Expanding Patient Access to Merck's Investigational Medicines

When results from clinical trials suggest that one of our investigational medicines may offer benefits for patients facing life-threatening conditions, Merck is committed to bringing that medicine to those patients as quickly and equitably as possible.

Three core principles guide Merck when determining whether and how to provide patients with access to Merck's lifesaving medicines prior to regulatory approval outside of clinical trials:

  • Physicians, in consultation with their patients, are in the best position to determine whether their patients are appropriate candidates for investigational medicines.
  • Patients who need a life-saving medicine should have access as soon as possible when the potential benefit to their health outweighs the risk of harm.
  • Providing potentially life-saving medicines should be done on a fair and sustainable basis without undermining ongoing clinical trials.

Patient Access to Investigational Medicines Prior to Regulatory Approval

Enrolling in a clinical trial is the primary way for patients to access Merck investigational medicines prior to regulatory approval by governments. These clinical studies are needed to demonstrate that the medicine meets the standards for safety and efficacy that government regulatory agencies, such as the U.S. Food & Drug Administration or the European Medicines Agency, have established for granting approval. Gaining regulatory approval for a medicine is the only way to bring rapid access to the greatest number of patients who may benefit.

There may be patients facing serious or life-threatening diseases who may not qualify for an ongoing clinical trial and who might benefit from the investigational medicine. For these patients, Merck may be able to provide access to its investigational drugs through individual compassionate use or expanded access programs.

The names and types of expanded access programs vary from country to country due to differences in regulations. Depending on country regulations and the program criteria, access to investigational medicines may be provided through individual Compassionate Use protocols, Expanded Access Programs, or Country-Specific Authorization to Use cohorts.

Click here for the criteria that guide Merck's expanded access programs and compassionate use programs.

Process for Seeking Access

Patients are asked to speak with their physician about their eligibility to enroll in any of Merck's clinical trials and expanded access programs. If the physician feels a clinical trial or expanded access program may be suitable for the patient, the physician should contact Merck to make the request on behalf of the patient. This will enable the physician to work with experts within the company to determine the best course of action.

Information about available Merck clinical trials can be accessed here. Physicians seeking help on behalf of their patients in the U.S. may contact the Merck National Service Center (MNSC) at +1-800-672-6372. Outside of the U.S., physicians may contact the local MSD office within their country to speak with a member of our Medical Affairs department.