| Clinical trials are tests conducted to find out the | | | | Phase II: |
| safety and efficacy of drugs before they are | | | | If the results of phase I suggest that the drug is |
| launched in the market. Clinical trials are conducted | | | | safe, then the company moves towards the |
| on a small group of people and analyzed to see if | | | | second phase of clinical trials. Here the drug is |
| there are any adverse reactions to a particular | | | | tested to see if it helps patients. Here the sample |
| drug. These trials also monitor the effectiveness | | | | size is large and the treatment may be |
| of drugs. | | | | administered to over a hundred patients. Common |
| There are different phases of clinical trials that are | | | | side-effects of the drug is tracked and analyzed. |
| closely monitored by regulatory bodies. Almost all | | | | Phase III: |
| pharmaceutical companies and biotechnology firms | | | | In Phase III, the new drug is usually compared to |
| utilize an efficient Clinical Trials Management | | | | the existing treatment to see if it helps patients |
| System (CTMS) to manage the huge amount of | | | | better. Studies are done to see if the new drug |
| data that clinical trials produce. A quality Clinical | | | | fares better or worse than the existing ones. Or |
| Trials Management System helps track, collate | | | | whether the new drug produces the same results |
| and analyze data during clinical trials. | | | | as the old one. The trials are conducted over a |
| Here are the three different phases of clinical | | | | large section of patients with half the number of |
| trials: | | | | patients receiving the new drugs while the other |
| Phase I: | | | | half receives the old one. The efficacy of the new |
| First test of a new drug for treatment of a | | | | drug is then studied through comparison. This |
| particular medical problem. The test is done | | | | phase of clinical trials is generally more complex. |
| because the drug has shown some promise of a | | | | The development in Information Technology and |
| cure in the laboratory. Tests are done to find out | | | | the stringent regulations of regulatory authorities |
| if the treatment is safe. What is the best mode | | | | have increased the need for quality |
| of administration of the treatment? What is the | | | | pharmacovigilance system. These systems help |
| right amount of dosage? The first phase is done | | | | make clinical trials and other drug development |
| on a very limited number of persons. | | | | processes so much easier and quicker. |