Investigators, clinical trial guidelines

Information for investigators, healthcare professionals, and patients related to cancer drug development and clinical trials guideline and policy information for clinical trials and investigation drug use and accountability. 

Clinical trial methodology and guidelines for special disease-related therapeutie fields are discussed. In cooperation with other working parties, guidanee for modified-release oral and transdermal dosage forms, pharmacokinetics, and clinical investigation of new vaccines, gene therapy, and cell-cultured influenza vaeeines has been... 

The requirements of GCP, as described in the ICH guidelines, are presented in Chapter 7 and will not be discussed further here. However, it is emphasised that the standards required of large clinical trials in patients apply equally to small clinical pharmacological studies in healthy subjects. Studies should be conducted in accordance with SOPs. Many SOPs will resemble those pertaining to later phase clinical trials, but some will be specific to healthy volunteer studies. Details of procedures not covered by SOPs should be specified in the protocol. Studies must be monitored by the sponsor or a representative the monitor should not be one of the investigators so that monitoring visits and assessments can maintain objectivity. 

There should be consistency between the possible adverse events described for the study drug in the protocol, investigator s brochure and ICF. Most coimtries have specific requirements for their ICF. It is essential that the requirements are known when the country-specific ICF is prepared. These examples could easily have changed by the time the reader is checking an ICF. In the United Kingdom, reference should be made to the ABPI (Association of the British Pharmaceutical Industry) Clinical Trial Compensation Guidelines. In other countries, for example, Ireland, the study subject is allowed a specific length of time to decide whether to enter the study. 

The investigator in the institution conducting the study should be aware of what happens to the medical records of study subjects who have participated in clinical trials. The medical authorities or the institution should have guidelines for the retention of records before they are changed into an electronic form by scanning, microfiched or destroyed. Usually when they are changed into another form, the medical records will be reviewed by administration staff and those items deemed not essential will be... 

However, tempting it is for the pharmaceutical physician, the investigators and the sponsors to use advertising, they should be aware that there are certain guidelines and regulations to observe before embarking on any advertisement for a clinical trial. 

In order to promote a uniform approach to offering compensation to subjects and indemnity to investigators and institutions conducting clinical trials, Medicines Australia has published a Form of Indemnity for Clinical Trials and Guidelines for Compensation for Injury Resulting from Participation in a Company-Sponsored Chnical Trial. These documents are based on those published by the Association of the British Pharmaceutical Industry and are available from www.medicinesaustralia.com.au (the Medicines Australia website). 

In addition, these guidelines shall lay down adapted provisions relating to labelling for investigational medicinal products intended for clinical trials with the following characteristics ... 

FTIH trials are discussed in the Guideline on strategies to identify and mitigate risks for first-in human clinical trials with investigational medicinal products, EMEA/CHMP/SWP/28367/07issued by the European Medicines Agency (EMEA), in 2007. 

Information for Clinical Investigators. Provides regulations and guidelines to scientists who design and run experiments (clinical trials) to test the safety and effectiveness of new drugs on human subjects. 

European Medicines Agency—Committee for Medicinal Products for Human Use (CHMP). Guideline on Strategies to Identify and Mitigate Risks for First-in-Man Human Clinical Trials with Investigational Medicinal Products. EMEA/CHMP/ SWP/2836707/2007. 19 July 2007. http //www.emea.europa.eu/pdfs/human/swp/ 2836707enfin.pdf... 

Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products [5]... 

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