Tufts CSDD Releases January/February 2022 Impact Report
Tufts CSDD has released the latest version of its bi-monthly Impact Report. In this January/February 2022 edition, the focus is on an issue that has plagued the pharmaceutical industry for years: the incidence of protocol deviations and amendments in clinical trials. While these hurdles are both at new highs across all phases, they have been steadily increasing since the start of the COVID-19 pandemic.
From the results a new Tufts CSDD analysis conducted in 2020, some of the highlights in the report are:
- Actual timelines for protocols with three or more substantial amendments are nearly three weeks longer than planned treatment durations.
- In a typical Phase III trial, 119 protocol deviations, on average, are implemented, involving approximately one-third of all patients participating in that trial.
The full report is available for purchase here.
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.
HHS Cancels Moderna Grant for Late-Stage Development of mRNA Vaccine Candidate
June 4th 2025Despite positive results from a Phase I/II trial of its investigational pandemic influenza vaccine, mRNA-1018, Moderna’s award for almost $600 million to accelerate vaccine development will be terminated.
