Clinical trials unit
Encyclopedia
Clinical trials units are specialised biomedical research
units which design, centrally coordinate and analyse clinical trials and other studies. Some CTUs specialise in different methodologies, such as randomised controlled trials
, cluster randomised trials
, surgical trials, and health services research. Some specialise in one disease type, whereas others are generic units. Some CTUs focus on specific phases and types of clinical trials; others conduct all phases and types of trial.
Provisional CTUs tend to be newer and evolving CTUs and have not yet built a track record but have relevant expertise and experience that is worth building on. Evaluation criteria for Provisional Registration were developed for CTUs that did not meet the criteria for Full Registration status, but that are working towards possessing sufficient expertise to enable Full Registration in the future.
Medicinal clinical trials are only a subset of all trials undertaken by Registered Clinical Trials Units in the academic sector. Such Units may also specialise in surgical trials, therapy trials and other complex interventions such as educational interventions.
In the United Kingdom
, clinical trials of medicines are approved by the Medicines and Healthcare products Regulatory Agency
. This it does through its Clinical Trials Unit, which enforces standards through the Good Clinical Practice Inspectorate. In 2007, a revised version of Phase I clinical trial regulations was issued following the heavily publicized multiple organ failures
in several volunteers for a study of TGN1412
.
Biomedical research
Biomedical research , in general simply known as medical research, is the basic research, applied research, or translational research conducted to aid and support the body of knowledge in the field of medicine...
units which design, centrally coordinate and analyse clinical trials and other studies. Some CTUs specialise in different methodologies, such as randomised controlled trials
Randomized controlled trial
A randomized controlled trial is a type of scientific experiment - a form of clinical trial - most commonly used in testing the safety and efficacy or effectiveness of healthcare services or health technologies A randomized controlled trial (RCT) is a type of scientific experiment - a form of...
, cluster randomised trials
Cluster randomised controlled trial
A cluster randomised controlled trial is a type of randomised controlled trial in which groups of subjects are randomised...
, surgical trials, and health services research. Some specialise in one disease type, whereas others are generic units. Some CTUs focus on specific phases and types of clinical trials; others conduct all phases and types of trial.
United Kingdom
The UKCRC evaluates CTUs in the UK and they may be given either Full or Provisional CTU registration status. All Registered CTUs are required to provide evidence that their work is of high quality by demonstrating (1) experience of coordinating multi-centre randomised controlled trials or other well-designed studies, (2) a presence of a core team of expert staff to develop studies, (3) a presence of robust quality assurance systems and processes to meet appropriate regulations and legislation, and (4) evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio.Provisional CTUs tend to be newer and evolving CTUs and have not yet built a track record but have relevant expertise and experience that is worth building on. Evaluation criteria for Provisional Registration were developed for CTUs that did not meet the criteria for Full Registration status, but that are working towards possessing sufficient expertise to enable Full Registration in the future.
Medicinal clinical trials are only a subset of all trials undertaken by Registered Clinical Trials Units in the academic sector. Such Units may also specialise in surgical trials, therapy trials and other complex interventions such as educational interventions.
In the United Kingdom
United Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
, clinical trials of medicines are approved by the Medicines and Healthcare products Regulatory Agency
Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....
. This it does through its Clinical Trials Unit, which enforces standards through the Good Clinical Practice Inspectorate. In 2007, a revised version of Phase I clinical trial regulations was issued following the heavily publicized multiple organ failures
Multiple organ dysfunction syndrome
Multiple organ dysfunction syndrome ', previously known as multiple organ failure or multisystem organ failure , is altered organ function in an acutely ill patient requiring medical intervention to achieve homeostasis...
in several volunteers for a study of TGN1412
TGN1412
TGN1412 is the working name of an immunomodulatory drug which was withdrawn from development after inducing severe inflammatory reactions in the first human subjects to receive the drug....
.