Clinical research is booming! There are currently over 270,000 active studies on https://clinicaltrials.gov. As a research coordinator, I want to discuss the need for participating in research initiatives for Sickle Cell Disease (SCD), as well as what is involved.
As of today, there are about 500 studies devoted specifically to Sickle Cell Disease (SCD) which is a higher number than in the past. What does this mean for people with SCD?
This means that pharmaceutical companies are not only interested in SCD, but they are actively funding research to find new drugs to treat it. Currently, there are only a couple of drugs approved for use to help prevent most SCD complications. If you cannot use those medications then management of the disease can become more difficult. In order to generate more medication options for SCD, more individuals have to enroll in research studies.
It’s not as simple as approving a new drug for use. Research medications must be evaluated on how well they work in humans. Research is heavily regulated and monitored by organizations like the US Food and Drug Administration (FDA) and local Institutional Review Boards (IRBs), so every drug approved for human use, even Ibuprofen and cough syrup, has been tested on a human subject. Enrolling an individual in a research trial requires several steps. First, anyone who wants to enroll in a study has to fit the guidelines for who can participate, otherwise known as eligibility guidelines. Second, the informed consent form (ICF) must be reviewed. The ICF is a document that explains, in layman’s terms, the study procedures, risks/benefits, requirements to participate, and what is hoped to be gained from the study. These documents go into great detail to eliminate questions and concerns about what will take place during the study. The ICF is reviewed, page by page, before consent to participate is obtained. The most important thing to remember is that consent is voluntary, non-binding, and can be withdrawn at any time. After the patient provides consent, he/she must complete a screening process to validate the person’s eligibility and have multiple clinic visits for labs and routine monitoring.
In other words, research requires a lot of steps!
As a research coordinator, I love what clinical trials provide for medicine. Hopefully, this has sparked interest for others as well. For more information, contact Adrianna, IHTC Research Coordinator, at 317-871-0000.