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Clinical Trials For Some Cancer Treatments Are Taking Less Time

Recent data from Citeline - the world’s leading authority on pharmaceutical clinical trials - show that, contrary to popular thinking, clinical trials are getting shorter.  So, why are healthcare development costs rising?

Durations of clinical trials in two key types of cancer have declined over a 15-year period, highlighting that the length of late-stage studies may not be solely to blame for rising pharmaceutical development costs, according to a new Citeline/Scrip 100 analysis.

Citeline examined two high prevalence diseases in oncology – breast cancer and lung cancer – as well as looking across cancer types for trials involving targeted therapies. The study uses a larger data set than in previously published analyses. 

All three key parameters - enrolment, study duration and total trial duration - showed a declining duration trend of between 12 and 16 months during the past 15 years.   This was in contrast to rising number of sites and countries used in trials, both of which likely contribute to increases in development costs.

The Citeline study is published in Scrip Intelligence, the world’s leading news, analysis and data service for the global pharmaceutical industry.  Results will be presented at the Partnerships in Clinical Trials Congress running 6 – 9 November.

It is widely accepted in the biopharmaceutical industry that clinical trial protocols are growing in complexity. Many in the business decry that the duration of trials is increasing, with patient enrolment a frequently-cited problem in clinical development. These three purported truisms are the most frequently cited reasons for the rising costs of clinical trial development.

“Unexpected trends in trial timing benchmarks have been revealed,” said Christine Blazynski, Chief Science Officer and Sr. VP of New Product Development at Citeline.  “Our analysis pours cold water on at least two of the notions that enrolment and trial durations are universally getting longer.”

The Citeline analysis focused on Phase II and Phase III trials in breast cancer, non-small cell lung cancer and also cancer diseases where targeted therapies were being studied. The time frame covered approximately the years 1995 – 2010, and the total data set consisted of 471 Phase III trials and 1101 Phase II trials.

Average durations for enrolment period, treatment period and total trial period (enrolment + treatment periods) were found to decrease. In the meantime, the numbers of sites increased during each five year period, although the geographic breadth of those sites decreased slightly with one exception. The analysis of lung cancer trials does reveal increases in geographic breadth in sites.

The trial duration data were grouped into five-year time cohorts, the average decrease in Phase III breast cancer trials between cohorts of the two most recent five year periods (2001 – 2005 vs 2006 – 2010) was 16 months. For trials looking at first line therapy, the difference was 12.5 months.

“It is highly likely that the growth in numbers of sites is driving much of the timeline shifts, and improving enrolment efficiency,” Blazynski said.

Trends in trials involving genetically segmented patients, biomarker stratified patients, or those using personalized medicine are all topics that bear study. There has been a significant growth in development and launch of biologics.

These shifts bring critical new questions on the efficiency of both development and use of this new wave of science and potentially more-targeted biologics.  Citeline plans to use its expanding database to bring new analysis and understanding to the crucial question of clinical trial development trends and productivity.

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