Good Clinical Practice standards

Phase IV trials must be conducted according to the same ethical, scientific and Good Clinical Practice standards as those required in Phase I III studies. A more detailed account on PMS studies can be found in a chapter by Hollister et al (1994). 

This was a single-center, randomized, active-controlled, double-blind parallel-groups study performed at ABG. The clinical protocol was reviewed and approved by the Western Institutional Review Board (Olympia, WA), and the study was perlbrmcd according to Good Clinical Practice standards. Each subject provided writtrai informed consent. 

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 ... 

FDA resources are expended in areas based not on their absolute importance but on the lack of industry capability to control a particular concern. When manufacturing processes were primitive, unclean, and uncontrolled, the FDA issued the Good Manufacturing Practices and eventually the Good Laboratory Practices, Good Clinical Practices, and Good Tissue Practices. Together these Practices provide standards for the industry operations. 

Provision of adequate competent medical staff is essential for the safe and ethical conduct of studies in humans. Decisions about whether a volunteer fulfils the entry criteria for a healthy subject or should be withdrawn from a study, how to respond to an unexpected adverse event and when to discontinue a study can prove challenging to the most experienced physician. Similarly, research nurses need many organisational and other skills over and above those that they acquired during their basic clinical training. Scientific staff must be competent in the techniques that will provide the essential data. All must be properly briefed about what will be required of them during the course of a study, and must be fully familiar with local standard operating procedures (SOPs) in compliance with good clinical practice (GCP). 

The verification of compliance with the standards of good clinical practice and the need to subject data, information and documents to inspection in order to confirm that they have been properly generated, recorded and reported are essential in order to justify the involvement of human subjects in clinical trials. 

Today, clinical trials must adhere to nationally and internationally agreed codes of good clinical practice, which define ethical and scientific standards. Good clinical trial design and conduct should apply scientific methods. Skilful analysis can never correct for poor design. The purpose of the trial should be defined and specific hypotheses stated in the written study protocol, which will also include details of how the trial will be conducted. Errors in the data have two components, purely random errors and systemic errors or bias, which are not a consequence of chance alone. Randomisation of subjects is important both to avoid observer bias and to prevent or minimise the influence of unknown factors that might influence the results. 

Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. For more information on the FDA s GCP program, go to http //... 

Whereas GMP as well as GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) are mainly acting on the operational or technical level, other quality assurance standards have been established by the International Organization of Standardization (ISO) to assure quality at the organizational level. Inadequate organizations with unclear tasks and responsibilities can severely influence the quality of products and services. 

Good Clinical Practice (GCP) The standard by which clinical trials are designed, implemented and reported so that there is public assurance that the data are credible, and that the rights, integrity, and confidentiality of subjects are protected. [Defined for this book.]... 

Office of Compliance and Standards. In this department, data compliance to good laboratory practice (GLP), good clinical practice (GCP) and good post-marketing surveillance practice (GPMSP) is carefully controlled. Applications are checked to determine if they were prepared according to the Criteria for Reliability of Application Data. 

The second most important criterion is compatibility. Are the CRO s procedures and practices compatible with the sponsor s Is the chemistry between the CRO and sponsor good The sponsor should examine the CRO s standard operating procedures (SOPs) and talk with CRO staff to determine not only whether the CRO is meeting the requirements of good clinical practices (GLP), but also whether its practices closely parallel the sponsor s. CROs sometimes claim they can work according to the sponsor s SOPs , but the results are likely to be disappointing if the two companies have vastly different approaches or use incompatible technologies. 

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