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Analysis Commercial Influence in Health: from Transparency to Independence

Pathways to independence: towards producing and using trustworthy evidence

BMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l6576 (Published 03 December 2019) Cite this as: BMJ 2019;367:l6576

Commercial influence in health: from transparency to independence

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Re: Pathways to independence: towards producing and using trustworthy evidence

Dear Editor

At present, the design of pivotal Phase 3 clinical trials is typically discussed in advance between regulators and drug companies, and the subsequent trials are often conducted by Contract Research Organizations (CROs) directly sub-contracted by the drug company.

Two small tweaks to this system may be able to improve the quality and trustworthiness of evidence generated by pivotal Phase 3 trials.

First, trial designs could be opened up for review and comments for a short time period before regulators give the go-ahead. This would enable regulators to benefit from input from the 'many eyes of science', including from stakeholders like Cochrane, HTAs and patient groups, before regulators decide on whether to give the green light for pivotal trials, and under what conditions. (At present, critical review of trial designs by independent experts is only possible once a trial's design has become public through a trial registry entry, at which point it is difficult or impossible to modify the design.)

Second, CROs could be sub-contracted by regulators instead of by drug companies. Under this approach, once the trial design has been finalised, the regulator would issue a tender for running the trial and select the winning CRO. The regulator would then recoup the trial's cost from the drug company, and pass that payment on to the CRO. This seemingly small procedural change would make CROs accountable to regulators rather than to drug companies. (At present, CROs may feel incentivised to produce trial outcomes that favour to their clients' commercial interests in order to improve their chances of winning future contracts.)

Till Bruckner
TranspariMED

Competing interests: No competing interests

05 December 2019
Till Bruckner
founder
TranspariMED
Bristol, UK