What happens during a clinical trial?
The clinical trial process is determined by the kind of trial being conducted. Keep in mind that clinical trials are designed to test treatments under very specific scientific and ethical guidelines. The team of doctors, nurses, social workers and other healthcare professionals utilizes the same research protocol. This protocol explains what the trial will do, how and where it will be conducted, who may participate and how and when the participants will be evaluated. There are many sponsors of trials including pharmaceutical companies, physicians and grant recipients. Most cancer clinical trials are conducted by the National Cancer Institute.
The sponsor must review its protocol for safety and appropriateness, and then that protocol must undergo a second neutral review by an Institutional Review Board. The IRB is responsible for overseeing any clinical trials performed in the specific healthcare institution where the clinical trial is offered and typically involves physicians, healthcare providers and individuals not involved in healthcare, including clergy or ordinary citizens. IRB members do not have any personal interest in the clinical trial results, making them reliable to evaluate the clinical trial fairly and safely. This committee is charged to look at a trial's scientific value, scientific validity, risks to patients, potential benefits, selection process, safeguards, accuracy and provisions for privacy.