Clinical Trial Information
Definition of a Clinical Trial
A clinical trial is an investigation in human volunteers, who receive investigational treatments under supervised conditions by medically qualified personnel. The investigational treatments are developed by pharmaceutical and biotechnology companies, called the sponsor companies, the sponsor companies identify qualified investigators (doctors) to conduct the trials under conditions regulated by Regulatory Authorities and Ethics Committees in each country, with the objectives to determine the benefits of the investigational drugs. And to ensure the safety of the participants in the trial.
Clinical trials are usually conducted in four phases (I, II, III, IV). Phases I to III are the pre-registration phases during which only a small number of people participate in phase I trials while the later phases involve a larger number of volunteers. Phase IV trials are called post registration trials during which pharmaceutical companies may continue to conduct studies that compare the new drug—in terms of its safety, effectiveness, and cost—to other drugs already on the market or assess a drug’s long-term effectiveness and its impact on the quality of a person’s life.
Who qualifies for a Clinical Trial
Before joining a clinical trial, a volunteer must qualify for the study according to study specific guidelines. These guidelines are all described in a study specific protocol (recipe) “Inclusion Criteria” are the factors that will allow volunteers to participate in a clinical trial and “Exclusion Criteria” are the factors that will disallow volunteers from participating in a study. These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Phase II and III studies seek participants with specific illnesses or conditions to be studied according to a study specific protocol, while phase I studies, require healthy participants. The inclusion and exclusion criteria are used to identify appropriate participants, to ensure participants’ safety and ensure the delivery of quality data and information to researchers.
How does the process work?
Once a volunteer qualifies to participate in a clinical trial, the individual is randomised (assigned) to a specific study group, who either receives the investigational drug or a placebo or a treatment already available.
A placebo is an inactive product that mimics the investigational drug to compare the effectiveness of the investigational treatment to non-treatment. The participant, investigator and research staff are blinded to which participant receives the placebo or which patient receives the active treatment. This ensures that the treating staff observes the participants objectively throughout the trial. Regardless of which treatment volunteers receive, the level of medical attention and care that each participant receives is the same.