Cycle Time Reduction Remains Elusive
KMR Group reports that the duration of clinical trials continues to hold steady or increase despite ongoing efforts by biopharmaceutical companies to reduce cycle times.
KMR Group reports that the duration of clinical trials continues to hold steady or increase despite ongoing efforts by biopharmaceutical companies to reduce cycle times. KMR Group assessed cycle time trends for more than 6,000 Phase II/III clinical trials using proprietary industry data across 27 companies going back to 2005. The analysis focused on clinical trials across all therapeutic areas. KMR defines total cycle time as the interval from Protocol Approval to Clinical Trial Report (PA-CTR). The analysis reveals that both Phase II and III trials have increased significantly over the last 10 years and continue to rise. Phase III trials took a median 35.7 months for industry in 2005-07 and takes 42.9 months in 2012-14.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.
Pfizer Reports Strong Phase III Results for Hympavzi in Hemophilia Patients with Inhibitors
June 26th 2025The Phase III BASIS trial found that once-weekly subcutaneous Hympavzi reduced treated bleed rates by 93% in patients with hemophilia A or B with inhibitors, offering a promising new prophylactic option for a population with limited therapeutic choices.
