How do researchers know if a clinical study is a success?

How do researchers know if a clinical study is a success?

May 31, 2016

Clinical trials help researchers compare and contrast medications, which leads to better outcomes for patients across the country. The main objective of a researcher is to collect data to establish the effects of an investigational drug, but his or her specific goals may differ depending on the study.

Declaring a clinical trial a success means that the researchers have successfully met their objective. The following list details fundamental attributes of a successful clinical trial:

  1. A sufficient number of participants to generate accurate data.</h2

Researchers must first meet the specific threshold for study participants before they can investigate a drug’s safety and efficacy. The volume of participants, based on study protocol and the Food and Drug Administration (FDA) requirements, must be sizeable enough to clearly demonstrate the validity of their findings.

  1. A clear difference in the data from the experimental drug and the placebo.

During a clinical trial, a “control” group receives a placebo drug, enabling researchers to avoid unintentional biases, and identify the statistically proven benefits or potential health concerns associated with an experimental drug.

Clinical researchers closely monitor participants for changes and meticulously document findings during the study. The more noteworthy the difference between these two groups, the more they can attribute to the drug’s effect.

  1. A demonstration of how the medication is metabolized in a certain segment of the population.

Researchers need to understand exactly how the medication is tolerated within unique segments of the population in order to complete the Investigational New Drug Application (IND). They also research which segments of the population experience the highest success rate with the investigational drug.

Both the FDA approval and the pharmaceutical manufacturer’s vested interest hinge on the results of the clinical study. If the drug does not perform well in clinical trials, it likely be reformulated or abandoned altogether.

Learn more about clinical research

ClinicalTrials.gov, the FDA website and our blog catalog are all great sources for information about clinical studies. Our staff at OCRC is also happy to offer tours at our state-of-the-art clinic to volunteers who meet study criteria.

At Orlando Clinical Research Center, study participants receive complimentary treatments and medical care related to the trial. Additionally, participants may be compensated for time and travel. Health insurance is never a requirement.

If you are interested in volunteering for a clinical trial, please tell us a little more about yourself in the Contact section of the home page and we will respond to you to determine your eligibility for current and future studies.

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