We need to move the debate on open clinical trial data forwardBMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e8351 (Published 10 December 2012) Cite this as: BMJ 2012;345:e8351
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Following the debate proposed by a recent article of Matthew Thompson and Carl Heneghan in this Journal (1) and taking into consideration a few recent reports, the time has come to advance proposals to make clinical trials more transparent and reliable.
The recent Cochrane systematic review on the clinical outcomes of trials sponsored by industry in relation to non-profit trials has clearly established that sponsored trials are more optimistic about reporting efficacy and minimizing adverse reactions than independent trials. (2) Furthermore, the conclusions put forward by industry are more favorable to their own drug(s) than those reached by non-profit organizations. (2) The exchange of letters between Fiona Godlee (3) and Michael Rawlins (4) about oseltamivir provides further evidence of the difficulties in obtaining all the clinical data necessary to evaluate the benefits and harms of pharmaceutical products objectively.
We would like to take this occasion to reiterate a proposal (5) to make it compulsory that one of the two pivotal phase-3 studies necessary to obtain approval of a new drug be made by a non-profit organization, independent from the manufacturer. This could be accomplished using a fund, made available by the industry and managed by the EMA or another European organization (e.g. SANCO), to commit European non-profit organizations to carry out multinational clinical trials. ECRIN (European Clinical Research Infrastructures Network) could be the hub for this activity.
The advantages are obvious because an independent trial serves as a sort of “control” of the industry-backed one. This in turn will simplify evaluation by the EMA’s Committee for Human Medicinal Products (CHMP) and will provide a guarantee for patients and NHS. Industry will be stimulated to improve the quality of their trials and will be able to reduce their current expenditure for pivotal clinical trials.
Silvio Garattini, Vittorio Bertele’
1. Thompson M, Heneghan C. We need to move the debate on open clinical trial data forward. BMJ 2012;345:e8351
2. Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L. Industry sponsorship and research outcome. Cochrane Database of Systematic Reviews 2012, Issue 12. Art. No.: MR000033. DOI: 10.1002/14651858.MR000033.pub2.
3. Godlee F. Withdraw approval for Tamiflu until NICE has full data. BMJ 2012;345:e8415
4. Rawlins M. We are asking more questions about NICE appraisal of Tamiflu. BMJ 2012;345:e8420
5. Garattini S, Bertele’ V. How can we regulate medicines better? BMJ 2007;335:803
Competing interests: No competing interests