Clinical trials unit

Last updated September 28, 2019

Clinical trials units (CTU) 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.

A randomized controlled trial is a type of scientific experiment that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—has the intervention being assessed, while the other—usually called the control group—has an alternative condition, such as a placebo or no intervention. The groups are followed under conditions of the trial design to see how effective the experimental intervention was. Treatment efficacy is assessed in comparison to the control. There may be more than one treatment group or more than one control group.

A cluster randomised controlled trial is a type of randomised controlled trial in which groups of subjects are randomised. Cluster randomised controlled trials are also known as cluster randomised trials, group-randomised trials, and place-randomized trials.

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.^[1]

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.^[1]

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.^[2]

The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a sovereign country located off the north-western coast of the European mainland. The United Kingdom includes the island of Great Britain, the north-eastern part of the island of Ireland, and many smaller islands. Northern Ireland is the only part of the United Kingdom that shares a land border with another sovereign state, the Republic of Ireland. Apart from this land border, the United Kingdom is surrounded by the Atlantic Ocean, with the North Sea to the east, the English Channel to the south and the Celtic Sea to the south-west, giving it the 12th-longest coastline in the world. The Irish Sea separates Great Britain and Ireland. The United Kingdom's 242,500 square kilometres (93,600 sq mi) were home to an estimated 66.0 million inhabitants in 2017.

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

Multiple organ dysfunction syndrome (MODS), also known as multiple organ failure (MOF), total organ failure (TOF) or multisystem organ failure (MSOF), is altered organ function in an acutely ill patient requiring medical intervention to achieve homeostasis.

Notes

1 2 "Mental Health and Neurosciences Clinical Trials Unit". clinicaltrialsunit.com. Archived from the original on 2011-05-12. Retrieved 2010-04-15.
↑ Clark, Todd D. (2007). PharmaHandbook: a guide to the international pharmaceutical industry. PharmaHandbook 5th Edition. p. 414. ISBN 978-0-9795443-0-9 . Retrieved 15 April 2010.

Related Research Articles

Neurology Medical specialty dealing with disorders of the nervous system

Neurology is a branch of medicine dealing with disorders of the nervous system. Neurology deals with the diagnosis and treatment of all categories of conditions and disease involving the central and peripheral nervous systems, including their coverings, blood vessels, and all effector tissue, such as muscle. Neurological practice relies heavily on the field of neuroscience, the scientific study of the nervous system.

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.

The Institute of Psychiatry, Psychology and Neuroscience (IoPPN) is a research institution dedicated to discovering what causes mental illness and diseases of the brain. In addition, its aim is to help identify new treatments for them and ways to prevent them in the first place. The IoPPN is a school of King's College London, England, previously known as Institute of Psychiatry (IoP).

Systematic reviews are a type of literature review that uses systematic methods to collect secondary data, critically appraise research studies, and synthesize findings qualitatively or quantitatively.^{Systematic reviews formulate research questions that are broad or narrow in scope, and identify and synthesize studies that directly relate to the systematic review question. They are designed to provide a complete, exhaustive summary of current evidence relevant to a research question. For example, systematic reviews of randomized controlled trials are key to the practice of evidence-based medicine, and a review of existing studies is often quicker and cheaper than embarking on a new study.}

Medical education in Australia includes the educational activities involved in the initial and ongoing training of Medical Practitioners. In Australia, medical education begins in Medical School; upon graduation it is followed by a period of pre-vocational training including Internship and Residency; thereafter, enrolment into a specialist-vocational training program as a Registrar eventually leads to fellowship qualification and recognition as a fully qualified Specialist Medical Practitioner. Medical education in Australia is facilitated by Medical Schools and the Medical Specialty Colleges, and is regulated by the Australian Medical Council (AMC) and Australian Health Practitioners Regulatory Agency (AHPRA) of which includes the Medical Board of Australia where medical practitioners are registered nationally.

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.

Warwick Medical School is the medical school of the University of Warwick and is located in Coventry, United Kingdom. It was opened in 2000 in partnership with Leicester Medical School, and was granted independent degree-awarding status in 2007.

The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. HPTN studies evaluate new HIV prevention interventions and strategies in populations and geographical regions that bear a disproportionate burden of infection. The HPTN is committed to the highest ethical standards for its clinical trials and recognizes the importance of community engagement in all phases of the research process.

Idraparinux sodium is an anticoagulant medication in development by Sanofi-Aventis.

A glossary of terms used in clinical research.

The following outline is provided as an overview of and topical guide to clinical research:

Early intervention in psychosis is a clinical approach to those experiencing symptoms of psychosis for the first time. It forms part of a new prevention paradigm for psychiatry and is leading to reform of mental health services, especially in the United Kingdom and Australia.

The phases of clinical research are the steps in which scientists do experiments with a health intervention in an attempt to find enough evidence for a process which would be useful as a medical treatment. In the case of pharmaceutical study, the phases start with drug design and drug discovery then proceed on to animal testing. If this is successful, they begin the clinical phase of development by testing for safety in a few human subjects and expand to test in many study participants to determine if the treatment is effective.

The Research Domain Criteria (RDoC) project is an initiative being developed by US National Institute of Mental Health. In contrast to the Diagnostic and Statistical Manual of Mental Disorders maintained by the American Psychiatric Association, RDoC aims to be a biologically-valid framework for understanding mental disorders: "RDoC is an attempt to create a new kind of taxonomy for mental disorders by bringing the power of modern research approaches in genetics, neuroscience, and behavioral science to the problem of mental illness."

Myra Sally Hunter is Professor of Clinical Health Psychology at the Institute of Psychiatry, Psychology and Neuroscience, King's College, London, and a Clinical and Health Psychologist at the South London and Maudsley NHS Foundation Trust

Professor Colin Espie PhD, DSc, FRSM, FBPsS is a Scottish professor of Sleep Medicine in the Nuffield Department of Clinical Neuroscience at the University of Oxford and closely involved with the development of the Sleep & Circadian Neuroscience Institute (SCNi). His particular areas of research expertise are in the assessment and treatment of sleep disorders, most particularly the management of insomnia using Cognitive Behavioral Therapy, and in studies on the aetiology and pathophysiology of insomnia.

Clive Ballard is a British, world-leading expert in dementia. He is currently Professor of Age-Related Diseases at the University of Exeter and Pro-Vice-Chancellor and Executive Dean of the University of Exeter Medical School.

PSYCHLOPS is a type of psychological testing, a tool used in primary care to measure mental health outcomes and as a quality of life measure.

Intrusive research is the gathering of data from individuals through interviewing, observation, or surveying, when a consent is legally required, yet the test subjects don't have the capacity to give such consent due to mental illness or developmental disability. The United Kingdom Mental Capacity Act 2005 criminalizes such practice, it also applies to non-interventional research such as observational research. And it applies to clinical trials of treatments and procedures, but doesn't apply to trials of medicinal products, for which there is a separate regulation Intrusive research must be approved by a designated research ethics committee.

References

As of this edit, this article uses content from "Mental Health and Neurosciences Clinical Trials Unit" , which is licensed in a way that permits reuse under the Creative Commons Attribution-ShareAlike 3.0 Unported License, but not under the GFDL. All relevant terms must be followed.

External links

Clinical Trials at Curlie

This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.

[MHNCTU-1] 1 2 "Mental Health and Neurosciences Clinical Trials Unit". clinicaltrialsunit.com. Archived from the original on 2011-05-12. Retrieved 2010-04-15.

[Clark2007-2] Clark, Todd D. (2007). PharmaHandbook: a guide to the international pharmaceutical industry. PharmaHandbook 5th Edition. p. 414. ISBN 978-0-9795443-0-9 . Retrieved 15 April 2010.