Clinical studies

complete details on clinical studies

1. Lecture 02 Clinical Studies (phases) KRVS Chaitanya

2. What is the meaning of clinical trials? Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. Clinical trials are carefully designed , reviewed and completed , and need to be approved before they can start. People of all ages can take part in clinical trials, including children.

3. Characteristic Phase 1 Phase II Phase III Pha se IV Study types Human pharmacology Therapeutics exploration Therapeutic confirmatory Therapeutic use Participant number 10-100 50-500 1000-3000 Thousands Types of participant Healthy Patient Patient Patient prescribed drug Primary objective Safety and tolerability Efficacy Confirm safety and efficacy ADRs Study duration Month to 1 year 1-2 years 3-5 years No fixed duration Success rate 50% 30% 25-50%

4. What are the diff types of clinical trials? The FDA has seven different types of clinical trials:  Preventive trials Screening trials Diagnostic trials Treatment trials Genetic studies Quality of life studies Epidemiological studies

5. What is the clinical trials process? A clinical trial is  a research study conducted in human beings  with the goal of answering specific questions about new therapies, vaccines or diagnostic procedures, or new ways of using known treatments. Clinical trials are used to determine whether new drugs, diagnostics or treatments are both safe and effective

6. How long clinical trials take? Clinical trials alone take  six to seven years on average  to complete. Before a potential treatment reaches the clinical trial stage, scientists research ideas in what is called the discovery phase. This step can take from three to six years.

7. How many stages of clinical trials are there? There are  3 main phases of clinical trials – phases 1 to 3. Phase 1 trials are the earliest phase trials and phase 3 are later phase trials. Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed

8. How many clinical trials are required for drug approval? The FDA typically requires  Phase I, II, and III trials  to be conducted to determine if the drug can be approved for use. A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage

9. A  Phase II trial  uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety , including short-term side effects . This phase can last several years.

10. A  Phase III trial  gathers more information about safety and effectiveness , studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.

11. A  Phase IV trial  for drugs or devices takes place after the FDA approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.

12. Phases in short Phase 0 (Micro dosing) Phase I (Healthy volunteers & safety) Phase II ( Diseased volunteers & effective) Phase III (Both safety & effectiveness) Phase IV ( Post marketing surveillance) Phase V

13. Thanq