PhRMA Announces New Guidelines For Conducting and Publishing Clinical Trials

The Pharmaceutical Research and Manufactures Association (PhRMA) announced new guidelines on Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results go into effect today. The new guidelines seek to increase transparency of health care professionals in clinical trials, enhance standards for medical research authorship and improve disclosure to manage potential conflicts of interest in medical research.

PhRMA Senior Vice President Ken Johnson announced in a recent press release that the revised Principles adopted 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.

Disclosure requirements are also strengthened in PhRMA’s new principles by 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 are now required describe the role of sponsors in designing the study, collecting and interpreting data, and writing the report. Other key changes within the revised Principles include:

• “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; and
• “Expanding 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.

PhRMA hopes that by making information on clinical trials widely available to healthcare practitioners and patients, people who actually require medical care will respond to studies that test medicine in patients. The impact of bringing more patients in need to these studies would provide medical evidence regarding the safety and effectiveness of medicines in the precise population the medicine is intended to help.

Mr. Johnson also asserted that “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.” The new Principles also acknowledge the following conditions for payment:

· Clinical investigators or their institutions should receive reasonable payment based on work performed by the investigator and the investigator’s staff, not on any other considerations.

· Payments or compensation of any sort should not be tied to the outcome of clinical trials.

· Clinical investigators or their immediate family should not have a direct ownership interest in the specific pharmaceutical product being studied.

· Clinical investigators and institutions should not be compensated in company stock or stock options for work performed on individual clinical trials.

· When enrollment is particularly challenging, reasonable additional payments may be made to compensate the clinical investigator or institution for time and effort spent on extra recruiting efforts to enroll appropriate research participants.

· When clinical investigators and their staff are required to travel to meetings in conjunction with a clinical trial, they may be compensated for their time and offered reimbursement for reasonable travel, lodging, and meal expenses. The venue and circumstances should be appropriate for the purpose of the meeting; specifically, resorts are not appropriate venues.

· While modest meals or receptions may be appropriate during company-sponsored meetings with investigators, companies should not provide recreational or entertainment events in conjunction with these meetings.

· It is not appropriate to pay honoraria or travel or lodging expenses for those who are not involved in the clinical trial.

Authors submitting manuscripts to a medical journal must disclose all financial and personal relationships that might bias their work, and should state explicitly whether potential conflicts exist. Authors must also identify individuals who provide writing or other assistance and disclose the funding source for this assistance. In doing so, authors should describe the role of the study sponsor(s):

• In study design;
• In the collection, analysis, and interpretation of data;
• In the writing of the report; and
• In the decision to submit the report for publication.
• If the sponsor had no such involvement, the authors should so state.

This step from the pharmaceutical industry is extremely important to patients, physicians because it reveals a common goal of all stakeholders: keeping the trust of patients by being more transparent. As a leader in funding breakthroughs in medicine, PhRMA’s new policy will create a better understanding of the important relationship industry and research have without hindering scientists or scaring away researchers.

Once these Principles are put into practice, patients and the public will have a better understanding for the importance of collaboration between industry and physicians to carry out such research whose main goal is to save lives and make people healthier.