Opinion

Clinical Trials in the Spotlight: How to Solidify the Progress Made

Conversations about the significance of clinical trials and the development of new vaccines and drugs are no longer exclusive to high-minded academic conferences and medical journals. Instead, these discussions are happening in local community centers and even around family dinner tables. The pandemic thrust clinical studies into the spotlight — and the lessons we’ve learned since could redefine and expand their role in the world of medicine.

In late September, the U.S. Food and Drug Administration authorized Pfizer-BioNTech’s COVID-19 vaccine booster dose for people ages 65 and older, as well as for Americans deemed at “high risk” of contracting the virus. The announcement, which has been followed by a flurry of additional authorizations of vaccine booster candidates developed by Moderna and Johnson & Johnson, once again highlights the staggering speed of medical innovation over the last 18 months.

In many ways, the expedience of clinical advancements throughout the course of the pandemic is attributable to the individuals who — for the first time in their lives — volunteered to enroll in a clinical trial. For many who were not on the front lines of the crisis, enrolling in a COVID-19 vaccine or therapeutic clinical trial represented a way to make their own contribution to the global pandemic response and beyond. Just as their work and school lives “went remote” or hybrid, their participation in life-saving medical research shifted too.

But society’s eagerness to support clinical trials also had significant practical implications. As individuals sought to enroll in trials in unprecedented numbers, the clinical development industry — including biopharmaceutical and tech companies as well as clinical research organizations — recognized a historic opportunity to leverage innovative methodologies. These methodologies, though relatively new, offered patients more accessible and simplified ways to be part of a clinical trial.

Some of the new methodologies — like digital solutions such as telemedicine, electronic consenting, and remote monitoring technologies — allowed investigators to gather safety, efficacy and treatment outcome data without necessarily requiring that patients travel to clinical trial sites. As investigators received millions of clinical data points per day from remote sites, research organizations also leveraged artificial intelligence algorithms to streamline the analysis of the data, helping to ensure information could be interpreted quickly and accurately with reduced need for manual review. Finally, amid the historic social and economic disruptions of the pandemic, the clinical research industry also recognized an opportunity to fully embrace Decentralized Clinical Trials, or DCTs.

DCTs, unlike traditional clinical trials which usually require enrollees to make frequent visits to investigator sites for interventions and monitoring, allow participants to accomplish some of the study’s procedures remotely. For instance, participants may have their bloodwork or imaging data gathered at a local laboratory instead of a trial site far away — all while meeting the same quality and regulatory standards of conventional trial methodologies.

By reducing the logistical burdens of trial participation, DCTs offer a more patient-centric approach to medical research that tempers the operational limitations imposed by COVID-19. Given the disproportionate impact of the virus on underserved communities, DCTs also enable greater diversity of trial enrollees, many who would have been previously inhibited from participating due to geographical constraints or insufficient time, to attend clinical visits.

The confluence of patient enthusiasm to enroll, matched with the clinical development industry’s eagerness to leverage innovative, flexible data-collection methodologies, represents a paradigm shift in the history of medical innovation. The pandemic allowed research organizations to bring clinical trials closer to the patient communities which ultimately stand to benefit from them, while, at the same time, increasing awareness about the value proposition of clinical research among the general population.

The pandemic has caused turbulence, uncertainty and anguish. But it has also demonstrated our resilience and desire to innovate — in and out of the classroom, the office, and the lab. The clinical research sector is expanding to include more diverse and enthusiastic demographics of people looking to make a difference in their communities. In addition to scientists, entities such as companies, lawmakers and regulators have a duty to solidify the progress we’ve made in clinical trials while also maintaining the momentum moving forward.

We must continue to collaborate to ensure the legacy and lessons of the past year are not squandered. Creating a safer, healthier world depends on it.

 

Doug Peddicord is executive director of the Association of Clinical Research Organizations, which represents the world’s leading clinical research and technology organizations and advocates for better, more robust regulatory policies and institutions to support clinical development.

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