Worldwide Clinical Trials has extensive experience in rare disease and pulmonary arterial hypertension (PAH) trials, which is derived from our global PAH trial experience and enhanced by our medical and scientific understanding of unique PAH trial requirements.
Stalled recruitment, patient drop out, and limiting protocols are common challenges we solve at Worldwide for our sponsors. We recently were approached by a sponsor looking for a rare disease CRO to assist in developing a rare cardiovascular study with an exceptionally challenging patient population. We used our patient-forward approach to clinical development and provided full services for the Phase III, placebo-controlled, double blind, randomized clinical study for pulmonary arterial hypertension (PAH). Our approach was unique and well received, and ultimately was key to the program’s success and has led to further partnership on the sponsor’s cardiopulmonary pipeline. Though we solve problems for our sponsors on a daily basis, we know no two studies—especially rare disease studies—are alike. For this sponsor, we leveraged our experience solving similar challenges in the past but utilized a problem-solving mindset to build a custom strategy from the ground up. Informed by past successes and failures, we dove in. Five of the moves we made were: Gained a deep understanding of the patient population, disease, and their needs We knew from the start of this study that developing a comprehensive understanding of PAH, the patient, their symptoms, and quality of life, was going to be integral to a successful study. Patients with PAH experience symptoms that greatly impact their life, and characteristics of their disease…
You Need a CRO to Go the Extra Mile Rare and orphan disease clinical research presents a unique set of obstacles. That’s why your drug development program deserves a partner with the right tools to help you navigate the journey.
Cultivating cardiovascular success stories one patient—and study—at a time Cardiovascular trials often require teamwide dedication to a broad scope and a patient, detail-oriented operational approach. At Worldwide, we believe each study relies on the commitment of the individuals involved. Find out how this comes through in everything we do.
This question seems particularly appropriate in the midst of the coronavirus pandemic, given Dr. Anthony Fauci’s expressed support for a more rigorous investigational approach in response to a question about the published results of an open‐label non‐randomized clinical trial involving the use of hydroxychloroquine and azithromycin in treating patients with COVID-19. While neither anecdotal evidence nor observational research alone can justify the unquestioned endorsement of a novel interventional agent (based upon preliminary evidence of efficacy), the situation we face today does prompt us to ask the question that we at Worldwide often ask: Might a nontraditional but nevertheless methodologically rigorous approach to study design offer advantages compared to a conventionally structured clinical program, particularly for patients with significant unmet medical need?
Is your pharmaceutical organization creating new therapies for the treatment of pulmonary arterial hypertension (PAH)? Our latest blog explores how an uncommon CRO may increase the success rate of your PAH clinical trials.
Worldwide Clinical Trials (www.worldwide.com) and Bellerophon Therapeutics (www.bellerophon.com) have been selected as finalists in the 2017 Clinical Research & Excellence (CARE) Awards in the “Clinical Partnership of the Year” category. This category recognizes collaborations between organizations whose clinical trial activity has set a new benchmark in partnering activity.