Clinical trials are FDA-mandated steps in the drug development process that biopharmaceutical companies must undertake to prove the safety and efficacy of a proposed therapy. Navigating the clinical trial process is easily the most expensive phase in the drug development pipeline, primarily because this is the stage where so many drugs fail and because the costs of recruiting and retaining patients to participate in the trials are extremely high.
On July 27, Celiac Disease Foundation CEO, Marilyn G. Geller, will be presenting the “Role of Patient Advocacy in Clinical Trials” on a webinar hosted by the Society for the Study of Celiac Disease. Her presentation will explain why a patient advocacy organization can be an invaluable partner in drug development, benefiting both patients and researchers.
Our goal at the Celiac Disease Foundation is to accelerate research for treatments and a cure for celiac disease. This includes lowering, where we can, the cost of drug development for proposed celiac disease drugs. Patient advocacy organizations, and specifically patient registries, can make a real impact on lowering the cost of patient recruitment and retention in clinical trials. Fundamentally, patient registries favorably impact the economics of drug development, improving return on investment (ROI).
The most recent NIH study estimated that the average cost of developing a new FDA-approved drug is more than $1.3 billion. Confronted with that extraordinary hurdle, researchers and industry always seek to: a) prove that a sufficient market exists for the proposed drug to justify the massive investment, and b) trim the cost and time required for new drug development without adversely impacting safety or efficacy.
As for cost control, drug researchers need the capability to identify and target prospects for clinical trials with very specific demographics, biomarkers, symptoms, and geography. For celiac disease researchers, prior to the Celiac Disease Foundation’s iCureCeliac® patient registry, accessing and screening potentially thousands of patients to identify the several dozen or even few hundred who meet the research criteria was extremely expensive. Due to its national reach and size, iCureCeliac® has helped make this recruitment and retention process easier and quicker by inviting patients who meet the specific trial requirements to participate, thus lowering costs for FDA-mandated clinical trials.
While iCureCeliac® provides data and a patient pool, biopharmaceutical researchers continue to have difficulty populating clinical trials with qualified celiac disease patients using the existing recruitment infrastructure at costs they can afford. This is where our iQualifyCeliac Study Screening Platform comes in. Providing a customized screening tool to target patients who may qualify to participate in a celiac disease clinical trial or study near them, and an in-house call center to address questions patients may have, iQualifyCeliac has helped to fill both large and small clinical trials and studies in a fraction of the time of traditional recruitment methods.
We are grateful for the opportunity to share our work as a partner to biopharma in the research process, and as the trusted resource for the celiac patient community. Through our iCureCeliac® patient registry and iQualifyCeliac Study Screening Platform, we continue to work to lower the cost of drug development for researchers and empower celiac patients to make a direct impact on developing better treatments and, one day, a cure for celiac disease.
Please register for the upcoming webinar here.