CLINICAL RESEARCH

CLINICAL RESEARCH : 

CLINICAL RESEARCH Dr. Himali Bandiwdekar

What is CLINICAL RESEARCH : 

What is CLINICAL RESEARCH Medical research studies involving people are called clinical trials. Clinical trials look at • Preventing disease - using drugs, vitamins, foods to reduce risk • Treatments - new drugs or combinations of drugs; new ways of giving treatment, new types of treatment • Diagnosing disease - new tests or scans • Controlling symptoms - new drugs or complementary therapies

Trials aim to find out if a new experimental drug or procedure which• Is safe • Has minimal side effects • Works better than the currently used treatment • Helps you feel better New treatments have to be thoroughly tested. A new drug, for example is investigated first in the laboratory. If it looks promising, it is carefully studied in people. : 

Trials aim to find out if a new experimental drug or procedure which• Is safe • Has minimal side effects • Works better than the currently used treatment • Helps you feel better New treatments have to be thoroughly tested. A new drug, for example is investigated first in the laboratory. If it looks promising, it is carefully studied in people.

There are three different types of clinical trials. These are called phase 1, 2, 3 and 4. : 

There are three different types of clinical trials. These are called phase 1, 2, 3 and 4.

Phase 1 (phase I) : 

Phase 1 (phase I) These are the earliest trials in the life of a new drug or treatment. They are usually small trials, The trial is usually carried out on healthy individuals. When laboratory testing shows a new treatment might help treat a particular disease, phase 1 trials are done to find out • The safety • The side effects • How the body copes with the drug

Slide 6: 

The first patient to take part will be given a very small dose of the drug. If all goes well, the next person will get a slightly higher dose. With each patient taking part, the dose will gradually be increased and the effect that has will be monitored. Any side effects will be recorded. In a phase 1 trial, you may have lots of blood tests, as the researchers look at how the drug is affecting you. And at how your body copes with, and gets rid of the drug.

The aim of the trial is to look at doses and side effects as well as the pharmacodynamics (how the body metabolizes the drug and how the drug affects the body) and pharmacokinetics (Study of ADME i.e. What body does to drug ) of the drug This work has to be done first, before we can test the potential new treatment to see if it works.Phase 1 trials are important because they are the first step in finding new treatments for the future. : 

The aim of the trial is to look at doses and side effects as well as the pharmacodynamics (how the body metabolizes the drug and how the drug affects the body) and pharmacokinetics (Study of ADME i.e. What body does to drug ) of the drug This work has to be done first, before we can test the potential new treatment to see if it works.Phase 1 trials are important because they are the first step in finding new treatments for the future.

Slide 8: 

Phase 2 trials (phase II) These trials may be done on people who all have same type of disease, or with several different types of a particular disease. Phase 2 trials are done to find out • If the new treatment works well enough to test in phase 3 •It’s efficacy in treating the disease condition. • More about side effects and how to manage them

Slide 9: 

• More about the most effective dose to use Although these treatments have been tested at phase 1, you may still have side effects that are not known about.

Slide 10: 

Phase 3 (phase III) These trials compare new treatments with the best currently available treatment (the standard treatment). They may compare • A completely new treatment with the standard treatment • Different doses or ways of giving a standard treatment • A new radiotherapy schedule with the standard one Phase 3 trials are usually much larger than phase 1 or 2. This is because differences in success rates may be small. So, you would need very many results to show the difference.

: 

Phase 4 (Post marketing surveillance) Applies to all aspects of investigation following NDA approval and general availability of drug in widespread clinical use Claims for safety and efficacy appearing or advertising are reviewed and approved by FDA Reports concerning clinical studies must be sent to FDA: every three months during the first year every six months in the second year annually thereafter