Introduction to Clinical Trials_Final.pptx
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Introduction to clinical trials and there phases.
Introduction to Clinical Trials_Final.pptx
- 1. INTRODUCTION TO CLINICAL TRIALS By Gangadhar J
- 2. What is clinical Trial ? Clinical trials are research studies that investigate the effectiveness and safety of new treatments, drugs, or medical devices in humans. Purpose ; The primary goal of clinical trials is to evaluate the safety and effectiveness of new treatments or interventions. Classification of clinical Trials : Based on purpose and design they are classified Based on intervention : 1. Observational Trials : Observational studies are research methods where researchers watch and record events, behaviors, or phenomena as they happen naturally, without changing or influencing anything.
- 3. Interventional Trials : These studies assign participants to receive an intervention (e.g., a drug, device, or procedure) to evaluate its effects on health outcomes. Based on Design : Randomized Controlled Trials (RCTs) : Participants are randomly assigned to different treatment groups, which helps to minimize bias and ensure that the groups are comparable. Non-randomized trials : Participants are not randomly assigned to treatment groups, which can lead to bias. Parallel Design :Participants are assigned to different treatment groups and follow the same treatment for the duration of the study. Crossover Design : A type of clinical trial in which all participants receive the same two or more treatments, but the order in which they receive them depends on the group to which they are randomly assigned. Factorial Design : Multiple interventions are tested simultaneously, allowing for a more comprehensive understanding of their effect.
- 4. Phases of clinical Trials Pre-clinical studies: Preclinical studies(Animals or cells) play a crucial role in the journey toward new drug discovery and development, assessing the safety, efficacy and potential side effects of a target compound or medical intervention before any testing takes place on humans. Methods: • In Vitro Studies: These studies are conducted in a laboratory setting, using cells or tissues outside of a living organism to assess the drug's effects. • In Vivo Studies: These studies involve testing the drug in living animals, allowing researchers to observe its effects on a whole organism. Key Areas of Investigation : • Determining a safe starting dose for human clinical trials . • Identifying potential safety concerns before testing in humans. • Determining the potential harmful effects of the drug . IND Application Submissions.
- 5. FDA IND Review Team • Project Manager: Coordinates the team’s activities throughout the review process, and is the primary contact for the sponsor. • Medical Officer: Reviews all clinical study information and data before, during, and after the trial is complete. • Statistician: Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data. • Pharmacologist: Reviews preclinical studies. • Pharmakineticist: Focuses on the drug’s absorption, distribution, metabolism, and excretion processes. Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules. • Chemist: Evaluates a drug’s chemical compounds. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc. • Microbiologist: Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes. Approval The FDA review team has 30 days to review the original IND submission.
- 6. The phases of clinical trials for drugs Phase 1 20 – 100 people Phase 2 100 - 300 people Phase 3 300-3000+ people Phase 4 10,000+ people
- 7. Phase 1 Phase 1: These trials are also sometimes called ‘first in humans’ because it is usually the first time the intervention is tested in people. Study Participants : 20 to 100 healthy volunteers or people with the disease/condition. Length of Study: Several months. Purpose : Safety and dosage Conclusion after this phase: Researchers answer questions related to how it works in the body. The side effects associated with increased dosage. early information about how effective it is to determine how best to administer the drug to limit risks and maximize possible benefits. This Data helps to design the phase-2 Trials.
- 8. Phase -2 Once an experimental treatment is determined successful in Phase I, it can enter the second phase of clinical testing. The goal of Phase II is to further investigate the safety and effectiveness of the experimental treatment. Study Participants: 100-Up to several hundred people with the disease/condition. Length of Study: Several months to 2 years Phase-2 trials usually determines : Whether the treatment is safe to give to humans Which doses of the treatment are safe to give to humans Participants in Phase II clinical trials are usually given the highest dose of the treatment identified in Phase I. They are then monitored for side effects and signs of effective treatment. What side effects are associated with the treatment The safety and effectiveness of the new treatment compared to existing treatments
- 9. Phase -3 The purpose of a Phase III trial is to find out if the treatment under study is more effective than currently available therapies. Study Participants: 300 to 3,000 volunteers who have the disease or condition. Length of Study: 1 to 4 years. Purpose: Efficacy and monitoring of adverse reactions Phase 3 studies provide most of the safety and efficacy data. Drugs performing well in Phase III trials are often put forward for government regulatory approval(NDA). Purpose of an NDA: The NDA is a comprehensive document submitted to the FDA to request permission to market a new drug in the United States. When to Submit: You submit the NDA after completing Phase 3 clinical trials, which involve testing the drug in a larger group of people to assess its safety and effectiveness.
- 10. Timeline: The FDA review process typically takes about 1 year. Post-Approval: • Even after a drug is approved, it continues to be monitored in Phase 4 (post- marketing surveillance) to identify any long-term side effects or other issues. Phase -4 (post marketing surveillance ) Phase IV clinical trials, also known as post-marketing or therapeutic use studies, are performed on already tested and approved drugs. These studies are used to investigate rare but serious side effects the new drug or therapy causes. This is important because side effects affecting very few people (for example, 1 in 1000 people) During a Phase IV trial, researchers will observe: The frequency and severity of rare side effects in the general population
- 11. The frequency and severity of rare side effects in the general population. The efficacy of the treatment across a larger population sample size. Who is involved? Investigators Coordinators / Project managers Nurses, clinical officers, fieldworkers Pharmacists Data manager and entry clerks Monitor / QA Laboratory staff And possibly….