Clinical Research

An Indispensable Phase of Human Testing- Clinical Research!

The phrase- An idea can change your life, proves to a point that, yes, a small thought can provoke a human mind to implement a design or an action required at the right time. In context to drug development, Novel drugs are born among scientists, chemists and pharmacologists in a laboratory. These new-born drugs target the route of the disease. Researchers identify target factors in cellular and genetic process and bring about biological substances that target these markers and have drug-like effects.There are nearly thousands of new compounds identified, to be an effective drug but only a few progress to testing in clinical trials. A drug in the clinical pipeline takes about 10 to 15 years to be out in the market. The following strategies are implemented to process the development of new medicines or drugs for further testing:

1)      Target Identification:  Drugs or new medicines act in the body via various cellular/ genetic processes mainly by interacting with specific sites that are also known as targets. These targets are assumed to be in association of a specific disease. Scientists/ Researchers use a variety of techniques to identify and isolate individual targets to gain more insights about their functions and its impact on the disease. Various compounds that can interact with the target site are identified and their effects are studied in a hope that the treatment of that specific disease can be found.

2)      Target Validation: In order to select targets for treating a disease, we need to prioritize targets so as to analyze and compare target of drugs to others that is either based on its link to a specific disease and moreover its ability to regulate various biological and chemical compounds in the body. To confirm their interactions with the specific target of a drug, a number of tests are done to see for any desired change on the behaviour of cells that are diseased. Scientists further identify compounds that affect the selected target.

3)      Lead Identification: A substance or a compound is one that is assumed to possess high potential to treat a specific disease. Scientists in laboratories often compare and analyse substances with new compounds to identify and validate their rate of success. A collection or a library of a combination of molecules, or individual molecules develop into leads. The properties that these molecules possess are required in a novel drug. Further confirmatory tests are done on each molecule so as to confirm its effects on the target drug.

4)      Lead Optimization: Optimization continues to compare the various properties of these lead compounds that are identified and supports the lead with more information that further helps biopharmaceutical companies to be able to choose the compounds that are of high potential to develop safe drugs. Apart from this, in the same stage, leads are often prioritized and further in vivo and in vitro studies are conducted to be able to compare several lead compounds and observe their metabolism and affect it has in the body.

An intensive lab research for testing a drug or device is performed on animal models or human cells. If this stage of research & development proves a success then researchers send the data to the FDA (Food and Drug Administration) for a legal approval to further trials that are yet to be performed on human subjects i.e. clinical trials. Clinical Trials are conducted to collect data in an efficient way in developing new drugs or devices. Once an approval is obtained from the FDA, these experimental novel drugs that were first tested on animal models proceed to further testing on human subjects. Clinical trials are conducted in four phases.

Clinical Trials (Testing in Human Subjects):Stages-Clinical-Studies

Phase-1: In this phase, the safety of a drug or a device is tested on a small number of healthy volunteers (about 20-100) and are paid for participating in the study. The initial phase of testing mainly checks for the safety of a drug. The initial phase of study determines how the drug takes on in a human body such as the absorption, metabolism and excretion of the drug that helps to investigate the side effects that usually occur at increased dosage levels. It is known that about 70% of drugs usually pass this phase.

Phase-2: The drug’s efficacy is determined in this phase and it can prolong for several months to two years as it involves nearly a few hundred patients. Most phase II studies practice randomized trials i.e. a set of patients receives experimental drug while another ‘control’ set of patients receives a placebo or a standard treatment. More or less these studies are termed as “Blinded Studies” that means that neither the researchers nor the patients know of the experimental drug administered. This in turn allows investigators to further provide comparative information about safety and effectiveness of a novel drug to the pharmaceutical company and the FDA. It is observed that nearly one-third of experimental drugs complete phase I & II studies successfully.

Phase-3: This phase of studies particularly involves randomized trials & blind testing in several hundred to thousands of patients. It can signify large scale testing, which can last up to several years. This phase provides a thorough understanding of the effectivity of a drug/ device, its benefits and the varied possible adverse reactions to the pharmaceutical company and the FDA. Nearly 70 to 90 percent of drugs that enter phase III studies are completed successfully under this phase of testing. Once this phase passes successful completion, then the pharmaceutical company requests the FDA for an official approval for releasing the drug into the market.

Phase-4: A synonym for this phase is often called as the Post Marketing Surveillance Trials. They are conducted only after a drug or device is approved for its consumers. The main objectives by several companies at this stage are:

  1. To compare a drug with the other drugs already in the market.
  2. To monitor each drug’s effectivity & impact on a patient’s quality of life.
  3. To analyze the cost effectivity of a drug therapy relative to other traditional and new therapies.

    Which Training Program Can be Taken to Become a Clinical Research Professional?

    Few of the online training programs that an individuals can pursue to enter into this  clinical research industry are:

  1. Post-Graduate Diploma in Clinical Research
  2. PG Diploma in Clinical Research & Pharmacovigilance
  3. PG Diploma in Clinical Research & Clinical Data Management

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