By: Johanna Koddebusch - Senior Business Analyst - Pharmasol
Concerns have been raised among clinical trial sponsors, CROs, and others over the high turnover rate for clinical investigators. These concerns are only exacerbated by the growing complexity of trials as well as the proliferation of new trials. The pandemic has also had a lingering impact on hiring as the number of candidates with the necessary expertise has lagged behind the availability of open positions. Competition amongst sponsors seeking qualified investigators and others involved in trial management is also significant. As investigators play a crucial role in protecting the rights and welfare of patients involved, as well as having to be aware of regulatory and approved research requirements, it has become more difficult to find and retain investigators with the appropriate experience and willingness to shoulder the responsibilities involved on an ongoing basis.
A study from 2017, using the FDA’s Bioresearch Monitoring Information system, showed that out of 201 Principal Investigators (PIs) surveyed, a surprising 54.2% were classified as "one-and-done," meaning they had only ever worked on one clinical trial and were likely not interested in participating in another.
The survey also identified several factors that affect PIs’ decisions to conduct only a single FDA-regulated drug trial, including 28.9% of the PIs who decided, for personal reasons, to not conduct another trial, and 44.4% who showed interest in participating in another trial, but indicated that no opportunities were available.
In the same study, three categories of broad barriers were identified as generally burdensome or challenging by most investigators polled:
- 63.8% cited workload balance (balancing trial implementation with other work obligations and opportunities),
- 63.4% cited time requirements (time to initiate, implement, and conduct trials),
- 56.5% cited data and safety reporting.
Considering that investigator knowledge and experience can directly affect the quality, efficiency, cost, and success of clinical trials, it is imperative to identify and improve underlying reasons for these high rates of turnover amongst principal investigators.
The findings illuminate the challenges in enlisting highly qualified clinicians to perform these important clinical trials. A mechanism to match interested investigators with research sponsors is needed to solve the challenge of finding relevant opportunities. Another solution cited has been to invest in new investigators (sub-investigators) who can be mentored by the PI, manage some administrative tasks, and be supported with the training needed to gain the experience needed to qualify as a PI.
But more importantly, the workload and the complexity of additional tasks that come with participation in a clinical trial must be simplified and thus reduced, to motivate PIs and their study teams to remain interested and committed to participating in clinical trials.
Technology can assist in solving some of the data and safety reporting concerns. By automating these time-consuming reporting obligations, clinicians can focus on working with patients and performing more critical tasks that require their expertise. This supports efforts to enhance investigator retention by targeting issues that have been identified as problem areas, such as time constraints and data and safety reporting.
Putting the Focus on Data and Safety Reporting
Technology is often positioned as the answer to all problems, and it can, of course, often bring significant benefits, particularly in streamlining efficiency of processes. However, when looking at the needs of site staff, including investigators, and how their focus should be on the patients, it can be that the introduction of new software systems creates more friction within a process, and increased complications for the sites. Therefore, the aim of implementing new technology must be to make sure that the implementation of an automated system is not disruptive but, instead, is intuitive and reduces time, effort and thus costs for both the sponsor and the site.
In a survey conducted by the Clinical Trials Transformation Initiative (CTTI), a public/private partnership focused on generating more efficiencies in clinical trial management, they identified that “... investigators and research staff believe electronic portals have the potential to increase the efficiency of expedited safety reporting to research sites, but in practice are difficult to use and add to the complexity of the system.”
For example, safety letters are typically placed by the sponsor in a standalone study portal which requires the site teams to be trained for these new systems and for the sponsor to then keep track of the user accesses for each of the different tools. This is cumbersome and not adding any value to the work done by the site and can become a reason NOT to look at the safety alerts in a timely manner. Consequently, reminders to review the documents are being sent, which overwhelm the site further, and this spiral of notifications becomes a point of frustration for the study teams.
To mitigate the concerns cited about difficulties and complexities of an electronic portal, the access to relevant safety letters must be simplified and summarized across studies to reduce the workload for study teams.
Simplifying Reporting Systems
Summarizing emails to combine safety notifications for multiple studies can be one way to reduce email traffic and increase the overall efficiency in safety letter distribution and receipt. For example, if a site is working on multiple studies, it is vital that the required acknowledgment actions ACROSS these studies are handled elegantly by the software involved in the Safety Letter Notification process. If the site is expected to manually do this in each study, it again becomes an onerous activity which can become error-prone and a barrier to smooth working practices.
Considering that active multi-trial investigators, according to additional published research, emphasize the importance of a functioning team to be successful in clinical research, any tool dealing with automation should be able to allow and document fulfilment of delegated PI obligations through delegate team members. A transparent view of document status, via an intuitive and descriptive central dashboard, which provides all study team members with a real-time overview, can dramatically reduce the workload across the team and simplify (and amplify) communications in this area.
Depending on their local infrastructure and regulations, sites will expect to be able to receive information according to their preferred method. This could mean that they expect to have courier deliveries, email with attachments, email with a secure link, or even fax. Any systems that are supporting them must have this flexibility to ensure strong adoption but also bring with it a unified view of compliance for the sponsor so that regardless of distribution method the transparent oversight of activity remains.
An automated system, i.e., a dynamic and interactive data hub, can also provide full audit trails that are combined with alert mechanisms to enable full compliance, alleviating additional pressure on PIs and other study team members.
In Summary
Research indicates that, in addition to safety reporting issues, PIs are generally frustrated with workloads and time constraints. An automated, intuitive, and interactive dynamic hub with an easily accessible dashboard, creates more informed and faster decision-making across all sites by delivering information to the appropriate recipients in real-time. This approach can greatly relieve the safety reporting conundrum and thus have a significant impact on streamlining efficiencies throughout the entire trial process. With one centralized location for safety information, training time, errors, and maintenance considerations are all reduced. At the same time, compliance is enhanced with audit trails, PIs and study teams are relieved from laborious manual interventions, and sponsors and sites benefit from both cost and time savings.
About the Author
Johanna Koddebusch is a Senior Business Analyst at pharmasol (www.pharmasol.de), specializing in Safety Reporting. Coming from a CRO background, she has worked with a broad variety of pharmaceutical companies and developed a great sense of individual stakeholder's needs. Johanna earned a master's degree in Molecular Biosciences from the University of Heidelberg.
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