Clinical trials documentation presentation

The company that applies for approval of the generic product must present full chemical and pharmaceutical documentation. If the new product does not fall within the definition of a generic medicinal product compared to the reference product the results of the appropriate pre-clinical tests or clinical trials should be provided (EU 2001 specific Article 10 (3)). It should be noted that the pharmaceutical and chemical quality is strictly regulated and includes all medications. 

Summary The summary presents the case for the drug s approval. It includes discussion about the drug s mechanism of action, its effect on animals, results of clinical trials, manufacturing and tests methods, its stability, and proposed dosage and treatment protocol. The summary may run into hundreds of pages. It is one of the few documents being read by all the different reviewers as such, a good summary will assist with the review process. 

This term is generally used to denote the administration file kept for each trial and each investigation centre. Box 7.1 lists some of the documents that need to be present before a clinical trial starts. (See ICH GCP Chapter 8 for the full list.) Once the study has started, other documents will be added, including completed CREs, ICFs and subjects medical records and other documents directly involved in the study. Some documents have to be kept specifically at the sponsor s office or the controlling centre. Separate files will contain financial and budget-related documents. 

This document describes the objectives, design, methodology, statistical considerations and organisation of a trial. Other information should be present, such as the background and rationale, for the clinical trial. It is a document key to any clinical trial. There should be a logical approach to preparing a protocol (see Box 7.2). 

Experienced senior staff of the sponsor must always visit the investigator site before a new clinical trial starts, even if the investigator has been involved in previous studies. Most pharmaceutical companies have checklists and SOPs of the requirements of an investigator site. Key questions will need to be answered relating to staff support and the present workload of the site. The competence of the staff to conduct any procedures, the maintenance, calibration and QC of any equipment to be used, and whether other clinical trials demand too much resource are aU questions that need answers. In addition, the facilities should be inspected to establish whether the site could store and securely archive the large amounts of documents and study drugs that will be present. The pharmacy may play a major role in the study and therefore the facility and the pharmacist should be visited. 

Many investigator sites employ part- or fulltime nurses to support the clinical trials. Nurses should never be considered to be an extravagance, because without them, the onus of administration and QC is solely on the investigator. The clinical trial nurse can help the investigator in many ways, but two of the most important are ensuring that the CRT reflects what is present in the source documents, such as essential events of the medical history of the subject, and close liaison with the sponsor s monitor. 

While the issue of the ethical conduct of clinical trials in pediatric psychopharmacology is addressed comprehensively elsewhere in this book, it is important to present an FDA perspective on this important matter. It is also important to have the issue of ethics discussed in the context of the scientific needs for trials presented to the FDA in support of new drug applications. These trials must be adequate and well-controlled (U.S. Department of Health and Human Services, 2001). What this requirement essentially means is that, in order to support an efficacy claim, the trials must be interpretable and must be able to document efficacy. For treatments that are intended to improve symptoms, as is almost always the case for psychotropic drugs, placebo-controlled trials are the usual standard. This is especially true when there is a substantial failure rate in placebo-controlled trials for the drugs known to work in a particular therapeutic area, as again is the case for most psychotropic drugs. Where that is true,... 

Present an overview of the ICH clinical safety and efficacy documents and facilitate the user s access to guidance pertinent to clinical trials within these documents. 

Sponsors typically publish the results of important clinical trials in clinical communications in medical journals, and present the results at scientific conferences. As for the preparation of regulatory documentation, scientific communications depend heavily on the discipline of Statistics. Piantadosi (2005) made the following comment about publishing clinical communications ... 

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