Refers to the different stages of testing new drugs or medical interventions in people, including safety testing and assessing effectiveness compared to existing treatments.
Introduction to Clinical Trials: This topic provides an overview of clinical trials, explaining the need and importance of medical research, the ethical considerations involved in conducting trials, and the various phases of clinical trials.
Preclinical Research: This topic covers the phase of research that occurs before clinical trials, including the identification and isolation of a target molecule, exploration of its toxicology, and development of animal models for testing.
Clinical Trial Design: This topic discusses the various types of clinical trial designs, such as randomized controlled trials, crossover trials, and adaptive trials, and how they are used to test the efficacy and safety of a new treatment.
Informed Consent: This topic describes the process of obtaining informed consent from participants, the elements that must be included in the consent form, and the requirements for voluntary participation.
Ethics in Clinical Trials: This topic covers the ethical considerations involved in conducting clinical trials, including the handling of data, participant privacy, and conflicts of interest.
Phase 1 Clinical Trials: This topic discusses the purpose, design, and outcomes of phase 1 clinical trials, which are typically conducted with healthy volunteers to determine the safety and dosage of a new treatment.
Phase 2 Clinical Trials: This topic covers the purpose, design, and outcomes of phase 2 clinical trials, which involve testing the effectiveness of a new treatment in a larger group of patients and identifying potential side effects.
Phase 3 Clinical Trials: This topic describes the purpose, design, and outcomes of phase 3 clinical trials, which involve testing the effectiveness and safety of a new treatment in a larger patient population and comparing it to existing treatments.
Regulatory Approval: This topic covers the process of obtaining regulatory approval from government authorities, such as the FDA, for a new treatment based on the results of clinical trials.
Post-Marketing Surveillance: This topic describes the process of monitoring the safety and effectiveness of a new treatment after it has been approved for use by patients.
Phase 0: This phase involves a small number of participants, usually less than 15, and is conducted to test the safety and dosage of the drug.
Phase 1: This is the first phase of a clinical trial involving a small group of healthy volunteers or people with the disease being treated. The main objective of this phase is to assess the safety of the drug.
Phase 2: This phase involves a larger group of participants with the disease being treated. The main objective of this phase is to evaluate the effectiveness of the drug, and to determine the optimal dose.
Phase 3: This phase involves a large number of participants with the disease being treated. The main objective of this phase is to confirm the effectiveness of the drug and to monitor the side effects.
Phase 4: This phase is conducted after the drug has been approved by the regulatory authorities and is available for use by the general public. The objective of this phase is to monitor the long-term safety and effectiveness of the drug in the real-world setting.
Pilot trial: A small-scale trial to assess feasibility, usefulness and effectiveness of an intervention in a limited group of patients before embarking on larger trials.
Randomised Controlled Trials: A study in which a group of participants is randomly assigned to receive either the intervention being tested or a control (placebo or standard treatment) and then compared to the other group to see how effective the intervention is in the treatment of the disease.
Crossover trial: A type of clinical trial in which participants receive two or more interventions in a randomised order.
Open-label trials: In these trials, participants and researchers know the treatment being given.
Double-blind trials: In these trials, neither participants nor researchers know whether they have been given the treatment being tested or a placebo.