Traditional clinical trials are typically conducted at central locations or sites that patients must travel to in order to be evaluated and treated by trial investigators. These are referred to as centralized clinical trials.
In contrast, a decentralized clinical trial (DCT) has no set location for patients to report to. Rather, clinical trial activities are moved to more local settings (eg, the patient’s own home), which increases trial accessibility, and digital tools are often used to communicate with study participants and collect data. These types of trials are also referred to as patient-centric trials or virtual trials. Other elements of DCTs include
- Online recruitment
- Telemedicine visits (eg, remote adverse event reporting)
The incorporation of decentralized elements into clinical trials has been gaining traction since it began becoming more popular during the COVID-19 pandemic, which made it all but impossible to conduct traditional centralized clinical trials.
Since then, regulatory agencies around the globe, particularly in the United States, have shown increasing support for incorporation of DCT elements into registrational clinical trials. Here we summarize 3 reports that focus on the benefits of incorporating decentralized elements into clinical trials vs a traditional clinical trial design.
DCT Approach Can Increase Return on Investment
1) Tufts Center for the Study of Drug Development (CSDD) conducted a modeling study to evaluate the financial benefits of incorporating DCT elements into clinical trials. The results indicated that
- DCT elements have the greatest impact on reducing clinical cycle times (Phase 2 and Phase 3), and also significantly reduce screen failure rates and protocol amendments
- Incorporating DCT elements increases return on investment (ROI) by nearly 5-fold in Phase 2 trials and 13-fold in Phase 3 trials
The Tufts CSDD modeling study ultimately found that incorporating DCT elements can increase a drug’s market value by $20 million (if applied in both Phase 2 and Phase 3). The study concluded that DCTs substantially increase financial value based on key performance indicators.
2) IQVIA compared DCTs with more traditional trials. The study reviewed >300 DCTs and selected 12 that completed recruitment. Overall, the analysis showed that sponsors can achieve faster and less expensive clinical trials using DCT-driven protocols. Moreover, the analysis showed that DCT elements contribute to increased patient engagement, meaning that they are more involved and invested in the trial and in their own healthcare decisions. With respect to speed and efficiency, there were substantial reductions in
- Time from final protocol to first patient in (↓49%)
- Accrual time (↓78%)
- Screen failure rate (↓39%)
- Protocol deviations (↓54%)
The IQVIA analysis concluded that DCTs deliver a significantly better ROI and offer measurable benefits to sponsors in terms of time and cost efficiencies at virtually every point in the clinical research journey.
DCT Approach Results in Higher Quality Clinical Trials
1) Medidata surveyed 400 clinical trial executives who reported the average number of studies including at least one decentralized element was 43% before the pandemic, the current average is 55%, and the predicted average in 5 years is 66%. All respondents said there were clear benefits to a DCT approach, including improvements in
- Patient recruitment and retention
- Patient experience and overall engagement/investment
- Compliance and governance adherence
- Data quality
- Access to real-time data to make real-time decisions
The Medidata report also highlighted potential barriers to conducting DCTs, including
- Cost and investment in new technologies
- Training employees in the use of new technologies
- Relative lack of regulatory guidance on DCTs
The Medidata survey concluded that the COVID-19 pandemic has led to permanent improvements across clinical trial processes that create a more streamlined and efficient operating model and put the patient experience front and center when designing clinical trials.
The overall message conveyed by all 3 analyses is that incorporating decentralized elements into clinical trials can pay off big for Sponsors in multiple ways.
Aaron Csicseri, PharmD, is a clinical pharmacist with 15+ years of experience in medical communications, from developing accredited and promotional medical education to helping clients prepare for FDA Advisory Committee meetings and other health authority interactions. Connect with Aaron on LinkedIn.