Clinical research

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Clinical research is a branch of medical science that determines the safety and effectiveness of
medications, devices, diagnostic products and treatment regimens intended for human use. These
may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.

Contents
[hide]

• 1 Overview
o 1.1 Phase 1 trials
o 1.2 Phase 2 trials
o 1.3 Phase 3 trials
o 1.4 Phase 4 trials
o 1.5 Further trials
• 2 See also

• 3 References

[edit] Overview
The term clinical research refers to the entire biography of a drug from its inception in the lab to
its introduction to the consumer market and beyond. Once the promising candidate or the
molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where
different aspects of the drug (including its efficacy and toxicity) are studied.

In the United States, the data obtained from the pre-clinical studies are submitted as an
Investigational New Drug (IND) to the Food and Drug Administration (FDA) for permission to
conduct human studies.

In the European Union, the European Medicines Agency (EMA) acts in a similar fashion for
studies conducted in their region. These human studies are conducted in four phases in research
subjects that give consent to participate in the clinical trials.

[edit] Phase 1 trials

Phase 1 trials usually deal with investigating the studied drug in a minor number of research
subjects who are healthy volunteers. This phase is mainly targeted at identifying the safety,
tolerability, and the general mechanism of the action of the drug in humans.
These studies are usually conducted in tightly controlled clinics called CPUs (Central
Pharmacological Units), where participants receive 24-hour medical attention and oversight. In
some diseases in which the therapy under study is known to be too toxic for healthy subjects
(some cancer medications, for instance), phase 1 trials are performed in patients with diseases to
test these parameters.

[edit] Phase 2 trials

The goal of phase 2 trials is to grasp additional understanding of the studied drug's safety and
efficacy. It also determines the appropriate dose to be administered to deliver the desired
treatment effect while minimizing the safety risk of future research subjects. This usually
requires more than 100 patients to demonstrate relevant results, although the actual number of
subjects varies widely based on the disease under study. Thus, multiple clinics are utilized to
recruit subjects with the disease under study to sufficiently enroll the study(ies) in a reasonable
period of time.

[edit] Phase 3 trials

Multiple phase 2 studies are often required to define the appropriate patient population to study
during phase 3. Once the drug is deemed a potentially safe and effective candidate in Phase 2, it
is then studied in Phase 3 trials. This phase often exposes more than 1000 research subjects with
the disease, and is usually performed at many clinics (sometimes well over 100) to enroll the trial
(or trials). There is a focus on the effectiveness of the study drug in a variety of demographic and
socioeconomic subjects with variants of the disease under study. A comparison is usually made
with standard drugs available on the market. It is imperative that the drug is shown to be
effective and safe in this phase.

When phase 3 trials are completed (as well as the data demonstrating safety and efficacy of the
study drug), a New Drug Application (NDA) containing all manufacturing, pre-clinical, and
clinical data is filed with the FDA for review. If deemed safe and effective, the FDA grants
approval of the NDA, which then allows the company to market the product. This approval
usually comes with strict requirements for the company to conduct additional studies to keep the
NDA active (usually involving pediatric trials and additional safety trials).

[edit] Phase 4 trials

In phase 4, the aim is to further characterize the safety of the drug through the identification of
unknown adverse reactions and to potentially research new therapeutic indications. Companies
often use this phase to gain exposure to different physicians and clinics, which aids in the
marketing of their product. The entire process of a drug from lab to market may take
approximately 12 to 18 years (but not always), costing billions of dollars.

[edit] Further trials

Clinical research continues throughout the lifetime of the drug to include post marketing
surveillance where a periodic 'progress report' is submitted to the regulatory authorities once
every 2 years after the drug is released into the market, and Pharmacovigilance where the safety
of marketed drugs, biologics or medical devices are monitored.

The focus of clinical research is wide enough to include important items such as data
management, medical writing, regulatory consultation, and biostatistics.

The clinical trials are regulated by country specific Health Regulatory Agencies such as the Food
and Drug Administration (FDA) in the U.S. and the European Medicines Agency (EMEA) in the
European Union.

Definition of Clinical trials

Clinical trials: Trials to evaluate the effectiveness and safety of medications or medical devices
by monitoring their effects on large groups of people.

Clinical research trials may be conducted by government health agencies such as NIH,
researchers affiliated with a hospital or university medical program, independent researchers, or
private industry.

Usually volunteers are recruited, although in some cases research subjects may be paid. Subjects
are generally divided into two or more groups, including a control group that does not receive the
experimental treatment, receives a placebo (inactive substance) instead, or receives a tried-and-
true therapy for comparison purposes.

Typically, government agencies approve or disapprove new treatments based on clinical trial
results. While important and highly effective in preventing obviously harmful treatments from
coming to market, clinical research trials are not always perfect in discovering all side effects,
particularly effects associated with long-term use and interactions between experimental drugs
and other medications.

For some patients, clinical research trials represent an avenue for receiving promising new
therapies that would not otherwise be available. Patients with difficult to treat or currently
"incurable" diseases, such as AIDS or certain types of cancer, may want to pursue participation
in clinical research trials if standard therapies are not effective. Clinical research trials are
sometimes lifesaving.

There are four possible outcomes from a clinical trial:

• Positive trial -- The clinical trial shows that the new treatment has a large beneficial effect and is
superior to standard treatment.
• Non-inferior trial -- The clinical trial shows that that the new treatment is equivalent to standard
treatment. Also called a non-inferiority trial.
• Inconclusive trial -- The clinical trial shows that the new treatment is neither clearly superior nor
clearly inferior to standard treatment.
• Negative trial -- The clinical trial shows that a new treatment is inferior to standard treatment
Clinical Research

The pharmaceutical industry has seen a continuos growth and has been a major
contributor to the economic growth in India. This industry has become self -sufficient
and has gained recognition across the world for producing high quality drugs at low prices. The
development in the field of medicine has made its mark in the national as well as the foreign graphs
and has now taken up the wheel of test to prove its competence in the field of universal clinical
research. Various factors have contributed in the growth of India as the core center of clinical
research.

Growth in the field of Clinical Research in India

The prime factor for the rise in the field of clinical research is the talent that India can provide. These
people are a group of well- trained staff and are technically strong. This is supported by the quantity of
the clinical equipments that are available in plenty in India. Secondly, in terms of the infrastructure
and cost of commodities, India proves to be cheaper in comparison to other countries. The research
and the development process can be done at a more affordable price.

Moreover, India is known for its diverse cultures and traditions. Many alternate medicines like the
Siddha, Unani, Ayurvedic, homeopathy etc are in practice with Allopath medicines. This also has a
global recognition, which is attracting many foreign medical companies to take up shared outsourcing
policy to hit the Indian clinical research market.

As clinical research can help in the development of various hospitals and providing better
health care facilities can be improved by means of transfer of knowledge. Many
international institutes have now come up in India that is providing curriculum for clinical research
studies.

Prominent Clinical Research Institutes in India

Some of the well-known institutes in India are - Aghrakar Research Institute, Bhava-Atomic Research
Center, Birbal Sahni Institute of Palaeobotany, Visva-Bharati University, University of Madras,
University of Delhi, Kurukshetra University, Jawaharlal Nehru University etc.

Clinical Trials
URL of this page: http://www.nlm.nih.gov/medlineplus/clinicaltrials.html
Clinical trials are research studies that test how well new medical approaches work in people.
Each study answers scientific questions and tries to find better ways to prevent, screen for,
diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is
already available.

Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes
what will be done in the study, how it will be conducted, and why each part of the study is
necessary. Each study has its own rules about who can participate. Some studies need volunteers
with a certain disease. Some need healthy people. Others want just men or just women.

In the United States, an independent committee of physicians, statisticians and members of the
community must approve and monitor the protocol. They make sure that the risks are small and
are worth the potential benefits.

NIH: National Institutes of Health