Re: Pathways to independence: towards producing and using trustworthy evidence
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.)
Competing interests: No competing interests