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The act creates serious concerns about the industry's ability to recruit and retain well-qualified investigators.
A recent survey of more than 200 active investigators by the Association of Clinical Research Organizations (ACRO) found that 24 percent of physicians in the United States currently conducting clinical research would be less likely to do so if their income were disclosed.
The Physician Payment Sunshine Act, which resulted from the passage of US healthcare reform legislation, is meant to create transparency in relationships between sponsors and investigators and ensure that payments do not impact scientific objectivity.Yet, nearly one quarter of the US investigator pool is at risk, and the requirements of this act create serious concerns about the biopharmaceutical industry's ability to recruit and retain a large population of well-qualified investigators.
To put these fees in perspective, the median payment to an investigator in the United States is approximately $3,500 per patient. This payment compensates the physician for what are often several visits by each patient. In addition, many investigators employ research assistants and use specialized technology to manage their research practices. These fees are hardly exorbitant given the time, effort, and skills involved.
While ACRO supports disclosure of payments to clinical trial participants, the association has concerns about the broad disclosure of fees and the perception that fees paid for legitimate research may constitute a conflict of interest. The association is also concerned that requiring sponsors to report payments for clinical trial grants and research may impede scientific excellence.
According to clinicaltrials.gov, 52 percent of all clinical studies today are taking place in the United States. Legislators, regulators, and academic institutions must balance concerns over conflicts of interest and the Physician Payment Sunshine Act with the need for public disclosure in a way that does not take away from advancing drug discovery and development.
The first reports to the US Department of Health and Human Services (HHS) are due March 31, 2013, for payments made in the 2012 calendar year. While payments made for research must be reported with all other payments such as gifts, consulting fees, education, and travel, HHS is directed not to disclose the research payments until four years after they are made or upon the drug's approval. This delayed disclosure is intended to protect proprietary information for sponsors but creates a potential data management headache for HHS.
While all regulations and reporting requirements related to the act have not been decided, ACRO is already reaching out to the pharmaceutical, biotech, and medical device industries to collaborate on guiding principles and the development of a template for reporting physician and teaching hospital payments. Our focus is on ensuring compliance with the law and creating a consistent way for sponsor companies and contract research organizations to gather and report data.
Currently, six states have their own "sunshine" laws, adding another layer of complexity to reporting. Perhaps these states could adopt the federal standard to somewhat ease the compliance burden.
Clinical research is, and should be, a highly regulated industry. But whether the issue is privacy, medical liability, conflict of interest, or payment disclosures, we must weigh the benefits of the regulations against the possible negative consequences. In this case, is the increased value of "sunshine" really worth the potential loss of one quarter of the US investigator pool?
William Sharbaugh Chief Operating Officer, PPD, Inc. Chairman, ACRO