infocusnov22

Underrepresentation in clinical trials presents serious challenges to public health.  By Curebase According to the 2021 U.S. Census Bureau, Non-Hispanic Whites represent 75.8% of the U.S. population, Hispanic/Latinos represent 18.9%, and Black/African Americans represent 13.6%. Yet, according to the FDA 2020 Drug Trial Snapshots, on average, Non-Hispanic Whites comprise 75% of traditional trial participants, while Hispanic/Latinos comprise only 11% and Black/African Americans comprise only 8% of participants. Recent guidance by the FDA emphasizes the importance of trial participants accurately reflecting the real-world population in an effort to ensure that all are properly represented in clinical research. Otherwise, any conclusions may portray a skewed public health message that can further healthcare inequities. A decentralized approach to clinical research leads to greater diversity in clinical trial participation by using local, virtual, and at-home care models.  Across our partnerships, clinical trial makeup has had up to 50% more Non-White participation, including up to 67% more Black/African American participation. This can be attributed to the fact that decentralizing clinical trials addresses major obstacles to equity and access by removing barriers for patients such as geographic location, distrust of healthcare systems, accurate collection of patient symptoms, pain points, and outcomes, and much more. Removing geographic barriers for patients in healthcare through virtual trial sites Most traditional clinical trials are run at hospitals, academic research centers, or universities, therefore only people with the ability to get to the facility can participate. Many trials also involve frequent visits to the physical site location. This requires participants to afford numerous trips on private or public transportation or live within a commutable distance. Obviously, this prevents many patients from participating and providing valuable data. Incorporating virtual clinical trial site models allows researchers to expand patient access to these trials.  With this model, patients across the globe can contribute to the same study without leaving their homes or traveling further than their local urgent care or physician’s offices. Concurrently, researchers can gain key insights into how different lifestyles and environments influence health and medication effectiveness – this type of data can also be a key element to understanding and fighting against disparities and inequities in the healthcare ecosystem.  Building patient-provider relationships As we have seen quite clearly with the rollout of the Covid-19 vaccine, many people are wary of the American healthcare system. The Tuskegee Study, for instance, is one example of historic abuse of minority groups causing ongoing generational trauma. To overcome this systemic issue, patients need to feel that they can trust the clinicians collecting their data and developing their treatment plans. Utilizing patient-centric software designed to help providers focus on building patient relationships, physicians become researchers just by treating the patients they see every day. Not only does the physician-centric model encourage diversity in trial participants but it also provides opportunities for patients who might not otherwise hear about clinical trials. Represent the underrepresented with us While underrepresentation in clinical trials continues to be an issue, there is a general consensus among the life sciences community that we need a transformation. But how do we make sustainable and meaningful change? At Curebase, we recognize that decentralized clinical trials are the future of R&D. Every day, we are innovating and improving access for physicians, patients, and researchers. We are on a mission to ensure every patient can participate in cutting-edge medical research. We believe that including patients with varying backgrounds, experiences, and identities in clinical trials is essential for advancing healthcare. Decentralizing clinical trials can address healthcare disparities across race, gender, and ethnicity by increasing equitable access and broadening the representation of clinical trial participants while collecting quality real-world data. Read more about diversity in clinical trials: Supporting Women’s health: Addressing gender disparities in clinical trials

Observations from the SCRS Global Site Solutions Summit By Kelly Brown, Chief Marketing Officer, Teckro At this year’s Global Site Solutions Summit hosted by the Society for Clinical Research Sites (SCRS), there were a few stand-out themes – workforce constraints, budgeting and contracting challenges, and the proliferation of technology in clinical research. It wasn’t just conversations about too much technology that struck me. It was the visceral, emotional expression of how this technology is affecting people. For example, one of the main stage events was called “Tech or Terror: What Does the Exponential Increase in Technology Mean to Current & Future Operations of Research Sites?”. I’ll come back to some observations from the session in a minute, but the word choice of terror is a good example of what I mean about strong emotions. Someone from a site network told me, “If (name redacted) were a building, I would light it on fire.” I’m not about publicly shaming anyone, so I’ll keep the vendor’s name to myself. Yet again, this is an example of anger and fury at things that are making life harder for research staff. What worries me is that “technology” is a catch-all category for anything and everything digital. If we peel back the onion a bit, there are a few things that are muddying the waters when it comes to clinical trial technology. Passwords Galore Several people during the conference said how they wished there would be mergers and acquisitions because there are too many clinical trial technology vendors. I haven’t done a scientific analysis of the per capita vendors compared with other industries, but certainly there are a lot and constant newcomers trying to join the party. Innovation comes by trying to make things better, but better is in the eye of the user. More vendors trying to innovate with solutions that improve clinical trial operations isn’t a bad thing. However, the unintended consequence is the number of different systems that research sites must manage by study and across sponsors. The proliferation of portals to log into and passwords to remember is at a point that is unsustainable for sites. One solution I heard debated will make IT security people cringe: to have non-expiring passwords. I seriously doubt that muting password security gets to the heart of the problem and likely will introduce more issues. Electronic Is Not Disruption The clinical trial industry is an obvious target for disruption, which is why there are so many solutions out there. But one of the observations made during the “Tech or Terror” session is that, by and large, clinical trial technology is simply making physical, manual processes electronic. There really isn’t a substantial improvement in how things are done – so to “modernize” them with technology doesn’t really fix the core underlying issues. Now, this “Tech or Terror” session was held in a ballroom and there were probably 100 people or more in the audience. The best indication of just how slow things are to evolve was about half of them are still using fax machines. Remember, fax machines were once innovative… decades ago. Clinical trials are still dominated by paper-biased processes, which is a bit of a paradox because your average physician is rarely dealing with paper outside of research. Yet, I talked with an investigator who said he printed every electronic communication to sign and include in his investigator site files. During a session that I moderated about remote monitoring, there were discussions about documents being printed and then held up to a video camera for CRAs to visually inspect remotely. Patients, Not Techies Recall that workforce shortage was another topic of the conference. Just like many other industries, there simply aren’t enough qualified people. Research staff are being lured away for better pay, and CRAs are leaving the industry at an alarming rate. So, it was shocking to me to hear that sites are investing in full-time positions to deal with tech support issues that patients have with their devices and apps. It’s no wonder that one of the research site owners that I talked with was adamant that he didn’t want anything to do with technology. He was lumping everything together and did admit his frustrations were with patient-facing technology. Not all people in clinical trials are tech savvy – or even appreciate technology. There are clear use cases for patient solutions, such as capturing real-time data and simplifying the patient experience. However, the burden on sites to troubleshoot their patient technology is untenable. Research Sites Take the Driver’s Seat Technology is here to stay. Research sites recognize this and are hiring IT support. Some are also carving out IT budgets and deciding their own tech stack for themselves. As a business, this makes absolute sense. Sites are pushing back. Some are refusing to use sponsor or CRO-mandated technology. Others are increasing the pass-through costs of technology training and enablement. For example, sites are spending between 10-20 hours per month per trial on training related to DCT technology, according to the annual SCRS site survey landscape. Sites are also declining studies due to unacceptable budgets, which also goes to the budget and contracting discussions during the conference. In a risk-averse industry, the status quo is safest. And paper is the “safe” choice when it comes to audit and inspection readiness – or so the belief goes. This then lends itself to clinical trial operations stuck between modern and antiquated – and research staff caught in the middle. Giving sites the flexibility to decide their own technology is just one step in the right direction to advance drug development and clinical trials, ultimately better serving patients. What’s Next At Teckro, we support the SCRS initiatives to help navigate approaches to advancing clinical trial technology. To that end, we will be a major contributor to the new SCRS Tech West conference in June. We look forward to leading discussions that will align technology with the needs of the clinical research industry and what sites really want. We encourage as many stakeholders as possible from sponsors, vendors, CROs and sites to work with us and SCRS. Read more site-related content

In October, SCRS came together with more than 1,200 clinical research professionals at the Global Site Solutions Summit to commemorate 10 years of advancing site success. We also celebrated forward-thinking organizations creating innovative solutions and partnerships advancing the clinical trials industry. In the November Sites NOW discussion, 2022 SCRS award recipients highlighted the initiatives and strategies that helped them stand out and earn well-deserved recognition. Putting patients at the center In 2021, DM Clinical Research decided to implement data-driven decisions to enrich the patient journey.  Patient-focused practices were already a core value of this year’s Excellence in Patient Centricity award recipient, DM Clinical Research, but they wanted to take that value a step further by making it a strategic goal. Hera Arham, Director of Marketing & Patient Engagement at DM Clinical Research, shared that they first worked to identify roadblocks and pain points their patients experienced. Through a sophisticated tracking system, they created an internal dashboard to identify issues at each site with the goal of changing staff behaviors to be more mindful of the patient experience. “Using data to operationalize patient centricity is the key,” said Arham. “How do we innovate to become a patient-centric company if we don’t have the data and tools?” DM Clinical then created a dedicated patient engagement team that was responsible for assessing, improving, monitoring and reporting on the end-to-end patient experience. Additionally, DM Clinical established an additional customer support team to manage real-time calls for all patient inquiries. This team answered questions ranging from transportation to the clinics, trial compensation, communication with staff, and even eDiary or compliance issues. Within the first six months, the dedicated team answered more than 17,000 phone calls that would have been missed and resolved 1,000+ patient issues in real time. Gathering patient feedback was also critical for DM Clinical. Patient input was collected through a combination of automated surveys and spot-individual interviews after each interaction. This allowed unfiltered contact with patients that were enrolled or considering enrolling. Scorecards were created for each site that measured Google reviews, focus group data, and survey data. The scorecards were reviewed by both site and leadership teams to determine solutions needed for improvement. Patient retention and referrals increased after implementing these practices. “Our shared-decision making helped us create a more patient-centric approach to identifying common trends and unique situations that impacted the way participants perceived research, DM Clinical, and medicine in general. We knew changing the culture within an organization to be more patient-centric meant that we’d need to support the change through reliable metrics and KPIs. Real data helps identify blind spots and track progressive improvement. At DM Clinical, we knew one thing to be true – we all needed to become patient advocates,” said Arham. Moving the needle in diverse community outreach and recruitment Javara, recipient of the Site Patient Recruitment Innovation Award (SPRIA), developed a recruitment plan to reach a variety of patients through different mediums, including social media advertising, doctor-to-patient email marketing, direct mail and newspaper ads. “Innovation isn’t just technology; it’s about taking existing processes and making them better,” shared Mike Clay, Chief Operating Officer at Javara. The recruitment efforts prioritized community engagement and human interaction. They worked with the non-profit organization Greater Gift to support this component. Greater Gift’s mission is to increase awareness of clinical research, especially among underrepresented communities. This partnership allowed Javara to develop relationships within diverse communities. By developing relationships and cultivating a community before recruitment efforts, the patient population was more receptive and in turn, Javara and SouthCoast Health were able to exceed enrollment for this study and increase diverse patient participation. Increasing the clinical research talent pool As we learned in the August 2022 Sites NOW discussion, there is a significant gap between the number of jobs available for clinical research coordinators (CRCs) and the number of qualified staff to fill those positions. To address this, Site Tank Award recipient UC Davis Health School of Medicine – Clinical and Translational Science Center (CTSC) developed a program to train the next generation of clinical research staff in 16 weeks. In collaboration with local community colleges, Medix, and UC Davis Health’s Diversity and Inclusion program, a pilot training program was launched to address the persistent shortage of CRCs and increase diversity of the clinical research workforce. The comprehensive training program also opened a pipeline to STEM careers for people historically underrepresented in these fields. Stipends, internships and shadowing opportunities were provided. This was the first comprehensive CRC training program administered by a public-private partnership. The program was unique in that it offered a combination of classroom learning with workplace exposure to clinical research processes. After completing the training, Medix helped place the clinical research coordinators in open roles with UC Davis or other organizations. UC Davis plans to expand the program by collaborating with more colleges and organizations nationwide. Site-centricity from the CRO perspective As the 2021 and 2022 recipient of the Eagle Award, PPD, part of Thermo Fisher Scientific, has been prioritizing site-focused approaches to everything they do. A more recent initiative by PPD has focused on improving training for sites that are new to clinical research and help those sites gain experience to earn more trials. As more sites adopt decentralized elements in their trials, PPD actively requests feedback from sites on how to make DCTs better overall and acts on that feedback. Diversity is another critical need for the industry that PPD is prioritizing. For diversity efforts, they have been working with sites to determine their needs for better diverse enrollment and developing programs to adapt to those needs. What can sites do to stand out and be noticed by CROs? Lisa Dyment, Senior Director of Site Collaborations at PPD, part of Thermo Fisher Scientific, encourages open dialogue and staying in close contact with the sponsor and CRO. “Have open dialogue with your points of contact at the sponsor and CRO. Be very honest about your enrollment objectives and what you can realistically achieve. Give feedback. Let us know what you like and don’t like about the study and challenges you might be facing. As an intermediary, we may not always have the power to make changes in a study, but we can definitely commit to passing the message along,” added Dyment. Establishing consistency at the sponsor level After the world was turned upside down from the pandemic, 2022 Eagle Award recipient Merck decided to get back to basics, working to analyze and understand the areas where sites needed support the most. Merck asked their sites about their pain points and then developed a strategy to step up to those needs. Sites have consistently asked for single points of contact for both CROs and sponsors, and Merck delivered in an especially critical area: budgeting and contracts. Merck appointed one person to negotiate budgets and contracts with each site, so that sites would only have to communicate with one person. Another initiative kept CRAs at the same sites to establish relationship, cadence and familiarity. Additionally, Merck created a dedicated, real-time technology support team to help sites with onboarding and implementing new technologies. Amplifying the voice of the sites Viviënne van de Walle, the Christine K. Pierre Site Impact Award winner, has been a huge advocate for SCRS and clinical research sites for decades. As an SCRS Leadership Council Member and European Site Solutions Summit chair, she is a remarkable leader and voice for sites around the world. Improving lives of patients is at the heart of Viviënne’s work, and improving processes at sites and throughout every stage of clinical research is a large part of that. Vivienne shared that clinical research stakeholders are understanding each other’s sides of the story by coming together often and communicating openly through mediums like Site Advocacy Groups, online and in-person events, and the SCRS online community. Congratulations again to all of the 2022 award recipients and finalists! Learn more about each award at sitesolutionssummit.com. Watch the replay of the Sites NOW discussion here: