How not to do medical researchBMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7400.1221 (Published 29 May 2003) Cite this as: BMJ 2003;326:1221
- Philip Belcher, senior lecturer in cardiac surgery (firstname.lastname@example.org)
- University of Glasgow
I was approached by a major pharmaceutical company in October 1996 to conduct a small study into penetration into tissue of an antibiotic after oral administration. This was one among many such trials. My department's research funds would be given much needed money on a per patient basis for six complete studies. These surgical patients would receive our routine antibiotic prophylaxis as well as the study drug. The subject of antibiotic penetration is an important one in my specialty, and we thought the project worth-while. All well and good so far. Next: to organise the trial, which was to take place—once our selection had been confirmed—at the end of March 1997.
Would I do it again? No way
The company wanted the 20 page protocol to be clarified, revised, completed, and signed. A two page form from the Food and Drug Administration had to be completed and signed. Nine pages of informed consent documentation were also needed to satisfy FDA and EU regulations. Fortunately the company …