COVID-19 has driven innovation in clinical trials, but what happens next and how can pharma prepare?
Pre-pandemic many companies were curious to explore the potential of decentralized clinical trials (DCTs), but now see this approach as a necessity for recruiting and retaining patients while minimizing physical contact. The advantages are many: faster results, shorter time to market, reduced overheads and reduced on-site burden. While DCTs may never replace traditional clinical trial practice it has the potential to radically streamline the process. Many industry thinkers believe decentralized studies may become the 'new normal,' raising the question: what changes must pharma make to smoothly transition to the DCT model and what challenges must it overcome?
To help you understand the drivers and limiters of a DCT future we interviewed, in The Future of Decentralised Clinical Trials, knowledgeable experts to give you a clear perspective of the current environment and future development pathways this rapidly emerging field could take.
Experts explore decentralized clinical trials
What are Decentralized Clinical Trials?
The term 'decentralized clinical trial' has often been used interchangeably with virtual, remote and hybrid trials. While definitions vary, the key difference between approaches is that while 'virtualized' can refer to trials that are conducted without human participants, in silico, or to trials that require no site visits, 'decentralized' is more inclusive and can refer to fully remote studies or hybrid studies that use a blend of technology and traditional trial methods.
Read Virtual Medical Conferences: The new normal? to hear from leaders in the field about their virtual conference experiences over the last few months of the pandemic as well as their thoughts on what the future holds for the medical events sector.
What our experts say…
"Virtual meetings have expanded the global reach: Virtual meetings broadens accessibility, enabling people that would otherwise have not been able to participate, to take part. In addition, it also widens accessibility in terms of conference content through having information available on-demand. This way, knowledge can be harnessed from any location at one time and be shared with a wider audience."
R'Kes Starling
CEO Reveles Clinical Services
"The rate-limiter for DCTs tend to be the availability of robust endpoints that can be captured at a decentralized site. The slow but steady adoption of digital endpoints will be the catalyst for more studies to embrace DCTs and decentralized research methods. Out-dated and fragile endpoints that require patients to visit a site to avoid any semblance of noise will remain a barrier to adoption; sponsors must embed time into their development plan to evaluate and invest in novel digital endpoints."
Craig Lipset
Founder of Clinical Innovation Partners
"The regulatory landscape is already changing to support decentralized study approaches such as eConsent, eCOA, sensors, telehealth, and device-reported outcomes. As these solutions become more of the standard, regulators are expected to detail these solutions by name within updated regulations so that these solutions are less 'grey' in their descriptions of use and context in clinical trials. Many in our industry (including me) believe that hybrid decentralized studies will become the norm with regulators in the next 5–10 years."
John Reites
President of THREAD
Case Studies
What to expect
Expert contributors
Contributors to this report were carefully selected and screened to ensure they:
Contributors to the report
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