Good clinical practice , principles

Expert reports are not a promotion platform for the product but an assessment of the data generated, an explanation of the results and an interpretation. An expert report should not normally exceed 25 pages of A4. Reports should also make clear whether or not the preclinical studies submitted have been conducted according to good laboratory practice, and whether the clinical studies have been conducted according to good clinical practice principles and in accord with the Declaration of Helsinki. 

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products... 

Clinical trials must be conducted in accordance with the principles of Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Its purpose is twofold ... 

Table 5.2 The core principles of Good Clinical Practice.

VICH guideline GL9 sets out the principles of Good Clinical Practices for clinical trials of veterinary medicines. The guideline has not been incorporated into specific... 

From this and other guidelines have developed current principles of good clinical practice ( GCP ) centred on ethical review by committee, with a favourable opinion being at least a moral precondition of the commencement of any human research project. In 1989, the CPMP (the Committee for Proprietary Medicinal Products) adopted GCP guidelines (based on a previous 1987 version) for the European Union. Although they were not in themselves legally enforceable, the pharmaceutical industry saw compliance with the guidelines... 

The principles of good clinical practice and detailed guidelines in line with those principles shall be adopted and, if necessary, revised to take account of technical and scientific progress in accordance with the procedure referred to in Article 21(2). 

All clinical trials, including bioavailability and bioequivalence studies, shall be designed, conducted and reported in accordance with the principles of good clinical practice. 

Guidelines for the conduct of clinical trials of pharmaceutical agents have been published (e.g., WHO, 1995), and internationally recognized EC Principles of Good Clinical Practice have been developed (EC,... 

Once the animal studies are completed human studies can commence, moving through phase I (up to 50 naive patients to establish a sufficient immune response) phase (several hundred patients in several locations) to phase III in which expanded studies on as many as thousands of patients. The trials require to be randomized and closely controlled by being blinded to avoid bias in interpretation. The patients all have to provide informed consent and strict adherence to good clinical practices in accordance with ethical principles is required to ensure risk-benefit considerations justify the risks associated with all trials of this type. The safety of the patients is an overall requirement and trials must be supervised by the appropriate independent ethics committee or the local Institutional Review Board. 

Principles for the conduct of clinical research are set forth in internationally recognized documents, such as the Declaration of Helsinki and the Guideline for Good Clinical Practice of the International Conference on Harmonization (ICH) [14]. 

All clinical protocols and supporting documents are reviewed and approved internally by a group of senior Clinical Research Development managers. This group assesses the overall study design and ability of the study to meet its objectives, as well as the quantity and quality of the data. In addition, the group reviews the procedures for the safety and welfare of the subjects to ensure compliance to good clinical practices and ethical principles. 

Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). Annotated with TGA comments. Therapeutic Goods Administration [TGA] (Australia), Commonwealth Department of Health and Aged Care. The TGA has adopted CPMP/ICH/ 135/95 in principle but has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of local regulatory requirements , July 2000. http //www.health.gov.au/tga/docs/html/ ichl3595.htm. 

Contract research organizations (CROs) should be inspected as part of the assessment process to verify that raw data correspond to submitted data, and to assess compliance with standards during the conduct of clinical and bioequivalence studies. Monitoring and requalification should ensure that the principles of good clinical practices (GCP) (20), good practices for quality control laboratories (10) and GLP (19) are adhered to. 

Since finalization in 1996, the International Committee on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) underpinned by the ethical principles of the Declaration of Helsinki have been the cornerstones upon which most clinical research has been conducted outside the United States (1,2). However, in such a widely disparate and expanding territory as Europe (EU), the national differences in complying with local national requirements have presented a highly resource-hungry administrative workload for sponsors. 

Conduct 10. Conduct of a clinical trial Detailed guidelines on the principles of good clinical practice in the conduct in the EU of clinical trials on medicinal products for human use. Draft 5.1, July 2002... 

The present guidelines supplement both the WHO guide on GMP and the guidelines on good clinical practice (GCP) for trials on pharmaceutical products (3). The application of the principles of GMP to the preparation of investigational products is necessary for several reasons ... 

Clinical research in the UK is governed by statutory requirements in the form of the EU Directive (2001/20/EC) on Good Clinical Practice (GCP), ethical principles (Declaration of Helsinki), the Research Governance Eramework for Health and Social Care (Department of Health, 2005) and the duty of care in the National Health Service (NHS), the high professional and ethical standards that most care professionals and researchers uphold. 

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