PCORI says Pharmas may bias trials

The US Patient-Centered Outcomes Research Institute (PCORI) has suggested the pharmaceutical industry is introducing bias into clinical trials through selective use of inclusion/exclusion criteria and comparators.

The PCORI – a group set up in 2010 under the US patient protection and affordable care act to examine the "relative health outcomes, clinical effectiveness, and appropriateness” of drugs – made the comments in a report on trial methodology issued for industry consultation earlier this week.

It said that: “A pharmaceutical company that conducts studies of its own products will normally choose whom to study, what to compare, and what outcomes to measure so as to support an application for regulatory approval and ultimately success in the marketplace.

“As a result, the apparent efficacy or safety of a medical treatment may depend on who is studying it and what they have to gain or lose by the results.”

The organisation also suggested that some drugmakers – with the support of regulators - choose to compare new products against inferior drugs rather than the best available alternatives to ensure the best possible outcome.

The organisation was not immediately available for comment when contacted by Outsourcing-pharma.com.

Public comment

The draft methodology report, which identifies 60 standards for PCOR, was produced by PCORI’s 17-member Methodology Committee, a panel of top research methodology experts appointed by the U.S. Government Accountability Office.

"We believe that methods matter – that patients deserve research results that meet the highest scientific standards," said Committee Chair Sherine Gabriel, MD, professor of medicine and of epidemiology and the William J. and Charles H. Mayo Professor at the Mayo Clinic.

"We now need the input of all health care stakeholders to ensure that their perspective is reflected in this resource."

Comments are being accepted through an online comment and survey tool where respondents may answer a series of questions about the report. In addition, respondents may upload a document to provide any additional comments. All responses received through pcori.org will be displayed for public view on the website, as required by law.

Parties interested in commenting on PCORI’s proposed methodologies have until September 14 to provide feedback.