The health of patients is of the utmost importance. We strive to ensure the safety and efficacy of our therapies in every step of the product development process—from pre-approval studies to post-marketing monitoring.
In all cases, we comply with applicable laws, regulations and international standards, including the Declaration of Helsinki, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), the Biotechnology Industry Organization Statement on Protecting Research and Research Participants, and the Pharmaceutical Research and Manufacturers of America’s (PhRMA) Code on Interactions with Healthcare Professionals. Biogen Idec complies with all clinical trial registration and disclosure requirements to ensure the integrity and transparency of every aspect of the clinical trial process.
Clinical trials are used to determine whether a new drug, or therapy, is safe and effective, as well as beneficial to patients. Clinical research allows doctors and researchers to gain valuable data on the benefits, side effects and possible applications of new drugs, as well as different combinations, doses and new indications of existing drugs. We have policies, processes and procedures to ensure that clinical trials are conducted in a manner that fully complies with regulatory requirements and protects the safety, welfare and privacy of study participants. Some of these include:
Obtaining Study Protocol Approval
With every clinical trial, Biogen Idec submits extensive regulatory commitments to the health authorities, as well as central/local ethical review committees (ERCs) or institutional review boards (IRBs). These commitments provide information on the study drug, the Investigator’s Brochure, the proposed protocol and the informed consent form (ICF). The ICF informs the participants, in lay language, of the protocol requirements and procedures, as well as any potential risks or benefits associated with their participation. The ERC or IRB is composed of individuals fully independent of the study site, and whose primary responsibility is to ensure that proper safeguards are taken to protect the rights and welfare of study participants throughout the conduct of the trial.
Providing Payments to Investigators
We employ stringent guidelines in identifying and contracting with investigators (physicians and other personnel) who implement the clinical trials sponsored by Biogen Idec. We also conduct extensive capability assessments to determine whether investigators are able to comply with the requirements of the protocol. We require both investigators and the institutions that employ them to review the services they will perform in conjunction with a trial and agree to an associated budget and payment structure. Biogen Idec conducts fair market value assessments to ensure that investigators are paid fairly for their work conducted as it relates to the clinical trial. We also have policies that require investigators to disclose any financial interests in our company, thereby reducing the potential for conflicts of interest.
The geographical location of the studies is based on the clinical trial phase, the required number of participants (e.g., our Phase 1 studies may involve as few as 20 participants, whereas Phase 3 studies may enroll several thousand patients), the epidemiology of the disease being studied, and specific requirements of the protocol (e.g., participants who have never received treatment or have a certain severity of the disease). In 2011, more than 5,000 patients in 46 countries participated in Phase 1-3 clinical trials sponsored by Biogen Idec. In accordance with regulations and GCP guidelines, once appropriate candidates are identified, we require written informed consent from every study participant. As the clinical trial progresses and new safety data are collected, Biogen Idec provides this information to investigators and may require them to re-consent all participants, as necessary. Unless they are healthy subjects, participants are not paid to either enroll or stay in clinical trials, other than reimbursement for incidental expenses.
Conducting Clinical Trials
Our world-renowned investigators oversee clinical trial participants at more than 1,000 sites globally. Biogen Idec and its contract research organization (CRO) partners rigorously train site personnel on the clinical trial protocol. CROs also visit sites regularly to make sure the studies are being run appropriately according to GCP. In addition, Biogen Idec provides co-monitoring activities and selective periodic audits to ensure adequate oversight of the trial and sites. During the study, patient progress is closely monitored. If problems arise, we report issues to the corresponding ERC/IRBs and regulatory bodies and follow up accordingly. Additionally, our late-stage clinical trials are usually overseen by an independent data monitoring committee, which assesses the progress of the clinical trial, monitors patient safety and may review accumulating efficacy data.