Against the backdrop of recent statistics showing that applications to run clinical trials in Europe fell 25% between 2007-2011
Against the backdrop of recent statistics showing that applications to run clinical trials in Europe fell 25% between 2007-2011, the SAT-EU study group, an independent non-profit collaborative initiative, supported by the European Forum for Good Clinical Practice (EFGCP) and several other trade and not-for profit organizations, announced the results of a survey, Factors Influencing Clinical Trial Site Selection in Europe: The Survey of Attitudes towards Trial Sites in Europe. Published research based on that survey is now online in the British Medical Journal's BMJ Open.
Apparently, administrative burdens and unhelpful bureaucratic barriers are key deterrents to running clinical trials in Europe, according to the survey, while costs of running trials, as week as any governmental or financial incentives are considered to be of lower importance. “This study seems to indicate that fostering competitiveness of European clinical research may not require additional government spending/incentives. Rather, harmonization of approval processes, greater visibility of centers of excellence, and reduction of hidden indirect costs, may bring significantly more clinical trials to Europe,” commented Ingrid Klingmann, Chairman of the European Forum for Good Clinical Practice (EFGCP).
The research paper also found considerable variability in the perceived receptivity of countries to undertake clinical trials. Germany, the United Kingdom, and the Netherlands were consistently rated the best trial markets, which led authors to suggest a best practice audit of provisions governing clinical trials in these countries would be helpful.
Applied Clinical Trials supported the survey by providing outreach for the collaborative study group survey to our readership.
You can read the full release here.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
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.
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.