Forbes reports that an estimated 85 percent of all clinical trials will experience delays. Of that group, 94 percent are delayed by more than a month, causing major financial strain – as much as $8 million per day during a delay period. Financial frustration notwithstanding, delayed trials can also disrupt the schedules of research participants. So, why do clinical research trials get postponed?
Why Do Clinical Research Trials Get Postponed?
How Regulatory Delays Postpone Clinical Trials
Regulatory issues are frustratingly common in the clinical trial world. One review published in the Nature Public Health Emergency Collection in 2021 outlines some of the most common regulatory issues. One example is a postponed site initiation visit (SIV) date. Trial staff must be prepared with functional equipment and procedures in place prior to the SIV date, at which point the trial is supposed to officially begin. Unfortunately, technical and functional delays can impact these visits, slowing down the site initiation process. The Nature review also addresses other regulatory issues: for example, data backlogs and infrequent ethics committee meetings. Recruitment issues may also fall under regulatory delays. One study by CenterWatch, a clinical trial industry resource, shows that as much as 69 percent of patients fail pre-screening, with 8 percent dropping out after initial enrollment. To comply with regulatory requirements, study organizers must be able to demonstrate effective participating recruitment and retention.
Clinical Supply Concerns
Clinical supply delays are also a common issue with clinical trial initiation, particularly in the case of international clinical trials. During the height of the COVID-19 pandemic, the vulnerability of global supply chains became abundantly clear. Even if supplies are delivered in a timely fashion to remote study locations, those supplies must be stored, labeled, and administered in a way that is in keeping with clinical trial regulatory standards. This forces trial administrators to jump over a number of hurdles, including cultural and regional complications.
Global Issues Impact Trial Speed
Finally, global issues can dramatically postpone clinical trials. During the first year of the COVID-19 pandemic, life science analytics firm GlobalData found that slow participant enrollment was causing delays in as much as 49 percent of clinical trials. Later, Russia’s invasion of Ukraine dramatically delayed clinical trials that were underway in Ukraine – permanently ending several of them. Issues like these can make timely global trial development extremely challenging.
Trial postponement is frustrating, but it certainly isn’t unusual. Issues like regulatory delays, recruitment issues, and global phenomena can all contribute to delayed trial initiation dates. Fortunately, clinical trial operators are continuing to work toward efficiency, which may become easier in the digital age.
Have you ever thought about participating in a clinical research study? You could be a part of history! QPS Missouri is looking for new participants. Since opening its doors in 1994, QPS Missouri has conducted more than 1,500 FDA-regulated studies, paying out nearly $50 million to local participants. Your local participation could have a global impact, as QPS is an international leader in contract research with facilities in North America, Europe, and Asia. Our mission is to accelerate the development of drugs worldwide by enabling breakthroughs in pharmaceutical innovation. This includes several pediatric studies across several age ranges. If you would like to join us in this crucial healthcare mission, consider applying for a clinical trial.
To get started, you simply need to fill out an online application. After that, within 48 business hours, a recruiting coordinator will contact you for your pre-screening assessment. To learn more, please visit the QPS Missouri website, review the study participation process, or check out our list of frequently asked questions.