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What Is Clinical Trial Management?

Article Details
  • Written By: D. Jeffress
  • Edited By: Bronwyn Harris
  • Last Modified Date: 06 April 2014
  • Copyright Protected:
    2003-2014
    Conjecture Corporation
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In order for a clinical research trial or medical study to be reliable, it must be carefully implemented and monitored by trained professionals. Clinical trial management refers to a team effort to make sure that a study is precisely scientific, ethical, and unbiased. Careful management is essential from the formulation of initial design ideas to the final publication of statistical results to ensure that participants are kept safe and that result are reliable.

Research scientists carry out clinical trials to study the safety and usefulness of new pharmaceuticals, vaccines, medical devices, and therapy techniques on humans. Only after a drug or device has been carefully studied in the laboratory is it deemed safe for clinical trial. Once researchers have a thorough understanding of how a clinical trial will be administered, they can create a detailed clinical trial protocol in which the parameters of the study are carefully explained.

The entire team of researchers thoroughly reviews and revises the protocol, and present it to a governing board. A group of officials from a government agency, pharmaceutical company, or another authoritative organizations implements clinical trial management throughout the study by closely monitoring the work of researchers. Officials make sure that participants are fully cleared for the study and that scientists follow safety and ethics guidelines carefully.In addition, they ensure that studies are completed in a timely manner and that they stay within a prescribed financial budget.

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The scientists themselves practice clinical trial management to make sure that they get accurate results. Most clinical trials include two or more groups of participants that are as similar as possible. In order to obtain meaningful statistics, researchers must protect against external variables such as gender, age, and underlying medical conditions. One group is designated the control group, meaning that the participants do not receive any actual medication or treatment. The remaining experimental group or groups do receive the medication in closely regulated doses.

An important aspect of clinical trial management in many studies is removing possible bias from the studies. Many trials are performed using a double- blind technique, in which neither the participants nor the researchers know who is receiving the actual drug until after the study is over. This prevents scientists and volunteers from misrepresenting results. Without this form of clinical trial management, a scientist's personal feelings or stakes in a medication might persuade him or her to deem it more effective than results actually show. The ethical application of the scientific method is paramount to clinical trial management and a reliable research study.

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