Clinical trial delays are a pervasive issue in the research industry. In fact, almost 80 percent of trials fail to meet their initial targets and timelines, and 23 percent of participants who enroll in a study don't complete the trial.1,2 These delays are often caused by underperforming or underpowered sites, missed enrollment milestones, and inefficient study review processes.
Connecting Site Selection, Recruitment, Retention, and IRB Review
While site identification, recruitment and retention, and Institutional Review Board (IRB) are independent steps in a study, they are interconnected and require an integrated approach. When each step is managed separately, the trial suffers from compounded delays. There is an inherent interdependency in identifying and determining the feasibility of potential sites with their recruitment and retention of study participants. The study decision of site selection has a direct impact on the later process of participant recruitment. Additionally, when sites struggle to recruit and retain participants, the study may require new sites to be onboarded to ensure the study progresses. Then, because new site activation requires mid-study IRB approval, at a site-level, the delays are exacerbated.
When sites are selected with the end goals in mind, it allows for speedier trials that deliver dependable data. To improve efficiency and overall trial performance, effective integration of these dependent tasks is essential. By understanding their mutually reliant nature, sponsors can make informed decisions that mitigate trial delays.
Avoiding costly delays through comprehensive planning is crucial. While site selection kicks off the clinical phase of the research process, real challenges often arise upstream, originating in the study protocol. In many instances, site feasibility is being conducted prior to having a final protocol, or the protocol is subject to major changes. Frequently, the trial design laid out by the protocol is impractical, impacting both site efficiency and participant enrollment. Selecting a site that prioritizes identifying and engaging potential participants will impact recruitment and enrollment down the line.
Recruitment and retention are critical steps where sites seek to identify and enroll participants based on assumptions discussed during the earlier site selection phase. Poor recruitment and participant dropout rates are often cited as reasons for failing trials.3 Establishing practical enrollment expectations with sites is essential so sponsors can determine if they need more sites or can achieve their goals with their current list. Adding more sites to the study and beginning the site identification and assessment process during trial conduct can increase delays.
The IRB process includes reviewing the study protocol, informed consent documents, and any other materials related to participant recruitment and retention. Therefore, when additional sites are added, further IRB reviews may be required if materials were not submitted at the study level. By integrating IRB review with site selection and participant recruitment strategies, sponsors can streamline the process and reduce delays. WCG provides a comprehensive approach for efficient IRB review processes that are intricately connected with other trial components, ensuring that ethical considerations are addressed promptly and effectively.
Breaking Down Silos for Maximum Efficiency
Comprehensive planning can minimize common risks, especially when collaborating with the right partner. An organization like WCG can tailor a strategy that harmonizes operations across multiple sites. WCG's site feasibility process leverages proprietary data and insights for precise site-to-study matches; WCG customizes recruitment and retention solutions that identify the right participants and keep them engaged; and WCG’s IRB review delivers determinations at unmatched speeds without compromising on quality.
Understanding the interdependency among site feasibility, site selection, recruitment and retention, and IRB review is key to minimizing delays in clinical trials. Built on a 55+ year legacy leading ethical review, with 3,600+ institutional and 5,000+ biopharmaceutical and CRO partners, WCG knows this truth better than anyone. That’s why 92% of all FDA-approved therapeutic agents in the past five years are supported by WCG. By strategically combining these solutions, WCG reduces delays, eliminates operational friction, and accelerates trial execution, and ultimately, sponsors save both time and money and drive research to results, faster.
References:
- Brøgger-Mikkelsen M, Ali Z, Zibert JR, Andersen AD, Thomsen SF. Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. J Med Internet Res. Published November 4, 2020. https://pmc.ncbi.nlm.nih.gov/articles/PMC7673977/ Accessed April 1, 2025.
- https://www.ciscrp.org/wp-content/uploads/2021/11/2021-PI-Participation-Experience-Report-04NOV2021-FINAL.pdf.
- Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. Published August 7, 2018. https://pmc.ncbi.nlm.nih.gov/articles/PMC6092479/. Accessed April 1, 2025.
Authors:
Seth Halvorson, JD, general manager, WCG
Seth Halvorson is the general manager of WCG’s Site Solutions that includes study start up teams, site network, CTMS, recruitment and retention services, study acceleration, and site augmentation solutions. Seth joined WCG in 2018 as the general manager of WCG Site Solutions (f.k.a. WCG ThreeWire). Seth has worked in the clinical research industry for more than 20 years.
Michelle Yu, MS, associate director, WCG
Michelle Yu is the associate director of Clinical Strategy at WCG responsible for the development and implementation of innovative solutions in study start-up. Michelle has been in the clinical trial industry for more than 12 years with much of the time focused on feasibility. Michelle joined WCG in 2018.
Cheri Sumner, MBA, vice president, operations, WCG
Cheri Sumner joined WCG in 2023. In addition to leading IRB Operations, Cheri is responsible for platform governance, continuous improvement, and client support services. Prior to WCG, Cheri was the chief operating officer of a patient recruitment and clinical research marketing firm.