Access to Investigational Products Outside of a Clinical Trial
Merrimack supports the clinical research process. Through controlled clinical trials in which patients volunteer to participate, we gather data on our investigational products. This data helps Merrimack, regulatory authorities and treating physicians in determining the most appropriate patients to receive the drug. In exceptional cases, Merrimack may permit access to an investigational drug outside of the context of a clinical trial. A treating physician may apply for access to Merrimack’s investigational products on behalf of a patient with a serious or life-threatening condition, who is not eligible for ongoing clinical trials or who has exhausted all other treatment options.
To request access to one of our investigational products, please contact us by email at email@example.com. Merrimack will acknowledge receipt of all requests within 10 business days. Merrimack maintains full discretion over supply of its investigational products and makes no guarantees that requests for access will be approved.
Policy on Access to Investigational Products Outside of a Clinical Trial
This policy applies to compassionate/expanded access to a Merrimack investigational product that is not approved for any purpose in the country where the requested product would be used. This also includes the time between regulatory approval of an investigational product and its commercial availability in a country. Any use of a Merrimack investigational product outside of a clinical trial must be in accordance with local laws and regulations governing such programs, including Merrimack’s policies and procedures. In general, where permitted by local regulation, the investigational product supplied via compassionate access will no longer be provided by Merrimack when it becomes available via the local healthcare system.
Patient Eligibility Criteria
To be eligible for access to a Merrimack investigational product, patients must meet the following criteria:
- Suffer from a serious or immediately life-threatening disease or condition;
- Have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition;
- Are ineligible for participation in any ongoing clinical trial of the investigational product, which includes lack of access due to geographic limitations; and
- Meet any other pertinent medical criteria for access to the investigational product, as established by the Merrimack clinical or medically responsible individual.
Investigational Product Criteria
In addition to the patient eligibility requirements, the Merrimack investigational product must meet the following criteria:
- The product is under investigation in one or more clinical trials;
- There is sufficient evidence, as judged by Merrimack, to expect that the potential patient benefit justifies the potential risks of the treatment use, and those potential risks are not unreasonable in the context of the disease or condition to be treated;
- The provision of the investigational product will not interfere with or compromise the clinical development of the product; and
- There is adequate supply of the investigational product to perform necessary clinical trials in addition to provide access to patients who do not have alternative treatment options.
Treating Physician Criteria and Responsibilities
The physician attending to the patient who is receiving the Merrimack investigational product must be properly licensed and fully qualified to administer the drug. The physician must agree in writing to comply with:
- Any applicable country-specific legal and regulatory requirements related to providing an investigational or unlicensed product under compassionate access; and
- Any Merrimack requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property.