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Despite agreement on recommendations between European regulators, DCT unclarity remains.
The life of regulators is a constant struggle to stay abreast of developments that are always, by definition, ahead of them, and, notionally, a threat to them. As Pierre Joly, the president of the French pharmaceutical industry association SNIP (as it then was), famously remarked as far back as the early 1980s, "If industry was developing a new car it would start by designing the motor, but regulators would start by designing the brakes."
Regulators in Europe have just made a gallant attempt to catch up with something else they haven't designed: decentralized clinical trials. In the final working week of the year (in Europe, anyway—my apologies to those operating under stricter regimes), the European Commission, the Heads of Medicines Agencies and the European Medicines Agency have agreed on recommendations with the dual aim of facilitating the conduct of decentralized clinical trials (DCTs) but at the same time safeguarding both the well-being of participants and robustness and reliability of the data collected.
The move is welcome, because it responds to an evident reality driven largely by shifts in technology. The growing availability of digital tools and telemedicine make possible more mobile and local healthcare. The wider use of home health visits, remote monitoring and diagnostics, direct-to-patient shipment of study drugs and electronic informed consent has eased the introduction of approaches in which patients no longer necessarily have to travel to trial sites to participate in a trial, thus making trials accessible to a wider demographic of participants—and helpfully, reducing the drop-out rates that complicate or even frustrate so many trials.
The paper addresses the roles and responsibilities of the sponsor and investigator, electronic informed consent, the delivery of investigational medicinal products, trial related procedures at home, data management and monitoring in a decentralized clinical trial setting—many of the issues where clarity of procedure would obviously be helpful. But these are sketched out over little more than a dozen pages. The document itself can be seen here.
And Europe being Europe (with apologies again to those operating in more harmonized contexts), this is only a collection of recommendations, because even the august institutions that have put them together have no mandate to actually tell the countries of Europe what to do. As it says on the first page, "The views expressed…are not legally binding." They were put together by the European medicines regulatory network with experts from regulatory bodies responsible for the authorization of clinical trials, members of ethic committees, good clinical practice inspectors, methodology experts and representatives of patient organizations, and drafting of the paper was coordinated by the national officials and experts who make up the EU's clinical trials coordination group.
But "it is at the discretion of the member state involved in the assessment of a clinical trial whether the use of certain decentralized elements is acceptable in a specific clinical trial," the guidance makes clear. So although a helpful appendix provides an overview of the current national provisions applicable in each member state, this is explicitly "for guidance purposes only as it is not feasible to give a complete overview of all scenarios for implementing decentralized elements in a clinical trial." The recommendations are—on the admission of the authors—"a first and important step towards clarifying the use of DCTs in the EU." They are—unsurprisingly—expected to evolve as knowledge increases and experience is gained, and the overview of national provisions will be updated on a continuous basis.
So regulators across Europe are still only inching towards a coherent view, each applying its own touches on its own brakes, but with little more than signs saying "caution" at European level. Any definitive "go" or "stop" instructions are still a long way distant, and basically, on DCTs, you're still on your own in Europe.