Clinical research is integral to improving patient care and advancing medical knowledge. Through clinical research, researchers can develop new drugs to save humanity.
In recent years, clinical research has become increasingly difficult with the rise of many challenges, like complex trial design, monetary investments, cooperation among stakeholders, time, personnel, medical supplies, and other support systems, all part of the clinical research infrastructure. These complex challenges have burdened clinical research sites, many already facing issues like enrollment challenges, increased technology burdens, and more. This has brought many types of research to a stop, mainly in the fields of oncology and neurology.
According to the Clinical Research Site Challenges Survey Report, WCG ⓒ 2023
More Complex Trials + Inefficient Processes = Increased Challenges at Sites, Research Delays & Lost Opportunities.
It is, therefore, important to understand the industry’s challenges to improve patient outcomes and advance medical knowledge. Finally, this leads to implementing more effective strategies and running more efficient trials at clinical research sites in the future.
In this blog, we look at the top issues impacting clinical research sites.
- Staffing and retention– Staffing and retention is a serious issue at clinical research sites with statistics of September 2022, where, according to CareerBuilder, over 6.6 million clinical research jobs were posted in the U.S., yet only 5.7 million available hires. Seven jobs are open for every clinical research coordinator looking for a job.This is because of many clinical trial employees’ retirements, job transfers due to the pandemic, or bad work experience. In addition, standard approaches to staffing and recruitment are different from the current scenario as per the WCG report, staffing/retention impacts clinical research sites at around 63%.
- Patient recruitment and enrollment– It is necessary to find eligible patients for the research and convince them to join. Mayer showcased a report from the Harris Interactive Survey of 6,000 cancer patients, reporting that 85 percent were unaware that participation in clinical trials was an option. Out of the patients surveyed, 75 percent said they would be receptive to participating in a clinical trial, and 71 percent would choose not to participate. Compared to earlier times, enrolling patients is becoming more and more complex, given the various increases in ongoing studies and sites. The feasibility of surveys for new trial considerations depends on having the resources, and the enrollment remains closely tied to site resourcing levels. As per the survey report, the recruitment/enrollment percentage stands at a whopping 48%, highlighting the tremendous issues faced.
- Trial complexity– Clinical studies are becoming more complex year after year. According to Tufts’ Ken Getz, the design elements associated with protocol execution have grown rapidly. As per the survey report, trial complexity is ranked at 36%, a significant burden, which leads to research centers attentively examining trial design complexity to avoid initiating certain clinical trials and favoring studies with simpler protocol designs.
- Study start-up- The study start-up at the WCG report is tied at 36%. This phase occurs during the research launch and involves activities like investigator selection, regulatory and ethics review, site training, site initiation visits, and more. It is time-consuming and can be significantly delayed because of manual and heavily paper-based processes.And there is a shortage of researchers with the required skills to take on crucial tasks for trial start-ups, like coverage analysis, budgeting, contracts, and regulatory submissions. These gaps in the start-up functions prolong trial delays and increase site activation times.
- Physician Interest & Engagement– According to the WCG survey, physician interest and engagement stands at 19%, which has reduced from the previous years. On the one hand, there are disincentives to refer their patients to clinical trials. On the other, the physicians involved are few, and a lack of interest and engagement leads to a less evidence-based botched scientific outcome.
- Technology and Trial Financial Management– There have been many trends on the rise in 2022, like site enablement that enables research teams with site-friendly technology to speed up drug development timelines and help with new treatments to reach patients. The use of technology has slowly crept up in momentum and still has not yet reached the phase where physicians and investors can focus on other factors like communication and recruitment. It stands at 18% despite much technology advancement during the COVID-19 period.Tied with technology at 18%, as per the survey by WCG, is the trial financial management. Trial financial management is the financial aspect of clinical research success, but it is difficult to get finance managers who oversee the expenses and more.
- Patient Access Challenges– Challenges regarding patient access are a pivotal point for a clinical research site. It includes geographical distances from the center to the place of stay and significant travel and time costs associated with participation. In addition, few trials purposefully eliminate certain participants due to factors like age, disease progression, and reaction to a certain medicine.Few patients might be unwilling to change their main medical provider for the sake of a clinical research site. According to the review, patient access challenges stand at 16% despite a lot of education about the clinical trials that are available and accessible.
- Accurate reporting of adverse events – In clinical trials, the subjects are everything. To protect their health and well-being, trial participants willingly trust the sponsor, the clinical investigator, and the trial staff. Safety reporting systems are essential to the procedure since they aid in recording drug-related incidents throughout clinical trial procedures.
- Other challenges, according to the WCG report, include Remote Monitoring, which stands at 9%, Decentralized trial components at 7%, and Ethical/Regulatory Review at 5%.
We must remember that clinical research sites are required as an industry to promote change by advancing science. We as individuals must adapt continuously to flourish, and importantly, the research sites must intentionally innovate. The research sites must mitigate the issues, from staffing to regulatory review, by implementing new approaches. Similar to the issues that impact the least, extra care must be taken to understand and address staffing, patient enrolment, and more.