Academic clinical trials are a valuable component of the health care system; they benefit patients 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:

• 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 trials as members of SMOs.

[edit] See also

• Clinical investigator
• Clinical monitoring
• Clinical research associate
• Clinical site
• Clinical trial protocol
• Clinical trials publication
• EORTC (European Organisation for Research and Treatment of Cancer)

v • d • e Biomedical research: Study designs / Design of experiments Overview Clinical trial · Clinical trial protocol · Clinical trial management · Academic clinical trials · Study design Controlled study (EBM I to II-1; A to B) Randomized controlled trial (Blind experiment, Open-label trial) Observational study (EBM II-2 to II-3; B to C) Cross-sectional study vs. Longitudinal study Cohort study (Retrospective cohort study, Prospective cohort study) Case-control study (Nested case-control study) Case series · Case study/Case report Epidemiology/ methods occurrence: Incidence (Cumulative incidence) · Prevalence (Point prevalence, Period prevalence) association: absolute (Absolute risk reduction, Attributable risk, Attributable risk percent) · relative (Relative risk, Odds ratio, Hazard ratio) other: Virulence · Infectivity · Mortality rate · Morbidity · Case fatality · Specificity and sensitivity · Likelihood-ratio test Trial/test types In vitro/In vivo · Animal testing · Animal testing on non-human primates · First-in-man study · Multicenter trial · Seeding trial · Vaccine trial Analysis of clinical trials Risk-benefit analysis Interpretation of results Selection bias · Correlation does not imply causation · Null result Category • Glossary • List of topics