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Compliance In Focus
Posted by Sandra Maddock on Fri, Nov 30, 2012

How Will the Sunshine Act Change Clinical Research?

As part of the Patient Protection and Affordable Act, the Sunshine Act requires medical device,How Will the Sunshine Act Change Clinical Research pharmaceutical and similar companies to report any payment or other transfer of value to the Health and Human Services (HHS). This will effect many companies that conduct clinical research and clinical trials, but the question remains- will this negatively impact physician’s willingness to participate in research?

Here is a list of those participating in clinical research that may be impacted by the implementation of the Sunshine Act:

#1: Companies participating in clinical research
As pointed out on an article published on The Clinical Trials Guru, “The intent of this law was to provide transparency for any money being paid to physicians by drug companies (or medical device companies), and it is undoubtedly important for the general public to have this information.  One key nuance that affects us in the clinical trial space is the fact that the Sunshine Act also includes fees received by companies related to clinical trial activities.”

#2: The role of the Physicians/Investigator
Earlier this year another useful resource was published on The Pharma Compliance Blog touching on the role of the PI. It states that the “research payments are published for the PI only, and not sub-investigators, which may make physicians reconsider their roles in conducting clinical trials.  For each trial site, the PI is the individual that is ultimately responsible for the conduct of the research at their site.  Sites may begin assigning this role to other less-qualified individuals, which could negatively impact patient safety and data integrity.”

#3: The patients
While the impact on patients is yet to be seen, at the very least, this Act will help provide more transparency and public knowledge surrounding money and payments regarding those products in clinical trials. Hopefully this will further make all parties aware of their accountability to patients and to conduct research in the highest ethics in all aspects of a clinical trial.

This is federal requirement for our industry; how do you think it will impact the medical device market? Will this hinder the clinical trial process? Please share your concerns below.

Photo Credit: onlinewoman

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Topics: Sunshine Act, Patient Protection and Affordable Care Act, Clinical Research


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