Thomson Reuters Cortellis Competitive Intelligence
4A: In India, the primary driver for clinical trials is cost-savings, which runs upwards of 50 to 60 percent as compared to trials in the U.S. However, government and regulatory rules are changing very quickly, more quickly than foreign pharmaceutical companies can keep up. Guidelines for audio-video recording of informed consent have been implemented, trial registration has been mandated, a call for compulsory accreditation of independent ethics committees has been answered, panels of experts for clinical trial application approval and serious adverse events reviews have been compiled, GCP compliance is being ensured by India’s new clinical trial inspection program, and safety update reports are required to be submitted every six months during the trial. Coupled with lost patent cases by Novartis, Roche, Merck, Gilead, and Pfizer in the country, have led to a decline in trials initiated in India since 2010.
SOURCE: Thomson Reuters Cortellis Competitive Intelligence
Read the full report here.
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
July 10th 2025In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.
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.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.