Author: MRN
The operational challenges of clinical trials are a long list of nuanced situations that are specific to each individual protocol, for each individual site and each individual patient. Sitting around the table with leaders in Clinical Operations, Patient Engagement and Recruitment, Supply Chain Management, Biostatistics, and others, we were able to gain a better understanding of the current challenges faced by trialists trying to get new therapies to patients.
Throughout the day, and during many conversations around the challenges of running clinical trials, three key themes bubbled to the surface, and were clearly top of mind for those facing these challenges on a daily basis. Let’s take a look at these challenges and review the possible solutions:
- Sites are saturated. From large scale trials to ultra rare disease trials, going to the same large, urban institutions or the familiar site will start to or is currently, straining the ability for trials to recruit the appropriate number of patients. The solution lies in finding new PIs, new sites and new patient pools to recruit from. Sponsor representatives were acutely aware of the risk to their upcoming trials when going back to the same sites but unsure of how to get new sites ready for research. Onboarding new sites will need to be done carefully and managed with the appropriate support for sites. Sites that are part of an existing network are more likely to have the appropriate infrastructure support such as systems, logistics management, contracting and payment, as well as patient recruitment support and solutions.
- Diversity Action Plans will need to deliver. There was growing concern around the table of how we, as an industry, deliver on the FDA requirements while being able to build protocols to reach the right patients. The aim of the FDA requiring trial diversity strategic action planning is to make trials more inclusive and reduce the risk of trials failing due to lack of representative data. Sponsors looking to increase recruitment of diverse patient populations will need to consider strategies and solutions that are right for the protocol and right for the patient. Getting trials into the community can be an option but new facilities will need to be managed appropriately. Remote or in-home trial support may work for some patient populations but not for others. No approach to achieve results should be “standard”, but rather customized in design.
- Patient recruitment and patient access continue to be challenges and are paramount to a trial’s success. Community-based trial models to bring trials closer to patients can increase clinical trial diversity and ultimately improve health care outcomes. By simply eliminating logistical constraints for patients, the barriers to trial entry, and continued participation, are minimized. It is an elegant and realistic solution for many protocols, and when approximately 20% of patients drop out of trials after enrolled and recruitment accounts for an average of 32% of the overall trial budget, it is one that should be considered. Simply put, making trials more accessible by bringing the trial to the patient’s own community has clear benefits for patients and, if you look at the numbers, clear benefits for the Sponsor.
Planning to implement community-based, patient-centric solutions will not be a one-size fits all strategy. Operational teams will need to look at where and how to expand into new sites, when to introduce technology solutions and when to move clinical visits to a patient’s own home.
The future of successful trial delivery will take the form of building balanced protocols that utilize brick-and-mortar sites, virtual sites, in-home clinical visits and technology solutions, all centrally managed to ensure the highest standards of scientific research, patient safety, and data integrity.