How to Manage Clinical Trials

Clinical trials serve as the testing ground for new medications, medical devices and medical procedures including gene therapy. Clinical research is done on animals before progressing to human trials to determine the toxicity of the treatment. The Food and Drug Administration is responsible for setting safety and disclosure standards for participants, as well as providing host organizations with operating regulations. This was a result of past unethical behavior on the part of test organizations. Because there are risks involved, it's important that participants be made aware of potential side effects.

Instructions

• 1

  Develop appropriate recruitment methods. The way you recruit your participants should be appropriate for the facility and size of the staff. For example, recruiting online might be too intrusive for a study conducted in a high-traffic hospital ward causing too much additional activity. Excessive and time consuming pre-testing may discourage participation, and data should be limited to information that will be reported as part of the study. Preliminary site visits to the test location help trial managers develop recruitment methods that won't interfere with the site's daily operations.

• 2

  Establish Good Clinical Practices (GCP) and Human Subject Protection (HSP). The FDA established clinical trial standards in the 1970s. GCP and HSP include giving participants informed consent about the duration, possible effects and compensation for the study, and drafting a consent document that is easily understandable. The clinical investigator must also make their financial consideration clear to the FDA. If the investigators stand to gain financially from the production of the drug it could affect the reliability of the findings.

• 3

  Record comprehensive data. Every aspect of the trial process should be recorded including recruitment, inventory control and randomization procedures. Trial managers should have computerized data collection that has the ability to compile, categorize and clean information giving them the ability to produce reports based on every aspect of the trial. It's important that the collected data reflects, as closely as possible, the actual situation, and trial managers should use a universal system to verify all information.

• 4

  Distribute results accurately. According to the collaborative authorship policy, trial managers do not get credit for participation when results are distributed, making it hard for them to establish credibility as a competent manager. It's important that managers work with host companies to ensure that they get credit in the final results. All results distributed to medical journals and trial registers and presented during conferences should adhere to the standards set by The Consolidated Standards Of Reporting Trials (CONSORT). Not publishing results can be interpreted as scientific misconduct.