Clinical research practice

A formally recognized and certified IRB must review the proposed clinical research practical to determine whether the relative safety and anticipated benefits to subjects/patients are adequately and fairly represented in the protocol design. If the research is to be done at a large hospital or teaching institution, it is likely... 

Volume 3 Interim Good Clinical Research Practice Guideline, August 1998... 

General Clinical trials of products approved for registration are not covered by the above categories and are considered to be subject to the Therapeutic Goods Administration s Guidelines for Good Clinical Research Practice (GCRP) in Australia.55... 

Guidelines for Good Clinical Research Practice in Australia (www.tga.gov.au/docs/pdf/euguide/ich/ichl3595.pdf). 

Bohaychuk W, Ball G. 1994. Good Clinical Research Practices. An Indexed Reference to International Guidelines and Regulations, with Practical Interpretation (available from authors). 

Ball, Graham Good Clinical Research Practices Consultants, Lakehurst, Ontario, Canada, and Oxford, UK. 

Outside the discipline of clinical research, there are few who are aware of, or understand, the principles of good clinical (research) practice (GCP)—a fact that those involved in it every day sometimes forget. It is therefore essential to invest time and effort in... 

Today, a growing activity to improve patient safety in all domains of medicine is reality. This chapter deals with patient safety research in general, but is also about strategies to implement this evidence in the daily clinical work treating patients on dialysis. Good clinical research practice has been well established for some years. In the domain of dialysis access, further basic, clinical, epidemiological and health service research will be important to further improve patient safety as a whole. 2015 S. Karger AG, Basel... 

World Health Organization. Handbook for Good Clinical Research Practice (GCP) Guidance for Implementation, 2005. http //whqlibdoc.who.int/publications/2005/924159392X eng.pdf. 

The Association for Clinical Data Management (ACDM) and Statisticians in the Pharmaceutical Industry (PSI) publish an excellent document called Computer Systems Validation in Clinical Research A Practical Guide, which can be found at http //www.cr-csv.org/. 

Statisticians in the Pharmaceutical Industry (PSI), at http //www.psiweb.org. They have published the excellent Guidelines for Standard Operating Procedures for Good Statistical Practice in Clinical Research, at http //psiweb.org/pdf/gsop.pdf. 

Recall that liability for malpractice requires proof that the defendant-physician violated not the jury s standards, but the standards of fellow practitioners when prescribing DES. The allocation of the liability risks in the DES cases between manufacturer and physician is only illustrative rather than prescriptive of the form of allocation that will occur for the products of pharmacogenomics. The main thrust of the DES cases is to illustrate that the standard of care for physicians undergoes a major shift when physicians are operating on the frontiers of medical practice or engaged in clinical research. This allows for the manufacturer s responsibility to be derivative of the physician s duty to deal "fairly" with patients with regard to the risks. 

SMOs operate with two business models some acquire physician prachces and operate them as clinical research centers exclusively, while others affiliate with existing practices and manage the administrative elements of the clinical trials. In both models, the corporate entity is responsible for marketing and sales. 

Study monitors or clinical research associates (CRAs) can be employed by the study sponsor, CRO, or independently contracted for a specific study and, according to the International Committee on Harmonisation (ICH) and formalized by FDA in the Guidance for Industry Good Clinical Practice (GCP), the purpose of a CRA is to ... 

There are of course practical considerations in clinical research. We may find patient recruitment difficult in single centre studies and this is one of the major drivers to multicentre and multinational trials. Alternatively, we may need to relax the inclusion/exclusion criteria or lengthen the recruitment period. Unfortunately, while each of these may indeed increase the supply of patients they may also lead to increased variability that in turn will require more patients. A second issue is the size of the CRD which, if it is too small, will require a large number of patients. In such circumstances we may need to consider the use of surrogate endpoints (Section S.3.3.2). Finally, the standard deviation may be large and this can have a considerable impact on the sample size - for example, a doubling of the standard deviation leads to a four times increase in the... 

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