Welcome to the October 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: Kristin Scalva
- MetricsThatMatter: Unique and current metrics supporting your success.
- SiteSpotlight: Site stories of innovation and success. This month: Clinical Trials of Texas
Thank you to all who attended the 2018 SCRS Global Site Solutions Summit for helping us make it a huge success. The SCRS staff works diligently to ensure that attendees are provided with industry-leading content and ample time to connect with partners and peers.
The Summit also provides opportunities to honor site and sponsor/CRO achievements. Congratulations to this year’s winners! In recognition of their dedication to establishing and maintaining strong site partnerships and voted upon by clinical research sites globally, AstraZeneca and Syneos Health are the sponsor and CRO winners of the 2018 Eagle Award. Seth Mayberry, representing Chattanooga Medical Research, won SPRIA with a patient recruitment campaign on a contraceptive study that exceeded the enrollment goal of five patients by enrolling a total of eighteen patients. Finally, Claudia Gomes, representing Envision Physician Clinical Research, won Site Tank with an innovative dashboard that was created for billing compliance.
Thank you to the almost 1,000 SCRS site members, Global Impact Partners, leadership council and committee members, speakers/facilitators/panelists/judges, and all others who attended for helping us make this our best Summit yet.
We hope you will join us for an upcoming Summit in 2019.
When Kristin Scalva was two years old, her grandmother was diagnosed with colon cancer and told she had three months to live. Unsurprisingly, her family fought for more time, and they got it – a clinical trial allowed Kristin’s grandmother to live for six more years.
This experience inspired her mother to become a coordinator, then a CRA, at a local air force base, and Kristin grew up assisting her. Twelve years ago, Kristin and her mother opened their own clinical research site called MCB Clinical Research Centers.
The site saw tepid growth for their first two years. “We started small. Many companies dive in with grandiose ideas, but you have to build a strong foundation and going too big too fast can be harmful,” Kristin said. MCB Research started as a 200 square-foot office space and has since grown to 8,000 square feet with thirteen exam rooms and multiple doctors.
When I asked Kristin what keeps her invested in clinical research she shared a poignant story. “Right around the two-year mark I was burning out,” she said. “MCB Research was working on a clinical trial for early term pregnancies. The sponsor’s end point was getting patients to 37 weeks, and I kept thinking, we have to get there. One patient made it to 34 weeks.” Kristin recalled holding the baby born at 34 weeks in the NICU and apologizing to the crying mom for not meeting the end point. “The mother/patient’s response was, ‘I’m crying because I’m so happy – after losing four babies, this is the first baby who has survived, and you gave us that.’ From then on, I’ve always remembered that helping the patient is the end point that matters most.”
It can be difficult to keep this at the forefront when so many other necessary elements are moving at a dizzying speed. Kristin believes that the industry is losing some of its heart. “It used to feel like we were a team working toward a common goal, but now it feels like the us vs. them mentality is taking over,” she said. Many in the site community agree – when something goes wrong, the trend seems to be passing the blame on instead of seeking resolution. “We’ve had several interactions with sites where things were too competitive for us to be able to help each other,” she said. This mold needs to be broken. SCRS has made strides in breaking it with member benefits like the online community forum, where site executives can share and receive candid feedback when it’s desperately needed.
MCB Research has taken internal steps toward improvement by making changes to how they treat both employees and auditors, among others. When I asked what the site has done to ensure audit compliance, Kristin shared that they talk to the auditor like they’re on the same team, provide them with a comfortable space to work and make it as easy as possible to access the information they need to do their job. When I asked what Kristin would suggest to other sites to ensure compliance, she said, “Over-document. You can’t go back two years and figure out what you meant from what you wrote.”
MCB Research has also made strides in improving employees’ work life by providing opportunities to decompress. They’ve implemented four ten-hour work days, and in just two months Kristin has seen measurable improvement with employees showing up more relaxed, rested and ready for the work day.
Part of improving patients’ lives and breaking into a more sustainable method of conducting research is, in Kristin’s opinion, having more realistic inclusion/exclusion criteria. “We’re often asked to study drugs in a perfect, sterile environment, and this really hinders forward movement for both the trial and the patients,” said Kristin. Sometimes patients aren’t qualified because of mild comorbidities and the protocol disqualifies them even though the PI believes they’re perfectly good candidates for a trial. “It causes a lot of frustration on our end, when recruitment is already a significant challenge. We waste a lot of time and effort, and the patients who really need it aren’t receiving treatment.”
Keeping the heart in clinical research is the way that Kristin would sum up the change that she, and many others, feels will have a positive impact on the direction of clinical research. Speaking of heart – have you wondered what the name of Kristin’s site – MCB Clinical Research Centers – stand for? MCB are her grandmother’s initial- Marie-Claire Bossaert.
This year’s Global Site Solutions Summit saw a record number of attendees from clinical research sites, sponsors, CROs and professional solution providers. Likewise, nearly 550 site personnel completed this year’s Site Landscape survey. 77% of respondents came from SCRS’ almost 10,000 member sites, with 87% of responses coming from the US (Figure 1). Almost 50% of responses came from organizations with only 1-3 PIs, yet 75% of those who responded work for sites that have been in business for eleven or more years (Figure 2). While the number of years in business has remained consistent since 2016, the response rate to the survey has grown in tandem with the Summit, seeing an increase of almost 20% in the last two years.
Typically, SCRS president Christine Pierre single-handedly shares an incredible volume of data with attendees during the popular Site Landscape session. This year, SCRS invited in more voices by including a variety of industry leaders who engaged in a dynamic conversation around three key sub-categories:
- Study start-up and feasibility
- Finance and payment terms
- Relationships and communications
Though the number of sites who have to operate with less than three months of cash in the bank has remained within the range of 60%-66% over the last five years, new data show an unfortunate increase: while 60% of sites had less than three months of cash in the bank in 2017, this number grew to 64% in 2018 (Figure 3).
It is imperative that the number of sites who must operate without necessary funding begin to fall steadily and consistently. Without sufficient funding, site success falters. SCRS is committed to contributing to this dialogue and encourages sponsors and CROs to adopt more progressive payment terms that reflect sites’ needs.
Nevertheless, the industry has seen a considerable uptick in the adoption of monthly payment terms. In 2016, only 28% of sites were receiving monthly payments, while 49% were still receiving quarterly payments. In 2017, the number of sites receiving monthly payments grew to 39% (Figure 4). This ~40% increase is promising, and is an important contributor to site sustainability.
In the session’s final sub-category, survey data indicated that ~47% of sites don’t feel their partnership with sponsors and CROs have changed in the last two years. Of those who have noticed a change, 31% of sites feel their partnerships with sponsors have become stronger, and 33% feel their partnerships with CROs have weakened (Figure 5).
This hearkens back to 2017’s Global Summit theme: commit to change. At 2017’s Summit, sponsors and CROs raised their paddles to commit to change that sites identified as being important to them, and sites did the same. SCRS will continue to track and report on these changes.
SCRS will highlight more data from the annual Site Landscape survey throughout the coming year. If there are specific topics you would like to see highlighted, let us know!
Beginning in 2016, Clinical Trials of Texas – who was a Site Patient Recruitment Innovation Award (SPRIA) finalist at this year’s SCRS Global Site Solutions Summit – started to strategically prepare to enter the fatty liver disease clinical trial space by securing two news stories about fatty liver disease (including one with national reach) and creating an IRB-approved Fatty Liver Disease Fact Sheet to distribute to patients.
CTT was not provided sponsor funding for materials or local ads for study recruitment in most of their earlier fatty liver disease studies, so their marketing approach was entirely education-focused. All of CTT’s marketing materials were created in-house.
Included in the materials created by the marketing team was a video detailing symptoms of fatty liver disease which was distributed via YouTube, Facebook and Instagram in early 2018.
CTT distributed fact sheets such as Could It Be Fatty Liver? to their database of patients through multiple avenues such as email, text, flyers, blogs and organic social media posts.
Finally, regular special screening days were coordinated during the week and on weekends to provide free scans for fatty liver disease to pre-identify subjects for their studies. This was crucial for the success of the site’s multiple fatty liver disease studies the site conducted.
As a result of their multi-channel, strategic marketing and outreach plan, CTT has emerged as a premier site for fatty liver disease studies among multiple sponsors and CROs across Phase I-III studies.
Clinical Trials of Texas, Inc. (CTT) is located in San Antonio, TX. CTT has a highly-equipped and versatile 19,000 sq. ft. facility capable of conducting First-in-Man – Phase IV studies in a multitude of therapeutic areas. CTT’s Medical Director, Douglas Denham, DO, CPI along with 16 other board-certified physicians work with CTT to conduct studies in their respective medical specialties. This network of investigators has helped create one of the largest and most capable research sites in the United States.
|Strategic Partnerships with Investigative Sites Requires More than “New” Technology
October 23, 2018
12:00 PM EDT
|Privacy: The GDPR and Clinical Trials
October 25, 2018
12:00 PM EDT
|The Clinical Research Site of the Future: Are you Ready for Virtual Trials?
November 20, 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.