THE BASICS OF CLINICAL RESEARCH: WHAT IT IS AND WHY IS IT IMPORTANT
INTRODUCTION
Clinical research is the study of health and illness in people.it looks at new ways to prevent, detect, treat, or understand disease. It may test new drugs or combination of drugs; new surgical procedures or devices; or new ways to use existing treatments. Clinical research involves people and it is generally carried out to evaluate the efficacy of therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Any research that evaluates the aspects of a disease like symptoms, risks factors, and pathophysiology, among others termed as clinical research. to assess the potential of a therapeutic drug/device in the management, control, and prevention of disease.
HISTORY OF CLINICAL RESEARCH
1. Public health service Syphilis study (1932)
2. US Food, Drug and Safety act (1938)
3. Nuremberg Code (1947)
4. Declaration of Helsinki (1964)
5. The National Research Act (1974)
6. The Belmont Report (1979)
7.International conference on Harmonisation -ICH (1990)
WHAT IT IS?
Clinical research is a component of medical and health research intended to produce knowledge valuable for understanding human disease, preventing, and treating illness, and promoting health. Clinical research is a process of planning, implementing and analysis of clinical study involving interactions with patients, diagnostic clinical materials or data, or populations in any of the following categories:
(1) disease mechanisms (etiopathogenesis)
(2) bi-directional integrative (translational) research
(3) clinical knowledge, detection, diagnosis, and natural history of disease
(4) therapeutic interventions including development and clinical trials of drugs, biologics, devices, and instruments
(5) prevention (primary and secondary) and health promotion
(6) behavioural research
(7) health services research, including outcomes, and cost-effectiveness
(8) epidemiology; and
(9) community-based and managed care-based trials.
WHY ITS IMPORTANT?
New techniques for screening and diagnosis of a disease
New drugs to market
New method for surgery
New approach for standard therapy
New combination of standard treatment
New techniques such as gene therapy
MAJOR COMPONENTS THE CLINICAL RESEARCH
Sponsors: Include private and public sector funding organizations such as the National Institutes of Health, pharmaceutical companies, medical device manufacturers, biotechnology firms, universities, private foundations, and national societies.
Research organization: Include academic health center, private research institutes, survey research organizations, federal government intramural research programs, and contracts.
Investigators: Investigators are the scientists performing clinical research with a qualification (e.g., MD, Ph.D., RN, DDS, PharmD).
Participants: Human volunteers, medical information and biological materials of human origin, or data derived from volunteers. may be healthy volunteers or populations at large.
Oversight Entities: Include Institutional Review Boards, Food and Drug Administration, Department of Health and Human Services, Veterans Affairs, National Committee for Quality Assurance, and other national regulatory agencies.
Stakeholders/Consumers: Include health insurers, managed care organizations, health care systems, organized medicine, voluntary health agencies, patient advocacy groups, purchasers of health care, and providers of health care, public health systems, and individual consumers
TYPES OF CLINICAL RESEARCH TRIALS
BASED ON RESEARCHER BEHAVE BASED ON THE PURPOSE
observational study Prevention trails
Interventional study Screening trials
Diagnostic trials
Treatment trials
Quality trials
Compassionate use trials
PHASES OF CLINICAL TRIAL
CLINICAL RESEARCH PROCESS INVOLVES:
CONCLUSION
Clinical research strengthens its position as important component of the pathway from discovery to improved treatment outcomes for patients. All participants and stakeholders, including physician, patients, and health care providers, agencies, foundations, industry, must reevaluate their current roles and responsibilities in clinical trails and work together to develop a more effective health benefits to all involved in research. All the trials must be planned in such a way that prerequisites are ready in time after planning the study data must be maintained with accuracy for analysis and good practices. one must always strive for the ideal, but in most cases must settle for the best comprise.
REFERENCES
Institute of Medicine (US) Clinical Research Roundtable; Tunis S, Korn A, Ommaya A, editors.Washington (DC): National Academies Press (US); 2002 https://www.ncbi.nlm.nih.gov/books/NBK220715/
https://clinicaltrials.gov/ct2/about-studies/learn
https://s4be.cochrane.org/blog/2021/04/06/an-introduction-to-different-types-of-study-design/
Student name: Sanobar Shifali
Student Id: 081/052023
Qualification: Pharm-D
E-Mail ID: sanobarpharmd@gmail.com
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