Innovation is key to developing strategies for future pandemics

The coronavirus pandemic highlights perceived conflict between the imperative for scientific rigor in drug development and the acute urgency of a public health emergency (Angus 2020). Different stakeholders—the public, governments, the scientific community, patients, research subjects, and drug developers—bring unique perspectives and priorities. Against the backdrop of a global health emergency, it is important to remember the ethical principles that anchor clinical research for new therapeutics and vaccines. Innovative clinical trial designs may alleviate emerging challenges, and greater cooperation and data-sharing between clinical trials can bring significant benefits. As we strive to align our efforts, it is crucial that lessons learned from current COVID-19 challenges become the foundation for effective strategies in future pandemics.

The scientific path to novel, life-saving treatment lies in a rigorous system of phased clinical trials, but this is a painstaking process that stretches over months and years. In the presence of COVID-19 contagion, acute and long-term health implications, and unprecedented mortality rate, the randomized clinical trial (RCT) gold standard may not always seem to be the fastest vehicle to speedy anti-coronavirus vaccine and therapeutic investigations compared to nonrandomized trials with smaller sample sizes. These single arm trials may attract participants more rapidly due to the absence of a control arm, given the reluctance of many to be randomly assigned to a perceived “inferior” therapy or placebo in a control arm. The magnitude of the pandemic inspires compassion for the suffering and dying, and anxious desire to spring into action, but the answer is not to skip steps to work faster, it is to leverage innovation and work smarter.

Despite the urgency of the COVID-19 crisis, existing ethical parameters and best practices for valid science still hold, and with creative problem-solving, can address immediate dilemmas. The cornerstones of research ethics—autonomy, beneficence, and justice—speak directly to public engagement with treatment and prevention of the novel coronavirus. Before a patient decides on a medical treatment or a research participant joins a study, they need accurate, current, and understandable information about the intervention. The notion of autonomy is more than just “deciding for oneself,” it is having enough information to make an informed decision. This calls for transparency and support for health and science literacy. Beneficence refers to “doing good,” either for individual improvement or meaningful contribution to scientific knowledge. Finally, justice in healthcare refers to access and allocation of resources. The just involvement of humans in research not only includes equitable distribution of risk and benefit among study populations, but also using the best scientific data and methodology available. New strategies for leveraging data sources and innovative study designs exist, as discussed in the rest of the article.

The principles of autonomy, beneficence and justice are forward-looking and implicate each other in two important ways. First, the days of paternalistic and unequal partnerships between patient/physician and subject/investigator are over. In the past four decades, numerous disease-specific grass-root movements have engaged patient communities in comprehensive advocacy training, building a wealth of multi-media educational sources for treatment management and research engagement (Sigal, Stewart, and Merino 2020). Formalized systems that support patient-partners in the design of clinical trials, such as the FDA’s Patient Representative Program or the Patient-Centered Outcomes Research Institute (PCORI) have introduced an era that expects engaged participants not passive subjects (Bromley et al. 2015). The concept of “community-engaged research” is not a fad but has become a frequent requirement for receipt of private and federal funds.

As more prominently highlighted by the pandemic, the idea that research should benefit society, introduced in the Nuremburg Code (1949) and iterated in the Belmont Report (1981), implies that scientists have an obligation to be good stewards of public resources and conduct research that will bring substantial benefit (Resnik 2016). Today’s informed, self-advocating population of patients and research participants will demand that collaborative response to a pandemic leverages infrastructure already in place and innovative methods that have been proven to efficiently advance science. Innovative clinical trial designs and the infrastructure to support them, buttressed by long-standing ethical parameters, must be built now, during the COVID-19 pandemic, for better clinical trials tomorrow.