Is COVID A Game-Changer for Wider Drug Development Policy?

Much has already been written about the impact of the COVID pandemic on thinking about healthcare in general and drug development but the recommendations on clinical trials from an influential scientific panel received strong backing in late May from senior figures in world affairs, giving them a better-than-average chance of leading to some improvements.

The occasion was the—rather grandiosely—titled Global Health Summit that took place in Rome on May 21, organized under the G20 umbrella, and co-hosted by the Italian government and the European Union. This was a response to the pandemic at the level of the economic and finance ministers of the countries that between them represent some three-quarters of the world's economic activity and amounts to a heavyweight intervention from political figures who carry (with no disrespect to health ministers) real responsibility for decision-making.

Rome declaration

The conclusions from the meeting, contained in a so-called Rome Declaration adopted at the meeting, provide plenty of support for research, innovation, investment and incentivization (alongside, or course, plenty of commitments to equal access to care and better preparedness against health crises). But of greater interest to readers of ACT may be the background paper for the declaration, which sets out in greater detail some specific measures for raising the game in drug development in general, and clinical trials, in particular.

So, while the scientific panel notes with satisfaction that "research and innovation have been one of the few bright spots" in the COVID response, with "unprecedented advancements in record time," it laments the lack of a global strategy at the outset of the crisis "to optimize and coordinate research and development efforts."

Its central recommendation therefore is to establish an efficient and effective end-to-end R&D ecosystem, to accelerate research—and it has clear ideas on how to do this. They include creating an open-source library of phase II-ready drugs with broad cross-reactivity across major virus groups of pandemic concern, and a pipeline of just-in-case vaccines and monoclonal antibodies that target World Health Organization priority pathogens.

Collaborative trials

The familiar call for increased investments in basic research is accompanied by more concrete recommendations to deliver products, including digital innovation and infrastructure, data science, artificial intelligence, and modelling and forecasting. The panel calls for the urgent establishment of "large, pragmatic, collaborative clinical trials networks and protocols, globally and regionally, for therapeutics and vaccines." It wants to see early support by regulatory authorities for clinical trials. Other aspirations are for cross-disciplinary research, including risk communication, implementation science for more effective public health measures, as well as social and behavioral research. An end-to-end R&D ecosystem also demands real support for biotechnology entrepreneurship and innovation, it adds.

The international dimension of the recommendations is evident in calls to "genuinely" involve research groups in low- and middle-income countries. The pandemic underlines the urgent need for bringing together researchers and developers from all countries, to benefit from the diverse experience gained in different contexts, to ensure that the scientific outputs are relevant for and accessible in the countries in which they will be implemented, it says. This will also improve the coherence of the research response affecting all countries. "It is crucial to conduct clinical trials of medical products in a diversity of populations where products proven safe and effective will be rolled out," it insists.

This implies a strengthening of collaborative research networks regionally and globally, increased funding for "equitable" research partnerships, and sustainable finance that can "ensure research continuity, particularly in times of crisis." It also means better integrated disease surveillance, data collection, analysis and sharing "at all levels," it underlines. Countries need to have more capacities for data collection and analysis, including through genome sequencing for early detection, pathogen characterization, surveillance of pathogen spread, and assessment of disease dynamics. The corollary is the development of well-funded and coordinated global and regional networks for pathogen surveillance, underpinned by a common set of principles for data sharing. That in turn requires improved standardization and validation of tests and assays, and the comparability, sharing and interoperability of accessible digital data, along with adequate quality assurance. And repositories must be set up that provide for universally accessible sample collection.

Independent science

The interface between science and policy gets plenty of attention too. With absolutely no hint of a reference to Wuhan, the panel urges action to "promote transparent and rapid sharing of data and information on outbreaks and other health issues." And in a section entitled "strengthen and protect science advice", it recognizes that "scientific advice to policymakers may always be challenging." This may be even more so in pandemic situations when there are major uncertainties, knowledge is fast evolving, risks are large, and evidence is preliminary and limited. "Nevertheless," it goes on, "evidence from science is crucial to help develop sound public health policy and mitigation measures." Measures are therefore needed to "ensure independence of experts and government advisory bodies, and safeguard against the politicization of science." There should be new clarity brought to the boundaries between science, scientific advice, and politics, and this should include "a transparent definition and demarcation of advisory versus decision-making roles." The mechanisms for rapid advice and evidence-informed decision-making in times of crisis should be strengthened to reduce delays between scientific information and decision-making. And an open dialogue is necessary between the public, scientific experts, and authorities about uncertainties and disagreements between decision makers and scientists, as well as among scientists themselves. The simple slogan adopted is to provide clarity about what is known, partially known, unknown, and unknowable.

Over and above their relevance for tackling the pandemic, these recommendations resonate across many of the issues that regularly generate difficulties for drug development everywhere around the world, and across all therapeutic categories or pharmaceutical forms. It is not so much in the originality of the prescriptions—many of which are already well-rehearsed—that the potential significance of this event lies, but in the context in which they are made and endorsed. Now the ideas are formally backed by G20 countries, heads of international and regional organizations, and representatives of global health bodies, after co-hosting by European Commission president Ursula von der Leyen and Italian prime minister Mario Draghi. If nothing happens afterwards, everyone will know who is to blame.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium