IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For September 2015
By Ed Miseta, Chief Editor, Clinical Leader
Below are my top three articles downloaded on Clinical Leader for the month of September 2015. In case you missed them, take this opportunity to check them out and hear more about patient-funded trials, risk-based monitoring, and the effect of the Sunshine Act on clinical research spending.
The Ethical Dilemma Of Patient-Funded Trials
A recent article by Tom Blackwell, which appeared on the National Post website, caught my attention. In the piece, Blackwell notes there is a growing trend which has some critics alarmed: having patients pay for their participation in clinical trials. In the article, Blackwell mentions Regenastem Inc., an international medical practice company. Regenastem’s focus is on using a patient’s own adult stem-cells to treat severe heart, lung, and circulatory problems. The therapies, billed as safe, simple, and non-invasive, are geared towards patients who have exhausted the possibilities of other treatments.
Clinical Insights: “RBM Is The Biggest Game Changer Since EDC”
Mike McKay is the Associate Director of Operational Excellence for Shire Pharmaceuticals. He has been involved with clinical trials for more than 20 years, with the majority of that time spent in clinical operations. In his current position in the Operational Excellence department, McKay is focused on making Shire’s clinical trials leaner, meaner, and faster via process improvement, benchmarking performance, and implementing new technologies. I recently spoke with him about his job, the challenges he faces, and the role risk-based monitoring (RBM) will play in changing the future of clinical research.
Is The Sunshine Act Reducing Clinical Research Spending?
The intentions behind the passing of the Physicians Payment Sunshine Act, enacted in 2011 along with the Patient Protection and Affordable Care Act, were good ones. 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. I don’t think too many people would have a problem with that. If a pharmaceutical company is making payments of cash or gifts to a general practitioner, most would assume the reason is to encourage the physician to prescribe their drug over that of a competitor. Many would argue that taking that aspect out of the prescription drug process could have the effect of saving money for both the patient and the payers. 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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