The exact cause of ulcerative colitis (UC) is still unknown, but approximately 700,000 people in the United States suffer from this chronic, life-long disease that causes inflammation in the large intestine. A wide range of treatment options are available, but drug development sponsors are seeking additional ways to control inflammation, …
Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs
Introduction Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy …
Fixing the patient recruitment “leaky funnel”: blending data with a patient and site-centric approach to address the challenge
Most people in our industry are familiar with the “Leaky Funnel” analogy that describes the model where we approach a large number of patients for inclusion in a study, but they leak out of the pipe at every juncture. The loss of patients through planning, screening and execution of the …
Listening to – and learning from – the voice of the patient
Patient recruitment represents the biggest challenge in clinical trials. From general patient identification and participation to reducing screen failure rate or limiting patient drop out after enrollment, drug developers face many massive pain points to initiate their clinical trials. Patient recruitment and retention continue to be the biggest challenge in …
Mining real-world data with cutting-edge analytical tools: helping to achieve patient recruitment targets
In 1848, the most famous Gold Rush in American history began at Sutter’s Mill near present-day Coloma, California, shaping the US economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous finds were the starting point for what became, for …
Pop Quiz: What’s Your Patient Centricity IQ?
What issues do patients cite as barriers to clinical study participation? How far are they willing to travel to participate in a study and how much more willing are they to participate knowing that their physician is aware of the study? We asked these questions – and more – to …
Finding the Other 90%: Attracting Naïve Patients to RA Studies
A recent study by Tufts Center for the Study of Drug Development, based on a survey of 2,000 physicians and nurses primarily in the United States and Europe, found that 91% of physicians feel ‘somewhat’ or ‘very’ comfortable discussing the opportunity to participate in a clinical trial with patients, but …