Clinical research

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Clinical research is a branch of medical research that involves people and aims to determine the effectiveness (efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. [1] [2] These research procedures are designed for the prevention, treatment, diagnosis or understanding of disease symptoms.

Contents

Clinical research is different from clinical practice: in clinical practice, established treatments are used to improve the condition of a person, while in clinical research, evidence is collected under rigorous study conditions on groups of people to determine the efficacy and safety of a treatment. [1] [2]

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. [1] [3] 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. [1] [3]

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. [2] 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. These academic medical centers often have their internal Institutional Review Boards that oversee the ethical conduct of medical research. [4]

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. [1] [2] This is known as patient and public involvement (PPI). Public involvement involves a working partnership between patients, caregivers, people with lived experience, and researchers to shape and influence what is researcher and how. [5] 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. [6] [7]

Phases

Following preclinical research, clinical trials involving new drugs are commonly classified into four phases. [1] [3] [8] Each phase of the drug approval process is treated as a separate clinical trial. [1] [3] 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. [8]

Phase I includes 20 to 100 healthy volunteers or individuals with the disease or condition. [1] [3] This study typically lasts several months and its purpose is to prove safety and an effective dosage. Phase II includes a larger number of individual participants in the range of 100–300, and Phase III includes some 1000-3000 participants to assess efficacy and safety of the drug at different doses. [1] [3] [8] Only 25-30% of drugs advance to the end of Phase III. [8]

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. [3]

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. [3] 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. [1]

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. [9]

See also

Related Research Articles

<span class="mw-page-title-main">Clinical trial</span> Phase of clinical research in medicine

Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.

<span class="mw-page-title-main">Preclinical development</span> Stage of drug development

In drug development, preclinical development is a stage of research that begins before clinical trials and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.

<span class="mw-page-title-main">New Drug Application</span> Request US FDA approve new medications

The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.

<span class="mw-page-title-main">Common Technical Document</span> Internationally agreed format for drug approvals

The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond.

<span class="mw-page-title-main">Investigational New Drug</span> USFDA permission to test

The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines before a marketing application for the drug has been approved. Regulations are primarily at 21 CFR 312. Similar procedures are followed in the European Union, Japan, and Canada.

Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial. Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) and the World Health Organization (WHO), require data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

<span class="mw-page-title-main">Medical research</span> Wide array of research

Medical research, also known as health research, refers to the process of using scientific methods with the aim to produce knowledge about human diseases, the prevention and treatment of illness, and the promotion of health.

Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.

<span class="mw-page-title-main">Drug development</span> Process of bringing a new pharmaceutical drug to the market

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. The entire process‍—‍from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials‍—‍to approved vaccine or drug typically takes more than a decade.

<span class="mw-page-title-main">Children in clinical research</span>

In health care, a clinical trial is a comparison test of a medication or other medical treatment, versus a placebo, other medications or devices, or the standard medical treatment for a patient's condition.

A glossary of terms used in clinical research.

The following outline is provided as an overview of and topical guide to clinical research:

<span class="mw-page-title-main">Phases of clinical research</span> Clinical trial stages using human subjects

The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.

<span class="mw-page-title-main">Tezepelumab</span> Monoclonal antibody

Tezepelumab, sold under the brand name Tezspire, is a human monoclonal antibody used for the treatment of asthma. Tezepelumab blocks thymic stromal lymphopoietin (TSLP), an epithelial cytokine that has been suggested to be critical in the initiation and persistence of airway inflammation.

<span class="mw-page-title-main">Daprodustat</span> Chemical compound

Daprodustat, sold under the brand name Duvroq among others, is a medication that is used for the treatment of anemia due to chronic kidney disease. It is a hypoxia-inducible factor prolyl hydroxylase inhibitor. It is taken by mouth.

<span class="mw-page-title-main">Faricimab</span> Medication for macular degeneration

Faricimab, sold under the brand name Vabysmo, is a monoclonal antibody used for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Faricimab is the first bispecific monoclonal antibody to target both vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2). By targeting these pathways, faricimab stabilizes blood vessels in the retina. It is given by intravitreal injection by an ophthalmologist.

<span class="mw-page-title-main">Sotorasib</span> Chemical compound

Sotorasib, sold under the brand names Lumakras and Lumykras, is an anti-cancer medication used to treat non-small-cell lung cancer. It targets a specific mutation, G12C, in the protein K-Ras encoded by gene KRAS which is responsible for various forms of cancer. Sotorasib is an inhibitor of the RAS GTPase family.

Atoltivimab/maftivimab/odesivimab, sold under the brand name Inmazeb, is a fixed-dose combination of three monoclonal antibodies for the treatment of Zaire ebolavirus. It contains atoltivimab, maftivimab, and odesivimab-ebgn and was developed by Regeneron Pharmaceuticals.

References

  1. 1 2 3 4 5 6 7 8 9 10 "Learn about studies". ClinicalTrials.gov, National Library of Medicine, US National Institutes of Health. 24 May 2023. Retrieved 9 March 2024.
  2. 1 2 3 4 "What Are Clinical Trials and Studies?". National Institute on Aging, US National Institutes of Health. 22 March 2023. Retrieved 9 March 2024.
  3. 1 2 3 4 5 6 7 8 "What Are the Different Types of Clinical Research?". US Food and Drug Administration. 4 January 2018. Retrieved 9 March 2024.
  4. ↑ Mohamadi, Amin; Asghari, Fariba; Rashidian, Arash (2014). "Continuing review of ethics in clinical trials: a surveillance study in Iran". Journal of Medical Ethics and History of Medicine. 7: 22. PMC   4648212 . PMID   26587202.
  5. ↑ "Public Information Pack (PIP): How to get involved in NHS, public health and social care research". National Institute for Health and Care Research. Retrieved January 3, 2024.
  6. ↑ "Briefing notes for researchers - public involvement in NHS, health and social care research". National Institute for Health and Care Research. Retrieved January 3, 2024.
  7. ↑ Ball, Sarah; Harshfield, Amelia; Carpenter, Asha; Bertscher, Adam; Marjanovic, Sonja (2019). Patient and public involvement in research: Enabling meaningful contributions. RAND Corporation. doi:10.7249/rr2678. S2CID   198003937.
  8. 1 2 3 4 "The Drug Development Process; Step 3: Clinical Research". US Food and Drug Administration. 4 January 2018. Retrieved 28 June 2022.
  9. ↑ "Authorisation of medicines". European Medicines Agency. 30 October 2023. Retrieved 9 March 2024.
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