Applied Clinical Trials
Improved study completion times represents one of the most critical areas for clinical development organizations. Previous TTC research has demonstrated that paying sites more on a cost per patient basis does not improve study completions times.
Improved study completion times represents one of the most critical areas for clinical development organizations. Previous TTC research has demonstrated that paying sites more on a cost per patient basis does not improve study completions times.
Other variables, such as study and protocol design, or whether a CRO or sponsor directly runs the fieldwork may be important. According to http://clinicaltrials.gov, TTC subscribers conduct over 76% of all commercial trials around the world. A detailed analysis of study completion results for over 2,500 Phase III studies demonstrates that whether a CRO or sponsor company runs the study has no bearing on study completion times. It might be hypothesized that CRO-run studies would be slightly slower to complete because of the added information step between sponsor company and CRO embedded in outsourced studies from study start to study completion.
Still, study design factors such as the number of countries in a study, had clear affects on completion times. There is, however, no difference whether a CRO or sponsor company manages the study. —TTC (for more information, contact help@ttc-llc.com ).
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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.