infocusmay22

By Jennifer Sheller, Head of Monitoring Excellence, Trial Diversity & Site Engagement, Global Clinical Trial Operations, Merck Recent site surveys and feedback from industry conference attendees show that sites are looking for a collaborative relationship with sponsors to drive more productive conversations and foster better-informed decision-making. In fact, an SCRS site study dashboard white paper reported that 76 percent of sites never receive feedback from sponsors on their study performance, except for recruitment metrics. Survey respondents noted that they needed actionable performance information early in the process in order to take quality to the next level. What features should sites be looking for? What would help sites gauge their performance? Here are some considerations that both sites and sponsors can deliver: Organized and visual presentation: Compelling data will always be more impactful if it is clear and engaging. Relevant key performance indicators (KPIs) depicted in a convenient report will provide sites and CRAs with a vantage point for charting progress and focusing on areas to improve. This can include enrollment, start-up timelines, data entry, query resolution and protocol deviations. Real-time tracking: Sponsors and sites that can share insights throughout a clinical trial develop strong partnerships. For example, a report that shows patient screening and randomization metrics allows a site to monitor enrollment progress, highlighting how many patients were targeted before the activity began, the current number of patients in a particular study and how this compares to other sites in a given study. Transparent benchmarking: It is an advantage for sites to know how their own performance compares to other sites within a given study at the country, regional and global level. Equipped with this information, sponsors can discuss specific strengths and collaborate with sites on areas for improvement to take action. Insights to elevate discussions: CRAs can generate reports to proactively prepare for site visits, help sites interpret their data and anticipate site needs throughout the study. By continuing to update reporting based on end-user feedback, sponsors can make site conversations as effective and efficient as possible. Sponsors should offer a unique perspective and support to boost clinical research sites’ operational excellence. A site’s clinical trial performance data, when shown visually and in the context of other study measures, can enhance sponsor-site collaboration. This is critical to the identification of issues and collaboration to secure quality and compliance and manage expectations. Merck is committed to providing access to this robust information. Site personnel who would like to learn more can ask their Merck CRA about Site Health Check, a reporting tool designed by sites for sites to help focus on what matters—ultimately resulting in better quality research and operational excellence.

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.

By Chris Wells, Senior Director, Patient Concierge, at Illingworth Research Group, a Syneos Health™ company More non-essential appointments are moving from virtual back to in-person visits at sites, bringing up new worries for clinical trial participants and resurrecting some old ones. Where site visits are essential, travel and logistics support can make a huge difference to ease the burden imposed on patients and families. Getting patients and their caregivers to sites has been an ongoing challenge, but recent patient concierge technologies are on the market to help ease patient (and site) transportation burden. Travel and logistic support can make a huge difference, especially those traveling longer distances, traditionally marginalized or chronically ill. By working with a patient concierge service to ensure logistics – from ground, air, and rail travel to short- or long-term housing accommodations and out-of-pocket expense reimbursement – are managed according to the visit schedule, pressure can also be relieved from site teams to ensure a smoother patient experience. As site administrators investigate the details of these services in order to identify the most effective transportation program to connect patients and sites, there are four critical questions to ask of any potential vendor: Can you connect with non-fluent English speakers? More patients and their caregivers are expecting fluent outreach (and support) in their native languages. Any service that is meant to help patients connect to their healthcare providers – especially in a clinical trial setting – should be offered in several languages, not just English. Is your service user-friendly? When evaluating the potential effectiveness of a site transportation program for patients, sites need to think through the user experience. Does your service offering include mobile-friendly (and non-mobile!) ways to make appointments and view travel-related reimbursement expenses? Are there hidden fees for sites after start-up? Some services require sites to sign up to all, or a minimum portion of professional fees. Other providers limit the number of communication exchanges between the site and patient/caregiver.  These can expose clients to paying for activity regardless of site or patient uptake, providing no incentive to deliver a quality service since revenue is guaranteed. Does the service integrate well with our specific patient population, and will it add value? A trusted transportation vendor will have experienced patient coordinators with a vested interest in proactive and efficient patient management and should be experienced in building a rapport with patients and families. A robust, patient-centric approach not just provides a better trial experience to participants, it enables sites to confidently recruit from further afield. Clinical trial patients and their families can often be faced with unique and often indication-specific transportation challenges that can be affected by the distance between home and site. At Illingworth Research Group, a Syneos Health™ company, we believe no person should have to forego healthcare – or basic social needs – because they cannot get there. Our mission is to help to ensure that every patient, especially those that are traditionally marginalized or chronically ill, can access the care and resources they need to ensure good health. Having a travel vendor that understands and appreciates these niche requirements is key to removing patient burden, offering both compassion and a duty of care to those who need it.