Study Conduct

Spotlight Continues to Shine on Pragmatic Clinical Trials

Friday, July 1, 2016

Federal human subject protection regulations have gone a long way to protect the safety of clinical trial participants. However, research professionals say that these regulations view clinical research as a highly controlled system somewhat separate from medical practice.1 This results in medical decision-makers not having high-quality evidence to make the choices in treating patients, they say. “As the field of clinical research has evolved to address this gap, it has become challenging to apply the current regulatory and ethical paradigms.” They say this is particularly evident among an increasing number of “pragmatic” clinical trials. Pragmatic trials are designed to reflect real-world medical care by recruiting broad populations of patients, embedding the trial into the usual healthcare setting, and leveraging data from health systems to produce results that can be readily used to improve patient care, according to the Patient-Centered Outcomes Research Institute (PCORI) in Washington, DC.

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Three resonating patient-centric initiatives

Friday, July 1, 2016

Sponsor companies are piloting patient-centric initiatives at a furious pace. Although few initiatives designed to engage patients as clinical research partners have achieved widespread adoption, several are making substantial inroads. In this issue, CenterWatch profiles three major patient-centric initiatives that appear to be resonating across the clinical research enterprise.

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Beyond the buzzword: Patient centricity takes hold

Friday, July 1, 2016

Patient centricity has become a bit of an industry darling—the buzzword is everywhere. Thousands of articles, images and conference talks have been devoted to raising the patient-centric bar in an effort to elevate patient perspective and find better ways to incorporate the needs of patients and caregivers—all as a path to improved clinical research.

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