Views from ACRP Members
Topics highlighted include diversity and inclusion, decentralized clinical trial (DCT) elements, workforce challenges, and a possible role for sponsors and contract research organizations (CROs) in supporting outreach by sites based in diverse communities.
Nadege Gunn: Need for study-agnostic funding for sites in diverse areas
“The need for improved diversity of all kinds among trial participants will continue in 2024, with sponsor and CRO support critical to success,” said Nadege T. Gunn, MD, CPI, Gastroenterology/Hepatology, Medical Director, Senior Scientific Advisor, Velocity Clinical Research.
“Staffing at sites in underserved geographic areas will still be an issue, with high turnover and loss of site staff to CROs, sponsors, or sites in locations with more competitive salaries,” according to Gunn. “Improving workforce diversity at these sites would be helpful, since this is known to support recruitment of diverse study participants. A promising approach is to recruit early-career staff from non-traditional backgrounds. These recruits might include high school graduates with an interest in becoming pharmacy technicians or nursing assistants, who can be given fast-track introductory courses to clinical research, and then advanced through ACRP certification.”
“I’m hoping 2024 will bring more solutions in this area,” stated Gunn. “A promising way forward might be for sponsors and CROs to fund a long-term presence for sites within diverse communities. This would be based on consistent outreach and support rather than focused on recruitment for a specific trial. We should consider setting up a working group – perhaps spearheaded by ACRP, SCRS, or one of the smaller consortia of stakeholders – to investigate the options for some kind of ‘study-agnostic’ funding to support site staffing and outreach in underserved regions.”
“We’re also still facing many of the same issues around uniformity and streamlining of the processes around clinical trials,” noted Gunn. “To reduce site burden, there is a need for more automation and improved interoperability between systems. Hopefully solution providers will be active in this area in 2024, helping us to execute better at site level.”
Steve Satek: A push for “optionality” in study protocols
“Elements of diversity programs are coming to fruition, and I expect even more progress in 2024,” said Steve Satek, Executive Vice President, Great Lakes Clinical Trials. “Decentralized trial elements are currently being used less than during the pandemic. Now there is a push for ‘optionality,’ with participants able to select from various options how they interact with the study site. This allows for the fact that some people – including some from diverse populations – prefer to receive study-related care remotely, while others prefer in-person interactions with the healthcare team. Having a menu of options can increase the appeal of study participation and optimize patient experiences.”
“Artificial intelligence (AI) is making an impact across many industries, including healthcare,” noted Satek. “In clinical trials, we are using AI in areas such as database searches to identify possible study participants. In future, I hope we can use technology to link portals, databases, and technologies to a central platform. Interoperability will help address the increasing complexity of trials, easing the burden of technology use for site staff, as well as facilitating the process of managing multiple vendors.”
“Looking ahead, patient centricity must be kept in mind as study complexity increases,” stated Satek. “For example, in vaccine studies, which are highly competitive and fast enrolling, sponsors may benefit from taking a little more time to set up their studies and reduce the screening competition by guaranteeing enrollment slots for each study. This would help to avoid the excessive rescheduling and delays that we’re seeing at the moment. This will improve the patient experience, help with retention, and protect the site, study, and sponsor reputations.”
“At the sponsor level, trends for 2024 include incorporating more biomarkers into studies, particularly in Alzheimer’s disease, where there is increased activity following recent therapeutic breakthroughs,” according to Satek. “Platform studies are increasingly popular with sponsors, although at site level, any change in the main protocol must be reflected in each substudy, increasing the effort required for regulatory issues, paperwork, and financial aspects. Sites do benefit from involvement with platform studies due to their long-term nature, however, which enables appropriate staffing to be put in place well in advance.”
“I’m in favor of the concept of working with sponsors and CROs to help fund an ongoing presence for sites in diverse neighborhoods, unrelated to recruitment for specific studies,” Satek concluded. “This type of outreach – for example, having a presence at local farmers’ markets and offering health screenings — enables strong relationships with the community to flourish. As clinical research sites, we should work together to consider how best to achieve this goal – and to gain sponsor and CRO buy-in – by speaking out.”
Nancy Sacco: Sites are suffering from technology overload
“The various clinical research stakeholders have priorities for trials that do not always intersect,” according to Nancy Sacco, PhD, Head, Clinical/Site Development Operations, SiteBridge Research, Inc. “In any discussion, sponsors’ perspectives tend to prevail since they pay both sites and CROs – and sponsors almost inevitably press for the study to be done as quickly as possible, using the most experienced sites, and within a certain budget and timeline. Often, additional operational and infrastructure support is needed by sites, for example, to implement decentralized study elements in support of diversity. These may be vital to the sponsor for meeting its regulatory targets fo diversity, yet there can be barriers to obtaining this site support. Further, those most experienced sites historically don’t have the most diverse patient access, requiring a need to reach more sites and build future capacity.”
“In 2024, we need to draw the reins in, bringing clarity to what sites need and why, and how best to meet these needs,” stated Sacco. “For example, major advances in DCTs were made during the pandemic, and there is broad agreement on the value of decentralized elements. In 2024, we need to ensure that there is adequate support and training for these at the site level.”
“Multiplying technologies are causing issues for sites,” Sacco points out. “Currently, each sponsor has preferred systems and technologies for each trial – yet these rarely overlap. Each one requires separate training, as well as separate passwords and logins, causing frustration as well as a significant burden to site staff. This is especially true for study coordinators, who may be running half a dozen studies, all on different platforms. Having more say in technology choice would be more in line with the fact that sites are accountable for carrying out the study, including the Principal Investigator’s (PI’s) obligations to protect patient safety. Responsibility also needs to be allocated to an individual or group to ensure that sites are well trained and can use the required technology.”
“There is also a need for additional regulatory clarity on DCTs,” according to Sacco. “The U.S. Food and Drug Administration (FDA) draft guidance on this topic, published in May 2023,{1} is unclear about the PI’s responsibilities, especially for services from home healthcare companies and the use of technology, both of which may be chosen by the sponsor. This draft guidance will hopefully be improved based on feedback provided by sites and other stakeholders.”
Pamela Nelson: Need for consistent control over DCT elements
“Diversity and inclusion will still be huge issues in clinical trials in 2024,” according to Pamela Nelson, PhD, MSN, Founder and CEO of Bracane Company, Inc. Bracane is a research organization that specializes in clinical research and program management in underserved communities. “Adaptations to timelines and inclusion/exclusion criteria can help ensure that diverse participants are not being excluded inadvertently. One example I’ve come across is the requirement of some trials for female patients to take a pregnancy test or use an alternative form of contraception. This requirement can be highly offensive for members of the LGBTQ community with same-sex partners; the protocol should include an option for participants to say that this provision is not applicable to avoid this issue.”
“Scheduling of visits, including telehealth, should be flexible to allow for participants’ schedules, including work and childcare responsibilities,” added Nelson. “Health equity is also an issue, with many people who lack health insurance effectively being excluded from some trials due to the cost burden. ‘Wraparound’ or concierge-type services can help support diversity and inclusion; these add to costs, but can offer essential support for recruitment and retention. Making trials more inclusive is a complex endeavor, requiring cultural sensitivity and attention to equity.”
“DCT elements, which also support diversity and inclusion, are certain to continue in 2024,” noted Nelson. “Hopefully in future, we’ll see a less disjointed use of service providers and more consistent control over operational aspects of DCTs. This is especially important in patient care, including home health visits, lab services, and the increasing use of wearables. These wearables rely on consistent internet and troubleshooting support. There is an assumption that everyone has internet access, but this is not the case. Even in cities such as Dallas, there are residential pockets without access. While DCTs can improve patient access to clinical trials, they require tools to support this access, which in turn are associated with costs.”
“Despite recent draft guidance on DCTs from the FDA, clarity is still needed around the responsibilities of the PI for remote services. In 2024, we will continue to refine the processes that work and fix those that do not,” concludes Nelson.
Michelle Rowe: Simplifying trials, training the workforce, and finding tech solutions
“At HCA Healthcare, we are focusing on three main areas for 2024 – rising numbers and complexity of trials, workforce training and development, and technology and data solutions,” said Michelle Rowe, RN, Vice President, Operations, HCA Healthcare Research Institute at HCA Healthcare. HCA Healthcare consists of 182 hospitals and more than 2,300 sites of care in 20 states and the United Kingdom.
“Increasing numbers of trials represent ever more opportunities for HCA Healthcare to respond to,” explains Rowe. “We are leveraging the expertise of our physicians and the capabilities of our sites to ensure that we are selective in the studies we take on, matching the right studies with the right capabilities.”
“For workforce training and development and opportunities within the area of diversity, equity, and inclusion, we are partnering with industry leaders including ACRP to develop resources and further expertise around these complex trials, balancing productivity, business challenges, and diversity in our workforce and talent recruitment strategies,” notes Rowe. “There is a general need for further education and development, along with specific subspecialty education solutions to meet the needs of studies, support continued colleague development, and build out general awareness of research as a profession within the industry.”
“In the areas of technology and data solutions, our goal is to identify offerings that can help us do our job more efficiently, enroll in studies swiftly, and support innovations in science and medicine that can ultimately improve patient outcomes,” said Rowe. “We’re investing in information technology leadership capabilities, and working with other organizations to share experience with various technologies. Technology planning is a priority for the coming year.”
Paul Evans: Expecting an era of realism for DCTs
“I expect 2024 to usher in an era of realism for DCTs,” said Paul Evans, President and Chief Executive Officer at Velocity Clinical Research. “Much of what has been written about DCTs has been aspirational. Efforts have largely focused on approaches that make sense for the back office of the sponsor or CRO. This coming year, I’m expecting a more pragmatic approach.”
“We need to ask patients about their preferences so that we can increase protocol flexibility to reflect these,” noted Evans. “It has been assumed that patients do not want to go to bricks-and-mortar sites. This is not the case. Many patients appreciate and benefit from the option of in-person meeting with specialists in their disease area. In addition to physical site visits, protocols should offer remote options for those who cannot or do not wish to come to the site.”
“There has been talk about DCTs improving diversity and inclusion, but this seems to me to be largely ‘virtue signaling’ by entities with an interest in providing services,” Evans asserted. “Whether these views are backed by data may be another story. Either way, diversity, equity, and inclusion will continue to be an important area of focus, with pressure ratcheting up for more improvements. As is typical for our industry, this will involve evolution, not revolution.”
“On a regulatory front, the issue of drug supply within a decentralized model has still to be resolved,” said Evans. “The current FDA draft guidance on DCTs says PIs should release the investigational product to patients, yet this has traditionally been handled by sponsors, leaving investigators with little experience in this area. Clarity is needed in this area.”
On the question of whether pharmaceutical companies and CROs might support site outreach in underserved areas, Evans believes that this building of community relationships by sites is one of the costs of doing business. “Sites that with insufficient access to diverse populations are already at a competitive disadvantage – and may be unable to bring in business in future.”
“The site landscape is currently changing based on increased interest in dedicated research sites from venture capital companies,” concludes Evans. “Over the past two years, I’m aware of at least 20 private equity companies investing in these sites, and I expect this trend to continue. By focusing solely on clinical research, these investors may be able to bring about much-needed change. This may improve efficiency, reduce fragmentation, and address the high number of ‘one-and-done’ investigators who leave research after a single trial.”
Reference
Edited by Jill Dawson and Gary Cramer
