How to Set Up Clinical Trials

A clinical trial is a method of biomedical or health-related research that uses human participants as research subjects. Clinical trials are most commonly used for experimental studies to investigate new medical treatments, drugs and therapies. A clinical trial follows a defined protocol for collecting and analyzing data, and investigators are obliged to uphold certain ethical and legal standards for protecting the rights and well-being of their research subjects. The process of setting up a clinical trial requires a clear plan of research that details how to measure treatment outcomes and minimize possible harms to participants.

Instructions

• 1

  Plan the research course. A clinical trial typically involves the evolution of medical research from the laboratory to human testing to applied practice. Although trials are generally conducted in four discrete phases, in which each represents a new investigation, it is necessary to plan for how the study will proceed in its entirety. Consider what data collection methods and evaluation tools will be used in each phase.

• 2

  Select research participants. Develop selection criteria based on the nature of the experiment and the population for whom the treatment is intended. Make sure the participants in the study are a representative sample. For instance, if the clinical trial is investigating a new drug for men and women, the subject population should be gender balanced.

• 3

  Establish study controls. A clinical trial uses control groups to examine how the treatment under investigation differs from other existing treatments or the effect of no treatment at all. For the purposes of study design, control groups are generally created by random sampling, in which research participants are randomly assigned to different treatments for the sake of drawing unbiased comparisons between groups.

• 4

  Uphold ethical protections. Clinical trials are obliged by the government to maintain standards for protecting the health and well-being of study participants. Because clinical trials are experimental by nature, they can pose risks to participants. It is the responsibility of investigators to minimize these risks as much as possible, and to inform participants as to the study details and its possible hazards.

• 5

  Obtain informed consent. Informed consent is an on-going process of agreement between the investigators and the research subjects to ensure that participation in the study is voluntary. Informed consent is typically provided in writing at the beginning of study participation and then offered verbally throughout the duration of the trial. Participants have the right to withdraw from the study at any time.

• 6

  Conduct phase 1. The first phase of a clinical trial tests the safety of a treatment or therapy. Phase 1 trials use a small number of participants, and examine how the treatment affects the subjects. In the case of a drug trial, for instance, the first phase considers dosage, drug metabolism and side-effects.

• 7

  Conduct phase 2. Phase 2 of a clinical trial investigates the efficacy of a treatment. In this stage, investigators draw comparisons between a treatment and a placebo, using a study population of several dozen to several hundred people.

• 8

  Complete phase 3. The third phase of a clinical trial examines the wider range of a treatment's effects. Phase 3 trials typically involve hundreds if not thousands of subjects, and employ randomization to better understand the possible harms and benefits of the treatment. If the phase 3 findings demonstrate safety and efficacy, the new treatment will be approved for wider use.

• 9

  Continue observation. After a new treatment or therapy has been been approved for general use or sales, investigators continue to monitor its safety and outcomes. This final stage of a clinical trial is known as a phase 4 study, and it also is used to measure the cost-effectiveness of the treatment relative to other options on the market.