Number of Clinical Trials
ClinicalTrials.gov is a federally mandated database with a large and growing, number of required data fields. Organizations are required to report any study being conducted under FDA auspices. One of the mandated reporting fields is the date that the FDA receives notification of a clinical trial’s initiation, with less than 3% of the studies in the database missing that information.
ClinicalTrials.gov is a federally mandated database with a large and growing, number of required data fields. Organizations are required to report any study being conducted under FDA auspices. One of the mandated reporting fields is the date that the FDA receives notification of a clinical trial’s initiation, with less than 3% of the studies in the database missing that information.
The data show an initial spike in received studies by the FDA in 2008, when organizations conducting clinical trials were first required to report a study’s initiation date. Previous to that date, the reporting had been voluntary. Since 2008 the number of pharmaceutical company sponsored studies has most certainly not grown. If anything, there has been a slight decrease in recent years as many pharmaceutical companies look for ways to target more effectively their clinical trial efforts. This is most clearly seen with Phase II studies. To be sure, drug develop is a complex and uncertain undertaking. Moreover, conducting an individual clinical trial may be becoming ever more challenging. However, there is no verifiable database that indicates that pharmaceutical industry is increasing the number of Phase II and III clinical trials it conducts.
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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.
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