From the Archive: How Merck Is Increasing the Representation of Diverse Patient Participants and Clinical Staff
To address high saturation of clinical trials in traditional sites, in conjunction with the need to increase the representation of diverse patient participants and clinical staff, sponsors must look to expand their community site footprint. Kelly Clark, Head of US Partnerships and Global Site Development at Merck, spoke with us last year and described how she is helping to develop research-naive community sites to take on industry trials.
How is Merck adapting to achieve greater representation of patients at the site level?
It begins with identifying community-based oncologists who want to offer clinical trials as a care option for their patients. Once interest has been established, we will work with the institution and investigator(s) to understand their patient populations, current capabilities and offerings, and clinical research infrastructure needs. The site partnership involves sharing knowledge of upcoming trials that might be a good fit for their patients and providing the necessary training and support to enable them to execute clinical trials with high quality.
"If we're going to reach groups that have been historically underrepresented in clinical trials, we need to expand beyond the traditional site"
Our aim is to build and sustain collaborations with key sites that are both located in and serving diverse populations across the United States, with the desired outcome of expanding access to clinical trials. The majority of people with cancer are treated and cared for in the community and therefore it’s important we bring clinical trials closer to the people. Academic medical centers are saturated and, alone, cannot enroll the ever-increasing number of clinical trials. There’s a shortage of clinicians and institutions, particularly in the community setting, who can conduct oncology clinical trials at the scale and quality needed. If we're going to reach groups that have been historically underrepresented in clinical trials, we need to expand beyond the traditional site.
How are you identifying sites with less research experience?
De Novo and/or less-experienced sites may not surface in traditional clinical trial databases, because we haven't worked with them in the past. So we rely on recommendations from our field-based staff, such as our CRAs and Medical Affairs colleagues. We sometimes receive site recommendations from known sites and investigators. They may know a provider in their community, serving a diverse patient population who would be interested in participating in clinical trials. This grassroots approach to identify research-inexperienced yet interested sites can be quite effective.
We can also use data analytics to help us identify potential clinical trial sites. There is a burgeoning industry focused on analyzing large data sets, such as insurance claims information, to understand where patients with particular diseases are being diagnosed and treated. By understanding this better, we can then identify high volume providers not already involved in clinical research who might be interested in starting.
What are some of the common needs that sites have to participate in more research?
Time and infrastructure, both physical and human. A community-based clinic and/or hospital still must run their day-to-day practice and therefore devoting time to clinical trials may prove challenging. Sites need to have qualified and dedicated personnel, a quality management system, including standard operating procedures and training programs, as well as the necessary facilities and equipment to execute clinical trials.
A small community-based clinic may not have a sophisticated infrastructure nor dedicated departments and specialized roles like an AMC has. A smaller site with fewer staff might require people to wear multiple hats. For example, a nurse or other healthcare professional might need to perform certain study coordinator duties such as patient recruitment, participation in the informed consent process, and even data management activities. As a sponsor company, we need to enable this by implementing customized training and support methodologies that meet the unique needs of community-based providers.
"The greatest need for us is finding more oncology clinical sites, serving the community, because the AMCs are saturated"
Are you approaching sites with a specific trial in mind, or are you more focused on building relationships and capacity?
We are trying to identify sites that match the company's pipeline and the therapy areas that we're focused on. There's an advantage to being part of a large organization like Merck, because our products in development span across a broad array of therapeutic areas. We are always looking to engage with new sites serving diverse patient populations with interest and capabilities in conducting general medicine, vaccine, infectious disease or oncology trials. The greatest need for us is finding more oncology clinical sites, serving the community, because the AMCs are saturated.
How does that contribute to advancing immuno-oncology?
The high saturation of oncology clinical trials in the United States, in conjunction with historically low representation of diverse people in oncology trials, requires sponsors to expand their community site footprint.. By developing research-naïve hospitals and clinics in diverse communities, we anticipate increasing diverse representation in our clinical trial populations to help bring new IO combinations to all people. We also recognize the importance of growing and diversifying the clinical research workforce to enable the IO advancements of the future.
What are the challenges unique to finding new sites for oncology trials?
The greatest challenge for a research-naive site is getting started. It’s somewhat of a chicken and egg situation. A small community-based site, new to clinical research, needs to stand up their resources and capabilities to be able to execute trials. Yet to build these resources, there needs to be a steady revenue stream associated with clinical trial activity. But without the revenue from clinical trials, it becomes difficult to make early investments towards building up a clinical trial infrastructure. I imagine it’s an enormous risk for a small site to make such an investment- they need to know that a steady flow of clinical trials will follow. As a pharma company, we need to be willing to provide a steady flow of trials to smaller sites who are just getting started.
How can pharma help to mitigate that challenge?
As an industry, we first need to be patient. It might be that we elongate the trial startup period to allow the site more time to get trained before activating patient enrollment. Sponsors might also provide extra resources, time and support during the study start up period and provide the site dedicated CRAs to provide ample coaching, training and oversight.
We can also think about temporarily augmenting a site’s resources, through the various site solution providers, with experienced skilled research staff, even on a temporary basis until such time the site is ready to execute on its own. There are site solution providers that can support research naïve sites with resources and administrative support needed for trial conduct. A centralized administrative support model that provides the site with the tools and resources to conduct the trial with high quality that allows providers to focus on patient care and trial execution is a great option.
What do you hope to see more companies doing in the future?
I hope to see a groundswell of other companies doing similar things. I'm not saying that we have it all figured out. We still have a lot to learn. But we can't manage this one study at a time or one organization at a time. We need to come together as an industry to be able to address lack of clinical trial access, in general, and in particular under-represented racial and ethnic groups.
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