Clinical Trials

(asked on 9th January 2018) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will consider the merits of introducing a national audit system for clinical trials; and if he will make a statement.


Answered by
Jackie Doyle-Price Portrait
Jackie Doyle-Price
This question was answered on 17th January 2018

All clinical trials of investigational medicinal products in the European Union are registered and information on the trial and a summary of results is made public in the EU clinical trials register, except for adult phase 1 trials which are considered commercially confidential.

Good clinical practice (GCP) is a set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people. To ensure compliance with GCP, the Medicines and Healthcare products Regulatory Agency carries out inspections in the United Kingdom of organisations that are involved in clinical trials.

The Government’s National Institute for Health Research (NIHR) which is the country’s largest public funder of health research and trials, has implemented a number of initiatives on publication of research results. The NIHR is the world’s first health research funder to publish comprehensive accounts of its commissioned research within its own publicly and permanently available journal series. The NIHR Journals Library comprises a suite of five open access peer-reviewed journals reporting results from a range of health research areas. The reports provide a full account of the research project, including methods and a full description of the results, and complement shorter articles submitted for publication in other peer-review journals, which the NIHR actively encourages researchers to do as part of their dissemination strategy. In addition – contracts for NIHR funding include requirements on publication of the results from NIHR funded and supported research.

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