What are Clinical Trials?

Clinical trials are used to test the safety and effectiveness of drugs and devices. Usually, they are sponsored by pharmaceutical companies and are conducted by research teams that include doctors and other medical professionals. Trials are typically conducted in four phases:

–    Phase one is when generally healthy people are given the medication to test if the ingestion of the pill or treatment has any adverse side effects;

–    Phases two and three dive deeper into the safety, effectiveness, and dosage of the medication, and it is after these stages when the FDA would approve the drug or device; and

–    Phase four examines new uses for previously approved treatments.

All of the phases in clinical trials are governed by strict protocols, and are overseen by many regulatory bodies, from the Food and Drug Administration (FDA) to small Institutional Review Boards (IRBs). IRBs are a group of independent medical experts, ethicists, as well as lay people. Researchers report periodically to the IRB, outlining such things as contact with patients, the tests conducted, and if any serious side effects have been reported.  IRBs are accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). (Resource: https://www.policymed.com/2010/05/the-importance-of-clinical-trials.html)

Please Click here to learn about the studies listed below.

• Novartis Research Study to Gain Insight into How Adult Patients Are Impacted by Sickle Cell Disease
• Sickle Cell Trait Study by the Consortium for Health and Military Performance (CHAMP) at the Uniformed Services University of the Health Sciences (USUHS)
• Jason Carter Clinical Trials Program
• National Minority Quality Forum Joins NIH in Launching the All of Us Research Program to Advance Precision Medicine
• Aruvant’s MOMENTUM trial evaluating an investigational therapy (given only one time) that allows the body to produce fetal hemoglobin

(Sickle Cell Disease Association of America, Inc, 2019)

Patient Recruitment for Clinical Studies by Novartis

Contact Novartis Pharmaceuticals Corporation at 1-833-SCD-CALL (1-833-723-2255) or visit sicklepaincrisis.com for more information!