Summit Reflections

The 2024 SCRS Global Site Solutions Summit brought together 1,700 clinical research leaders to explore new approaches to enhance site performance and patient outcomes. The four-day event brought together research sites, sponsors, CROs, and solution providers to foster new insights and partnerships through an in-depth look at real-world challenges in site operations. The theme for the 2024 Summit – “Partner for Progress, Innovate for Impact” – served as a central focus for our discussions, sharing challenges and opportunities for improving the clinical research ecosystem. On Wednesday, SCRS hosted a Hidden Costs of Conducting Clinical Trials workshop, a foundational learning experience showcasing strategies for calculating true study costs and negotiating fair budgets with sponsors and CROs. The Summit officially commenced on Friday with insights from the annual Site Landscape Survey, innovation showcases from Site Spark award finalists, and inspiring stories from patients and sites. On day two, plenary sessions focused on how to transform research for greater inclusivity, followed by additional insights from the Site Landscape Survey. 40+ breakout discussions were hosted on Saturday, covering topics such as business development, patient recruitment, workforce management, regulatory guidance, DEI, legal considerations, and more. Ken Getz, Director of the Tufts Center for the Study of Drug Development and Research Professor at Tufts University School of Medicine, kicked off the final day of the Summit. Getz highlighted evolving challenges and opportunities in the clinical trial landscape, particularly with rare disease therapies, rising costs, and growing complexity. Trends, Challenges, and Opportunities In his keynote presentation, Getz noted several industry trends such as increased layoffs, budget constraints, and global volatility impacting clinical trial startups and overall drug development. A prominent challenge impacting today’s trials is the complexity of protocols, data volume, and the growing use of multiple data sources. These factors have contributed to longer trial durations, increased patient burden, and higher failure rates in studies—particularly in rare diseases and oncology. Further complicating the landscape is the increasing customization of trials, driven by small biotech companies and CRO partnerships. This has led to a high volume of site feasibility assessments, resulting in an estimated $350 million spent by sites last year on qualification processes, often without securing study grants. To address these challenges, Getz identified three key optimization areas: patient engagement, data management, and risk management. By focusing on integration, cross-functional collaboration, and continuous monitoring, there are opportunities to reduce risk, share costs, and better engage critical partners like sites and patients. Additionally, a shift toward shared risk models between sponsors, payers, and patients was suggested as a path forward to meet the increasing complexity of clinical trials. Getz emphasized the urgent need for the industry to seize opportunities to embed clinical research into patients’ broader healthcare journeys and utilize AI, real-world data, and novel trial designs to enhance data collection and operational efficiency. Trial Complexity and Timelines A key obstacle raised throughout the Summit is the complexity of trial protocols, which drives the need for more assessments and specialized site requirements. Additionally, the lack of standardization across portals and systems further complicates the process, creating a fragmented experience for sites. There is a call for greater data interoperability and better integration of systems to simplify site management, but progress remains slow. From a sponsor perspective, there is sometimes an urgency to “fail fast” in clinical trials, particularly in high-risk phases. Sponsors are often forced to accelerate timelines in response to portfolio risks, which can place sudden, high-pressure demands on sites. This dynamic illustrates the broader issue of miscommunication between sites and sponsors regarding the risks and pressures each party faces. The role of site engagement and relationship management teams was also recognized as critical factor to improve site-sponsor collaboration. Feasibility Clinical research sites face overwhelming time demands of feasibility questionnaires and qualification visits. A striking observation was that site staff spend about a week per month on these tasks, diverting valuable time away from supporting trial participants. Sites are often asked for the same information repeatedly, so it’s imperative that we continue to streamline repetitive processes and invest in better systems to reduce this time burden on sites. Site time spent on feasibility assessments could be streamlined or reduced if sponsors and CROs find ways to utilize existing site data. Innovation and Technology Integration  Sites are increasingly leveraging technology to improve efficiency. Many sites discussed the adoption of electronic data capture (EDC) systems, telemedicine solutions, and other digital platforms that have streamlined site management and patient interactions. The role of artificial intelligence (AI) and data analytics in predicting patient enrollment trends and improving trial outcomes is also growing substantially. The use of digital tools to engage patients was a recurring theme. Investing in the latest tech for patient recruitment can enhance study visibility, though it’s imperative to recognize that technology solutions may not suit every study or patient demographic. Understanding patient preferences and tailoring approaches to meet their needs is a key first step. By integrating patient feedback into trial design, we can ensure that studies are patient-friendly and responsive to their concerns. YPrime’s Aubrey Verna remarked that we’re in a state of “Frankensteined” technology where sites struggle to manage multiple disjointed systems. She pointed out that technology should simplify, not complicate, site workflows. Seamless integrations, such as API solutions, and better partnerships can simplify the user experience for site staff. Further, there is a prominent need to reduce the number of vendors and align preferred vendor lists between sites and sponsors to further minimize bottlenecks. SCRS reiterated the call for sponsors, CROs and vendors to reduce site technology training requirements by at least 25% in 2025. Training should be “right-sized” to eliminate unnecessary duplication and focus on what is truly essential. This goal can be accomplished by switching to role-based training, deferring training until after protocol startup, allowing for training test-outs, and allowing for training reciprocity among sponsors and vendors. If the goal is to reduce site burden and improve site operations through unified, user-friendly platforms, it’s imperative to involve sites in technology decision-making, development, and testing. Early engagement with sites during protocol reviews can create alignment and reduce ambiguity with technology-enabled trials. Moreover, technology implementation budgets need to account for indirect costs, such as time away from patient care, and ensure risk mitigation to avoid further burdening sites. Sites, sponsors, CROs, and vendor partners can work together to improve processes end to end. As always, system and process improvements should be balanced with the need to focus on supporting the people who drive clinical trials forward – sites and patients. Record Retention Some sponsors and CROs continue to obligate their sites to retain study records for years or even decades beyond regulatory obligations. Sites have clearly expressed that they do not want to take part in long-term record archiving, and the industry collectively agrees that current budgets are not adequate for long-term storage. Ironically, the 2024 Site Landscape Survey showed that only 21% of sponsors and CROs feel sites are “very competent” in meeting the demands of long-term electronic record archiving. It’s recommended that sponsors work with their own storage vendors to keep study records, taking this burden off of sites and allowing secure access to files when needed. Diversity and Inclusion There is a need for culturally competent recruitment approaches, especially to make trials more accessible among diverse populations. Training site staff on cultural sensitivity and awareness to build trust with different patient communities. To start, sites are encouraged to promote a diversity-first hiring strategy that attracts candidates with a range of skills and backgrounds. Community outreach funding is also essential for enhancing inclusive research, although it has been challenging to include under traditional marketing budgets. Further, developing long-term partnerships with community organizations that serve underrepresented groups has helped increase research participation and improve trial inclusivity. Workforce Although the state of the site workforce has improved compared to prior years, attendees collaborated on ways to bring more site staff into the ecosystem, along with improving training and retention. Proper onboarding and creative benefit structures were highlighted as essential to reducing employee turnover and meeting cultural demands. Creative benefits that align with the cultural and personal needs of employees can further reinforce engagement. Onboarding and training are vital for ensuring long-term staff engagement and reducing turnover. A well-structured onboarding experience fosters a sense of belonging and enhances performance from the start. Sites should develop thorough onboarding processes with targeted training programs that address specific roles, helping new employees integrate smoothly. Alison Liddy from IQVIA also emphasized the importance of bringing new investigators into the fold, partnering with sponsors to ensure these sites have the tools they need to succeed, and preventing them from becoming “one-and-done” investigators. Investigator training and mentorship are crucial for developing the skills needed to lead effective clinical trials, where the guidance of seasoned study coordinators and mentors can help new investigators navigate challenges. Training should balance clinical knowledge with practical business skills, covering essentials such as Good Clinical Practice (GCP) and regulatory processes. There was a call for sponsors and CROs to invest in new, research-naïve sites by offering infrastructure support and avoiding common pitfalls like underpaying or overwhelming these sites with complex processes. This includes funding investigator training, which increases preparedness and reduces turnover. Innovating for Impact Partner for Progress, Innovate for Impact: our hope is that this theme is not just words, but the core of what we achieve together in 2024 and beyond. The connections, ideas, and collaborations we form will drive the progress we are collectively striving for and create a lasting impact on our industry. The work ahead requires working together with evolved purpose, collaboration and, of course, action. It’s remarkable to think of the progress our industry made together at the Global Site Solutions Summit and the transformations to come. Our collective achievements are possible because of the partnerships we build, the challenges we face, and the solutions we pursue to solve those challenges together. Let this be a reminder that when we unite with purpose, we don’t just progress – we transform. Thank you for your contributions and commitment to making a difference. We hope to see you again soon.

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.

Over 400 clinical research professionals recently gathered at the SCRS Global Oncology Site Solutions Summit in Austin, Texas, for oncology-focused education, networking and a look at the offerings of leading service providers. Sixty-four speakers in 19 sessions over 1-1/2 days provided a wealth of insights and practical tips for clinical research sites, sponsors, CROs and solution providers, such as the following: Technology The current chaos in clinical research technology may pass as providers address their technology problems, superior products become dominant or merge together, fewer new products emerge, and sites discover which technologies best fit their needs. Sponsors should obtain input from sites on the sponsor-provided technologies that sites will have to use. Integration across technologies is essential. Smaller sites often cannot afford modern technology for clinical studies. Patients need options and flexibility in the technology they use (or don’t use). Elderly patients, in addition to any infirmities, may lack general technology competence and affinity. 100% of sites polled in the SCRS Oncology Landscape Survey are open to decentralized oncology studies, meaning some or all components are done virtually or off-site. Site Workforce Workforce is the number-one site issue now. Personnel shortages limit capacity, stress personnel, and can reduce employee retention, productivity and work quality. Because of workforce issues, some sites are refusing studies with complex protocols or unfamiliar technology. The shortage of study coordinators has spread to investigators and regulatory and other specialists. Hire quality people with the right attitude. Train for skills. Broaden searches to entry-level people, community college programs, pre-meds, etc. Arbitrary requirements, e.g., at least two years of experience, should be replaced with competency requirements and assessed by the site. When appropriate, outsource functions that can be outsourced. Financial Toxicity Most cancer patients must make serious money vs. health tradeoffs. Financial issues increase stress, damaging patient health outcomes. Patients need a comprehensive financial plan but accuracy can be problematic. Study personnel, including investigators, rarely have the expertise or inclination to advise patients about their treatment costs, which vary by patient, be very complicated, and may be unknowable in advance. Patient navigators/advocates/concierges should be able to advise patients on financial issues. Study physicians are often out of network. A five-percent copay on a $50,000 treatment is significant. In addition to treatment-related costs, patients may incur travel, lodging, caregiver, childcare, lost wages, and other out-of-pocket costs. The Medicare secondary payor rule constrains the patient costs that the study sponsor or site can cover. IRBs should not object to even substantial cost reimbursements to patients, which do not constitute income. Given that financial toxicity can hinder enrollment, retention and adherence, study sponsors should consider conducting fewer trials so they can afford better financial support for patients. Identify each patient’s specific needs. Lazarex and other non-profit organizations may be able to help patients with the financial aspects of clinical study participation. Include patients in the design of all aspects of a study that touch them. When hospitals create an oncology grid that provides one study for each combination of cancer type and stage, enrollment in many of the studies can be problematic. The hospitals in a community should, therefore, cooperate on filling the parts of the grid that will be used infrequently. Site Centricity “Site centricity” means seeing a study from the site’s perspective (empathy), giving them a voice in study design, and making their priorities your priorities. You can’t consider a site without considering its community. Sponsor and CRO study personnel need to understand what is happening at the site, e.g., by shadowing a study coordinator. (However, some sites do not allow CRAs (or colleagues) on site.) Studies should employ key performance indicators that reflect site priorities. Hold periodic meetings with personnel from multiple sites. Decentralized Clinical Trials (DCTs) DCTs are not one size fits all. DCTs are not siteless. Use DCTs to reduce patient burden. Beware of using DCT to transfer, rather than decrease, burden. Sites are not adequately compensated for the additional costs they incur in DCTs. Investigators are concerned about their ability to oversee remote personnel (e.g., home nurses) and the related safety and liability issues. Sites are often not equipped to deal with patient technology issues. Fully inform sites and patients and set expectations. Options (e.g., mobile phone vs. paper data eCOA, telephone/email/text/app communications) are essential. Flexibility (e.g., car service for participants without a smartphone, community locations like libraries for Internet access) is essential. Use home visits and online options to prepare for site visits, e.g., QoL questionnaires, tests and assessments. Be creative, e.g., let participants take photos of food rather than logging meals in a diary. Before a study starts, test DCT processes and technology in a protocol simulation with sites and patients. Include someone familiar with the technology at the first patient visit. DCT allows studies to cast a broader net but, so far, it does not appear to have helped improve the principal measures of diversity. Home visits can create numerous issues, e.g., safety for the nurse in a dangerous neighborhood, making a patient with limited mobility feel they have to clean their home, or falling off a chair when replacing a lightbulb at the patient’s request. Keep in mind a lot of study processes are the same with or without DCT. Diversity There is less diversity in oncology studies than in other therapeutic indications. Many or most oncology protocols do not include diversity-related requirements. According to the SCRS Oncology Site Landscape Survey, 36% of oncology departments have implemented diversity-related policies, practices and procedures. Improving diversity requires collecting sensitive personal data (e.g., income) that does not appear related to healthcare, so clearly communicate the diversity objective to patients when collecting such data. Sites with a high concentration of financially well-off, Caucasian patients can contribute to age, sex, gender and other measures of diversity. Do not assume that study coordinators have the skillset or time to conduct community outreach activities. The patients in an oncology study are the study’s biggest cheerleaders. Learn more about the SCRS Global Oncology Site Solutions Summit. About the Author Norman M. Goldfarb is managing director of Elimar Systems, which is developing a technology platform to transform clinical research into a collaborative, learning enterprise. He is also executive director of the Site Council and the Clinical Research Interoperability Standards Initiative (CRISI). Previously, he was chief collaboration officer of WCG Clinical, founded and led the MAGI conferences, and published the Journal of Clinical Research Best Practices.

More than 400 clinical research professionals, including many key industry personnel and decision-makers, recently gathered at the SCRS Diversity Site Solutions Summit in Austin, Texas, for education, networking and a look at the offerings of leading solution providers. Sixty-seven speakers in 18 sessions over 1-1/2 days provided a wealth of insights and practical tips for clinical research sites, sponsors, CROs and service providers, such as the following: Perspectives The clinical research industry lacks a consensus definition of “diversity” or even explicit agreement on why we want diversity (e.g., clinical relevance, commercial relevance, and/or inclusion of underserved populations). Any definition should be quantitative so diversity can be measured and managed in a consistent, actionable and accountable manner. The Diverse and Equitable Participation in Clinical Trials (DEPICT) Act requires clinical studies reviewed by the FDA to include a diversity action plan, including socioeconomic considerations, such as occupation, education, income, wealth and location. Although diversity in COVID vaccine studies has been high, diversity plummeted in other studies during the COVID pandemic. Because increasing diversity in a study population increases variability, it reduces statistical power, meaning that a larger sample size and budget are required. Higher diversity does not necessarily mean that subgroup analysis will be possible. If a small subgroup has a disproportionate number of serious adverse events, establishing causation may be problematic. It may make more sense to assess diversity over a clinical research program with multiple studies. It is unclear whether any study sponsors are doing causal analysis or A/B testing (comparing two options while holding other variables constant) of measures to improve diversity in clinical studies. Populations Caucasians constitute 59% of the U.S. population and 75% of study participants, meaning that Caucasians have more than double the likelihood of enrolling in a clinical study than non-Caucasians. Disabilities and chronic diseases: Over 50% of the adult U.S. population has a disability (including hidden ones). Service animals may be prohibited from site premises, excluding these populations from participating in studies with on-site visit requirements. Sixty percent of the adult U.S. population has a chronic disease. Excluding these populations without a solid scientific reason drastically reduces the available population. LGBTQ+: Ten percent of the of adult U.S. population is LGBTQ and are strong advocates of clinical research because of their community’s history with HIV/AIDS. Nevertheless, HIV prevention medication (PREP) is an exclusion factor in over 50% of studies, including life-saving cancer trials. Regional differences: Diversity means different things in different countries. Race and ethnicity are unusually important in the U.S. Other countries may focus on religion, caste, tribe, national origin or other factors. Intersectional patients (in more than one group) add an interesting twist to diversity. Diversity Landscape Survey In the SCRS Diversity Landscape Survey, 65% of site survey respondents said structured site diversity enrollment capabilities affect the site selection process by a “significant” or “good” amount. 62% of site respondents said their site does not have the support it needs to meet FDA guidance and sponsor requirements. Site respondents rated trial budget support and trial-specific community support as their highest priorities. Respondents indicated only 23% of protocols include diversity-related budget items. However, 53% of sponsors indicated that they plan to offer diversity-related budgetary items in the future, and 23% do already. Notably, survey results indicated that technology has not enabled diverse patient enrollment for most sites (60%). 40% of survey respondents said approximately 40-70+% of their tools and materials have diverse patient preclusive language, meaning diverse populations may not be able to participate if they are non-English speaking or LGBTQ+, for example. In a verbal survey of about 200 conference attendees, only two attendees had ever been asked by their physician to participate in a therapeutic study. Other factors may be responsible for low study participation in underserved populations. Challenges and Obstacles Each dimension of diversity presents its own unique collection of obstacles. Because of their life challenges, retaining low-income patients in a clinical study may be more difficult than recruiting them in the first place. For example, low-income or rural populations may not have smartphones or WiFi access, leading to digital exclusion. Additionally, patients may not be able to use payment cards, and those without a bank account may not be able to cash checks. Taxes on patient payments and stipends remain a barrier for many patients, especially those without a social security number. It is likely a lack of awareness from the U.S. government – not active malice – that makes study stipends taxable, which can disqualify low-income patients from income-tested benefits programs. Sites often need to negotiate for patient travel reimbursement. Note, however, that study budgets do not typically include additional budget for site staff to help patients that may require more support or assistance than others. Also, underserved populations are often ineligible for some studies because their insurance does not cover the costs of a first-line therapy study or the previous first-line therapy that well-insured patients have already had. On the other hand, they can be an excellent source of treatment-naïve patients. While giving investigators discretion on patient enrollment makes sense, it may open the door to arbitrary exclusions based on convenience, prejudice or preconception. Moving Forward & Practical Tips Industry leaders from sites, patient advocacy groups, solution providers, sponsors, CRO and regulatory agencies shared many practical and applicable tips to improve diversity, equity and inclusion in clinical trials. Community outreach came up repeatedly at the conference as the solution to just about every problem. Clinical research sites need to proactively and consistently build trust with underrepresented populations. Sites can collaborate with other sites, healthcare providers, physicians, and community leaders to develop a coordinated community outreach program. Many healthcare institutions have health-disparity programs with dedicated community outreach resources that clinical researchers can leverage. It was discussed that community outreach programs could be funded by a “3% Pledge” program by which sponsors and sites agree to allocate at least three percent of patient recruitment budgets for community outreach. Additionally, Clinical and Translational Science Awards (CTSA) to academic medical centers include community outreach funds. Sites need to move from transactional relationships with patients (study by study) to long-term relationships in which they can build trust. Both study sponsors and sites need a solid diversity plan with measurable goals and accountability. Furthermore, be mindful of the imagery and language used to recruit patients. Artificial intelligence can be used to create racially diverse images for patient recruitment advertisements, although it would reduce the income of photographers and diverse models. Try to put yourself in the patient’s shoes, which requires an in-depth understanding of their situation. Guessing is not an adequate substitute. Most importantly, study design (e.g., eligibility criteria) must consider diversity. Do not mindlessly recycle text from previous studies (#StopTheCopyPaste). Hire diverse people to work at your site and organization. Teach your staff basic conversational and medical phrases in languages your patients speak. Explore funding options with study sponsors, industry organizations and advocacy groups to ensure your site has adequate funding for community outreach, patient transportation, translation services and other resources to facilitate access and inclusion. Assess your site’s knowledge and understanding of the needs of diverse populations with the SCRS Diversity Site Assessment Tool (DSAT), which is being used by more industry sponsors to understand site capacities for diverse recruitment. Learn more about the Diversity Site Solutions Summit. About the Author Norman M. Goldfarb is managing director of Elimar Systems, which is developing a technology platform to transform clinical research into a collaborative, learning enterprise. He is also executive director of the Site Council and the Clinical Research Interoperability Standards Initiative (CRISI). Previously, he was chief collaboration officer of WCG Clinical, founded and led the MAGI conferences, and published the Journal of Clinical Research Best Practices.