Academic clinical trials
Encyclopedia
Academic clinical trials are a valuable component of the health care system; they benefit patient
s and help determine the safety and efficacy of new drugs and devices.
A typical area of academic clinical trials is the advancement and optimization of already existing therapies. Thus, academic clinical trials may for instance test how a combination of registered drugs may improve treatment outcomes; or they may apply registered treatments in additional, less frequent indications. Such research questions are not a primary focus of for-profit companies, and thus these trials are typically initiated by individual investigators
or academic research organizations.
There are many different organizations which have an interest in academic clinical trials and facilitate or take part in their conduct. These organizations include:
Academic clinical trials are run at academic sites, such as medical schools, academic hospitals, and universities; and non-academic sites which may be managed by so-called site management organizations (SMOs). Site management organizations are for-profit organizations which enlist and manage the physician practice sites that actually recruit and follow patients enrolled in clinical trials. In some cases, academic members participate in clinical trial
s as members of SMOs.
Patient
A patient is any recipient of healthcare services. The patient is most often ill or injured and in need of treatment by a physician, advanced practice registered nurse, veterinarian, or other health care provider....
s and help determine the safety and efficacy of new drugs and devices.
A typical area of academic clinical trials is the advancement and optimization of already existing therapies. Thus, academic clinical trials may for instance test how a combination of registered drugs may improve treatment outcomes; or they may apply registered treatments in additional, less frequent indications. Such research questions are not a primary focus of for-profit companies, and thus these trials are typically initiated by individual investigators
Clinical investigator
A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the...
or academic research organizations.
There are many different organizations which have an interest in academic clinical trials and facilitate or take part in their conduct. These organizations include:
- Hospitals, universities, researchers and institutions who view trials as a source of income and prestige, and receive private, charitable and governmental funding.
- Pharmaceutical or biotech companies who view the development and commercialization of treatments as their business.
- Regulators who wish to ensure treatments are safe and work effectively.
- Patients and patients' organizations and associations who want faster access to advanced treatments.
Academic clinical trials are run at academic sites, such as medical schools, academic hospitals, and universities; and non-academic sites which may be managed by so-called site management organizations (SMOs). Site management organizations are for-profit organizations which enlist and manage the physician practice sites that actually recruit and follow patients enrolled in clinical trials. In some cases, academic members participate in clinical trial
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...
s as members of SMOs.
See also
- Clinical investigatorClinical investigatorA clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the...
- Clinical monitoringClinical monitoringClinical monitoring - Oversight and administrative efforts that monitor a participant's health during a clinical trial. The government and other clinical trial funding agencies require data and safety monitoring boards to oversee clinical trials...
- Clinical research associateClinical research associateA clinical research associate is a profession defined by Good clinical practice guidelines .The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract...
- Clinical siteClinical siteA clinical site is a medical facility staffed with a clinical investigator and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to...
- Clinical trial protocolClinical trial protocolA clinical trial protocol is a document that describes the objective, design, methodology, statistical considerations, and organization of a clinical trial...
- Clinical trials publicationClinical trials publicationClinical trials publication is having research published in a peer reviewed journal following clinical trials. Most investigators will want to have such a publication but the nature of clinical trials may create special considerations and obstacles....
- EORTCEORTCThe European Organisation for Research and Treatment of Cancer or EORTC is an international non-profit organisation that develops, coordinates and stimulates cancer laboratory and clinical research in Europe...
(European Organisation for Research and Treatment of Cancer)