On October 1, PhRMA released its "Principles on Conduct of Clinical Trials. Communication of Clinical Trial Results." PhRMA
states that it "adopts these voluntary Principles to clarify our members' relationships with other individuals and entities
involved in the clinical research process." The Wall Street Journal's Health Blog linked to the document in an entry regarding concerns over ghostwritten medical journal articles, some concerns
of which are being initiated in Congress, specifically by Senator Chuck Grassely. Ghostwriting in medical journals rarely
falls under the confines of clinical operations but instead to the medical writing departments of sponsor companies.
Lisa Henderson
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But the fact is that the physician investigators writing (or not writing, as the case may be) these articles are focused
on the research discovered in clinical trials. Which then drills down into other areas of what principal investigators can
and can not do in regard to clinical trial conduct, which may constitute a conflict of interest.
Disclosure recommendations
Under the Informed Consent section of the PhRMA Principles, it states: "Clinical investigators should disclose to potential
research participants during the informed consent process that the investigator and/or the institution is receiving payment
for the conduct of the clinical trial." I checked in with Erica Heath, president of IRC, an IRB, and Felix Khin-Maung-Gyi,
CEO of Chesapeake IRB, both members of our Editorial Advisory Board. Heath agreed that this financial disclosure on the informed consent is not a current requirement of FDA (CFR Part 50 or CFR
Part 54), however, it is becoming routine to include it. "We often include a section titled 'Financial Information' that includes
any cost to subjects, payment to subjects, payment in the event of injury, and payment to the investigator."
She notes that she would suspect that everyone would expect an investigator to have a budget for doing a study that would
include some sort of pay. This falls under the PhRMA Principle, Payment to Clinical Investigators. "Payment...should be reasonable
and based on work performed by the investigator and the investigator's staff, not on any other consideration."
Gyi also commented that this type of disclosure has been part of the informed consent standard practice for a while. He noted,
"It is good to see PhRMA support this in principle. How this is implemented across the board remains to be seen...for example,
will all sponsor companies feel comfortable in stating that they are paying the investigator a fee to conduct the study? I
suspect they will."
PhRMA also noted in the report: "In the strict sense, some conflict of interest may exist in all research settings. For example,
physicians who are specialists and/or leaders in their field are often extensively engaged by both the private and public
sectors to provide their expertise." Key Opinion Leaders, or KOLs as they are called, are being called to task more under
political scrutiny, but PhRMA is laying a brick for their importance.
Lisa Henderson
Editor-in-Chief
email: lhenderson@advanstar.com
http://www.appliedclinicaltrialsonline.com/
