Post-Trial Access Program Solutions
Post-trial access is the provision of investigational medicinal product after successfully completing a phase 2 or 3 clinical study and requiring treatment for a prolonged interval beyond the end of the clinical study.
At the end of a trial, pharmaceutical companies may continue to provide treatment to participating patients through a post-trial access program. Simply put, this is ‘continued access’ after completing a trial, if deemed medically necessary. Different countries use different terminology and have country-specific regulatory requirements. In the United States, post-trial access can be provided through one of three pathways: Individual IND, Intermediate Expanded Access Protocol, or Treatment IND. Early Access Care consultant services will provide guidance on options most suitable for client specifications. Our medical writers provide protocol development services to support all three.
Industry best practice is to include wording in the clinical trial protocol document, if permitted in country-specific regulations, and only if the treating physician deems continued treatment with the investigational drug is in the best interest of the patient. Such information may include a duration of treatment, or wording about availability until the investigational drug becomes approved and available through the local healthcare system.
Our consultancy and medical writing services can assist pharmaceutical companies with options for wording suitable for any trial. Early planning Considerations for post-trial access may include eligibility criteria, and also that post-trial access is expected to end when the patient is no longer receiving benefit from the investigational medicinal product
How Does Post-Trial Access Differ From An Extension Study?
It is often the case that a pivotal clinical trial is double blind, and patients requiring treatment for a prolonged interval beyond the end of the clinical trial are offered an open label extension (OLE) study. An OLE is a GCP-controlled clinical trial, and is considered a ‘covered’ registration study. For a pharmaceutical company that means as many bells and whistles as a clinical trial, just simpler because patients are all receiving open label investigational medicinal product. Sure, it is simpler than a clinical trial, but it is also a registration study. Pharmaceutical companies frequently face the dilemma of an OLE going on for several years, wanting to provide continued treatment to patients in need, and not knowing how to transition the program into something simpler that is not a registration trial. The key question to ask is ‘do we need the data?’ to fulfill a registration requirement. If the answer to that question is ‘no’, pharmaceutical companies need to consider the alternatives.
Early Access Care provides post-trial access program solutions customized to your needs.
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