As the passage of the 21st Century Cures Act opens new possibilities for using real-world data to support medical products’ regulatory path, CROs are prepping themselves for growing demand. Worldwide Clinical Trials is the most recent one to make a move in that direction.
The CRO just took in Continuum Clinical’s Late Stage research practice and folded it into its Evidence business unit. Worldwide said in a release that the acquisition will expand its observational research study services, as well as add health economics services, patient-reported outcomes research and patient registries, among other real-world initiatives on both the pre- and post-approval sides.
“Sponsors, healthcare providers and regulators are seeking better data and evidence to design, deliver and manage healthcare,” said Peter Benton, Worldwide’s president and COO, in a statement. “CROs can be their greatest ally—by helping to accelerate generation of evidence and real-world outcomes data on the clinical, economic and humanistic impact of new drug and device solutions.”
With the divestiture, suburban Chicago-based Continuum is actually backtracking. It was the product of a 2014 merger between Blue Chip Patient Recruitment, which provided support for clinical trial patient recruitment, and J Trotter Research & Consulting, which had been offering late-stage research for about three decades. Now, the patient-centric company is back focused on getting clinical trials more participants, improving their experience and informing protocol development.
Worldwide clearly values the Continuum team’s experience, as it’s appointed Jeff Trotter, president of Continuum Late Stage, to lead the expanded Evidence unit.
The Cures Act really hit the gas on leveraging the power of real-world data and evidence. It mandates that the FDA must issue guidance on the circumstances where it’s appropriate to use real-world evidence, as well as on acceptable standards and methodologies for collecting and analyzing such information.
Last August, the agency issued a new guidance on the use of real-world evidence to support regulatory decision-making for medical devices. And the new FDA Commissioner Scott Gottlieb, M.D., also appears so far determined to accelerate the drug development process and help lower the cost.
“The FDA’s interest in advancing the adoption of RWE in support of its programs remains a top priority,” he said during a speech last September to the National Academy of Sciences.
As the agency is now working on policies to support the use of real-world data and evidence in drug approvals, CROs anticipating big changes, including Syneos Health and Parexel, are making investments in the field.