Phases of clinical Trials

There are three phases of trials. They are phase 1, phase 2 and phase 3 trials. Each is performed at various levels and has various goals.

Aims of phase 1 trial:

Phase 1 trials are conducted to find out,
1. Safe dosage range of the drug tested. This is done by the SAD and MAD tests on the subjects chosen
2. Side effects. Again, with the SAD and MAD tests, the side effects or the adverse effects of the drug can be identified.
3. How the body cope with the new drug. This is very essential. Since, a drug may cure a disease, but it may leave the body vulnerable to other attacks or the body may be affected by the drug itself.
4. If the treatment has shrunk the occurrence of the disease. The treatment in this phase itself could be enough for shrinking the effects of the disease. Such possibilities are analyzed.
5. The ‘dose escalation study’ is performed with the dose of the drug.

Aims of Phase 2 trials:

The phase II trials aim in finding out,
1. If the treatment of the phase 2 works good enough to pass to the phase 3 trials.
2. Which stages or type of disease considered, the treatment works well for.
3. Example: cancer. Various types of cancer patients may be involved. The drug may perform well for leukemia rather than lung cancer. Under circumstances, the effectiveness of the treatment is evaluated specific to the type of the cancer.
4. Greater information on the dose and side effects of the drug used and how to manage them.

Aims of Phase 3 trials:

Phase 3 trials are aimed to find out,
1. How effective is the current treatment in comparison with the already existing best standard of treatment
2. Idea to get a broader view on how the treatment works as a whole
3. All the phase trial results are sometimes combined to form the Meta analyses.
4. The side effects of the drug once released onto the market.
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Advantages of Clinical Research Organization

1. With the increase in the clinical trial results and its complexity also, the research organization was able to handle and manipulate the data results well.
2. Outsourcing to particular CRO in a region can help in identification of regionalized diseases and the market development on that region.

3. When there are less service-in houses or unavailability of service-in houses, CRO helps the company to perform the routine work without interruption.

The benefits of outsourcing to the CRO have its effects on the global market. Global economy analyzers estimated that the cost covered for the Research and Development field of the pharmaceutical and medical companies was about $14billion for the services offered by the CRO industry. As the CRO outsourcing is slowly reaching the countries like china and India the cost to cover the phase 1 and 2 trials will go up to over $20 billion by 2010, says the economists.

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The profit margins for the competitors and the manufacturers were affected due to ‘downsizing’ of the market. Therefore, they had to search for a new option of survival. With the pressure in external and internal cost effects on the company and considering the urge for leading a future market, the pharmaceutical industry started to outsource research projects and clinical trials to the contract research organizations. This approach of outsourcing has resulted in the development of product for the companies and delivery of the products on time to the consumers. The profit margins are also maintained without any bigger loss. With the demand on the market and the increasing cost pressure in the future, the Contract research organizations are better solutions for the pharmaceutical industries and in the field of medical research. It therefore becomes the responsibility of the companies to develop the CRO market and the key players.