Phase I-III randomized controlled trials alone are not generating enough data to extrapolate conclusions and theories about therapeutics to the global population. Not all drugs demonstrate the same efficacy in the real world as shown in the clinical trials. Because of this, we are seeing a rise in long-term follow-up …
Technologies, tools and processes to support patient-centric oncology trials
There is a gap between the number of patients needed to participate in new cancer trials and the number who give consent to take part. Decentralized clinical trials (DCTs) are helping to address this gap by increasing the reach of clinical studies beyond conventional research sites. DCTs provide an opportunity …
Patient-Centric Sampling Evolution
As the pharmaceutical industry continues to seek ways to increase efficiency in bringing life-saving treatments to the patients who need them, a focus on both the ethical and financial benefits of patient-centric sampling has intensified. In this blog, our Director of Bioanalytical Science, Stephanie Cape, PhD, discusses the benefits, evolution …
Building efficiencies into decentralized long-term follow-up studies
As part of an ongoing effort to improve efficiencies and increase patient centricity, long-term follow up (LTFU) studies are increasingly using decentralized clinical trial (DCT) models and reducing the need for patients to visit physical investigator sites. While the prospects of cutting study costs and reducing patient burden are attractive, …
Incorporating the patient voice to improve ulcerative colitis recruitment
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, …
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 …
Building awareness with National Diabetes Month and new T2DM treatment guidelines
Coinciding with National Diabetes Month is the recent publication, Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), which contains the most up-to-date, impactful set of new treatment guidelines for patients with …
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 …