SCRS comments on the Federal Drug Administration (FDA) 2023 Draft Guidance: “Decentralized Clinical Trials for Drugs, Biological Products, and Devices Guidance for Industry, Investigators, and Other Stakeholders”
First, we applaud the FDA for preparing this guidance and its intent to foster the extension of the traditional research site via various mechanisms. It’s vital that the industry enables patients to have increased access to the necessary items and services required to successfully enter and complete clinical trials. We concur that there are proper ways to extend a clinical trial site/investigators’ traditional “brick and mortar” model to one that can be extended by technology, mobile research staff and healthcare providers that are more proximal to the patient at their time of need.
Although
it challenges the traditional business model of the site industry, the SCRS
Site Landscape Survey results indicated that sites are participating in these
kinds of studies in a post-COVID environment, the top two reasons being “would
be beneficial to the participant” and “desire to bring my site into the
future”.
While we see the investigator/site industry as concurring with the purpose of this draft guidance and with many of the FDA’s recommendations herein, certain components of the current draft are having the opposite of the intended effect. Some components codify several systems and gaps that are known to contribute to investigators/sites’ unwillingness to facilitate decentralized components due to fear of regulatory retribution. Herein we take the approach of highlighting key issues we believe the FDA should address in this guidance to accomplish our shared goal.
We cannot emphasize enough that the erosion of site/investigator oversight and the expected regulatory consequences have a negative effect on the adoption of decentralized/hybrid trials.
Based on the 2023 SCRS Site Landscape Survey, overwhelmingly the sites’ answer to the question “what have you experienced to be the biggest challenges for your site in participating in decentralized trials” was “oversight of remote vendors that would interact with the patient, record source data”. For sites that refused to conduct trials with the added decentralized components, the second and third most common reasons cited were “not comfortable with this type of trial” and “lack of understanding on how the trial would operationalize”.
The great majority of our comments relate to this theme of the site/investigator’s eroding control over the operation of the clinical trial, coupled with the reiteration that they remain ultimately responsible from a regulatory perspective.
Thank you to our project contributors:
Lisa Bjornestad, DM Clinical Research
Daniel Fox, Clinical Research Payment Network
Christie Fry, AbbVie
Nadege Gunn, Impact Research Institute
Kathleen McNaughton, Mayo Clinic
Lindsey Morales, Gilead Sciences
Debra Rogge, AstraZeneca
Shivani Shah, DM Clinical Research
David Vulcano, HCA Healthcare & SCRS
Scott Whitt, Triad Clinical Trials
Jennine Zumbuhl, Dignity Health
July 31, 2023 — The Society for Clinical Research Sites (SCRS) has announced the launch of its new Global Site Excellence in Diversity Award to recognize and celebrate the exceptional efforts made by clinical research sites in promoting diversity, equity and inclusion within clinical trials. Syneos Health® (Nasdaq:SYNH), a leading fully integrated biopharmaceutical solutions organization and SCRS Global Impact Partner, is proudly sponsoring the award as part of its commitment to fostering equitable access to clinical trials. The award is open to SCRS site members globally and will evaluate initiatives such as culturally tailored outreach, community partnerships, educational programs, and recruitment strategies that prioritize diversity and inclusion. “At Syneos Health, we are unwavering about our organizational commitment to Diversity By Design™, our integrated approach to improve equitable opportunities across the clinical to commercial continuum through education, awareness, and access,“ said Batisha Anson, Global Head of Patient Diversity & Equity, Syneos Health. “We are proud to partner with SCRS to introduce this novel award that recognizes sites that share both organizations’ dedication to incorporating patient diversity into standard practices to improve scientific knowledge and health equity.” “SCRS is honored to work with Syneos Health to launch this award recognizing the outstanding work of clinical research sites in engaging underrepresented communities,” said Jackie Kent, Vice President of Diversity & Special Projects, SCRS. “By supporting sites that are champions for diverse, equitable and inclusive recruitment, we can collectively address barriers faced by underrepresented populations in clinical research. This award will serve as a testament to sites’ outstanding achievements, enabling solutions for excellence in patient care and diversity initiatives within the healthcare industry. We look forward to seeing the innovative programs developed by sites that are setting an example in this space.” Nominations for the Global Site Excellence in Diversity Award are open from July 31-September 8, 2023. The judging panel, consisting of SCRS Diversity Awareness Program committee members, will evaluate the submissions and select the award recipient. The recipient will be announced at the SCRS Global Site Solutions Summit, which will take place in Hollywood, Florida from October 6-8, 2023. For more information on the Global Site Excellence in Diversity Award, including submission guidelines and eligibility criteria, please visit the Global Site Solutions Summit website. About the Society for Clinical Research Sites (SCRS) The Society for Clinical Research Sites (SCRS) is the leading advocacy organization dedicated to unifying the voice of the global clinical research site community. Representing more than 10,000 sites in 47 countries, SCRS facilitates industry collaborations and conversations dedicated to site-focused advocacy, education, mentorship and connection. SCRS is an active and influential champion for sites in industry initiatives to ensure that the perspective of sites is heard and valued. Learn more and get involved at myscrs-new.local/. Our voice. Our community. Your success. About Syneos HealthSyneos Health® (Nasdaq:SYNH) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment. To learn more about how we are Shortening the distance from lab to life®, visit syneoshealth.com or subscribe to our podcast.
October 10, 2023 – Today the Society for Clinical Research Sites (SCRS) is pleased to announce the recipient of the 2023 Excellence in Patient Centricity Award, Velocity Clinical Research. The award, sponsored in 2023 by Sanofi, celebrates a clinical research site that places patient experience at the center of its operations. Velocity Clinical Research demonstrated a strong commitment to patient-centricity and engagement in clinical trials through several innovative initiatives. They established a Patient Advisory Committee (PAC) comprised of diverse clinical trial participants who offer valuable feedback, sharing these insights publicly to improve patient engagement across the industry. Velocity has also prioritized health equity by addressing disparities in clinical research participation by utilizing culturally tailored materials, including resources in Spanish, to ensure inclusivity and accessibility. Velocity also focuses on a diverse workforce to better understand and meet the needs of various communities. Their #VelocityCares program provides employees with cash stipends to donate to charities and engage in spontaneous giving, fostering community support. Nick Spittal, COO of Velocity Clinical Research, commented, “This recognition reaffirms our commitment to putting patients at the heart of everything we do. I’m proud of our entire global team for their embrace of the Velocity core value of ‘care’, working tirelessly to ensure that every participant in a Velocity clinical trial has an exceptional experience. Thank you also to the research volunteers who are essential to the advancement of new therapeutics. We will continue to strive for excellence in delivering innovative and compassionate solutions for the benefit of research participants and their caregivers.” Jimmy Bechtel, SCRS Vice President of Site Engagement, shared, “The Excellence in Patient Centricity award celebrates those who don’t just talk the talk but walk the walk when it comes to patient-centricity. Velocity Clinical Research exemplifies this commitment by consistently putting patients at the heart of their work. SCRS proudly applauds the Velocity team for their industry-leading initiatives that have transformed the patient journey into a seamless experience from start to finish. Their forward-thinking, community-focused programs have set a precedent for the industry, and SCRS is thrilled to recognize and celebrate their unwavering dedication to enhancing the patient experience.” Vicky DiBiaso, Head of Patient Informed Development & Health Value Translation, added, “Sanofi is once again proud to sponsor the annual SCRS Excellence in Patient Centricity Award. We founded this award because we feel a deep appreciation for trial sites, and the pivotal role they play in making clinical research a positive experience, and one that is obtainable to individuals traditionally under-represented. Being able to thank sites going above and beyond is a privilege!” For more information about the Excellence in Patient Centricity Award and the SCRS Global Site Solutions Summit, visit sitesolutionssummit.com. About the Society for Clinical Research Sites (SCRS) The Society for Clinical Research Sites (SCRS) is the leading advocacy organization dedicated to unifying the voice of the global clinical research site community. Representing more than 10,000 sites in 47 countries, SCRS facilitates industry collaborations and conversations dedicated to site-focused advocacy, education, mentorship and connection. SCRS is an active and influential champion for sites in industry initiatives to ensure that the perspective of sites is heard and valued. Learn more and get involved at myscrs-new.local/. Our voice. Our community. Your success.
