Medical Research Studies Clinical Trial Phases and Other Hightlights


Clinical study

Medical research studies are needed for a variety of important purposes. They assist, for example, in providing clinical drug development. A recent survey on the topic of clinical trials found that 96% of the respondents had never participated in medical research studies. It’s interesting to note, however, that 46% of the respondents agreed somewhat that participating in medical research studies such as clinical trials is as important to the health care system at large as donating blood.

The Importance of Informed Consent>/h3>
Many people may not realize what’s involved if they choose to participate in a clinical trial. Informed consent, for example, is critical for both legal and ethical reasons. Due to the importance of informed consent, the 9th revision of the American Psychological Association’s Ethical Code now has a detailed section on this important aspect.

When children under the age of 18 are needed to participate in a medical research study, parental consent needs to be obtained. A child’s legal guardian may also provide this consent.

The Duration of Clinical Trials

Clinical trials are of various durations, and these have expanded over the years. In 1999, for example, a clinical trial usually lasted for 460 days. In 2005, however, these trials lasted for 780 days. This extended period of time was indicated in order to provide a more thorough analysis and to address other vital issues, including legal and ethical mandates.

An Overview of Clinical Trial Phases

Phase I groups usually consist of 20 to 80 people. The purpose of a Phase 1 clinical trial is to test an experimental drug or treatment protocol with a small group of people in order to evaluate whether it is safe. Furthermore, if there are any side effects, this will be determined during this period.

Phase II groups usually consist of 100 to 300 people. The purpose of this phase is to determine whether or not the experimental drug or treatment is effective and the degree to which it is so. In addition, the drug or treatment’s safety will also be further evaluated.

Phase III groups usually consist of 1,000 to 3,000 people. The purpose of this phase is to confirm whether the experimental drug or treatment is effective and to what degree. Side effects are also monitored during this phase. Additional purposes include comparing the experimental drug or treatment with standard or equivalent treatments. Information will also be collected in order to determine whether or not the experimental drug or treatment can be used safely.

Once Phase IV has been completed, a New Drug Application needs to be submitted by the clinical trial team. If approved, the drug will be available on the market. However, even though there are 5,000 to 10,000 drugs that undergo research and development on an annual basis, just 250 actually go through the pre-clinical trial testing phase. Just 5 of these 250 drugs will undergo clinical trial testing, and only 1 will be approved by the FDA.

Study Results and the P-Value

When a medical research study is conducted, it’s important to determine whether or not the study’s results were due to chance or a difference between the treatments that were undergoing testing. The p-value is used to provide this information. When the value is less that 0.05, for example, this is a significant finding. Basically, this means that the chance the results were due to chance are less than 5%.

The Importance of Participating in Medical Research Studies

When individuals participate in a clinical study, they are assisting the health care system as well as others that may receive benefit from new drugs and treatment protocols. Given the legal and ethical standards of informed consent and other measures, it is hoped that more individuals will choose to participate if qualified.

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