While decentralized trials are expediting innovation and promoting diversity, challenges remain, including complex stakeholder ecosystems, skills gaps and regulation.
Pictured: A patient takes her own vitals during a remote doctor’s visit / iStock, Maria Symchych-Navrotska
The COVID-19 pandemic changed every aspect of life and every industry—especially healthcare. From providers and payors to pharmaceuticals and MedTech startups, every company is facing radically different market conditions nearly four years later. But perhaps the most significant transformation and impact occurred within the lifecycle of pharmaceutical clinical trials.
The decentralized clinical trials (DCTs) that were permitted out of dire need to produce COVID-19 vaccines caught the attention of government and healthcare leaders. The success we’re seeing with these initial DCTs, including those supported by my company, Capgemini Americas, presents a preview into a forthcoming era of remote, digitized, personalized medicine.
Innovation Born of Necessity
Prior to 2020, clinical trials were conducted in accordance with strict legislation and under extremely rigid practices that remained largely unchanged for decades. But when the world shut down, healthcare leaders and legislators knew exceptions had to be made for remote clinical trials to ensure the continuation of critical research. In the U.S., the government permitted virtual clinical trials in May 2020 and extended the ordinance in May 2023 after three years of successful DCTs—some of which famously led to one of the most widely used COVID-19 vaccines.
As a result of this mass adoption of DCTs, pharmaceutical organizations can now drastically expand and diversify their participant pool. They can enlist patients at home from across geographies by using remote monitors and wearable injectables and collecting data.
Unsurprisingly, nearly every major pharma company is exploring DCTs. Across the board, the industry is finding that remote clinical trials lead to increased efficiency, enhanced generalizability, reduced operational costs, faster time to market and, more importantly, improved health outcomes for patients.
Derailments on the Road to Decentralization
Despite the many benefits they offer and the support from the public and private sectors, decentralized clinical trials are not without their challenges. DCTs, and the technology and data management protocols used in these remote trials, present complex issues that must be addressed in the nascent stages of this new medical era.
Pharmaceutical companies now must provide participants with white-glove care. This may change from trial to trial—and is largely dependent on the drug or device being studied—but oftentimes, organizations must send trained employees or partner with healthcare providers to administer and monitor complex drugs and devices. In fact, companies will not only have to manage a network of care providers, but their stakeholder ecosystem for most DCTs also involves insurers, medical device companies, trial service providers and numerous technology vendors that offer various software, data, analytics, cloud, cybersecurity and telecommunications solutions.
Talent shortages and skills gaps are also beginning to emerge. Although digital transformation agendas are not new to technologically adept pharmaceutical companies, no one is fully prepared or properly staffed for these digitally advanced DCTs.
And lastly, we cannot forget the volatility of clinical trial regulation around the world. Legislators are rightfully monitoring DCTs as they are new, evolving healthcare functions, and many questions surrounding best practices remain unanswered. If governments choose to limit or continually adjust DCT authorizations, pharmaceutical companies will be left scrambling to adjust trials accordingly—which will only lead to increased costs and delayed timelines.
6 Tactics to Improve DCT Initiatives
There’s no doubt decentralized clinical trials are the future of healthcare—and table stakes for pharma industry players. So how can companies ensure these extremely complex, highly regulated, novel trials succeed in spite of so many challenges?
Solutions won’t occur overnight. In fact, it will likely take years of continually and methodically improving DCT strategies and regulations. What we do know, even in these early days, is that companies must implement these foundational tactics:
- Reskill, upskill and attain talent—with a focus on digital skills
- Enhance cyber capabilities
- Partner with legal experts to address and monitor HIPAA considerations and other regulations
- Establish an ecosystem strategy with clearly defined leaders, responsibilities and regular touchpoints
- Improve data quality practices and protocols as well as data-sharing policies
- Utilize software and platforms to communicate with participants and partners, schedule appointments and manage e-consent forms and other documentation
There is still a long road ahead before we reach wide-spread, large-scale, industry-standard remote trials. Legislators are still anxiously waiting to see if healthcare companies can responsibly study and produce drugs and devices remotely. Any mistake pharma makes during the nascent stages of DCTs may very well be detrimental to the progression of clinical trials; enterprises must leave no margin for error when developing their DCT strategies.
Chris Scheefer is a VP and the North American lead for intelligent industry at Capgemini Americas, which offers next-gen clinical development services. Chris has over two decades of experience within life sciences, specifically within biopharma and MedTech, with an emphasis on data-driven transformation, bioinformatics and applied artificial intelligence.
