What Is The Importance Of Clinical Trial Phases

Posted by Alexander Dsouza on October 30th, 2017

Clinical Trials have an important role in the development of new drugs or treatments for different diseases. For instance, if a new drug needs to be developed for treatment of pancreatic cancer then clinical trials will have to be conducted for determining whether or not a new treatment will be effective.

The main aim of clinical trials is to collect data for the efficacy and safety of new drugs and medical devices. In the process of a trial, there are various steps and stages that need to be passed before a device or drug can be sold in the consumer market. The human testing of experimental drugs or devices are started and conducted in four phases. Each phase is considered a separate trial and once each phase is complete, researchers have to submit the data for approval before they can continue to the next phase.

Here is the importance of each phase in a clinical trial:

• In phase 1 clinical trials, the safety of drugs or devices are assessed. This is the first stage of testing the new drug of treatment and it can take several months for completion. Phase I is conducted on a small group of participants (20-100) and the main aim of researchers is to determine the effects of the device or drugs on human body. They learn how the drug is absorbed, excreted and metabolized in the human body. In this phase, side effects of the drugs are also investigated. This testing phase is passed by approximately 70% of experimental drugs.
• In phase 2, researchers study the drug or device’s efficacy. This testing can also last for several months and involve a group of more than a hundred participants. In this stage, one group receives the drug and the second ‘control’ group receives a standard treatment. This provides comparative information about the effectiveness of the drug.
• In phase 3, large scale testing is done on a group of several hundred or thousand patients. This large scale testing can also last for several years because the pharma companies want to get a clear understanding of the drug or device’s effectiveness. They also want to understand the possible adverse reaction of the device or drug.
• In the last phase also known as the Post Marketing Surveillance Trials, studies are conducted once the drug or device has been approved for consumer sake. The objective of this phase is to compare the drug with other existing drugs, monitor the long term effectiveness of the new drug and to determine the cost-effectiveness of the drug as well.

Whether it be creation of clinical development programs or pharmacovigilance services, it is important that only experts handle these tasks. Many pharma or biotech companies have started outsourcing clinical trial requirements to a CRO (Contract Research Organization). This is helping them save time and money.