The Importance of Clinical Trials for Introducing New Drugs and Treatments to the Market


 

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Have you ever participated in a clinical trial? A recent survey was conducted in the United States on this subject. The results showed approximately 96% of the participants had never participated in a clinical study before.

If you’ve ever donated blood, you know how important this act can be to the health care system to assist them with saving lives. The clinical trial survey showed that around 46% of the participants “somewhat agreed” that participating in clinical trials was as valuable as donating blood.

The Importance of Informed Consent

When someone participates in a clinical trial, they need to provide their informed consent. Basically, this means that prior to participating in the study, potential participants will receive information about the study so that they will be able to make an informed decision.

In order for individuals under 18 years to participate in a study, researchers are required to obtain consent from parents or legal guardians. This is a legal requirement; otherwise, these children would not be allowed to participate.

The American Psychological Association’s Ethical Code now has a dedicated section on informed consent. This information can be found in the 9th revision within section 8.02. This new section was included to stress the importance of informed consent when conducting clinical trials and other types of medical studies.

Phase 1 Clinical Trials

During Phase 1 clinical trials, researchers will test an experimental drug or treatment for the first time with a small group of people. The size of the group may vary between 20 to 80 individuals.

The primary purposes of Phase 1 clinical trials are to determine the drug or treatment’s safety and whether or not there are any side effects.

Phase II Clinical Trials

After Phase 1 clinical trials have been completed, researchers will administer the drug or treatment to a larger group of individuals. The size of this group will also vary, and may include between 100 to 300 people.

The purpose of this phase is to further determine the drug or treatment’s effectiveness and safety.

Phase III Clinical Trials

Once each phase of a clinical trial has been completed, the drug or treatment is administered to larger groups of people. During Phase III, there may be 1,000 to 3,000 individuals within a trial group.

There are several purposes for this phase of the trial:

  • To confirm the drug and/or treatment’s effectiveness
  • To monitor side the drug and/or treatment’s effects

  • To compare the drug and/or treatment with standard or equivalent treatments
  • To collect information that will enable safe usage of the drug and/or treatment

Phase IV Clinical Trials

Once Phase IV is completed, a New Drug Application is submitted for approval by the clinical trial team. When this is approved, it can become available on the market.

Every year, between 5,000 to 10,000 drugs undergo the research and development process. Out of this number, just 250 will be submitted for pre-clinical trial testing. Given these 250 drugs, just 5 will actually be submitted for clinical trial testing. After these trials, the FDA will usually only approve 1 of these new drugs.

The Importance of Clinical Trials

Medical research studies, which include clinical drug development, are necessary in order to determine the efficacy and safety of a specific drug or treatment. When people participate in these research studies, they are contributing to medical advancements which may be of benefit to them as well as other individuals.

These trials do take some time to complete, however, because a multi-staged process is essential. In 1999, for example, clinical trials generally lasted for 460 days. As recently as 2005, these trials lasted for 780 days.

If you have the opportunity to participate in a clinical study, it’s important to carefully consider the potential benefits of doing so. Whether you believe clinical trials are as essential to the medical field as donating blood or not, you may still be interested in participating in both of these activities.

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