Clinical Trials at Boehringer Ingelheim
Clinical trials are an essential part of new medicine development. Boehringer Ingelheim is committed to advancing the discovery of new medicines to ensure the wellbeing of our patients, and in the last decade, we have conducted or sponsored close to 1,300 clinical studies involving more than half a million patients.
What is a Clinical Trial?
A clinical trial (also called medical research) is a research study to answer questions about a new medicine, device or new ways of using known treatments in patients affected by a particular disease or condition.
Carefully conducted clinical trials are the fastest, safest and most reliable way to find treatments that work for diverse patient populations.
We determine whether our new innovations are both safe and effective by recruiting a diverse and representative patient population and fostering their continued participation.
Clinical trials are usually classified into one of four phases
Phase I Trials are the first studies conducted in humans and evaluate how a new drug should be given, how often, and what dose is safe. Usually only a small number of patients are enrolled in a phase I trial, sometimes as few as a dozen.
Phase II Trials continue to test the safety of the drug and begin to evaluate how well the new drug works.
Phase III Trials involve giving a new drug or treatment to large groups of people. During this stage, researchers monitor a drug or treatment’s side effects, confirm effectiveness, compare it with commonly used treatments and collect information that would allow the experimental drug or treatment to be used safely.
Phase IV Trials continue to investigate a drug after its initial regulatory approval. The focus in phase IV is on further evaluation of the use for which the drug was approved, for comparison to, or combination with other established drugs, and to generate more data on safety under broader use. Phase IV trials are an important tool to strengthen the understanding of the drug and to give guidance to prescribers and patients on the safe and appropriate use under various clinical conditions.
Diversity and Clinical Trial Awareness
Representative patient populations in clinical trials are essential to determine whether a new treatment will be safe and effective for those whom it is intended for. We are committed to promoting awareness of our trials to patients, with a broad range of differences in age, race, ethnicity, sex, and other characteristics. This includes making resources for further information and trial availability readily and easily available. Inclusion and education are important pillars of Boehringer Ingelheim company culture and are actively reinforced with internal colleagues and external partners.