Applied Clinical Trials
Industry Standard Research has recently released its 3rd annual "CRO Quality Benchmarking Report." The report not only profiles the delivery quality of leading CROs, but also provides a wealth of information that relates to larger industry trends, including the value of recruitment speed.
Industry Standard Research has recently released its 3rd annual "CRO Quality Benchmarking Report." The report not only profiles the delivery quality of leading CROs, but also provides a wealth of information that relates to larger industry trends, including the value of recruitment speed.
After three consecutive years of collecting data, a critical mass to reflect upon has been collected. The basic statistics class axiom: "It takes three data points to make a trend," has been met.
Source: ISR Reports: Survey participants were asked to indicate their preference for one benefit over the other. n=160 (2009); 150 (2010); 169 (2011)
After examining the data, it is clear and undeniable: sponsors are expressing an unmet need for faster recruitment. It's not difficult to make sense of this. Project manager job appraisals and compensation are tied to trial speed. In addition, the rule-of-thumb is that for each day's delay in getting a drug to market, the manufacturer loses a million dollars in revenue. Perhaps to some readers this qualifies as a "duh" take-away, but the magnitude of the disparity remains interesting—price is important too.
Patient recruitment continues to be a source of consternation in the industry, and service providers are constantly measured against this metric. The ones that do it well will establish loyalty among their customers and the ones that do it poorly will struggle.
—Industry Standard Research, www.ISRreports.com.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.