Clinical trial protocol
Encyclopedia
A clinical trial protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial
. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in other documents referenced in the protocol (such as an Investigator's Brochure
).
The protocol contains a study plan on which the clinical trial is based. The plan is designed to safeguard the health of the participants (while limiting their financial liability) as well as answer specific research questions. The protocol describes, among other things, what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, study participants are seen regularly by the research staff (usually medical doctors and/or nurses) to monitor their health and to determine the safety and effectiveness of the treatment(s) they are receiving.
The format and content of clinical trial protocols sponsored by pharmaceutical, biotechnology
or medical device
companies in the United States
, European Union
, or Japan
has been standardized: they are written to follow the Good clinical practice
guidance issued by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Regulatory authorities in Canada and Australia also follow the ICH guidance.
Clinical trial protocols for other clinical trials do not necessarily follow the standard format.
The existence of a clinical trial protocol allows researchers at multiple locations (in a multicenter trial
) to perform the study in exactly the same way, so that their data can be combined as though they were all working together. The protocol also gives the study administrators (often a contract research organization
) as well as the local researchers a common reference document for the researchers' duties and responsibilities during the trial. Some journals, such as Trials
, purposefully publish trial protocols.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in other documents referenced in the protocol (such as an Investigator's Brochure
Investigator's brochure
In drug development, the Investigator's Brochure is a comprehensive document summarizing the body of information about an investigational product obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new information...
).
The protocol contains a study plan on which the clinical trial is based. The plan is designed to safeguard the health of the participants (while limiting their financial liability) as well as answer specific research questions. The protocol describes, among other things, what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, study participants are seen regularly by the research staff (usually medical doctors and/or nurses) to monitor their health and to determine the safety and effectiveness of the treatment(s) they are receiving.
The format and content of clinical trial protocols sponsored by pharmaceutical, biotechnology
Biotechnology
Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...
or medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
companies in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
, or Japan
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
has been standardized: they are written to follow the Good clinical practice
Good clinical practice
Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
guidance issued by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Regulatory authorities in Canada and Australia also follow the ICH guidance.
Clinical trial protocols for other clinical trials do not necessarily follow the standard format.
The existence of a clinical trial protocol allows researchers at multiple locations (in a multicenter trial
Multicenter trial
A multicenter research trial is a clinical trial conducted at more than one medical center or clinic. Most large clinical trials, particularly Phase III trials, are conducted at several clinical research centers...
) to perform the study in exactly the same way, so that their data can be combined as though they were all working together. The protocol also gives the study administrators (often a contract research organization
Contract research organization
A contract research organization, also called a clinical research organization, is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services...
) as well as the local researchers a common reference document for the researchers' duties and responsibilities during the trial. Some journals, such as Trials
Trials (journal)
Trials is an open access, peer reviewed online journal regarding performance and outcomes of randomized controlled trials. The journal is published by BioMed Central whose editors in chief are Doug Altman Curt Furberg, Jeremy Grimshaw, and Peter Rothwell...
, purposefully publish trial protocols.