Welcome to our Clinical Studies section

Clinical studies involving healthy volunteers and patients play a vital role in the development of new drugs. These studies are conducted to ensure that all investigational drugs are safe and effective. Over recent years, along with drug discovery, drug development and clinical studies have benefitted from scientific and technological advancements as well as a greater understanding of the needs clinical study participants have.

At UCB we’ve moved away from seeing patients as just patients. By really listening and engaging with them as partners we are striving for greater understanding of their needs or ways to improve our clinical studies. To improve and accelerate development, we will keep patients’ needs front and center, leverage new technologies, and adaptive clinical study design to improve the patient experience.

Diversification of clinical trials is critical, and UCB is working to increase representation and inclusion of underrepresented patient populations through digital and data-driven approaches as well as connecting directly to patient communities. We are committed to working toward a clinical trials infrastructure that addresses health disparities and closes the gap in clinical trial diversity to better reflect the intended treatment population. We continue our work to identify best practices around key drivers such as scientific rigor, informing innovation, and addressing health inequities in clinical trials now and into the future.
 

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Four phases of clinical research

For pharmaceutical companies to make new medicines available to the general public, the safety, quality and efficacy of all potential new drugs must be proven. This is done through a series of rigorous clinical studies, also referred to as clinical trials, research studies or medical research. Clinical research consists of four phases. The first three are conducted before approval is granted and the last phase takes place after approval.

PHASE I
50-100 HEALTHY VOLUNTEERS
Goal
  • Assess drug safety
  • Determine the side effects
  • Evaluate how the drug should be taken
Description

They help researchers to understand how a new drug works in humans and to learn more about what dose should be used in the next phase of studies. Phase I trials are short and volunteers are closely monitored at the research center where the trial is being conducted.

PHASE II
100-300 PATIENTS
Goal
  • Assess short-term safety and effectiveness
  • Find the dose at which the drug works best with the least side effects
  • Small-scale placebo comparison
Description

With the condition for which the medicine, device, product or treatment has been developed.

Phase II studies test how safe and effective the study medication is in a group of approximately 100 to 300 patients with the condition for which the medicine has been developed. Several Phase II trials are generally performed to test the drug in different patient groups and at different doses. Patients are closely monitored in Phase II trials but do not need to stay at the research centers.

PHASE III
+100 - +1000 PATIENTS
Goal
  • Confirm safety and effectiveness
  • Compare the new drug to other compounds (e.g. a placebo or other therapies)
Description

Phase III studies are much larger, involving between approximately several hundred and several thousands of patients. They help to determine if the new drug can be considered both safe and effective in the medium to long term. As in phase II studies patients are closely monitored but do not need to stay at the research centers.

PHASE IV
MANY THOUSANDS OF PATIENTS
Goal
  • Conducted after the drug is approved
  • Study the effectiveness of the drug in a wide variety of patients
  • Monitor safety in a large group to enable the development of new uses for the compound
Description

Phase IV research is conducted after the new drug has been approved. In these studies, the new drug is prescribed in an everyday healthcare environment. As safety is a major focus of Phase IV trials, which often involve several thousands of patients, this allows rarer side effects, if any, to be detected. In phase IV studies patients are also closely monitored but do not need to stay at the research centers.

Frequently Asked Questions (FAQ)

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