Resources & Training

Placing Patients at the Heart of the Clinical Trial Ecosystem

May 6, 2022 infocusmay22

Leads to successful trials & answering the needs of patients sooner

Hosted by Sanofi, the Heart of the Entire Clinical Trial Ecosystem symposium explored what patient centricity means to sponsors and site investigators in February 2022.

Patient-centric Clinical Research

Following presentations from Victoria DiBiaso, Global Head of Patient Informed Development & Health Value Translation and Ellen Price, Director of Patient Engagement with Meridian Clinical Research, it emerged that patient centricity takes an ecosystem fueled by the insight, energy and passion of site investigators, sponsors, clinical research organizations and most of all, the perspectives and real-world experiences of patients.

From a sponsor view, DiBiaso explained how Sanofi’s trials and clinical development programs are informed in alignment by the needs and priorities of sites and patients. With a key focus on trial optimization and simplification, Sanofi provides end-to-end support to sites, as they play a vital role in the clinical trial experience.

Sanofi’s research environment considers health value for the global patient community and physicians in its commitment to patient centricity, starting from the pre-clinical stages through post-approval of new medications. Patient-informed trials and development programs are shown to bring meaningful healthcare solutions to patients faster and offer a vital source of hope to people without available treatment options. Intentionally establishing elements of clinical trials and research programs based on patient insights, patient-reported outcomes and diversity and inclusion strategies is necessary to make clinical trials part of people’s health care continuum. After learning, from patient advisors how difficult it is to find studies, Sanofi launched Sanofistudies.com in 2021, which allows people to find clinical trials in their US geographic location (soon to be expanded to other countries). To illustrate the scope of Sanofi’s integrated approach, patients and caregivers advised 57 programs with 67 unique disease indications between Research and Development. This covers 100% of its clinical trials and they collaborated with Patient Advocacy Organizations from across 33 countries in 2021 on the advisement and public awareness of those studies.

Patient-centric Practices for Sites

Community advocacy is a critical component of site’s patient-centric toolkit. Price highlighted the power of partnering with advocates to build bridges between communities and clinical research sites. Patient participant advocates can help increase trust and access to study opportunities by successfully raising awareness, supplying educational materials and reassuring people that steps are taken to protect the rights and welfare of patients. Advocates also bring feedback to Meridian and their network of sites about barriers and obstacles to participation, allowing for improvement of the patient experience and Meridian’s operational processes.

The symposium concluded with breakout sessions for sites to share best practices on bringing the patient voice to the forefront of clinical trials. Several patient-centric trends at sites were raised, including fostering communication through patient testimonials on social media and local news channels, implementing decentralized clinical trials and collaborating on recruitment materials with sponsors.

Watch the full recording here.

SCRS Creates Toolkit to Help Sites Address Workforce and Inflation Challenges

Hanover, MD, May 4, 2022 – The Society for Clinical Research Sites (SCRS) today announced the release of a toolkit created by several of its largest site network members to address the clinical research industry’s workforce challenges and inflationary pressures. The Site Toolkit for Challenges in Workforce Retention and Inflation is available to SCRS member sites and offers best practices to maximize revenue, minimize costs, and recruit and retain employees. A companion deliverable to the toolkit is an open letter to industry Sponsors and CROs, outlining current challenges sites face with staffing and budgeting, and solutions urgently needed to address those issues. “The goal of these tools is to encourage an honest dialogue about the industry’s shared responsibility to each other during this especially challenging time,” said Allyson Small, Chief Operating Officer of SCRS. “It’s imperative that we address these issues now to ensure we have a viable research infrastructure required to continue to conduct safe and effective clinical trials at scale, whether traditional or hybrid.” William Smith, CEO of Alliance for Multispecialty Research and SCRS Task Force Committee co-chair added, “Sites are increasingly challenged by both inflation and the even more accelerated costs of healthcare workers. The data and best practices SCRS has collected through this Task Force Committee will be instrumental to help sites and industry work together to reach mutually-beneficial solutions.” “While SCRS members are working with each other in sharing best practices to address these headwinds, even our most experienced site leaders state they cannot pull through this alone,” commented David Vulcano, Honorary President of SCRS. “They need help from sponsors, CROs, and other stakeholders involved in clinical trials and the progress of new therapies.” SCRS encourages all sites and industry partners to share the letter with their respective organizations and networks. SCRS will continue to host meaningful discussions between industry sponsors, CROs, solution providers, and sites through webinars, Site Solutions Summit sessions, and Sites NOW meetings. Suggestions for other solutions or resources to address site workforce and inflation challenges can be submitted to the SCRS leadership team at info@myscrs.org. About The Society for Clinical Research SitesFounded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/. Contact: Marissa Hill Communications Manager Society for Clinical Research Sites communications@myscrs.org 267.865.3296

Technology’s Role in the Patient Experience

By Will Wing, Director, Innovation and Feasibility at Clincierge Healthcare and technology have always gone hand-in-hand. In fact, some of medicine’s earliest innovations are the most enduring. Invented in 1816, the stethoscope remains one of modern medicine’s most widely recognized symbols. First used in 1895, X-rays paved the way for electrocardiograms, CT scans, dialysis machines, and more. For clinical trials, the convergence of healthcare and technology creates a constant stream of innovation in the pursuit of novel treatments and therapies. Likewise, the pandemic and subsequent growth of decentralized trials demonstrate how technology can play an essential role in the patient experience. COVID-19’s impact on innovation At the onset of COVID-19, clinical research organizations (CROs) and trial sponsors embraced quick digital transformations to ensure trials continued and patient care remained uninterrupted. A 2021 survey of clinical operations leaders at CROs, academic medical centers, trial sites, and other industry segments found 47% of study sites and 36% of sponsors increased technology investment to minimize disruptions due to COVID-19. Major investments focused on remote connectivity and access technology. Companies that proactively ramped up their use of technology saw the most significant benefits. Today, the pharmaceutical industry is doubling down on innovation. Many organizations are devoting vast resources to technologies aimed at advancing their mission. Some are adding innovation to the c-suite, and some, like Clincierge, are building teams focused on innovation and feasibility. How technology benefits trials From straightforward software applications managing data collection to complex systems integrating nearly all elements of a trial, technology has the potential to improve almost every aspect of clinical trials. CROs and trial sponsors are already using technology to address long-standing challenges like patient recruitment and retention and data security. Technology also enables the industry to adopt decentralized clinical trials and remote patient care. Cloud-based systems and artificial intelligence are streamlining data collection and greatly reducing time spent on data analysis, resulting in shorter trials and benefitting both sponsors and patients. Similarly, wearable devices and telemedicine offer safe at-home solutions which reduce site visits, resulting in easier methods of recruiting and retaining trial participants. While the focus tends to be on technologies to improve the clinical and research phases of trial design, innovations to ease the burdens of participation for patients and caregivers could be equally beneficial to trial outcomes. Just as sponsors use technology to find and recruit patients, patient service providers can integrate technology to improve patient experiences. Technology developed with patients in mind is critical. Not only is every trial unique, but so is every patient. The most effective approaches to technology are at least flexible, if not customizable. They must account for elements such as location, the severity of patient health, patient comfort with technology, local regulations, and privacy. Successfully addressing patient needs with technology has the added benefit of freeing up trial staff, allowing them to focus more time on data collection and crucial trial endpoints. Patient support services in clinical trials While technology can improve trial efficiency and enable remote operations, it is important to note technology alone cannot replace the human element of patient care. Consider a hypothetical trial with 1,000 enrolled patients, each required to visit the trial site 12 times per year. That equates to 12,000 site visits over the course of just one study. At some point, patients will have questions or special requests that require human interaction. Many CROs and trial sponsors look to patient support services providers to manage a wide array of logistics, such as reimbursements of out-of-pocket expenses, patient transport, housing, and translation services. Patient coordinators become trusted advocates, providing hands-on support to ease emotional and logistical burdens for trial patients and their caregivers.” Patient coordinators become trusted advocates, providing hands-on support to ease emotional and logistical burdens for trial patients and their caregivers. These relationships are especially essential in trials involving rare diseases or pediatric patients, which often require cross-border travel and complex medical accommodations. Tech-enabled innovation streamlines business services and empowers clinical trial teams to focus on serving patients. For all of the benefits that technology provides, it is important to remember they can be quickly overshadowed when reliance on technology feels like more of a hindrance than a source of support. A human touch will always be essential, whether on an individual level or the ability to reach an experienced team when things go wrong. As we continue developing and refining what it means to build patient-centricity into clinical trials, the overarching goal remains: selecting the most effective tools to improve the patient experience and deliver life-saving and life-enhancing products to market.

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