A tsunami of change is impacting the clinical research landscape, from accelerated development of novel therapies to digital transformation of trial execution, an increased focus on finding diverse populations, and an urgent need for qualified clinical research professionals. Investigator sites, arguably the most impacted by these changes, need practical solutions for navigating this new environment. Success relies on a bold vision for collaboration.
The first article outlined challenges and solutions for attracting diverse populations in a three-part series. The second article offers new ideas on how to solve the most persistent operational challenges at the site level.
There are a lot of discussions devoted to the inherent inefficiencies in clinical research – brought about by a fragmented stakeholder ecosystem, leading to operational silos, task redundancies, and research duplication. As an industry, we’re only beginning to consider new collaboration, resource sharing, and standardization models as potential solutions for these inefficiencies. Collaboration is easier said than done because of fierce competition among sites, CROs, and sponsors to recruit from a finite pool of patients and investigator sites. There’s a lot of give and take, so research stakeholders must be unified by a collective willingness to help patients to make it work.
As sites, too often, we believe we’re on the receiving end of the change introduced at the sponsor or CRO level. However, in this new era of research, sites must be able to influence how clinical research is delivered. Where can we start? A few areas for consideration include the following:
- Site advocacy for a platform approach to patient identification and recruitment. There are hundreds of singular recruitment solutions and trial-matching services, yet patient recruitment remains the most persistent challenge of clinical research. As clinical research intersects with healthcare, there is a huge opportunity to expand the utility and awareness of clinicaltrials.gov from a registry of clinical trials to a centralized matching solution. While .gov needs significant UX improvements, it’s a good starting point. Here’s why:
- Recruitment is too fragmented. Ask any patient who has tried to find a clinical trial. Centralizing efforts under a singular platform can build familiarity and trust among patients and caregivers looking for alternative treatment options across all therapeutic areas. If patients can create profiles in one system – that can be matched to the nearest site when study opportunities arise, the patient burden is significantly reduced, and the cost of recruitment can be greatly reduced on a trial level.
- Existing solutions to prevent dual enrollment can be much more effective when applied to large databases of potential participants. With the increase of decentralized trials, this challenge is on the rise across the industry and isn’t limited to individual studies.
- The model exists. We can look to organdonor.gov to learn more about the intricacies of a national registry and how the fundamentals of this model can be applied to clinical research for better national reach.
- It benefits everyone, especially patients and sites. While a central repository won’t replace the need for research education and local community engagement, it’s a much-needed tool for reducing the burden of clinical trial accrual.
Sites must advocate and help create novel solutions for the challenges we experience in every single study. Recruitment is only the tip of the iceberg.
- More collaboration among sites. The traditional path to broader collaboration across sites was acquisition. To support the burgeoning pipeline growth, sites need to work together to reduce some of the longstanding bottlenecks in research. Consider the potential synergies between established networks, independent sites, and community practices interested in research. A few scenarios include the following:
- Shared investigator resources across sites. A commonly-used model in academic sites, principal investigators at large central sites take on additional oversight of satellite sites. It’s especially beneficial in therapeutic areas such as CNS and immunology, where investigators are scarce. It also expands research participation to sites with qualified staff and access to the right patient populations (who may otherwise be excluded from participating in a trial). In addition, this model almost always reduces travel requirements for participants.
- In addition to the centralized/satellite model, site networks should partner with independent sites to augment recruitment based on their therapeutic specialization, proximity to target patient populations, or other criteria.
- Larger site networks can offer support to independent sites through investment support in systems used by ancillary sites to streamline collaboration across recruitment, eConsent, regulatory document management, data capture, and study administration.
- The adoption of standard operational practices and process libraries will drive consistency and quality.
- Additional investments in a centralized learning management system provide training to ancillary sites and less experienced investigators.
- Community physician practices provide a bridge to broader populations but also bring additional risk if they are not adequately supported with systems, experienced qualified staff, and research coordination knowledge.
Meaningful collaboration requires commitment and investment. Considering the expanding research activity and the increasing pressure on our current research infrastructure, I believe these are worthy bets to support the future pipeline.
- Earlier involvement with pipeline planning. Among the many challenges sites face is the ability to forecast. Most sites cannot invest in the pipeline intelligence tools that CROs rely on for business development and feasibility. Shifting the study allocation focus from a study level to a development program or portfolio level with sponsors and CROs helps all stakeholders. These include opportunities for longer-term resource planning and more efficient resource utilization. With pipeline visibility, sites can prioritize “best fit” studies and assign the same staff across studies for training, process familiarity, and related technology efficiencies. On a site level, longer commitments to a therapeutic portfolio provide an incentive for the development of impactful community engagement programs around specific disease areas. Local communities will benefit from education and outreach programs from sites that invest in these programs. Community engagement is especially important for disease areas with diverse patient populations, but it takes time to build rapport and impact study enrollment. As sponsors build diversity strategies into their clinical development plans, community engagement and site partnerships will take on a greater role in the execution of these strategies.
I believe we can make quantum leaps of progress through new approaches to partnership across the research community. There are scores of opportunities, and the site level is one place to start.
Author: Matthew Maxwell, Chief Marketing Officer
