“Failure to recruit patients for trials leads to delays in drug development, which are bad both for sponsors and patients,” Sagar Vaidya, Chief Medical Officer of Cerevance during a presentation at the 13th Annual Outsourcing in Clinical Trials Southern California (OCTSC) 2025.
At OCTSC, which took place between 23-24 September in San Diego, California, UK, Vaidya discussed strategies for patient recruitment and retention in clinical trials.
Clinical trial success hinges on enrolling patients into studies, said Vaidya. According to the expert, drug development depends on three factors – a scalable drug, the right patients with unmet need, and funding. Delays in clinical trials lead to increased costs, specifically a one day delay can lead to operational costs of up to $37,000 per day whilst also racking up opportunity costs of $600,000 to $8m per day, he added.
Multiple stakeholders are involved in effective clinical trial recruitment
Vaidya stated that resources are finite, and sponsors must plan strategically to make trials truly patient-centric from the start, using outcomes that matter to patients and caregivers to drive interest and enrollment. The speaker said that successful clinical trials depend on strong collaboration between doctors, nurses, coordinators, and key opinion leaders (KOLs) to ensure protocols are aligned with current practices and measure the correct endpoints.
Involvement of institutional review boards (IRBs) and Ethics Committees (ECs) can lead to delays or even clinical holds when protocols are not designed to address their concerns proactively, Vaidya warned. Thus, regulatory authorities like the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) need to be engaged early to avoid delay, while payers also play a significant role in ensuring that trial outcomes align with reimbursement expectations, he said. For instance, a drug that will not be reimbursed is a wasted effort for the sponsor and therefore payer input on study design, such as trial duration, should be incorporated early.
Clinical trial protocol as the foundation for effective patient recruitment
A successful clinical trial protocol should be designed to reduce site burden by limiting unnecessary visits, risky or invasive procedures, or patient-unfriendly technologies that raise privacy or safety concerns, said Vaidya. Specifically, a strategy that the speaker suggested was leveraging precedent protocols, publicly available protocols and development plans to see what the FDA has already accepted. Vaidya mentioned that leveraging those existing protocols can save significant time; however, it is equally important for sponsors to go beyond previous protocols to drive innovation forward.
DCTs as the cornerstone of clinical research innovation
Decentralised clinical trials are transforming clinical research. DCTs improve access and participation not only for patients who are far away from sites but even for patients near top hospitals who prefer the convenience of staying home and participating remotely. While models such as DCTs boost enrollment, several challenges remain. Vaidya outlined that a lack of in-person contact can reduce commitment, some medical assessments may suffer in quality, costs are higher, and global adoption is uneven due to local regulations. Informed consent is another important aspect of clinical trials. Vaidya recommended that sponsors should ensure that consents are clear, concise, visually engaging, and transparent about risks, while long, jargon-heavy documents discourage participation.
Some other strategies for patient recruitment and selection that the speaker delved into was responsive PI selection, maintaining ongoing communication to ensure site readiness. Vaidya noted that there is a continuous need for engagement with advocacy groups, KOLs, and site staff and he recommended using tools like recruitment dashboards and recognition programmes.
Vaidya noted that trials also benefit from media campaigns, patient-friendly materials, and even social media campaigns to raise awareness. Retention strategies like open-label extensions reduce dropout, especially in placebo-controlled trials.
While recruitment remains challenging, patient-centric and multi-stakeholder approach leads to improved enrollment and trial success, speaker concluded that selecting a responsive PI and maintaining ongoing communication is important to ensure site readiness. Vaidya noted that there is a continuous need for engagement with advocacy groups, KOLs, and site staff and he recommended using tools like recruitment dashboards and recognition programmes.
Vaidya noted that trials also benefit from media campaigns, patient-friendly materials, and even social media campaigns to raise awareness. Retention strategies like open-label extensions reduce dropout, especially in placebo-controlled trials. While recruitment remains challenging, patient-centric and multi-stakeholder approach leads to improved enrollment and trial success, the speaker concluded.
