Clinical research

Description

The term "clinical research" refers to the entire process of studying and writing about a drug, a medical device or a form of treatment, which includes conducting interventional studies (clinical trials) or observational studies on human participants. Clinical research can cover any medical method or product 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.

The clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. Clinical research is often conducted at academic medical centers and affiliated research study sites.

Patient and public involvement

Besides being participants in a clinical trial, members of the public can actively collaborate with researchers in designing and conducting clinical research. PPI can improve the quality of research and make it more relevant and accessible. People with current or past experience of illness can provide a different perspective than professionals and compliment their knowledge. Through their personal knowledge they can identify research topics that are relevant and important to those living with an illness or using a service. They can also help to make the research more grounded in the needs of the specific communities they are part of. Public contributors can also ensure that the research is presented in plain language that is clear to the wider society and the specific groups it is most relevant for.

Phases

Main article: Phases of clinical research

Following preclinical 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. If the drug successfully passes through Phases I, II, and III, it will be approved by the national regulatory authority for use in the general population. Phase IV is post-approval studies.

Phase I includes 20 to 100 healthy volunteers or individuals with the disease or condition.

Clinical research by country

United States

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 preclinical studies or other supporting evidence, or case studies of off label use are submitted to the FDA in support of an Investigational New Drug application.

Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption 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 or Research Ethics Board and possibly other institutional committee reviews, Privacy Board, Conflict of Interest Committee, Radiation Safety Committee or Radioactive Drug Research Committee.

European Union

In the European Union, the European Medicines Agency 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.

References

References

1. (24 May 2023). "Learn about studies". ClinicalTrials.gov, National Library of Medicine, US National Institutes of Health.
2. (22 March 2023). "What Are Clinical Trials and Studies?". National Institute on Aging, US National Institutes of Health.
3. (4 January 2018). "What Are the Different Types of Clinical Research?". US Food and Drug Administration.
4. (2014). "Continuing review of ethics in clinical trials: a surveillance study in Iran". Journal of Medical Ethics and History of Medicine.
5. "Briefing notes for researchers - public involvement in NHS, health and social care research".
6. (2019). "Patient and public involvement in research: Enabling meaningful contributions". RAND Corporation.
7. (30 October 2023). "Authorisation of medicines". European Medicines Agency.