Standard internationally accepted research phases
The following major research phases are used in proving a treatment’s safety and efficacy:
Phase I: Testing a new therapy/medication in a small group (20-80 patients). This is the initial test to confirm safety, define drug dosages, and determine potential side effects. Many drugs are rejected during this early phase since even when efficacy is shown, toxicity or serious side effects make the drug unacceptable for use in humans.
Phase II: During this phase, the
treatment is tested primarily for effectiveness while information on safety and side effects is also collected. Trials in this phase enroll more patients than phase I studies, generally in the range of 100 to 300 individuals.
Phase III: Treatment is administered to a
large group of 1,000 – 3,000 people to prove effectiveness, establish safety, and identify any side effects.
Phase IV: This phase (also called post-marketing) takes place after the treatment or medication is approved for commercial use. Its objective is to collect
information regarding long-term effects and side effects that might have been missed in the earlier phase trials.
Research protocol
Each research study is conducted following a specific protocol, which is a set of specifications related to the treatment and patient follow-up. The protocol defines patient suitability for enrollment in the trial, duration of follow-up, testing schedules, medical processes, medication use and dosing. Patients enrolled in clinical trials are evaluated by the research team at regular intervals to determine their clinical stability and to confirm the safety and effectiveness of the intervention studied.
Patient features that are often used to determine suitability for a study include: age, medical history, medications taken previously, and general health. The protocol also defines criteria that might eliminate a patient from participating in order to ensure safety and to optimize study effectiveness. (Therefore, for example, pregnant women are generally excluded from cardiovascular clinical trials due to concerns about fetus safety.)
Tel Aviv Sourasky Medical Center Institutional (Ethics) Review Board for research oversight
All clinical trials conducted in Israel require approval by the Institutional Review Board (IRB), also known as the Helsinki Committee, prior to initiation. The objectives are to verify that any risks entailed in the study are minimized, to confirm that risks related to the trial are justified by the potential benefit, and to track research progress.
The independent IRB is composed of a range of professionals, including medical experts, statisticians, public lawyers, etc. The IRB is committed to maintaining ethical standards in research, ensuring patient safety, and protecting the legal rights of study participants.
The law dictates that patients must be both informed about the details of the clinical research they are participating in and consent to participate in it.
