By Beachy, Sarah H.; Berger, Adam C.; Olsen, Steven

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A better approach would have been to allow some institutions to try different approaches and then study the outcomes. Without data, policies are based on what people think is reasonable and a good idea, said Lo. Gathering the necessary data will be a challenge, because it will require characterizing, identifying, and analyzing the good and bad consequences of policies. ” Evidence and data are needed to form good policies. Sometimes there is not a strong evidence base, Rockey said, and in the case of the NIH financial conflict of interest policy, a proactive strategy for regulations was put in place.

For example, the Health eHeart Study is a clinical trial and therapeutic management platform based on social media that allows patients and providers to exchange information. Patient- and device-recorded data and surveys, genetic and blood analysis with specimen banking, and device integration allow for improved health care delivery and the rapid creation of large cohorts for registries and clinical trials. 3 The result is that the study, Cohen said, is similar to the Framingham Heart Study, except that it is able to be carried out on a global scale because of the digital nature of the data collection and analysis.

They then can work with FDA either one on one or in group calls. 2 Center for Devices and Radiological Health Network of Experts. htm (accessed December 9, 2013). PERSPECTIVES ON CONFLICT OF INTEREST POLICIES 29 The conflict of interest forms can be filled out rapidly, and the turnaround from the call to completed conflict of interest forms is 7 days. To achieve this so rapidly, the conflict of interest form is streamlined, McMurry-Heath said. The longest such form is one page and should take no more than 1 hour to complete.

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