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Clinical Research: Presented By: Deepali Khetmalis

Clinical research involves organized studies on human subjects to evaluate the safety, efficacy, and side effects of drugs and medical treatments. Clinical trials have various phases, starting with small safety trials in Phase 1 and expanding to larger effectiveness trials in Phases 2 and 3. India's clinical research sector is growing, with over 200 registered research sites conducting over 1,200 international studies annually. While clinical research presents opportunities for India, further development is needed to fully realize its potential as a global clinical trial destination.

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131 views16 pages

Clinical Research: Presented By: Deepali Khetmalis

Clinical research involves organized studies on human subjects to evaluate the safety, efficacy, and side effects of drugs and medical treatments. Clinical trials have various phases, starting with small safety trials in Phase 1 and expanding to larger effectiveness trials in Phases 2 and 3. India's clinical research sector is growing, with over 200 registered research sites conducting over 1,200 international studies annually. While clinical research presents opportunities for India, further development is needed to fully realize its potential as a global clinical trial destination.

Uploaded by

Amol Kokane
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPT, PDF, TXT or read online on Scribd
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Clinical Research

Presented By: Deepali Khetmalis

What is clinical research ? What is clinical trial ? Phases of Clinical Trial Clinical research in India. India On Clinical Trial Participation in clinical research

CLINICAL
RESEARCH
Clinical Research may be defined as organized research conducted on human beings, intended to provide adequate information on drug use as a therapeutic agent on its safety, efficacy and adverse effects

CLINICAL TRIAL
A Clinical Trial is research study in human volunteers to answer specific health question. Carefully conducted clinical trial are the fasted and safest way to find treatments that work in people and ways to improve health. Interventional Trial helps to determine whether experimental treatment or new ways of using known therapies are safe and effective under controlled environment. Observational; trial addresses health issues in large group of people or population in neutral setting.

Preclinical Trial Phase 1 Phase 2 Phase 3 Phase 4

Pre-Clinical Study
This stage is designed to assess the

chemical properties of the new drug as well as to determine the steps for synthesis and purification.
In this stage, the toxicity and

pharmacological effects of the drug are

evaluated through in vitro and in vivo animal testing. These studies are both short and long-term.
Typically, the drug is tested in a

rodent and non-rodent because a drug may affect different species in different ways.

Phase 1 Trial
Phase 1 clinical trials are done to see

if an experimental medication or treatment is safe. After a treatment is tested in the lab or on animals, it enters a phase 1 clinical trial that is done with humans.
A phase 1 clinical trial usually

involves only a small number of people to determine if a drug or treatment is

safe, and to determine the best dose of a drug and how it should be given (whether orally or intravenously).

Phase 2 Trial
Phase II trials are performed

on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients.
When the development

process for a new drug fails, this

usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.

Phase 3 Trial
Phase III studies are randomized

controlled multicenter trials on large patient groups (3003,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how

effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, timeconsuming and difficult trials to design and run, especially in therapies for chronic medical conditions.

Phase IV trial is also known as Postmarketing surveillance Trial. Phase IV trials

involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials).
The safety surveillance is designed to detect any rare or long-term adverse effects

over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses: recent examples involvecerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

Annual Revenues USD 120 M with 40% growth in past year 240 international studies recruiting subjects = 1.2% of the total studies worldwide 66% of international clinical trials are Phase III 207 sites FDA registered 40,000 subjects participated in clinical trials to date (<0.02% of population)

India is well placed to provide solutions for contemporary and future clinical research
Can facilitate affordable drug research Has required patient populations and qualified scientists and clinicians Has the information technology competitive advantage Has a regulatory framework which is moving towards regulatory harmonization

The socio-economic transformation in urban India understands contemporary

GCP requirements Rapid urbanisation and exposure to developed world facilitates cross-cultural understanding Product patents from January 1, 2005

MEDIA ON CLINICAL RESEARCH

Clinical research holds tremendous scope and opportunities. India is ready to face the challenges of proving its efficiency as the preferred

destination for global clinical trials.


It is certain that in future as the number of clinical projects expands, there will be

demand for qualified personnel.

HAVE A NICE DAY

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