A Brief Overview of Clinical Drug Development Trials

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Have you ever participated in a clinical or medical research study? During a recent United States’ survey on clinical trials, approximately 46% of the participants claimed to “somewhat agree” that participating in a clinical study is as valuable as donating blood. According to the same survey, 96% of the individuals polled stated that they had never participated in a clinical trial, however.

Ethical and Legal Guidelines

If you haven’t participated in a clinical trial yet, you may be interested to learn about protocols for medical research studies. It’s also important to note that informed consent is integral to participating in studies of this nature. This ethical mandate is outlined in the ninth revision of the American Psychological Association’s Ethical Code, section 8.02.

When a clinical drug development research team is planning to have children under the age of 18 participate in a study, the researchers are legally bound to obtain consent. This consent must be obtained in writing from the child’s parent or legal guardian.

The Purpose of Phase I Clinical Trials

The purpose of a Phase 1 clinical trial is to evaluate an experimental drug or treatment’s safety as well as identify any side effects. During these trials, the test group is usually small, and consists of approximately 20-to-80 people.

The Purpose of Phase II Clinical Trials

The purpose of a Phase II trial is to determine an experimental drug or treatment’s effectiveness as well as to further evaluate its safety. During these trials, a larger group of people are administered the drug or treatment. These groups tend to range between 100-to-300 individuals.

The Purpose of Phase III Clinical Trials

A Phase III trial is conducted to determine the following outcomes for experimental drugs and treatments:

    Confirm the drug or treatment’s effectiveness
    Monitor side effects
    Compare the drug or treatment with standard or equivalent treatments
    Collect information to ensure safety protocols

During these trials, the test groups are larger, and range from 1,000-to-3,000 individuals.

The Purpose of Phase IV Clinical Trials and the FDA Approval Process

Depending on the outcome of the previous phases, the purpose of a Phase IV clinical trial is to complete the evaluation process in order to submit a New Drug Application (NDA) to the FDA for approval. If approved, the new drug or treatment protocol may be available on the market.

On an annual basis, there are between 5,000-to-10,000 drugs under research and development. During clinical drug development, however, only 250 of these drugs actually undergo pre-clinical trial testing. Furthermore, while five of these drugs may make it to clinical trial testing, the FDA may only approve one to be released to the market.

If you have the opportunity to participate in a clinical drug development trial, you may also be interested to know the duration of these medical studies. In 1999, for example, the duration of a clinical trial was 460 days. By 2005, however, the duration of a clinical trial was 780 days. Currently, the duration of clinical trials vary, and may also be two years or longer.

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