George W. Merck, our modern-day founder, set the tone for our company many decades ago, when he said, “How can we bring the best of medicine to each and every person?” This question – combined with our mission to save and improve lives – is just as challenging, and compelling, today as it was when he first issued that call to action.
We strive to develop our medicines as safely and quickly as possible, so that patients in need may access them as soon as possible. For most of our medicines, this means that we work with regulatory agencies such as the Food & Drug Administration in the U.S. or the European Medicines Evaluation Agency in the E.U. to design and conduct clinical trials. The agencies then review the data from the studies, and, if the studies have established efficacy and safety, the agencies approve the medicine for specific uses.
That is why our first priority is always to ensure that we conduct the clinical trials that are required by the regulatory authorities and that answer important questions about the potential risks and benefits of our new medicines.
We encourage patients to speak with their physicians about eligibility to enroll in any of Merck’s clinical trials. A complete list of our clinical trials can be accessed here.
If possible, we want to help in cases where diseases are immediately life-threatening and alternatives for treatment are either absent completely or have been exhausted. That’s why if one of our medicines has shown what appears to be a favorable benefit/risk profile in an indication and access to clinical trials is not possible, Merck may create an Expanded Access Program (EAP).
An EAP is designed to provide a patient with access to a medicine before it is approved by a national health authority and outside of the clinical trial setting. When Merck is able to make a medicine available through an EAP, we work with regulatory agencies and patient advocacy groups to design the program. The type of program can vary by country, even for the same medicine. Our overarching goal is always the same – to bring the best of our medicines to each and every person – as soon as we are able to do so, and as fairly as we possibly can.
Merck has a history of creating EAPs for promising products where there is a significant unmet need. Our first major EAP was for Crixivan in 1995, one of the first HIV protease inhibitors. Most recently, we created an EAP for pembrolizumab, Merck’s anti-PD-1 antibody, for patients with advanced melanoma who have been previously treated with ipilimumab or, if indicated, a BRAF inhibitor. The program is still available outside of the U.S., but is no longer available in the U.S. now that the medicine has been approved here.
We are committed to helping as many people with serious, life-threatening illnesses, who might benefit from our medicines, as quickly as we can, and as fairly as we can. It’s important to me that patients and their families understand the seriousness of our commitment and that every decision we make is based on one foundational question: what is the right thing to do for patients?
To begin the process of determining whether or not a patient is eligible for a clinical trial or existing EAP, we must receive a request from the patient’s treating physician. We ask that patients work through their physicians because only physicians can enroll patients in a clinical trial or EAP.