BIO's Principles on Clinical Trials
BIO member companies are committed to addressing conflicts and potential conflicts of interest in medical research. Many conflicts and potential conflicts exist throughout the research enterprise. These conflicts are financial and non-financial in nature and exist in many different contexts. Policies to identify and manage conflicts should be tailored for each situation. BIO is committed to working with stakeholders including researchers, research institutions, and regulators to develop policy solutions that protect patient care and research integrity as well as promote productive relationships between industry and researchers.
BIO member companies ensure that financial conflicts of interest are disclosed to the institutional review board/independent ethics committee and/or independent conflicts of interest advisory board, in accordance with the board/committee's conflict of interest policies. Researchers can be paid at an appropriate professional rate for their time and expertise to conduct clinical trials for sponsors.
When payments are made to research participants, BIO member companies ensure that any such payments are fair and the terms are consistent with the principles of human subject protection. Payments to research participants can be based on factors such as time and/or reimbursement of reasonable financial expenses incurred. The terms of any payments should be specified in the informed consent form.
Prior to beginning a clinical trial, BIO member companies disclose the conditions under which patients participating in clinical trials will be offered medical treatment, including whether the experimental treatment will be available after completion or termination of the trial and for how long. These terms should be specified in the research protocol and the informed consent form, should address the availability of, conditions for and duration of access to treatment during and post-trial, and should be reviewed by the ethics committee. For trials in developing countries, access and standard of care should be in compliance with local customs and requirements.
BIO member companies may make investigational drugs available to seriously ill patients who have exhausted other appropriate treatment options, if so doing does not harm the integrity of the companies' research program. One way to make investigational products available in such circumstances is to enroll patients in clinical studies, where such access has been approved by regulatory authorities and an IRB/IEC, where there is sufficient data demonstrating a favorable benefit-risk ratio for such use, and where adequate supplies of the investigational drug exist. However, resources are typically best directed toward conducting clinical studies to support regulatory approval of investigational products.
BIO member companies register, in a public registry, all controlled Phase II, III and IV clinical trials that they conduct in patients. Patients and health care providers should have access to relevant information on active clinical trials and the medicines BIO members discover and develop so that products can be used safely and effectively.
BIO member companies are committed to helping ensure that patients and healthcare providers have access to key clinical trial results information. BIO members support efforts to increase the availability of accurate, scientific evidence to inform clinical decision-making. BIO believes that individual patients and their doctors should be armed with the best available information relevant to assessing the relative clinical benefits and risks of various treatment alternatives.
