Imagine a world where 80% of clinical trials recruit on time, where patient centricity is integral, access to research is inclusive and equitable and sites are fully armed for success.
Surely this isn’t rocket science? Yet still today, in 2024, traditional trials are sub optimal. 85% trials do not deliver on time and cause costly delays for Sponsors1. And the cause for these delays? Often, they are due to issues with patient recruitment2 or patients find the trial too burdensome and drop out mid-way through. And let’s face it, it’s not easy for patients to participate in a trial, 70% patients live more than 2 hours from a research site3 and many groups of patients are underrepresented in clinical trials. Compound all this with stretched Investigator sites, at a time where sites are being asked to conduct more complex protocols than ever before and the result is the perfect clinical trial storm.
If you, like me, are passionate about putting patients first and making a difference in clinical research, read on!
As professionals in clinical research, we are all striving to:
- Make life easier and better for the patient
- Make life easier and better for the site
- Make clinical trials more accessible, driving diversity and inclusion
- Deliver trials faster, increasing speed to market and access to new medicines for patients
- Or kill it quicker, so we can refocus and work on something else
Bringing Clinical Trials To The Community
Community based Trials (also known as decentralized or hybrid trials), put the patient at the center of clinical trial design. By strategically designing protocols and operationalizing with customized combinations of patient and site-centric solutions, we have the potential to deliver superior trial outcomes as well as maximize the return on investment for Sponsors.
Many of these solutions are not new. Indeed, the Covid-19 pandemic put decentralized trial solutions at center stage. They include a range of solutions that ease patient burden and increase participation in trials:
- Home care professionals conducting in-home visits – The array of clinical activities that can be undertaken in a patient’s home (or another place of their choosing e.g. work or school), is vast, for example, IMP administration, sample collection and processing, spirometry, ECGs & in fact anything that can be done by a mobile nurse with equipment they can carry!
- Telemedicine, eConsent and use of patient eDiaries
- Use of sensors and patient wearables
- Data collection customized for hybrid trials e.g. through eSource technology platforms
Hybrid and remote solutions lead to more successful recruitment and improved patient retention. Data from a Phase III Parkinson’s study showed that when 50% trial patients were offered in-home visits, the recruitment rate increased significantly, resulting in a 4.9 month speed up of the trial. Furthermore, community-based trials can boost diversity and inclusion by bringing the clinical trial into local communities. An analysis of MRN’s data, which reviewed 318 patients, showed that MRN’s Home Trial Support Healthcare Professionals were able to deliver clinical care to patients an average of 178 miles from the site, significantly expanding the reach of the site. (Data Source: MRN Analytics).
Supporting Sites is as important as supporting Patients
Patient centric solutions are one element of a bigger picture and to truly impact clinical trial delivery it’s important to remember all stakeholders involved in running clinical trials. Often a major stakeholder that gets overlooked is the site itself, along with the PI and site staff. Engaging and empowering sites, ensuring they are well-resourced and supported is fundamental to the success of any clinical trial. Sponsors should consider supporting sites more effectively, for example, through training programs and resource provision, so they are well prepared and equipped from the start.
The establishment of site networks has been playing a vital role in accelerating the development of new medicines. Site networks offer Sponsors access to large numbers of Sites through a single channel. Site networks often include less experienced sites (trial naïve) and therefore access to wider and new patient populations. Working with new sites can pose challenges and Sponsors are often uncomfortable to take that risk, but, those risks can be significantly mitigated if they are part of a larger network, who are committed to supporting these sites with training, resources and ongoing mentoring. In addition, through centralizing processes such as feasibility assessments, budgeting, contracting, and regulatory submissions, these networks streamline study startup, expedite patient enrollment and deliver efficiently on time.
Integrating Solutions Effectively Is Critical
Patient and site centered solutions can have a substantial impact on trial delivery when utilized together. However, it’s not just about bolting together different solutions and expecting a better outcome. For example, if you were given various components of a motor vehicle, they would have no value unless they were combined effectively to create a car. Sponsors, sites and patients won’t be able to realize the full value benefit these solutions offer if they are not efficiently integrated from concept to trial completion, with all stakeholders fully engaged in the adoption and implementation.
Better trial outcomes start with protocol optimization. Consider how protocol design can be optimized to reduce the burden for patients and sites. Boost site and patient participation through combining tailored site and patient centered strategies and most importantly, seamlessly integrating these is imperative to remove duplication, maximize returns and deliver superior trial outcomes for all stakeholders.
As a wise man once said, “The whole is greater than the sum of its parts” and this is true for clinical trial delivery.
Author: Catherine Jervis, General Manager, Integrated Trial Services.
Sources:
- Facts about clinical trials. (Online) Available at: http://www.arena-international.com/clinicaltrials/facts-about-clinical-trials/1063.article(Accessed 12.09.17)
- Clinical Trials AReNA Clinical Trial Delays: America’s Patient Recruitment Dilemma. 2012. Jul
18, [Last accessed on 2019 Dec 05]. Available from: https://wwwclinicaltrialsarenacom/analysis/featureclinical-trial-patient-recruitment/
- https://www.biopharmadive.com/spons/decentralized-clinical-trials-are-we-ready-to-make-the-leap/546591/