Clinical trials for safe and effective drugs

Clinical trials involving healthy volunteers and patients play an essential role in developing safe and effective drugs for the wider population. UCB is committed to transparency relating to the existence and results of sponsored clinical studies.

In this respect, we are also committed to disclosing balanced and accurate information regarding our hypothesis-testing clinical studies, regardless of outcome, to ensure that physicians and patients have access to relevant information from clinical studies.

For pharmaceutical companies to obtain marketing licenses and make new drugs available to the general public, the safety, quality and efficacy of all potential new drugs must be demonstrated through a series of rigorous clinical trials.

A customised study plan or ‘protocol’ is developed for each trial, designed to answer specific research questions and to protect the safety of any patients and healthy volunteers involved in the study.

Once the protocol is approved, selected clinical investigators will start to recruit healthy volunteers or patients to participate in the trial. An informed consent procedure is used to ensure that all recruits are fully briefed about the trial and the nature of their participation, both verbally and in writing. A written, informed consent document provides information about the trial, including its purpose, duration, and use of placebos or other comparators, as well as information about the trial procedures, potential benefits and potential risks.