Investigator Initiated Trials (IIT) – Considerations and Guidance from the Perspective of Clinical Trial Supplies and GMP
1 Introduction
Conducting a clinical trial is a complicated process because of the many factors to address and the numerous entities involved. One such area is management of the interaction between pharmaceutical companies and investigators/noncommercial sponsors in the planning and conduct of Investigator Initiated Trials (IIT). The aim of this Concept Paper is to offer best practice advice for early identification of the minimum information required by the supply chain roles within the pharmaceutical company/manufacturer, owner of the Investigational Medicinal Product (IMP) compound. In addition, the requirements to be fulfilled before an IMP can be supplied to the sponsor/investigator are reviewed. This may help pharmaceutical company/manufacturers and investigators more easily execute the expected level of control and comply with current regulations.
This Concept Paper is designed to give a better understanding of the challenges and requirements linked to IITs and to offer guidance to pharmaceutical companies/manufacturers providing medication to a sponsor, as well as to noncommercial sponsors sourcing medication independently.
The recommendations and advice given in this document are derived from regulations on GMP and Good Distribution Practice (GDP) in the European Union (EU) [1, 2, 3], but may also be useful for the supply of IITs in countries outside of the EU.
2 Background
Investigator initiated trials, also referred to as IIT, IIS (Investigator Initiated Studies) or IST (Investigator Sponsored Trials), have scientific and medical merit developed and sponsored by an independent investigator or academic sponsor. An IIT may be a clinical or non-clinical study conducted without the participation of a pharmaceutical company, for which the IIT sponsor may be requesting pharmaceutical support in the format of either funding, drug product, or both. This Concept Paper covers clinical studies and situations where drug product support is being requested from a pharmaceutical company for an authorized or non-authorized medicinal product (authorized means commercial product).
The sponsor must apply for approval of the study by submitting a Clinical Trial Authorization (CTA) application to the Competent Authority (CA) of the concerned member state that contains either [4]:
- A cross-reference letter to enable the CA to access a previously submitted Investigational Medicinal Product Dossier (IMPD) provided by the pharmaceutical company that owns the IMP. This may refer to a clinical study run by the pharmaceutical company that owns the IMP.
- A cross-reference letter to enable the CA to access an existing marketing authorization
- An IMPD (maybe simplified) provided by the pharmaceutical company that owns the IMP
- A cross-reference letter to enable the CA to access an IMPD submitted by the pharmaceutical company on behalf of the non-commercial sponsor