Medidata’s fourth-quarter earnings call offered a glimpse of how the company, which develops cloud-based technology and analytics tools to plan and execute clinical studies, envisions the future of clinical trial design. Glen De Vries, cofounder and president, painted a future of hybrid trial models that would embrace the use of technology to allow patients to participate remotely with little disruption to their personal lives coupled with the reality that drug development will continue still require in-person tests and evaluation. The balance between virtual and in-person settings will vary according to the needs of the study, he said.
De Vries also noted that the increasing complexity of drugs is making it critical for companies like his to demonstrate the ability to manage complex data streams to support clinical trials for the new generation of therapeutics.
“What we are seeing is, as an industry, we’re looking at patients in a more directed way as they are undergoing decision points in their care. It is actually…using in-home consent even before you show up for your first baseline evaluation. In a virtual trial, it is not like investigator supervision goes away, but it can happen in a remote location or there can be a geographic concentration of principal investigators… For us, the trend is about the ability to cover the entire spectrum.”
To support Medidata’s interest in covering that spectrum, it has made some acquisitions. Last year, the company acquired Mytrus, an e-clinical technology company with a portfolio of data collection tools and an electronic patient-informed consent product. Anthony Costello, the CEO, has since become Vice President fo Mobile Health for Medidata. In a phone interview, he talked about some of Medidata’s ambitions.
“We estimate that about 25 percent of clinical trials in the U.S. could be done as [completely] virtual trials. It is very much a future concept,” Costello stressed. “Of course, a lot more than that could be done as partially virtual studies and we are seeing a lot of customers interested in that type of study design.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Costello noted that in addition to the main part of a study, virtual components could be handy for long-term follow up for study participants which can be challenging because people move, and/or lose touch with their physicians and investigators. But longitudinal data is extremely valuable for drug companies.
One measure of the industry’s progress on virtual studies is Medidata’s work with PCORnet —a national, patient-centered clinical research network formed by PCORI which includes more than 100 health systems. They are in year two of the largest virtual clinical trial. The ADAPTABLE study with PCORI examining the impact of aspirin dosage levels on patients with heart disease has recruited 7,000 patients to date through electronic health records at PCORnet. It has ambitions to recruit another 8,000 participants in the next two years.
Although virtual trial models are far from mainstream, Medidata’s clinical trial products are aimed at supporting the hybrid models its management team envisions. Medidata has produced a variety of cloud-based products to support clinical trial planning and management referred to as Edge and for recruiting and retrieving data from participants in a product group called Rave. They are designed to support physical and virtual trials and some use analytics to provide insight to people involved in the various stages of a clinical trial from a life science executive to a site manager.
“We always try to see the future of where data capture is going,” Costello said. He noted that architecture will top the company’s to-do list this year. “We will spend a lot of time on that this year to improve the scalability of virtual trials. We want virtual trials on the Medidata platform to be just as scalable [as in-person] trials.”
One of the greatest challenges for clinical trials is simply recruiting enough patients that match the trial criteria. That will be increasingly difficult as more precision medicine treatments come up for clinical study. Last week, Medidata announced a partnership with Syapse to speed up clinical research in oncology. The collaboration will involve developing tools that do a better job of finding suitable trials for targeted patients and expanding trial recruitment venues to community sites, making it easier for oncologists and their care teams to identify and enroll patients.
Photo: Dmitrii_Guzhanin, Getty Images
