Study: Clinical Trials Industry Should Pursue Big Data, Patient Voice Strategies

With the clinical trials industry facing its lowest rates of recruitment and retention, drug developers must incorporate big data and patient voices to improve trial efficiency and hasten innovation, says a new report by the Tufts Center for the Study of Drug Development.

Roughly 48 percent of sites conducting a Phase 2 or 3 trial miss their enrollment targets. More data — both structured and unstructured — can help pinpoint patients and identify patterns in a disease or medical condition as well as patient responses to medication.

Electronic health records are one example of data that allows drugmakers to access larger volumes of data to develop more focused approaches, Ken Getz, an associate professor and director of sponsored research at Tufts, tells CTA.

“For a lot of trials targeting very specific characteristics, more of a big data and analytics approach helps find the right volunteer,” Getz says.

Getz’s points strongly echo those of FDA commissioner nominee Robert Califf, who has made several calls for a system to deliver better clinical trial results with a more representative population through the use of electronic health records (CTA, January).

The 21st Century Cures Act, which is stalled in the Senate, also would allow broader use of innovative statistical methods in clinical trial designs, including more use of adaptive clinical trials and Bayesian statistics (CTA, July 2015).

Getz also stresses the importance of the patient’s voice and engagement as essential components for enrollment and retention. By incorporating the voice of patients and healthcare providers, trials can be designed to be more relevant, he says. For example, a trial’s endpoints should come from the input of patients living with the disease.

The report found that 72 percent of physicians said that they would be willing to refer patients for clinical trials going forward, while 82 percent said they’d be more willing to refer patients if they developed a working relationship with an investigator.

The report also touts the importance of social media as a recruitment tool, while stressing that it is underutilized. It highlights the effectiveness of Google AdWords, which enables greater reach into specific populations, as well as Twitter, which can direct readers to a blog that speaks to specific patient populations.

“While social media is gaining traction as a patient recruitment tool, many drug sponsors and contract research organizations continue to rely on traditional tactics to recruit patients,” the report says.

Moreover, by enacting such reforms in the clinical trials system, the cost of drug development could be drastically reduced, Getz says. — Michael Cipriano


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