Clinical Research Units Featured Articles
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Transparency In Clinical Trials: Will It Ever Be Achieved?
10/1/2015
A lot has been made recently about transparency in clinical trials. In the EU a new regulation is about to address the issue, and CISCRP recently sent a petition letter to the FDA asking it to pass a similar regulation in this country. The petition, signed by hundreds of patients, hopes to make trials results more accessible to patients. It’s also not hard to understand why a patient participating in a trial would want to know the results of the study, and whether or not they received the active drug or a placebo. But while changes might help companies with patient recruitment and retention issues, will true trial transparency ever be possible?
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Is The Sunshine Act Reducing Clinical Research Spending?
8/24/2015
The intentions behind the passing of the Physicians Payment Sunshine Act were good. The Act required manufacturers of covered drugs, devices, biological products, and medical supplies to annually report to the Centers for Medicare & Medicaid Services (CMS) information regarding payments, ownership, investment interests, and other transfers of value to physicians and teaching hospitals. The intent was to reveal any conflicts of interest that might exist, with the end goal of hopefully bringing down healthcare costs. But even the most well-intentioned acts can have unforeseeable negative results. And it now seems the well-intentioned Sunshine Act may be having the unintended consequence of cutting down on the amount of investment making its way into clinical trials.
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Improve Clinical Sites By Bringing Together Pharma, Biomedical R&D and CROs
2/18/2015
How do you take pharma, and other biomedical R&D, as well as CROS, which for years have operated as separate entities, and get them to come together and create standards and an accreditation process to benefit the entire industry, indeed, the entire enterprise of a complex of multiple stakeholders, including regulators and the public?