Press Release

PhRMA Clinical Trial Rules Improve Authorship Standards

PhRMA May 1, 2013

Washington, D.C. (September 18, 2009) – Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding efforts to enhance transparency in clinical research:

“The PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, which take effect on October 1, 2009, fortify our commitment to patients and healthcare professionals by increasing transparency in clinical trials, enhancing standards for medical research authorship and improving disclosure to manage potential conflicts of interest in medical research.

“Among its key changes, the revised Principles move in lockstep with medical journal editors by adopting the authorship standards of the International Committee of Medical Journal Editors (ICMJE). Under these revised Principles, only individuals who make substantial contributions to medical manuscripts will be recognized as authors.

“What’s more, the strengthened Principles enhance disclosure standards for published research that companies sponsor by also aligning with ICMJE standards regarding disclosure in medical journal manuscripts of all financial or personal relationships that might present a conflict of interest – whether in an article or a letter. Authors of medical journal manuscripts should describe the role of sponsors in designing the study, collecting and interpreting data, and writing the report.

“The revised PhRMA Principles, endorsed unanimously by our member company CEOs, build on improvements already made in the 2004 revision and represent an integral part of our ongoing effort to help ensure objectivity in research and enhance transparency in clinical research.

“PhRMA member companies have a longstanding commitment to ethical conduct of clinical trials and to transparency in reporting. We hope that all companies – including non-PhRMA members – that sponsor clinical research and publish results on websites and in peer-reviewed journals will adopt PhRMA’s standards.

“Other key changes within the revised Principles:

  • “Increase transparency by committing companies to the timely registration of all interventional clinical trials involving patients – including some early Phase 1 studies – on a public website, to help patients who need medical care enroll in relevant studies. There are important public health benefits associated with making appropriate clinical trial information widely available to healthcare practitioners, patients and others. The most important clinical trials are those that test a medicine in patients – people who actually require medical care. Results of these trials provide medical evidence regarding the safety and effectiveness of medicines in the precise population the medicine is intended to help.
  • “Greatly expand transparency in medical research by committing to provide results summaries for all interventional clinical trials involving patients – once the medicines are approved or the particular research programs have been discontinued. By providing results summaries of safety and effectiveness data for clinical trials shortly after a drug’s approval or discontinuation of development, PhRMA members will significantly expand the universe of publicly available data about clinical trials in patients.

“In addition, the revisions bring the Principles regarding company-sponsored clinical trial investigator meetings in line with the revised PhRMA Code on Interactions with Healthcare Professionals, which went into effect January 2009.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.

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