Regulatory Requirements for Clinical Trials

Clinical trials are performed under Good Clinical Practice (GCP). Up to now, there has been no reference to the regulatory requirement. The reality is that every trial has to be approved and carried out under regulatory compliance to GCP requirements. Otherwise, the trials may be considered as noncompli-ant and become invalid. 

A normal course of event in initiating a clinical trial is for the Sponsor (see below) to prepare an Investigator s Brochure and select an Investigator to conduct the trial. The Sponsor and Investigator then prepare the trial protocol. 

Different countries have different requirements for clinical trials. However, the two main documents that most clinical trials are based on are the documents from the FDA and the ICH. The relevant documents are  

The scope of this book does not allow a discussion of all the requirements for GCE Readers are referred to Exhibit 6.7 for the headings in the relevant regulatory documents to gain further understanding of the requirements. Some important issues, however, are discussed to clarify the important aspects and requirements for clinical trials in accordance with GCP. Some of these aspects are  

Investigator Investigator s Brochure Informed consent Protocol 

Exhibit 6.5 Phase III Study Combination Therapy with IL-2 (interleukin-2) plus Antiretroviral Drugs to Treat HIV Infection 

This trial is sponsored by the National Institute of Allergy and Infectious Disease. 

In this study, the patients are divided into two groups. One group receives the antiretroviral drug alone, and the other receives IL-2 and the antiretroviral drug together. IL-2 is a protein that can activate the immune system. 

This is a randomized trial, and is open-label (not blinded). Patients are to be examined physically during the trial and their blood samples collected for analysis. 

Phase IV clinical trials are post-marketing approval trials to monitor the efficacy and side effects of the drug in an uncontrolled real-life situation. This is also known as a post-market surveillance trial. Information about the effectiveness of the drug compared with established treatment, side effects, patient7s quality of life, and cost-effectiveness is collated. 

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The preparation of a new drug substance or dosage form for evaluation in clinical trials must meet the same regulatory requirements and controls as a marketed product. The cGMP requirements for clinical trial products are outlined by FDA and are discussed in Chapter 20. 

Where you stand [on an issue] depends on where you sit is an old truism of public administration. It is essential, therefore, to clarify at the outset the perspective we bring to this examination of DoD-FDA interactions. The literature on commercial drug development emphasizes the complexity and uncertainty of research and development, especially clinical trials, and the FDA regulatory requirements for safety and effectiveness that a new drug must meet before... 

There are many regulatory requirements for new drug development and approval. Before a sponsor submits a request for a drug to be registered for human use, a tremendous amount of highly specified laboratory testing, nonclinical work, and clinical trials need to be performed. In all cases, the procedures and results must be documented appropriately. From a regulatory perspective, if the research is not documented, for all intents and purposes, it has not been done. 

Induction training in QA may comprise the general audit procedures employed at the company, key audit SOPs and documentation requirements in QA. A thorough review of the regulatory framework for GCP is recommended, as QA auditors are expected to be experts for clinical trial regulations and all GCP aspects. It would impair the QA auditors credibility if they knew less than the auditees of the requirements that must be adhered to in drug development. 

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