by Beau Bruneau, Innovations Business Analyst at Florence
More than 500 clinical trial professionals signed up for Florence’s February 2022 Innovation Summit, which included roundtable discussions on site selection, the Site Initiation Visit (SIV), and inclusivity in recruitment. The keynote was a panel with Diversity, Inclusion, and Equity expert Tiffany Whitlow of Acclinate.
Missed our event but want to know how you can make your recruitment, start-up, and site selection process more inclusive without sacrificing efficiency? Here are the main takeaways from the panels and roundtables:
Keynote Panel: Innovating Inclusive Study Startup and Recruitment
According to census projections, more than half of all Americans will belong to a racial or ethnic minority group by 2044. Historically, clinical trials have failed to accurately represent minority populations.
Why Representation Matters
To make healthcare effective and inclusive, Tiffany Whitlow points out that these patients must be included in the development of drugs and devices. This inclusivity does not start at recruitment but at protocol design. Are sponsors designing protocols that make trials accessible to all patients, including those who work strict hours or live long distances from clinical trial sites?
Whitlow also pointed out that representation doesn’t just mean representing the local populations of a site or an entire country. It’s about accurately representing disease prevalence according to populations. For example, drugs for sickle cell anemia need to be developed with the knowledge that this disease disproportionately affects Black and African American people, and clinical studies need to be designed to test those drugs in that population.
Why Inclusion is Still a Struggle for Many Clinical Trials
We’ve known inclusion was an issue for clinical trials: why hasn’t this problem been solved already? With historical events such as the infamous Tuskegee experiment, lack of trust in the healthcare system is one major barrier.
Whitlow points out that minority participation in clinical trials is part of a larger issue of health equity in the United States. Regulatory bodies are starting to draft regulations around representation in clinical research, with a new bill just submitted to the house in February, but this is only one small step. Defining and meeting required inclusion numbers will take planning and new strategies for reaching minority communities.
Fortunately, sites and sponsors can make small changes to move inclusivity in the right direction. One of these changes is actively engaging with communities outside of research.
Building relationships between patients and sites will increase trust and create access for both the research community and minority populations. This engagement must be intentional and mindful, with the goal of equitable care, not recruitment percentages.
Technology also has the potential to catalyze inclusivity in recruitment by allowing patients who work long hours or rely on public transportation to consent or see their physician from home. This technology has to be developed with inclusivity in mind, just like study protocols.
The technology should be accessible to everyone, including patients with disabilities or patients who are unfamiliar with computers and need extra training. In addition, sponsors and sites should provide devices and WiFi access to patients who don’t have those resources.
In the second half of our event, clinical trial professionals joined roundtables on the topics of site selection, the Site Initiation Visit (SIV), and recruitment. These roundtable discussions gave our community chances to share with and learn from each other on the best practices for each topic.
Using Data to Empower Site Selection
Determining which sites will participate in a trial is a tricky process. From feasibility questionnaires to qualification visits, site feasibility can burden sites with redundant work.
This process is made slightly easier when a site and sponsor have a previous relationship. Our community members said that sites, sponsors, and CROs want to invest in and strengthen those relationships. Building relationships can also help sponsors establish bonds with community sites that serve diverse patient populations.
What’s the magic wand solution for site selection? While there isn’t just one, our roundtable made suggestions about increased standardization of questionnaires, publishing the responses so that other sponsors may see them, and limiting the number of questions on a form.
One sponsor participant shared that their feasibility questionnaires are mainly used to efficiently assess sites for study eligibility and determine which sites may need more attention and resources during study start-up. It’s a part of their risk-based approach to site selection and start-up.
Reinventing the SIV in a Digital World
The Site Initiation Visit (SIV) is important for training on the study protocol, preparing for the start of the study, and ensuring all paperwork is accurate and complete. The roundtable participants shared experiences about SIVs during which the other party was not prepared. On the extreme, one participant told us they’ve had CRAs who seemed to have not read the protocol at all. This is frustrating for everyone involved and is not an effective use of anyone’s time.
The group concluded that preparation is essential for a smooth and effective SIV. Both site staff and sponsor/CRO staff need to understand not only the protocol but what is required and what will be the most effective use of time during the SIV. For example, one CRA participant shared that they often shorten GCP and HIPAA training in the SIV for sites that they know have already completed that training and understand the regulations in the context of the study. This preparation and tailored training are examples of streamlining the SIV that can come from a good sponsor/CRO-site relationship.
There are often miscommunications during study start-up, with disorganized communication channels and unanswered questions. Dedicated points of contact and communication channels can make start-up more efficient, transparent, and traceable.
Technology, once again, plays a crucial role in the solution. Distributing documents from a central platform allows sites to easily organize information and disseminate it to relevant staff. The right clinical trial software also allows sites and sponsors to collaborate on documents remotely and at any time, which means they can complete and sign documents faster, helping streamline the feasibility and SIV experiences.
Taking the stress out of the Site Initiation Visit empowers sites to get back to patients. To achieve meaningful change in this process sites and sponsors/CROs must work together to identify inefficiencies in old processes and establish trust to test new ones.
Increasing Inclusivity in Recruitment
Insights from the recruitment roundtable offered an extension to the inclusivity panel discussion. Diversity in recruitment is becoming a movement born from a genuine interest in conducting better science.
Sponsors are committed, invested, and willing to help sites engage with their communities and provide access to more diverse populations. One of the biggest challenges in inclusivity is that people don't know how to engage with specific underrepresented groups. Sponsors want to help provide with resources to bridge the gap, and companies like Acclinate are accelerating that change.
On a base level, many sites have a lack of data on their participant demographics. They may be reporting this information to sponsors as part of the study data but not tracking it internally. One roundtable participant stated, “we were not tracking this before, so we don’t know where to start to improve our processes.”
But in that question lies the solution. Awareness is the starting point. By increasing the visibility on demographics in trials and patient populations, the industry will know where to focus attention to better improve inclusivity campaigns.
- Inclusivity is important to achieve an accurate representation of the general population. But engaging with specific communities requires intentionality, authenticity, time, and relationship-building outside of research activities.
- The time is right for people to engage. Sponsors and CROs are here to talk, learn, and improve. Sites are learning how to own their processes and communicate with sponsors and CROs.
- Site, sponsor, and CRO relationships are incredibly important for smooth study execution. From site selection all the way through the SIV and monitoring visits, good relationships enable trust, which fosters communication and facilitates better outcomes.