infocusoct23

By Dan Braga, Vice President, Product Management, EHR and Healthcare Solutions, Medidata Repetition—depending on the task at hand—can be a positive or negative thing. On the positive side, repetition may assist in honing skills, enabling us to become proficient in what we do, whatever that may be. On the negative side, repeating specific tasks may be time-consuming, tedious, frustrating, or stressful. Data re-entry has been an issue in clinical trials for as long as many of us can remember. The question often asked is, why should busy professionals be forced to spend their limited time duplicating data that has been captured previously and is available from other sources, such as Electronic Health Records (EHRs), Clinical Trial Management Systems (CTMS), eSource, documents (e.g., lab values in a spreadsheet), or other systems? According to a survey conducted by Medidata and the Society for Clinical Research Sites in 2022, 98% of sites reported that they manually re-enter data into Electronic Data Capture (EDC) systems, with nearly 70% of them stating that more than 50% of their EDC data is re-entered using existing EHR data. This is inefficient, and it must be frustrating for research coordinators who could be spending time on more valuable study tasks or with their patients. In addition to the vast amount of time that this process takes, there is a high probability that transcription errors will be introduced, resulting in additional time and effort being spent by monitors and data managers on raising queries and by sites on resolving them—a laborious undertaking, given that the average number of queries per Phase III study was found to be 96,980 (Stokman, 2021). Also, remember that the data generated by clinical trials continues to increase yearly, adding to the growing burden. So, what has been done to resolve the issue, and why is it taking so long to find a solution? Isn’t technology meant to reduce or remove problems like this? Two Steps Forward and One Step Back Issues were recognized many years ago. EDC systems have long been used to collect, clean, transfer, and process clinical data. Efforts have been made by clinical researchers and technology providers to repurpose EHR data in a scalable way. Certain attempts to address the issues have shown great promise, and many positive steps have been taken to improve efficiency and reduce errors. Still, adoption and progress have been slow, with little change until recently. Additionally, automating EHR to EDC data transfer and integration benefits include reduced trial costs, earlier identification of safety events, and faster trial completion. With increasing complexity in clinical trials and the sheer volume of data being processed, automation reduces the burden of data entry and reduces data quality issues. On the other hand, in the background, progress has been slowed by issues that most users will not be aware of. For a start, the industry was initially working without universal standards, which we’ll come to in a moment. One limitation is the inability of specific EHR systems to interoperate (communicate and work together) with other EHRs. Another is the inability of data entry/transfer automation solutions to work with non-EHR data; some are limited to working with just a few selected EHRs. Variation in configuration from one EHR to another presents an additional issue. These challenges have led to longer implementation times due to complexity, higher resource requirements, and higher costs. This has meant that, while they have demonstrated promising results on single studies with a small number of sites, solutions have not proven to be easily scalable to multiple studies with large sites. Fortunately, a couple of crucial changes took place, paving the way for creating a new system that addresses the industry’s challenges and reduces the burden of data entry and re-entry for clinical trial professionals. The Turning Point On December 13, 2016, the 21st Century Cures Act was signed into law in the United States, with one of its aims being to enhance interoperability and reduce regulatory burdens associated with sharing healthcare data. This was a huge step, enabling specialist service and systems providers to create an interoperable ecosystem of solutions that help research sites and end-users. Additionally, EHR data interoperability was standardized by the Office of the National Coordinator for Health Information Technology (ONC) when they recommended using the HL7® FHIR® (Fast Healthcare Interoperability Resources) standard. Although extracting data from EHRs and feeding them into EDC systems remains complex, these changes have provided a tailwind and a standardized approach for data exchange. Furthermore, regulatory agencies have recognized the value of EHR data in clinical research and encouraged its use in guidance and recommendations. These changes enabled the creation of technology solutions that address industry challenges based on standards and interoperability. Is There a Solution Now? In 2022, a unique solution that exceeded the industry’s limited prior offerings and set a new standard was unveiled. The new system introduced interoperability beyond EHR and EDCs, expanding connectivity across multiple data sources while significantly improving the user experience. Using an alternative approach to other systems—one that doesn’t try to automate the process fully—provides easy-to-use tools that assist the Clinical Research Coordinator (CRC) in completing EDC forms (eCRFs – electronic case report forms) much more easily and quickly.  Because it doesn’t rely on costly, time-consuming, upfront mappings between EHR and EDC systems, which can change from study to study and system to system, set-up is quicker, easier, and scalable across multiple studies and sites. No automated solution has proven 100% accurate mapping between an EHR and an EDC’s specific clinical trial visit records. With the new system, the CRC always controls which data is submitted into the EDC system. The new solution takes a multi-pronged approach, leveraging multiple ways of getting data, and taps into existing networks and interfaces, including direct connections to sites’ EHR systems and data aggregation platforms. From a site user perspective, the solution is a data entry assistant that allows research coordinators to retain complete control over what is submitted into the EDC system. It supports structured and unstructured data, so it is simple to capture data from any source application or document. As it can operate with or without connection to an EHR system, it offers flexibility and adaptability to different workflows while leveraging multiple connectivity options whenever a link is necessary. With its more straightforward approach, the solution eliminates the need for an EHR to trial protocol mapping exercise, saving valuable time and effort for the research team. Most importantly, it removes the need for a highly tedious and time-consuming data re-entry process, replacing it ‘with just a few clicks’ for the user. Major US sites and site networks are rolling out this solution, and they’re seeing highly positive results, with site users finding it very easy to install and use; more importantly, they’re seeing significant time savings in completing EDC forms.  At one site, the time usually taken to complete an EDC form, requiring 48 lab values and seven other values to be entered manually (looking up the data in the EHR or other system/document and re-entering it into the EDC form), was 22 minutes. With the new data entry assistant solution, the same form, with the same data, can be completed in just 30 seconds. That’s 44 times faster, meaning that sites can complete data entry for more patients in less time, freeing them up for more valuable clinical research and patient care activities. An excellent white paper on this topic can be found here, and if you love podcasts, here is a link to the SCRS Talks Podcast with Jimmy Bechtel, MBA, VP Site Engagement, SCRS, and Dan Braga, Vice President, Product Management, EHR and Healthcare Solutions, Medidata. Summary By addressing interoperability challenges, enabling other source data to be captured quickly, and simplifying data entry, the new solution provides a user-friendly, simple solution for clinical researchers, eliminating the need to bounce between applications and making data entry and re-entry easier, faster, and more accurate. It means fewer queries, an easier workday, and more time to focus on critical tasks and patients. The result? Happy sites, CROs, Sponsors, and patients.  And all this is achieved “with just a few clicks.”

The 2023 Global Site Solutions Summit was one to remember, hailing our biggest turnout yet. More than 1,300 industry leaders joined us to share resources, knowledge and best practices while collaborating to improve the ever-changing world of clinical research. With more than 180 speakers across 12 plenary sessions, 40 breakouts and 8 therapeutic roundtables, many insights were shared on topics such as finances, inclusion, recruitment, staffing, business development and more. Site Landscape A new iteration of the annual Site Landscape presentation kicked off the Summit. Throughout the year, we’ve collected responses in micro-landscape surveys covering diversity, technology, and the site workforce. At this year’s Global Summit, we highlighted the most critical points industry stakeholders need to know. Record Retention New for 2023, experiences with record retention and storage were requested. What we’ve learned is that the nuances of voluntary record retention beyond a site’s regulatory retention period are becoming increasingly complicated. While some sites feel willing and capable of being long-term record storage vendors for the sponsor’s business needs, most don’t. Sites shared that they don’t want to be pushed into learning this new business. From these sentiments, it’s clear that sponsor support for alternate accommodations is needed. The most sensible option is for sponsors to use their own record storage vendors and remove the burden from the site. Accounts Receivable The site industry’s accounts receivable days are out of the norm for healthcare and a cause for concern. Although some sites may be partially responsible due to late delivery of deliverables, it is also heavily caused by poor payment terms in CTAs (i.e., quarterly payments and holdbacks). Even with 100% monthly payment terms, sites often see the sponsors/CROs not adhering to that schedule. There are things that are outside of our control, whether we work at a site, sponsor, or CRO, but it’s important to proactively communicate regularly and set the right expectations. Payment Terms The industry is making progress on getting back to monthly payments without holdbacks again. However, it is unfortunate that some sponsors are still initiating sub-optimal payment terms and switching to monthly payments without holdbacks only for the sites that ask for them. Having the cash flow necessary for optimal study conduct should not be subject only to good negotiating on behalf of the sites – it should be a standard issue in budgets. Study delays and cancellations are much higher now than they have been previously. To account for this, we are hearing budgets and contracts allocate study delay fees or cancellation fees to keep the sites afloat during that time. Having a contingency or “catch-all” budget is also gaining more traction to cover unexpected expenses that arise for a study. If you are involved in budgets at the site level and have not seen the SCRS Invoiceables Toolkit, this tool is available to help you calculate and negotiate budgets that better cover all your site’s costs. Workforce Workforce issues are still challenging sites, and several factors are at play. The most pressing challenge is the sites’ inability to compete with hyper-rising salary demands. Workforce development programs are needed for the industry as a whole, and some organizations have already begun offering scholarship and internship programs. Additionally, due to not having enough staff members, sites are having to be more selective in the studies they undertake and the sponsors/CROs they work with. Sponsors and CROs can also help sites understand upcoming trial pipelines so they can plan better for staffing needs. Technology & Training As we’ve become much more familiar and comfortable with DCTs, trials with decentralized components are now the norm. Now, we’re exploring the potential of AI. Many sites and industry partners have seen how AI can be a powerful tool for streamlining and enhancing our operations. Its potential to transform or automate processes, such as streamlining recruitment or feasibility questionnaires, is truly transforming the way we conduct research. As the use of technology in trials grows, so do training requirements. Unanimously, SCRS calls for industry partners to eliminate anything that is unnecessary, redundant or “check the box” training and shift to a more risk-based approach.  Provide options. Not every site or protocol is one-size-fits-all. Patient Perspectives As always, SCRS aims to help you reinvigorate your “why” by featuring incredible patient stories. Zahara Weeks shared her moving journey as a patient and trial participant with sickle cell anemia. Zahara and her mom, Kesha, walked us through their journey of finding a clinical trial and how they are working to expand trial opportunities for individuals with sickle cell. At only 14 years old, Zahara, with the help of her parents, has organized several donation drives for children with various chronic diseases and disorders, called “Marley’s Mission to Give.” In spite of the many ups and downs that life with sickle cell brings, Zahara is determined to live her best life and believes that faith and the support of her family and medical team will allow her to accomplish anything she dreams. You can learn more about Zahara’s story in her book, Born A Warrior. SCRS is also proud to partner with Oliver Patch Project (OPP) to empower pediatric treatment participants to find their inner warriors as they endure life-changing milestone events. Brian Burkhart, who also spoke at the 2023 Global Oncology Summit, shared more about his organization’s mission to create a free, engaging platform where children with childhood cancers and their families can connect through a series of unique patches. At the Summit, Brian distributed an Ignite the Possibilities patch for Global attendees to join the mission. Learn more about Oliver Patch Project and consider making a donation. Engaging Underrepresented Populations Diversity, equity, and inclusion was also a critical topic. Speakers shed light on comprehensive approaches to developing diversity plans, offering valuable insights into sponsor expectations for sites. We heard firsthand how sponsors prioritize and implement diversity plans and the pivotal role that sites can play in driving these initiatives forward. Ensuring diverse representation in trials is a priority for all, and sites are willing to help sponsors meet their emerging DEI goals, but not at the sacrifice of their core business. Many sites have made significant investments in diversity planning at their own expense, but not all sites are able to do this. To be successful with ongoing community engagement efforts, sites need non-study-specific resources and funding. Sponsors and CROs have reiterated that they are willing and able to help sites with DEI-focused initiatives, but that support is first dependent on the site understanding their needs and appropriately asking for them. Sponsors and CROs can also empower staff that negotiate contracts and budgets to say “yes” without the need for multiple levels of escalation, and to do so more quickly. Developing diversity action plans can be extremely useful in providing justification for community engagement-related funds. Celebrating Industry Innovation & Collaboration Honoring the achievements of sites and industry partners truly strengthens our work. At the annual Eagle Award Gala & Awards Dinner, sponsored by Advarra, we recognized several organizations that have made significant impact and progress on clinical research partnerships and trial modernization: Eagle Award: Merck as the sponsor recipient, and Parexel as the CRO recipient Site Patient Recruitment Innovation Award (SPRIA): Cedar Health Research Site Tank: AlzWell Christine K. Pierre Site Impact Award: Fabian Sandoval, MD, CEO of Emerson Clinical Research Institute Excellence in Patient Centricity Award: Velocity Clinical Research Global Site Excellence in Diversity Award: Ascension St. John Clinical Research Institute Summit Standout Awards: Best Exhibit Design: Digital Auxilius; Warmest Smiles: Transformative Pharmaceutical Solutions (TPS); Best Aim: Helios Clinical Research; Summit Spirit Award: Lauren Stockwell from Clinical Research Fastrack Never Stop Learning At the Summit, there are endless opportunities to hear different perspectives, understand new technology options, and share proven strategies to streamline operations. Now is the time to take lessons learned from the Summit back to your organizations. Share with your team and brainstorm how you can take action. If it feels like too much, focus on addressing one thing at a time. Let’s build bridges to better collaborate and #IgniteThePossibilities in clinical research.

Effective clinical research relies on strong partnerships between sponsors, CROs, and sites to ensure the success of trials. A recent panel discussion at Sites NOW shared valuable insights into how sites and industry partners can enable more transparency and better communication throughout every stage of the relationship. Open Communication & Feedback Building and maintaining strong relationships with research sites are crucial for successful partnerships. We have many tools for communication at our disposal, but open channels for feedback between sites and their industry partners are still underutilized. Establishing mechanisms to collect site insights and feedback should be a top priority for both sponsors and CROs. First, explore opportunities to streamline communication between clinical research associates (CRAs), site relationship managers, and finance departments to quickly address site issues and challenges as they arise. Regular retrospectives at the end of studies can also offer valuable insights for future decisions and site needs. Initiatives such as annual site satisfaction surveys and pragmatic budgeting can actively address site needs and bolster trust. In order to have effective collaboration between all parties, we must work to bridge communication gaps between sponsors, CROs and sites to develop a holistic and site-centric approach. Rethinking Feasibility Kylie Scheideler with CCT Research started the discussion stating, “We have unintentionally created this environment at the feasibility stage that is not conducive to sites. Feasibility has become a game. It’s very transactional.” How can we change this? First, feasibility questionnaires should be much more flexible. Sites are adaptable and can tailor their capabilities to various scenarios if provided with the right support, budget, and resources. Feasibility processes should allow sites to outline different scenarios and their potential impact on enrollment and study success, promoting realistic enrollment goals based on available resources. Sites can work to change the narrative by presenting their unique value and capabilities. With feasibility, it’s vital to strike a balance between ambition and realism. New sites in particular should avoid making overly ambitious promises during the feasibility stage. In many instances, new sites overestimate their enrollment potential, creating a gap between expectations and reality. While enthusiasm is commendable, it’s more important to set realistic enrollment goals and be aware of the challenges in recruiting patients. Rather than solely focusing on enrollment goals, sites should emphasize the quality of the data they can collect and their relationships with patients. While sites may have access to a pool of potential study participants, consider that patient engagement necessitates an appropriate budget to do so. Access to patients is just one part of the equation; the site’s staff must run reports, contact potential participants, and provide support to engage them effectively. Patient willingness to participate in a study can vary, and a site’s experience in engaging with patients can be a valuable asset. Leveraging Data Scheideler added that sites can strengthen their position during negotiations and demonstrate their value by leveraging KPIs and performance data. Key Performance Indicators (KPIs) are valuable tools for justifying budget requests and advocating for site needs. By highlighting enrollment rates, patient retention, and study completion, sites can demonstrate their competence and effectiveness to sponsors and CROs. If sites don’t have data, focus on establishing clear KPIs from the start. These KPIs can include metrics related to patient recruitment, retention, and adherence to study protocols. New sites can demonstrate their commitment to success by setting and tracking performance metrics from the outset. Scheideler also emphasized the importance of being proactive in building credibility. New sites should not shy away from highlighting their patient access and the quality of their patient relationships. While their enrollment goals may be more conservative, their ability to engage and collect high-quality data from patients can be a compelling selling point. Casey Orvin from CenExel added, “Know the value of your site and your assets and use them. Use metrics. Use your experience. Use what you’ve successfully done in the past. Educate and inform and use that to your advantage.” Hidden Costs Approximately 32% of research sites reported declining more than 10% of study contracts due to budget constraints. Furthermore, 12% of surveyed sites declined 20% or more of their agreements for the same reason. These statistics underscore a growing confidence among research sites in negotiating agreements, driven by a better understanding of their operational costs and the importance of sustainable financial arrangements. Sponsors and CROs are encouraged to be receptive to site requests, acknowledging that they are grounded in genuine expenses related to executing the study effectively. However, some sites have expressed fear of retaliation if they decline a study (i.e., the sponsor or CRO may not ask them to participate in another study if the site declines one). Sponsors and CROs are urged to keep in mind that honesty and transparency should be encouraged – never punished. As the industry increasingly embraces technology-driven approaches, ensure research sites are equipped with the necessary information to understand the true costs of conducting a trial. To make appropriate decisions, sites need more information early on, especially if a study needs to utilize new platforms or implement diversity, equity, and inclusion plans. Improving Technology Implementation Usability testing is essential to ensure technology is user-friendly and meets end-user needs. Sponsors should actively seek feedback from research sites about their experiences with various technologies to make informed decisions about vendors. By integrating site feedback, technology solutions can better meet the needs of research sites and their trial participants. Research sites, in turn, should ask about the purpose and value of the technology and tools they are asked to use. Lesley Freese from IQVIA Technologies suggested that sites consider questions such as: What purpose is this technology solving? What value is it bringing my site? And, what expectations do we have around this technology? Maintaining an open feedback loop with technology end-users (patients and sites) through interviews, surveys, and user panels is critical to enhancing the user experience. Enable sites to feel comfortable sharing their technology experiences, either through CRO or sponsor contacts or directly with technology providers. Additionally, solution providers can consider serving as intermediaries between the technology and end users, providing support, hearing suggestions, and reducing the site’s burden with technology-related issues. Fostering Site Partnerships: A Sponsor’s Perspective Some organizations have already established dedicated teams to communicate regularly with sites, preventing issues from escalating and enabling smoother study operations. Alisa Constance with Merck, the recipient of the SCRS Eagle Award for two years in a row, shared insights into how their organization is taking proactive steps to build and strengthen site relationships. One of Merck’s key initiatives is an annual site satisfaction survey, which allows sites to provide direct feedback. This feedback is analyzed and used to drive actionable changes in Merck’s clinical research processes.  Additionally, Merck places a strong emphasis on budget transparency, collaborating with sites to design comprehensive budgets that include recruitment funds. Engage with Sites Early For many sponsors and CROs, understanding the day-to-day operational needs of research sites can be a challenge. Early engagement with research sites, starting even before protocol development, has become essential. Collaborating with sites and principal investigators (PIs) during the early stages of study planning can significantly enhance the quality of study protocols and bid defenses. Sites possess valuable insights and resources that can be leveraged throughout the research process. It is crucial for sites to articulate their needs, and sponsors/CROs should either accommodate these needs or provide clear explanations for any deviations. Establishing a strategy for maintaining the ongoing relationship with sponsors and CROs, beginning with the Clinical Trial Agreement (CTA), will help partnerships thrive. Sponsors and CROs are also encouraged to continue advocating for improvements in site payment terms and withholding percentages to further enhance site-centricity. It’s clear that the clinical research industry has come a long way in ensuring the site voice is heard while working to establish long-term partnerships. As sites grapple with deploying new technology, workforce challenges, and managing rising costs, a new frontier of collaboration is coming to light. Embracing open communication, early engagement with sites, and transparent budgets are just some of the ways the industry can continue to work together to ensure successful, site-centric clinical trials.

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