill University Health Centre, Montréal, Que.;* Research Ethics Quality Assurance Officer, Research Institute, McGill University Health Centre, Montréal, Que.{dagger}

We commend Salim Yusuf for his reply1 to the call by Lorraine Ferris and David Naylor2 for additional monitoring of clinical trials. Yusuf's point on the increasing complexity of regulation for clinical trial research is well taken, as is the point that complying with complex regulations creates significant costs. Although one of us (J.A.C.D.) has previously argued against an excessive reliance on clinical trials,3 it is clear that they represent the modern gold standard. Given this reality, it is essential that we not choke off this important type of research.

Increasing costs through the requirement to deal with nontransparent and complex regulations actually makes it harder for independent researchers to do research. We have recently seen the consequences of restricting clinical trials to large drug companies4 rather than independent academic investigators. It would seem more appropriate to have well-trained auditors who could identify and rectify mistakes rather than merely increasing the burden of paperwork for researchers.

Ferris and Naylor rightly argue that their proposed measure is a reasonable addition to clinical trial monitoring in and of itself.5 However, too many individual straightforward and reasonable measures can result in a whole that is anything but. We agree with Yusuf that the correct direction is to reduce overhead costs and paperwork in the hope of making clinical trials more accessible.

Footnotes

Competing interests: None declared.


References

  1. Yusuf S. Randomized clinical trials: Slow death by a thousand unnecessary policies? [editorial]. CMAJ 2004;171(8):889-92.[Free Full Text]
  2. Ferris LE, Naylor CD. Physician remuneration in inudstry-sponsored clinical trials: the case for standardized clinical trial budgets [editorial]. CMAJ 2004;171(8):883-6.[Free Full Text]
  3. Delaney JA. The best type of trial [letter]. CMAJ 2004; 170(12):1772. [Free Full Text]
  4. Dyer O. GlaxoSmithKline faces US lawsuit over concealment of trial results. BMJ 2004;328 (7453): 1395. [Free Full Text]
  5. Ferris LE, Naylor CD. Rebuttal [editorial]. CMAJ 2004;171(8):892-3.[Free Full Text]




This Article
Right arrow Full Text (PDF)
Right arrow Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Delaney, J.A. C.
Right arrow Articles by Brennan, A. S.P.
Right arrow Search for Related Content
PubMed
Right arrow Articles by Delaney, J.A. C.
Right arrow Articles by Brennan, A. S.P.
Related Collections
Right arrow Clinical research