The 2 Most (Impactful!) Patient-Centric Things That Sponsors Can Do

Fall conference season is upon us and a cursory internet search shows no less than a half-dozen conferences focused on the topic of patient-centricity. Thankfully, the momentum around the topic continues as sponsors and CROs strive to find more patient-centric approaches to conducting clinical trials. At last count, there were 108 patient-centric initiatives posted on the SYNaPsE (SYNergising Patient Engagement) website.¹ The repository of initiatives on this site is not only impressive but makes for a fascinating read in terms of the breadth and depth of patient-centric approaches that are being implemented across the industry. What strikes me in reviewing all the projects, however, is the fact that involvement of the sites in these programs is consistently missing.

From my view in the trenches of clinical research operations, I see sponsors and CROs vying to get closer to the patients but failing to acknowledge the most critical stakeholder in the projects -- the investigative sites that implement the trials and that care for and interact with the patients throughout the process. Several recent “rescue” projects that I have evaluated revealed some interesting findings:

• The sponsors/CROs had implemented or were considering an impressive laundry list of tactics designed to help support or engage the patients (e.g., home-health visits, patient debit cards, transportation assistance programs, e-consent, patient appreciation, and a host of other items), but the uptake by the sites was very poor.
• In most cases, the sponsors/CROs never asked the sites about the initiatives, including whether they felt they would have an impact on enrollment/retention and/or the burden that implementing the various tactics would have on the sites.
• In the few cases when sites were approached for their input, nearly two-thirds of the sites indicated that the tactics were not likely to have a significant impact, yet the sponsors/CROs proceeded to foist the tactics on the sites in a quest to address the poor enrollment/retention issues (hence, resulting in low uptake by the sites).

For clarity, by low site uptake I am referring to the number of sites that submit the programs to the institutional review board (IRB)/ethics committee (EC) for approval, or upon ethics approval, fail to approach the patients to participate in the programs and/or fail to deploy the various tactics. While the intent of the sponsors/CROs is laudable and, no doubt, tremendous time, effort, and resources go into developing the programs, the unfortunate reality is that in many cases the sites simply have not bought into the initiatives. Without the sites’ endorsement, many of these well-intentioned patient-centric efforts fail.

In a previous post, I looked at one facet of site-centricity,² and here I will expand on what I believe are the most patient-centric things that sponsors can do, which, not surprisingly, focus on the sites.

1. Just Ask … Just Tell!

As alluded to above, sponsors/CROs frequently miss the opportunity to seek site input on their planned patient-centric tactics. By conducting simple site needs-assessment surveys or through guided discussions with the sites, sponsors/CROs can gain valuable insights about whether the planned initiatives will work. By alerting the sites to the planned tactics, sites can be prepared to submit the programs to their ethics committees and can plan for the time and resources necessary to implement the programs. Further, they can assess whether they have internal resources/programs that already address some of the issues (e.g., home health nurses, transportation support programs) and/or whether there are any institutional policies that might prohibit some of the tactics.

Through the site needs-assessment discussions, sponsors/CROs can learn a lot about other areas where the sites need help and support. Several years ago, I conducted a meta-analysis of more than 1,500 global needs-assessment surveys that I had implemented as part of study-specific enrollment and retention troubleshooting assessments.³ The results revealed the top five things sites need for study implementation success:

• A better understanding of the target patient population and the specific eligibility criteria
• Help translating the protocol into practice; practical interpretation of the schedule of events and protocol procedures
• Help (resources, job aids) identifying and prescreening patients
• Help with developing a recruitment action plan
• Help communicating the study effectively; help with the patient/family education process

The results haven’t fundamentally changed in the last five years. Patient-centric initiatives can be vastly improved if sponsors/CROs also address sites’ needs in terms of implementing challenging protocols. Thus, the number one recommendation is to adopt a Just Ask…Just Tell policy. Just ask the sites what their challenges are, what their needs are, and what they will need to ensure the implementation of the planned patient-centric initiatives is successful. If nothing else, just tell the sites what you have planned so that they are at least aware of what is coming.

2. Support Site Sustainability

It goes without saying that without investigative sites there will be no clinical research and no need for patient-centric clinical trials. For nearly 40 years, we have been discussing the challenge of the shortage of clinical trial investigators.⁴ And for nearly that long, the primary issues contributing to the shortfall involve financial hardships⁵ for which a successful resolution continues to elude us. It is not for lack of trying. The Society of Clinical Research Sites (SCRS) has made it its mission to address site sustainability, as evidenced by the myriad of white papers it has developed pertaining to this topic⁶. Cash flow issues at the site remain at the forefront of the financial hardships. Without an influx of cash, sites struggle to retain staff, and this has a huge trickle-down impact on research quality and the patient experience. Despite the recognition of these issues and the various efforts to address them, a recent article found that the situation is worsening. In a comprehensive analysis of site payments across 30,000 records from 312 studies, Tate and Hilty found that the average time it takes sponsors to pay sites increased from 99 days in 2009 to 154 days in 2016.⁷ Their analysis further noted that 66 percent of sites reported having less than three months’ operating cash on hand. This does not bode well for creating a sustainable environment of qualified investigative sites.

At the risk of sounding like a patient-centricity naysayer, I continue to be mystified by the disproportionate effort the industry is expending in patient-centric efforts over site-centric efforts. If just 10 percent of the investment sponsors and CROs are making in patient-centricity programs could be shifted to addressing the slow site payment issue, where would we be? What if the industry supported better educational initiatives to replenish the pool of qualified investigators and site staff? What if equal attention was paid to addressing the site as well as the patients’ burdens for participating in clinical trials? So, the next time your team is discussing the newest wave of patient-centric initiatives, don’t forget to include the topic of site sustainability into the conversation.

References:

1. Patient Focused Medicines Development (PFMD) mapping tool: https://involvement-mapping.patientfocusedmedicine.org/
2. Harper, B. “Calculating A Site Effort Score (SES): It’s Not What You Think.” https://www.clinicalleader.com/doc/calculating-a-site-effort-score-ses-it-s-not-what-you-think-0001
3. Harper, B. Meta-analysis of site needs assessment surveys 2006-2012.
4. Chalmers, T.C. “A New Physician Manpower Shortage: Clinical Investigators”. New England Journal of Medicine. 1979; 300: 1108-1109, May 10, 1979
5. Examination of Clinical Trial Costs and Barriers for Drug Development. 4.4 Increasing Competition for Qualified Investigators and Sites. Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. July 25, 2014. Retrieved from: https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development/44-increasing-competition-qualified-investigators-and-sites
6. The Society of Clinical Research Sites (SCRS) repository of white papers: http://myscrs.org/learningcampus/white-papers/
7. Tate, W. and L. Hilty. “Sponsor Payments to Sites: A New Award to Recognize Timely Payment.” Journal of Clinical Research Best Practices. Vol. 13, No. 6, June 2017.

About The Author:

Beth Harper is president of Clinical Performance Partners, Inc., a clinical research consulting firm specializing in enrollment and site performance management. She is also serving as the Workforce Innovation Officer for the Association of Clinical Research Professionals (ACRP). She has passionately pursued solutions for optimizing clinical trials and educating clinical research professionals for over three decades. Beth is an adjunct assistant professor at the George Washington University who has published and presented extensively in the areas of protocol optimization, study feasibility, site selection, patient recruitment, and sponsor-site relationship management. She is currently serving on the CISCRP Advisory Board as well as the Clinical Leader Editorial Advisory Board, among other industry volunteer activities.

Beth received her B.S. in occupational therapy from the University of Wisconsin and an MBA from the University of Texas.

She can be reached at 817-946-4728, bharper@clinicalperformancepartners.com, or bharper@acrpnet.org.