Glossary

The clinical phase of medicines development is the one involving humans, and is different from the 'non-clinical' or 'pre-clinical phase' in which studies are performed in labs or in animals (such as for pharmacology/toxicology analysis). Clinical studies are conducted in four steps, called 'phases' - each designed to answer separate research questions:

Clinical practice is the treatment and management of patients by healthcare professionals supported by clinical-based evidence. There are clinical practice guidelines that have been designed to assist health professionals and patients in decisions about appropriate health care for specific circumstances.

Clinical Practice Research Datalink (CPRD) https://www.cprd.com"

Clinical Research Associate

A clinical study is a scientific investigation in which participants receive a health-related intervention, such as a medicine, in order to learn about (discover or verify) how it works and interacts with the body (clinical, pharmacological, pharmacodynamic, and pharmacokinetic effects), or to identify any adverse reaction in order to understand the safety of and/or how well the medicine works (efficacy).
Previously, the terms clinical study and clinical trial were used synonymously. Refer to Regulation 2014/536 for more information.

A clinical study report is a document containing extensive detail about the plan, methods and conduct of the study so that it is clear how the study was carried out. This report should provide a clear explanation of how the design features of the study were chosen and include results of the trial. A clinical study report should also provide enough individual patient data, to allow the key analyses of data to be repeated, should the regulatory authorities wish to do so. It is a central part of any application for a new medicine to receive marketing authorisation, and it must meet the requirements of the regulatory authority that has to assess the application.

A clinical trial is a clinical study in which participants are assigned according to a pre-defined therapeutic strategy or plan (protocol) to receive a health-related intervention, such as a medicine, in order to investigate its effects on health outcomes, usually compared to another (or sometimes no) treatment.
Clinical trials are used to evaluate clinical practices that do not fall within the current practices of a country, or to evaluate a new medicine (investigational medicinal product).
Clinical trials are used to generate data on the safety and efficacy of the intervention. Clinical trials are conducted only after a regulatory authority approval and ethics committee review. Clinical trials are often characterised in Phases from I (first-in-human), II (exploratory), III (confirmatory) to IV (post approval).
Previously, the terms clinical study and clinical trial were used synonymously. Refer to Regulation 2014/536 for more information.

Clinical Trial Application

Before a clinical trial can start, the sponsor must apply for and be given clinical trial authorisation (CTA). Each European country has its own regulatory authority that assesses applications for clinical trial authorisations. For clinical trials that will take place in more than one European country, there is a ˜Voluntary Harmonisation Procedure™ which allows one application to be submitted to the authorities in all the relevant countries.

As well as clinical trial authorisation, a positive opinion from an ethics committee (or institutional review board) is needed before a clinical trial can go ahead.

ClinicalTrials.gov is an online resource that provides information about clinical studies on a wide range of diseases. It includes information on whether the studies are recruiting patients, and a summary of the results of studies once they have finished.

The resource can be found at https://clinicaltrials.gov (address correct November, 2015).

Studies can be searched for by disease or by country. Although it is funded by the US government, it includes studies based around the world. The resource is aimed at patients and their families, healthcare professionals, researchers and the public. The website is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).