List of clinical research topics

Clinical research is essential in healthcare science, determining the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens for human use. This field is vast and incorporates various aspects, from study designs to government regulations. This article provides an in-depth exploration of clinical research topics.

1. General Topics

Clinical research serves as the foundation for evidence-based medicine, covering:

• Drug discovery and development process
• Ethical considerations in research
• Placebo effect and its implications
• Evolution and importance of randomized controlled trials

2. Drug Terminology

• Investigational New Drug (IND)
• Biologic License Applications (BLA)
• Generic Drug
• Over-The-Counter (OTC) Drugs

3. Types of Study Design

• Randomized Controlled Trials (RCTs)
• Cohort Studies
• Case-Control Studies
• Cross-sectional studies
• Meta-analyses

4. Study Participant Confidentiality and Safety

• Informed consent process
• Protection of personal health information (PHI)
• Adverse event (AE) and serious adverse event (SAE) reporting
• Ethical considerations in vulnerable populations (e.g., children, pregnant women)

5. Clinical Study Management

5.1 Clinical Research Documents

• Study Protocol
• Investigator's Brochure
• Case Report Form (CRF)

5.2 Clinical Research Personnel

• Principal Investigator (PI)
• Clinical Research Associate (CRA)
• Clinical Research Coordinator (CRC)

5.3 Contract Research Organizations

Organizations that offer outsourced clinical research services, playing a significant role in drug development and clinical trials.

6. Data Collection and Management

6.1 Medical Term Coding Dictionaries

• MedDRA (Medical Dictionary for Regulatory Activities)
• WHO Drug Dictionary

6.2 Clinical Data Interchange Standards Consortium (CDISC)

An organization that establishes standards to support the acquisition, exchange, submission, and archive of clinical research data.

7. Data Analysis

• Biostatistics in clinical research
• Interpreting study results: p-values, confidence intervals
• Handling of missing data

8. Results Reporting

• Publication in peer-reviewed journals
• Clinical trial registries and result databases
• Open access and transparency initiatives

9. Notable Clinical Studies

• Framingham Heart Study
• Nurses' Health Study
• Diabetes Control and Complications Trial (DCCT)

10. Legislation, Regulations, and Guidances

10.1 European Union

• EU Clinical Trials Directive
• Good Clinical Practice (GCP) in the EU

10.2 United States

• Federal Food, Drug, and Cosmetic Act (FD&C Act)
• Health Insurance Portability and Accountability Act (HIPAA)

10.3 Other

• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

11. Government Agencies

11.1 Food and Drug Administration (FDA)

11.1.1 Departments

• Center for Drug Evaluation and Research (CDER)
• Center for Biologics Evaluation and Research (CBER)

11.1.2 Review and Approval Programs

• Fast Track
• Breakthrough Therapy
• Priority Review

12. See Also

• Pharmacovigilance
• Phase IV studies
• Patient-reported outcomes
• Glossary of clinical research
• List of biotechnology articles