SOURCE: Cutting Edge Information

Cutting Edge Information

December 08, 2015 11:24 ET

Only 29 Percent of Drug and Device Companies Contract With Patient Recruitment Organizations

Cutting Edge Information Study Finds That 75 Percent of Top 10 Pharmaceutical Companies Are Likely to Contract With a Patient Recruitment Organization

RESEARCH TRIANGLE PARK, NC--(Marketwired - December 08, 2015) - A new pharmaceutical benchmarking study found that only 29 percent of drug and device manufacturers contract with patient recruitment organizations (PROs). This percentage compares to the 96 percent of companies that work with contract research organizations (CROs), according to life science industry benchmarking firm Cutting Edge Information. The study also found that 75 percent of Top 10 pharmaceutical companies were likely to contract a PRO to assist in their clinical studies.

Patient recruitment organizations are trained to assess whether a protocol is patient-friendly and to determine if clinical trial enrollment will be a challenge. In fact, PRO expertise may help companies better gauge patients' potential interest in a given protocol by using new technologies. For a few thousand dollars, some PROs will host online focus groups and survey patients anonymously. This gives the clinical trial team a better sense of the trial's enrollment prospects given the current protocol's structure. In many ways, these focus groups can be better (and cheaper) predictors of a trial's success than more traditional clinical trial computer simulations.

Clinical Outsourcing: Leverage Sponsor-CRO Relationships to Accelerate Trial Timelines, published by pharmaceutical intelligence provider Cutting Edge Information, found that trial simulations focus on the likelihood that a compound will answer specific scientific questions given the trial protocol, a desired time frame and the trial budget. But in a focus group, trial teams can directly ask patients important questions, such as "What are the things that would interest you in a clinical study for your condition?" By getting responses to these questions, clinical trial teams will learn whether the trial protocol is offering the patients what they want.

During a clinical trial, PROs offer a singular focus on enrolling patients that is not often found within sponsor organizations or CROs. Patient recruitment is a local activity, but many sponsors attempt a centralized recruitment plan that treats all markets the same.

"Inevitably, clinical trial teams gravitate toward mass media campaigns rather than approaching local study coordinators," said Sarah Ray, senior analyst at Cutting Edge Information. "But the simplest catch-all approach is not necessarily the best solution."

PROs may also help companies facilitate patient recruitment by maintaining patient recruitment websites and working hand-in-hand with sponsor organizations to build complete recruitment strategies. Low-cost options for clinical teams seeking to bolster current patient recruitment rates include outsourcing individual tasks. As an example, companies may recruit third parties to develop educational materials for distribution to physicians by CRAs. These third parties may also follow up with physicians.

Clinical Outsourcing: Leverage Sponsor-CRO Relationships to Accelerate Trial Timelines, available at http://www.cuttingedgeinfo.com/research/clinical-development/outsourcing-selection-strategy/, provides best practices for vendor management. The report also examines patient recruitment, site selection criteria and outsourcing metrics. Report highlights include:

  • Metrics detailing clinical trial activities from pharmaceutical, device, CRO and site perspectives.
  • Data on surveyed teams' vendor selection process and preferred collaboration type (master services agreement versus functional service provider).
  • Best practice recommendations and projected costs associated with selected patient recruitment activities.
  • Profiles of 17 pharmaceutical, biotech, device and CRO-managed clinical trials, including overall trial costs, number of enrolled patients and sites and clinical team size.

For more information about Clinical Outsourcing: Leverage Sponsor-CRO Relationships to Accelerate Trial Timelines and vendor selection criteria, please visit http://www.cuttingedgeinfo.com/research/clinical-development/outsourcing-selection-strategy/.

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