Clinical research

See also: Clinical trial

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.

The term clinical research refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.

In the United States, when a test article is unapproved or not yet cleared by the Food and Drug Administration (FDA), or when an approved or cleared test article is used in a way that may significantly increase the risks (or decreases the acceptability of the risks), the data obtained from the pre-clinical studies or other supporting evidence, case studies of off label use, etc. are submitted in support of an Investigational New Drug (IND) application^[1] to the FDA for review prior to conducting studies that involve even one human and a test article if the results are intended to be submitted to or held for inspection by the FDA at any time in the future (in the case of an already approved test article, if intended to submit or hold for inspection by the FDA in support of a change in labeling or advertising). Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption (IDE) application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA. In addition clinical research may require Institutional Review Board (IRB) or Research Ethics Board (REB) and possibly Other institutional Committee reviews, Privacy Board, Conflict of Interest Committee, Radiation Safety Committee, Radioactive Drug Research Committee, etc. approval whether or not the research requires prior submission to the FDA. Clinical research review criteria will depend on which federal regulations the research is subject to (e.g., (Department of Health and Human Services (DHHS) if federally funded, FDA as already discussed) and will depend on which regulations the institutions subscribe to, in addition to any more stringent criteria added by the institution possibly in response to state or local laws/policies or accreditation entity recommendations. This additional layer of review (IRB/REB in particular) is critical to the protection of human subjects especially when you consider that often research subject to the FDA regulation for prior submission is allowed to proceed, by those same FDA regulations, 30 days after submission to the FDA unless specifically notified by the FDA not to initiate the study.

Clinical research is often conducted at academic medical centers and affiliated research study sites. These centers and sites provide the prestige of the academic institution as well as access to larger metropolitan areas, providing a larger pool of medical participants.

The clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. This has led to a growing field of technologies used for managing the data and operational factors of clinical research. Clinical research management is often aided by eClinical systems to help automate the management and conducting of clinical trials.

In the European Union, the European Medicines Agency (EMA) acts in a similar fashion for studies conducted in their region. These human studies are conducted in four phases in research subjects that give consent to participate in the clinical trials.

Phases

Main article: Phases of clinical research

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.

Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.

References

↑ FDA Page last updated 27 October 2014 Investigational New Drug (IND) Application

Clinical research and experimental design

Overview	Clinical trial Trial protocols Adaptive clinical trial Academic clinical trials Clinical study design

Controlled study (EBM I to II-1; A to B)	Randomized controlled trial Scientific experiment Blind experiment Open-label trial

Observational study (EBM II-2 to II-3; B to C)	Cross-sectional study vs. Longitudinal study, Ecological study Cohort study Retrospective Prospective Case-control study (Nested case-control study) Case series Case study Case report

Epidemiology/ methods	occurrence: Incidence (Cumulative incidence) Prevalence Point Period association: absolute (Absolute risk reduction, Attributable risk, Attributable risk percent) relative (Relative risk, Odds ratio, Hazard ratio) other: Clinical endpoint Virulence Infectivity Mortality rate Morbidity Case fatality rate Specificity and sensitivity Likelihood-ratios Pre/post-test probability

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 ratio Systematic review Replication Meta-analysis

Interpretation of results	Selection bias Survivorship bias Correlation does not imply causation Null result

Category Glossary List of topics

Research participant rights

Rights	Beneficence Justice Respect for persons Privacy for research participants Right to withdraw Return of results Informed consent

Human subject research	Clinical research Biobank Social research

Ethical systems	Research ethics Medical ethics Bioethics Clinical research ethics Biobank ethics

Guidelines for human subject research	List of medical ethics cases Nuremberg Code Declaration of Helsinki Belmont Report Common Rule

Monitoring in clinical trials	Institutional review board Data monitoring committee Community advisory board

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