Welcome to the September issue of InFocus, where we provide insights and solutions to help sites and other stakeholders ensure site sustainability.
- SCRSCurrent: News and information about SCRS.
- SCRSConnects: Exclusive interviews with industry leaders. This month: Jim Murphy
- MetricsThatMatter: Unique and current metrics supporting your success.
- SiteSpotlight: Site stories of innovation and success. This month: Segal Trials
2018 has brought with it an incredible amount of change and growth.
In addition to Jimmy Bechtel, we’ve welcomed two new staff members to the team this year. Susan Cole brings a wealth of marketing and community-building experience to her role as membership engagement specialist. Victoria Refermat joined the team as lead graphic designer after SCRS staff couldn’t get enough of her clean, engaging designs and experience seemingly tailored for the role.
We’ve made a few changes to our Global Site Solutions Summit format this year as well to ensure we’re delivering as much high-quality, engaging and change-directing content to our attendees as possible. This year’s Site Landscape plenary will feature a new approach that promises to dig deeper into several key areas affecting the clinical research site community, delivering unmatched insight that will help you shape your organization with an eye toward the future of our industry.
We’ve also begun reaching out to you to collaborate on articles. If you have an idea related to clinical research that you’d like to see published, reach out to us.
While working at a CRO at the start of his career, Jim Murphy experienced first-hand how technology was able to improve efficiency in a large, fast-paced global study. It was through this lens that he began to view technology as a powerful change-agent in the evolution of clinical research. “I’ve focused my career on the goal of leveraging technology to improve visibility, efficiency and quality across an increasingly global clinical research landscape. Ultimately, my professional journey has been about identifying problems and working to find solutions to them.”
Technology has introduced enormous change in the way clinical trials are conducted and promises to improve quality, safety, speed and efficiency. However, the change that drives these gains is not always easy for everyone to navigate. “Change is a difficult concept in general, and this is especially true in clinical research due to its fragmented and global nature,” said Jim. In addition to regulatory factors, the global clinical research community is made up of many different types of sponsors and sites, each with a different appetite and capacity for change. Exacerbating the situation is the fact that some new technology is not designed to deliver a benefit for investigative sites, who are already stretched very thin. “As a result, progress moves more slowly and incrementally than in many other industries.”
As the CEO of Greenphire, a company that provides software to both optimize global site payments and streamline patient reimbursement, Jim is unsurprisingly an advocate for Team Tech. “There are so many challenges and pressures in the industry, each of which has a direct impact on sites,” Jim said. Whether it relates to protocol complexity, participant recruitment and retention or other factors which increase financial and administrative burden, sites are having to juggle more and more. Jim believes that technology is essential to much-needed simplification: “Fundamentally, Greenphire exists to reduce business and administrative burden for all stakeholders in the clinical research process including patients, sites, sponsor and CROs,” he said. Technology may not make someone a better clinician, but by simplifying the non-clinical aspects of trial administration, more focus can be placed on caring for the patient. “This is why clinicians get involved in clinical research – to do research. Not to reconcile invoices and budgets, track payments, write reimbursement checks, manage tax compliance or arrange participant travel. Technology’s place is to eliminate administrative and financial barriers to clinical trial success. If it’s not doing that, it’s not doing its job.”
Annual market research conducted by Greenphire shows that there is overwhelming interest across the research community to improve site cashflow and financial visibility. So though change can be a disruptive factor, it is also desperately needed. It is no secret that sites around the world struggle to receive even quarterly payments from sponsors, and even this isn’t a sufficient payment frequency to keep a positive cashflow. Technology can be used to replace manual payment processes with a streamlined approach that actually reduces work for sites, CROs and sponsors while at the same time enabling more frequent payments. “The goal of clinical trial technology is to remove administrative tasks that create hurdles for sites and patients to be an effective participant in advancing human health.”
This is one of SCRS’s goals as well. “The SCRS movement has provided a vehicle for sites to communicate with one voice about what they need to succeed and challenge the industry to change,” Jim said. The more the community is able to align on the biggest challenges, the more rapidly we will be able to move forward as an industry to overcome them.
Diversity Survey Findings: Factors That Drive Site Success
In August 2014, the FDA delivered an action plan to enhance the collection and availability of demographic subgroup data. In January 2017, the FDA released a Drug Trials Snapshots Report showing the diversity of clinical trial participants in studies conducted in 2015-2016. The results of this report show an encouraging trend toward increasing the diversity of clinical trial participants, but a continued effort is needed to move the needle further in terms of including diverse patients in clinical trials.
The FDA has taken the initiative to set expectations for sponsors to enroll study participants from diverse backgrounds, and sponsors and other stakeholders have also stepped forward to address the diversity gap in clinical trials. One such initiative is the Diversity Awareness Program, launched by SCRS along with industry partners in 2017.
As a first step in the Diversity Awareness Program, SCRS completed a pilot study in which twelve randomly selected US sites were asked to provide information about factors that affect the enrollment of diverse populations in clinical research trials. SCRS published the findings in a white paper in September 2017.
A detailed survey was then created to conduct a comprehensive study of how successful sites perform in recruiting diverse patient populations in clinical studies and the factors that drive their success. The comprehensive study utilized a cross-sectional study design to survey SCRS members and consisted of 32 questions about participants’ own role at the site and numerous site characteristics. Site characteristics measured as independent variables in this survey included, but are not limited to site type, site location, US region, racial/ethnic makeup of the site’s community, community and site diversity rating, and incentives to patients and staff for recruiting diverse patients.
The dependent variable measured in the study was self-reported site recruitment results/success. When the survey closed in November 2017, a total of 412 usable responses had been collected with a total of 690 participants completing a portion of the survey. Descriptive, bivariate and multivariate analyses were conducted and are reported in the results.
Due to the comprehensive nature of this study, results are presented as a summary of each analysis. The descriptive statistics for the different variables examined in the study show that:
- Participants from very few sites (< 5%) report being able to recruit 100% of target diversity populations, and approximately one in six participants report being able to recruit only 0-25% target diversity populations. A little more than half of the participants reported being able to recruit > 50% – < 100% target populations.
- Participants from approximately one-third of all sites were from freestanding sites.
- Participants from two-thirds of all sites were from sites that had been involved in clinical trials for more than ten years.
- Participants from two-thirds of all sites indicated that their site was strongly or very strongly committed to recruiting diverse patient populations in clinical trials.
- Participants from approximately half of the sites indicated that their site made strong or very strong efforts to recruit diverse patient populations.
- Participants from approximately one-third of the sites indicated that their site provided strong or very strong incentives to patients in an effort to recruit diverse patient populations.
- Only one in six participants reported that their sites provided strong or very strong incentives to staff for recruiting diverse patient population.
- Participants from approximately one in six sites reported no or very weak community connections; participants from a little more than half of the sites reported moderate to strong community connections.
- Participants from approximately 30% of the sites reported that their sponsors engaged in diversity recruitment reinforcement actions.
- Participants from approximately 30% of the sites reported that their sites engaged in diversity recruitment reinforcement actions.
- Participants from approximately half of the sites reported that all of their staff could speak the language spoken by the majority population and were culturally competent.
The study further examined if participants’ perceptions/reports of the racial/ethnic makeup of their trial samples matched the real makeup of the community in which the site was located.
To read the findings in the full research paper, click here.
For more information, join SCRS for a webinar series on diversity in clinical trials. The first webinar, scheduled for October 18, 2018, will outline how to leverage your diversity experience to gain new study opportunities.
Segal Trials Brings Diversity Awareness to the Community
With passion and excitement, Segal Trials announced that they recently hosted a clinical trial awareness event at Marlins Baseball Park in collaboration with The Center for Information and Study on Clinical Research Participation (CISCRP). The goal of this event was to raise clinical trial awareness and promote the importance of diversity in clinical trials.
It took two years to get the event off the ground, so it was incredible to have over 10,000 people in attendance at the July game. Although Segal Trials had been doing community outreach for years, they wanted to take it to the next level and host an awareness event on a much bigger scale that could reach a larger and more diverse audience.
One of the main barriers to clinical research participation is the simple lack of awareness and understanding of clinical trials. At the event, Segal Trials & CISCRP worked to bring down that barrier by providing resources to current patients, potential patients and the general public. These resources helped to educate them on what clinical trials are, why they’re important and what the benefits of participation are. Additionally, Segal Trials enhanced relationships between community partners and their current and potential patients by offering them group tickets to the game.
The occasion was particularly unique due to the high concentration of a diverse audience at the baseball arena. It is imperative that clinical trials study diverse patient populations to ensure that as many groups as possible are well-represented in life-enhancing and life-saving medical advances. Segal Trials believes it is vital for the company to participate in events like this due to the diverse characteristics that their studies require.
With several hundred booth visitors, team members from Segal Trials and CISCRP were excited and grateful that they could help spread awareness about the importance of clinical trial participation. The staffs’ biggest takeaway was that they were able to offer information about alternative care options to those who were previously unaware of clinical research trials. Segal Trials’ staff shared joy in being able to contribute to the company’s values of advocacy, collaboration and patient centricity. This was a fabulous experience that Segal Trials was happy to share with CISCRP!
Several local community partners attended and/or shared the event to show their support and appreciation of their mission for the advancement of research, including the National Alliance on Mental Illness (NAMI) Broward County, Greater Gift Initiative, and more. Click here to watch a video announcing the event during the baseball game.
Segal Trials & CISCRP are hopeful that the event will kick off a larger awareness-building program where similar outreach campaigns are held at national sporting events and other arenas in the near future.
|Behavioral Economics and Clinical Trials: The Psychology of Negotiating
September 25, 2018
12:00 PM EDT
|Optimizing Participant Reinbursements: Travel and Stipends for Better Retention and Control
October 9, 2018
12:00 PM EDT
|All Your Hard Work Down the Drain if You Can’t Retain: Best Practices for Retaining Patients
October 16, 2018
12:00 PM EDT
Founded in 2012, SCRS is a global trade organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, connectivity and mentorship. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community.