Bayer follows the strictest scientific and ethical principles, always in accordance with applicable law, when carrying out research on humans – especially when it comes to patient recruitment.
Awareness of benefits and potential risks
Each patient needs to be aware of the possible benefits and risks involved in taking part in a clinical trial.
In addition to making a personal contribution to medical progress, one of the central motivating factors for participating in a clinical study is at the same time its most valuable potential benefit: patients have access to a medication that is not yet available on the market, a medication which may be able to shorten the course of their disease, prolong their lives or improve their quality of life.
A possible risk in taking part in a clinical trial is that the drugs being tested may be less effective or of lower tolerability than the currently used standard therapy. Furthermore, new forms of treatment may be accompanied by unforeseeable undesired effects.
Patients are informed that Phase III trials compare a new drug candidate with the current standard therapy or a pharmacologically inactive placebo if no standard therapy exists. Participants are randomly assigned to the standard therapy group or the treatment group under investigation, usually by computer. This method, called randomization, helps to avoid bias and ensures that human choices or other factors do not affect the study's results.
However, medical progress and innovation would not be possible without these patients – by participating, they play a crucial role in ensuring that a medicinal product, proven to be safe and effective, can be submitted for regulatory approval and made available to other patients.
Rights and responsibilites of trial participants
The decision to enroll in a clinical trial provides the patients with extensive rights. Before any clinical trial begins, the attending physician is required to inform patients of all important facts and details of the study in both written and oral form. The patients are asked to confirm their willingness to participate in the trial by signing a written Informed Consent form, a copy of which is provided to the patient for future reference. Informed Consent Forms must be approved by the respective institutional review board, also known as independent ethics committees or ethical review boards, before they can be provided to the patient.