BIO Principles on Clinical Trials
Adopted by BIO's Clinical Safety and Efficacy Committee in 2008
The integrity and safe/ethical conduct of clinical trials is of the utmost importance to biotechnology companies developing biomedical products. Through this statement of principles, the Biotechnology Industry Organization (BIO) continues to support and promote the ethical and scientifically sound design and conduct of clinical trials conducted in all regions of the world. The following principles for interventional clinical trials are based on the concepts enunciated in the Declaration of Helsinki, the Good Clinical Practices developed through the International Conference on Harmonization (ICH-GCP), as well as established industry practice and legal standards.
BIO member companies are committed to protection of research participants regardless of where clinical trials take place. No matter what country hosts clinical research, data collection or analysis, companies protect and value the contribution of each research participant. Participants throughout the world – including in developing countries – deserve protection based on the same fundamental ethical principles.
BIO member companies conduct clinical trials in compliance with Good Clinical Practices including those standards developed by the International Conference on Harmonization (ICH-GCP), and in accordance with all applicable laws and regulations. These standards help to ensure the ethical conduct of trials. In addition, companies conducting trials in developing countries seek to collaborate with local authorities to address ethical and clinical issues surrounding the conduct and design of the trial prior to enrollment of human participants.
BIO member companies ensure that clinical trial protocols are reviewed and approved by an IRB/IEC committee. Clinical trials are designed to fulfill scientific and ethical standards that must be conducted according to the pre-established criteria based in the study protocol. Introducing new therapeutic molecules into humans always has some risk, and first in human studies should be as safe for research participants as possible; this is always the primary consideration in study design.
BIO member companies ensure that medical research involving human participants anywhere in the world should only be performed if the importance of the research objective outweighs the risks to the participant. Even where there are no applicable local laws or established infrastructure for human subject protection, if a clinical trial involves more than minimal risk to a participant, an ethics review board operating in accord with the laws of the host country should review the potential risks to participating, and balance them with possible benefits to participants and society.
BIO member companies seek voluntary informed consent from all clinical trial participants. Voluntary informed consent is not coerced. Potential research participants should be informed that they will be participating in a research trial that may not benefit them; the nature, significance, implication and risks associated with participation in the research trial, including risks identified in preclinical (animal or in vitro) studies; and that they have the right to withdraw from the trial at any time without penalty. Participants should also have an opportunity to ask questions about the trial. The informed consent process may be different in the case of research involving emergency situations, children, unconscious patients, and mentally-incapacitated patients. The process for obtaining informed consent may vary depending on the social and cultural context of the community[ies] in which the proposed trial would be conducted and the potential participants’ education, culture, and literacy.
BIO member companies ensure informed consent is obtained. Informed consent should be obtained in writing, if possible. If a participant is unable to memorialize his or her consent in writing, any verbal consent should be formally documented and witnessed. Moreover, if a participant cannot provide consent because of a cognitive impairment or if the participant is a child or is unconscious or mentally-incapacitated, consent must be obtained from an appropriate legal guardian or representative, according to local laws. Children (generally children of school age) and mentally-ill individuals capable of providing their assent should be provided the opportunity to provide or withhold their assent to participate in a clinical trial, in accordance with applicable local laws. Once signed, a copy of the consent should be provided to the participant.
BIO member companies ensure the control group in the study are provided with an established effective treatment, when possible and appropriate. Placebo-controlled studies are also appropriate when an established effective treatment is not available, when the use of a placebo does not present undue risk to the health of the trial participants, or when there are compelling and scientifically sound reasons for the use of a placebo.
BIO member companies are committed to including populations that have previously been underrepresented in clinical research, when possible and appropriate. Including such populations in clinical research provides increased access to experimental treatments, including those that may provide benefit, and also helps ensure the collection of comprehensive clinical information.
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.