Keith Fern, vice president of corporate development at Elligo Health Research, and Matt Miller, CEO of StudyKIK, agree that the evolution of modern-day clinical trial operations need to continue, and data and technology is at the forefront of that progression.
Syneos Health, a fully integrated biopharmaceutical solutions organisation, was one of the companies helping adjust the clinical trial experience during the pandemic.
They recently acquired Illingworth and StudyKIK and partnered with Elligo Health Research intending to improve clinical research design and efficiency for patients, HCPs, and trial sites.
Each company presents solutions to enhance the complex clinical trial configuration, but the plight toward an effective trial model requires the industry to be open to feedback and necessary adjustments.
COVID forced companies to rethink clinical trial operations. Marie says Syneos Health looked at the commercial tools it could offer clinics to make enrolment easier. Thus, they partnered with Elligo.
Elligo’s model engages healthcare clinics by using data to find patient-participants before a clinical research study begins, therefore, streamlining the recruitment process.
The company separates patient identification from enrolment and uses electronic health records to find patient-participants within its network of healthcare practices and partnerships.
“By finding patients first, the enrolment period activities are split and, therefore, the model is changed and risk within the overall study process is lessened,” Keith notes.
Elligo then engages with physicians and provides the needed infrastructure to perform the study.
Using data to find participants in the clinical setting is quite valuable. Still, many patients seek information on how to volunteer for a clinical trial.
StudyKIK’s platform provides patients with information on what clinical trials are, how they work, and how to join a study in their area.
The company created over 1,000 indication-specific communities and uses these platforms to distribute information.
“At first, a lot of content generated was focused on the disease states,” Matt states. “We’d really try to bring value to those patients and introduce research as an option for them. One of the biggest barriers to patients joining a trial was the lack of knowledge on what a clinical trial is.”
“We’re now almost eight years in as a company, and we connect over 30,000 patients every month in clinical trials. Our communities reach over six million patients and growing, but there’s still a lot more to do,” says Matt.
Marie agrees and says 10 to 15 years ago, the industry was more focused on diversity and inclusion, and different materials were created to encourage engagement.
“We would have more interaction with patients and focus groups to ensure we were using the language and the tone that they recognised and felt comfortable with,” Marie says.
“Over the years patient recruitment became a commodity and wasn’t seen as something that clients wanted to invest time and money. It was something that, often, clients felt they had to include, and it just dropped off the radar.”
This is why the industry still has the same old issues with clients spending millions of dollars every day on studies that continue to lag in enrolment.
Including technology in the recruitment process is enormously beneficial as it can increase enrolment while improving diversity and inclusion since it expands the geographic availability of participants.
At Elligo, Keith says, the company has more diverse populations participating in trials because they practice research within healthcare in many rural and remote areas that never had access before.
“Utilising integrated technology is where we’ll see significant improvements from enrolment, retention, and overall study timelines,” Matt says. “We’re already seeing it today.”
“The clinical trial design will change by introducing technology earlier from the patient access side and streamlining the process for sites to identify highly qualified patients within their database,’’ says Matt.
Marie says improving protocol design is crucial to easing the process as well by holding patient focus groups and talking to patients ahead of protocol design.
“It’s really about making sure the protocol is designed so numerous amendments don’t have to be made before the first patient can be enrolled,” states Marie.
Technology will continue to be an excellent asset in connecting with clinics and patients. Still, Marie says there’s a tech burden that comes with using numerous platforms and having to keep track of logins.
“If a site is working on six or seven different studies, they could be working with six or seven different sponsors and CROs, each with their demands on platforms,” says Marie.
To decrease the tech burden Matt recommends implementing a widely used technology already adopted by research sites to streamline the overall work process or allowing sites to recommend platforms that they prefer to use.
Unfortunately, with the use of technology the need for data security becomes ever more critical, Marie says.
“Data breaches are going to be particularly concerning as we continue to move forward. We need ensure that we maximise data security as much as we can,” Marie says.
Navigating the elements that accompany increased use of technology will always be present. Still, each company’s ultimate focus is easing the clinical trial experience to secure the treatments patients need to optimise their journey.
“The beauty of the industry today is the rapid progression. Without the expedited approach to research, many people would be waiting longer than needed for therapies that are currently being developed,” says Matt.
“The motivation for us all is to streamline this process to reduce costs and timelines while ensuring patients get therapies that will best support them.”
Marie Emms, head of Patient Engagement at Syneos Health, has 25 years of experience in healthcare communications, spanning public relations, medical education and patient engagement. She has spent the past 20 years focused solely in patient engagement, supporting pharma and biotech clients. She specialises in the development and execution of strategic integrated communications programs to support sites and their patients through the clinical trial journey, from initial awareness, consent through to compliance and adherence. Marie has worked on a wide variety of therapeutic areas across neonatal, paediatric, adult and geriatric studies. Marie is responsible for developing engagement programs to support patient recruitment and retention globally across all Syneos Health studies.
Keith Fern joins Elligo with a decade of proven leadership in the CRO industry. As executive vice president and general manager of Worldwide Clinical Trials Early Phase Services, Fern managed all commercial and day-to-day operations of the company’s 300-bed clinic and state-of-the-art bioanalytical laboratory, growing EBITDA from 1 percent to 13 percent. Fern invested in automation and expanded service offerings in both the lab and clinic, positioning the company for future growth. Before taking on the role as general manager, Fern was senior vice president of business development, expanding the sales team and establishing key partnerships to meet the needs of sponsors. He joined Worldwide Clinical Trials Early Phase Services as chief financial officer, leading the $110 million acquisition of the former company, CEDRA, by Worldwide.
Fern began his career with Bank of America Securities, working in corporate and investment banking. He holds a Master of Business Administration from The University of Texas at Austin
Matt Miller is the Co-Founder and CEO of StudyKIK, a patient recruitment and retention technology company supporting clinical trial participants from start to finish of their trial journey. Matt has led the company to support thousands of clinical trials over the past 7.5 years in all areas of research across 32 countries. Prior to founding StudyKIK, Matt had spent time in the digital marketing and SEO industry. Additionally, he has spent time working at a contract research organization which owned early and late stage clinical units.
Syneos Health® (Nasdaq: SYNH) is the only fully integrated biopharmaceutical solutions organisation. The company, including a contract research organisation (CRO) and contract commercial organisation (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry-leading companies – INC Research and inVentiv Health – it brings together approximately 27,000 clinical and commercial minds to help its biopharmaceutical customers shorten the distance from lab to life.