Those working in the clinical trials industry are well aware that the drug discovery process is complex and demanding, and the clinical stage is resource-intensive and high-risk.
Just consider the following facts about the state of clinical trials:
- TRIAL COSTS: A CBO report states anticipated costs to develop a new drug are projected to range from ~ $1 billion — $2+ billion
- COST PER PARTICIPANT: One study found the estimated median cost per participant for pivotal clinical trials to be $41,413
- ENROLLMENT ISSUES: Some studies have shown that only 31% of trials meet enrollment goals
- DIFFICULTY: One survey showed 70% of investigative site staff believe conducting clinical trials has become much more difficult over the last 5 years
- COMPLEXITY: Studies indicate the average number of protocol deviations and substantial amendments has increased significantly over the past decade
TRIAL AND PARTICIPANT COSTS
The Congressional Budget Office attempted to quantify the cost of research and development in the pharmaceutical industry in 2021, reporting that in 2019 the industry spent $83 billion dollars on R&D.1
The cost per participant for studies can be a significant part of overall costs. A study published in 2020 examined the estimated costs of the pivotal clinical trials supporting the approval of 101 new therapeutic agents approved by the US FDA from 2015 to 2017. The estimated median cost per participant was $41,413.2
Recruitment, enrollment, and retention of participants is not only an expensive aspect of trials, but the process can even become a failure point. Failing to enroll enough subjects in a trial is a long-standing issue. Some studies have shown that only 31% of trials met enrollment goals. It has also been reported that a third of publicly funded trials needed a time extension due to failing to meet initial recruitment goals.3
DIFFICULTY & COMPLEXITY
A January 2023 article in Clinical Leader reported on the results of a survey conducted by Tufts Center for the Study of Drug Development. One finding was that 70% of investigative site staff believe conducting clinical trials has become much more difficult over the last five years. Respondents identified staffing, budgets, and protocol complexity as some areas that have gotten worse.4
The Tufts report also noted a threefold increase in the number of data points captured in Phase 3 trials over the past decade. An increase in the mean number of protocol deviations and substantial amendments, which are notoriously labor-intensive, was reported for all trial phases.5
HOW MERIT CAN MITIGATE TRIAL ISSUES
Site Support: Adequate site support from a clinical endpoint expert can lead to better participant retention and improve study enrollment. Our qualified experts can be contacted by one simple phone call or email. Sites get the swift assistance they need without waiting on hold or for a return phone call that never comes. Sponsors benefit with improved subject qualification and retention at screening and throughout the study.
Technology Platform. Given the current state of clinical trials, sponsors as well as sites want to mitigate the difficulty and complexity of studies by leveraging technology. MERIT’s easy-to-use software platform, EXCELSIOR, streamlines the clinical trial process, improving the efficiency and accuracy of data capture, management, and analysis of imaging data. Our software features highly customizable workflows that help facilitate rapid study startup and enrollment, resulting in cost efficiencies. EXCELSIOR helps sites upload data more easily, giving them more time to focus on the participant.
1Research and Development in the Pharmaceutical Industry, April 2021. The report is available on CBO’s website (www.cbo.gov/publication/57025).
2Moore TJ, Heyward J, Anderson G, Alexander GC. Variation in the estimated costs of pivotal clinical benefit trials supporting the US approval of new therapeutic agents, 2015-2017: a cross-sectional study. BMJ Open. 2020 Jun 11;10(6):e038863. doi: 10.1136/bmjopen-2020-038863. PMID: 32532786; PMCID: PMC7295430.
3Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. 2018 Aug 7;11:156-164. doi: 10.1016/j.conctc.2018.08.001. PMID: 30112460; PMCID: PMC6092479.
4Miseta, E. Clinical Sites Are Optimistic, Despite Growing Challenges. Clinical Leader web site, 17Jan2023, accessed 11Jul2023. https://www.clinicalleader.com/doc/clinical-sites-are-optimistic-despite-growing-challenges-0001
5Freel SA, Snyder DC, Bastarache K, Jones CT, Marchant MB, Rowley LA, Sonstein SA, Lipworth KM, Landis SP. Now is the time to fix the clinical research workforce crisis. Clin Trials. 2023 Jun 2:17407745231177885. doi: 10.1177/17407745231177885. Epub ahead of print. PMID: 37264897.
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