Mixed experience with the Sunshine Act

Pharmaceutical companies have finished submitting the third batch of data de­tailing their financial relationships with physicians and teaching hospitals under the Open Payments program, also referred to as the Physician Payment Sunshine Act. Investi­gators now face the prospect of implementing sophisticated new processes and systems that can track and verify clinical research grant payment information. The increasing burden associated with Open Payments regulatory requirements already has resulted in some investigators, particularly private practice physicians who conduct clinical research part-time, leaving the clinical research enterprise or cutting back on their participation.

Big Data in clinical trials: Promise and pitfalls

Privacy versus medical progress. Propri­etary ownership versus public informa­tion. Cost-effectiveness versus unneces­sary burdens. Welcome to the swirl of opinions and emotions around Big Data and its poten­tial—or not—in the clinical trials industry. A 2016 survey examining the views of the public and the industry about privacy con­cerns regarding the use of Big Data in clini­cal trials has reopened discussions about the potential and the benefits, the barriers and the concerns. The survey, conducted by SCORR Marketing in partnership with CenterWatch, recorded the opinions of 300 members of the general public and 39 professionals in the drug development industry.

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