Pharma Intelligence is part of the Informa Intelligence Division of Informa PLC
This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.
In my previous analysis of the top five Asian cancers , I did not delve deeply into the relationship between primary endpoints for later-stage oncology trials (phase II, II/III and III), outcomes and pharmacogenomic biomarkers. In this blog series, I will do just that – first by sponsor type, then by disease and finally by start year. The methodology I used in my analysis is listed below.
Overall, the number of trials with positive outcomes for primary endpoints was about equal to the number of trials with negative outcomes. This parity held true if trials were jointly sponsored, but not if trials had only one type of sponsor. Industry sponsored trials were completed or terminated with more negative than positive primary outcomes; while non-industry sponsored trials resulted in the opposite. Only four of the top ten industry sponsors, Eli Lilly, Otsuka/Taiho, Roche and Sanofi, had more positive than negative primary outcomes (data not shown).
Besides sponsor type, the choice of primary endpoints also influenced the primary trial outcome. Overall, trials with DFS, PFS or TTP as the primary endpoint resulted in more positive than negative outcomes while trials with OS resulted in the opposite. Industry sponsored trials resulted in more positive than negative primary outcomes with just DFS while non-industry sponsored trials resulted in more positive primary outcomes with PFS and TTP.
Finally, the use of PGX biomarkers to select or stratify patients was more likely to be associated with a positive than negative primary outcome only with PFS as the primary endpoint, regardless of sponsor type. However, this difference was noticeable with just completed rather than terminated trials. Outcomes for trials using a PGX biomarker to select or stratify patients with the other three primary endpoints were almost equal in their outcomes. As mentioned earlier in this blog, the subset of trials using a PGX biomarker to select or stratify patients was very small. Therefore, the correlation of PGX biomarker selection or stratification to outcomes would benefit from a more select pool of trials in which the use of PGX biomarkers was greater.
For my next blog, I will continue my analysis of the outcomes, endpoints and the use of PGX biomarkers for selection or stratification in this set of later-stage trials for each of the top five Asian cancers.
Trialtrove: gold standard clinical trials intelligence
A clear view of the past is often the surest way to plan for the future. The annual analysis of Phase I-III clinical trials from Citeline’s Trialtrove reveals the priorities and strategies of the biopharma industry. This infographic lets you clearly see the players, trials, and trends.
Topics Drug development landscape BioPharmaceutical Business strategies
Trialtrove: gold standard clinical trials intelligence
See last year’s clinical trial activity through the eyes of our expert analysts and get a better sense of where the industry is headed. This new whitepaper is the annual analysis of Phase I-III clinical trials, from Citeline’s Trialtrove, and reveals the priorities and strategies of the biopharma industry.
Topics Drug development landscape BioPharmaceutical Business strategies
Trialtrove: gold standard clinical trials intelligence
Get a visual snapshot of how the industry pipelines are faring with our 2018 Completed Trials snapshot. This graphic analysis paints a clear picture of the state of clinical trial completions, while pointing to some important changes that are emerging.
Request a Demo
Getting a demo tailored to your needs is the best way to see how our solutions will help you gain an advantage.
Request live demo now:
How can we help you?
Our team is always happy to hear from you. Please call us at:
Pharma Report Store
Have an immediate and specific information need?
Browse and buy from 1000s of analysis and research reports now:
Support the development and validation of your strategic plans and ensure commercial decisions are based on marketplace realities. Datamonitor Healthcare offers expert coverage of key diseases, treatments, companies, drugs, market access and market trends. Our primary research with physicians, payers, and KOLs (key opinion leaders) informs our treatment standards data and patient-based forecasts.
To build and maintain gold-standard, next generation R&D intelligence tools, Sitetrove, Trialtrove, Pharmaprojects, and Trialpredict have been undergoing a major program of investment. In addition to the many new and exciting changes on the horizon, the robust and reliable Citeline tools that you use to inform your business decisions will formally join Informa’s Pharma Intelligence family of brands.
The industry’s most trusted drug development database, Citeline's Pharmaprojects has been covering pharma R&D across global markets for 35+ years. With 68,000+ drug profiles including 15,000 drugs in active development, it’s the go-to resource for preclinical, clinical, and pipeline coverage, and lifecycle management tracking.
Looking for more products Product Finder
