Clinical trials protocol development

Further information and advice related to the use of the clinical trial design can be found in a variety of sources including textbooks, manuscripts, organizations and Internet sites. In addition to the chapter reference list which cites helpful sources of information related to clinical trial protocol development, design and analysis, the following sources are also recommended. 

No matter what its design, a well-planned clinical trial requires development of a suitable trial protocol prior to its commencement. The protocol documents outline all pertinent aspects of the trial (Table 2.8) and should be made available to trial participants and other interested parties. A core prerequisite of any trial is that participants be fully informed regarding the intervention and any likely associated effects. 

CSOs assisting clients with clinical trial design need to be an extension of the client s project team and have access to all the data to assist in developing a realistic clinical trial package to determine the safety and efficacy of a drug candidate. In addition to assisting clients with clinical development plans and preparing clinical trial protocols, many of these CSOs also offer... 

Department established in April 1997. Pharmaceutical companies have started to consult this department on their development plans, clinical trial protocols, necessary studies, etc., with fees (See Table 2). 

The main activities of the PMDA are to offer the pharmaceutical industry consultations with regard to clinical trial protocols and drug and medical devices development plans, to conduct new drug application review and to confirm the quality of the submitted data. The PMDA, or Drug Agency, is composed of 15 offices to conduct different services (see Figure 35.3). 

Because the framework of every clinical research trial relies on a number of interdependent disciplines, the development of a clinical trial protocol is ideally a multidisciplinary task. Teamwork, coordinated by one experienced person in clinical... 

Proper and comprehensive planning of a clinical trial is essential to the successful development of any drug. The first issue to be considered when developing a trial protocol is to define precisely what questions the trial results should be capable of answering. As discussed previously, the terms safety and efficacy are difficult to define in a therapeutic context. An acceptable meaning of these concepts, however, should be committed to paper prior to planning of the trial. 

Tests in Medical Practice. The ordering of laboratory tests in medical practice (as opposed to Phase I clinical trials) is extremely inefficient and often irrational. This suggests the need in some clinical situations to develop logical protocols and... 

Under the CTN scheme the sponsor of the clinical trial provides detailed information about the proposed trial to the principal investigator who submits an application to conduct the clinical trial to the HREC at the institution or other site at which the trial is proposed to be conducted. The clinical trial application generally includes the protocol, the investigator s brochure, related patient information, supporting data and the CTN form. HRECs usually have their own standard format for applications to conduct a CTN trial at their institution. The HREC evaluates the scientific and ethical validity of the proposed clinical trial and the safety and efficacy of the medicine in the context of its stage of development. The TGA does not evaluate any information about the clinical trial. 

Extensive early development work is thus essential. Any significant deviation from the production protocol, used to generate the trial material, could invalidate all the clinical trial results with respect to the proposed commercialized product (changes in the production process could potentially change the final product characteristics — both the active ingredient and contaminant profile). 

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