INTRODUCTION TO CLINICAL RESEARCH

What is clinical research?

Clinical research is specialized medical or health research done on people by studying them and sampling them to understand their health and disease. Clinical research governs the safety and effectiveness of the treatments, medications, diagnostic devices, and products used for human disease treatment.

Clinical research is a comprehensive study of the safety and effectiveness of all the activities and tools involved in patient care. The clinical research results are used to find new ways of treating a disease, new diagnostic tools and devices, or develop new and improved diagnostic methods. Clinical research enhances the knowledge of diseases and helps to prescribe medicines for the treatment of diseases based on established knowledge.

Types of clinical research

The clinical research or clinical trials are of two types. They are interventional and observational.

Interventional trials: An interventional trial involves a human study by assigning interventions to participants and evaluating the effectiveness of the interventions. The researchers can use the evaluation results to determine biomedical and health-related outcomes.

Observational Trials: In observational trials, the researchers observe the participants undergoing their current treatment plan and track the health outcomes. The participants are not put into groups. Participants are not tested on potential treatments. Observational trials take less time to research.

Various aspects of clinical aspects

Types of clinical trials

Pilot studies: The pilot study is a smaller version of the primary research. The pilot study helps to answer the research question. At times, the results obtained from the pilot study may be included in the main study.

Feasibility studies: A feasibility study evaluates whether the research/ study/ trial is feasible. A feasibility study also ensures that the proposed research is more likely to be completed.

Clinical trials phases:

Typically, a clinical trial has four phases. Each phase builds on the previous phase. Let’s discuss these phases.

Phase 1: The test is conducted on a small group, usually 20-80 members. The drug dosage range and its side effects are evaluated.

Phase 2: In phase two, 100-300 people are evaluated on the drug or treatment.

Phase 3: In phase three, the drug is administered to a larger group of 1000-3000 persons. The drug effectiveness, side effects, etc, are monitored.

Phase 4: In this phase, the drug risk, benefits, and usage are monitored.

Wide range of activities in clinical trial

Regulatory Error: A clinical trial should avoid a regulatory error. To monitor the clinical trial regulations, health authorities like the FDA monitor and regulate the research.

Ethical Considerations: Clinical research involves human participants. Hence, informed consent and participant confidentiality are critical elements of ethical clinical research.

Clinical study design: The clinical study requires a structured design to conduct the research systematically. Randomized controlled trials are commonly used gold standards in clinical research. Observational studies like case studies, cohort studies, and cross-sectional studies help assess the research outcome in a non-controlled environment.

Clinical trial/research outcomes: The primary objective of a clinical trial is to find outcomes relating to new drug administration, develop new treatments, find and reduce drug side effects, and enhance quality of life.

Key stakeholders in clinical research

The key stakeholders in the Clinical research are:

Sponsors: Sponsors fund the research. Typically, sponsors are pharmaceutical companies, pharmacy companies, government organizations, academic institutions, non-profit organizations

Participants: All the individuals and groups participating in the clinical research are participants.

Clinical research coordinators (CRC): Clinical research coordinators assist in everyday operations and management of the clinical research

Principal Investigator: A principal investigator leads the study or research at the site. A Principal Investigator has to oversee the entire research.

Regulatory authorities: The regulatory authorities make sure that the clinical research meets all the ethical and legal standards.

Conclusion: Clinical research helps the healthcare domain, the stakeholders, and the entire ecosystem identify and monitor all the factors involved in human disease treatment. Enroll in our Introduction to Clinical Research course to learn more about this challenging subject