Overcollection of data adds months to clinical trials and reduces ROI, finds new Phesi analysis
Patients increasingly burdened by overcomplicated trials, data from Phesi’s Trial Accelerator shows
Boston, USA. 1st Nov, 2024: Phesi, a leading clinical development analytics company, has unveiled new analysis from its AI-driven Trial Accelerator™ platform. The data show that a significant number of phase III clinical trials are over-collecting data because of overcomplicated protocol designs, leading to avoidable delays in drug development times and increased patient burden.
Phesi used proprietary data from its Trial Accelerator Platform to analyze 2,401 industry-sponsored Phase III clinical trials that have reached their primary endpoint since January 2020, 1,574 of which had reported patient data so far. From these, the company identified 5 top disease indications, including 146 protocols designed to capture 1,821 outcome measures, ranging between 1 and 102 measures per protocol, and including both primary and secondary outcomes. The full findings are available in a new report.
The analysis shows that the more outcome measures included in a trial protocol, the lower the percentage of those outcomes reported in results. On average, over a third (35%) of outcome measures were not reported. Trials with fewer than the median number of outcome measures in a protocol reported 94% of those measures in their results, whereas those that collected more than the median number of outcomes typically only reported 56% in their results.
“Collecting a good amount of data is important for clinical trials, but it has to be the right data at the right time,” said Dr Gen Li, founder and CEO of Phesi. “Many of the clinical trials we analysed had redundant outcome measures. For example, trials often use several different physical performance status measures on the same patients – which is a huge added burden for that patient even though each scale is measuring the same thing. This also puts undue pressure on investigator sites.
“Although the complexity of trial designs has long been known to affect the cost, timelines and patient burden of clinical development, it has previously been hard to measure that complexity in an objective way. Now, with advances in Phesi’s Trial Accelerator platform, we are able to analyze our proprietary data, assign a ‘complexity score’ to trial protocols, and model the true impact of the number of outcome measures in a trial.”
The analysis also showed a correlation between a lower number of outcome measures and better site enrollment, demonstrating that recruitment is improved when the trial protocol presents a smaller burden to the patients and investigator sites. Directly comparing type 2 diabetes trials from two different sponsors found that the sponsor using a median of 25 outcomes measures for their trials had lower site enrollment performance (10.2 patients per site vs. to 11.2) and a lower enrollment rate (0.46 patients per site per month vs 0.53) compared to the sponsor with a median of only 10 outcome measures. In the same indication of T2DM, one trial planned 39 outcome measures in the protocol, an outlier for a median of 10 outcome measures. While originally planned to complete in 19 months, it overran by seven months, completing in 26 months instead.
The top 5 diseases analyzed by Phesi in the analysis were COVID-19, Type 2 diabetes, atopic dermatitis, non-small cell lung cancer, and cystic fibrosis.
“Investigators need to avoid data FOMO (“fear of missing out”) and make sure they are only collecting the data they truly need,” added Dr Li. “Being more precise with outcome measures makes it easier to select trial sites, recruit more patients in a shorter period of time, and collect better quality data from those patients. All these compounded benefits lead to better return on investment, an increasingly pressing issue in the current economic environment for the pharmaceutical industry. By harnessing better insights about the potential impact of each outcome measure, guided by historial designs proven to be successful in patient enrollment, investigators can be reassured that they are using an optimized number of outcome measures.”
View the full report here: https://info.phesi.com/trial-complexity-report
Phesi uses the world’s largest clinical trial database to simulate clinical development and improve decision making, with AI-driven solutions for trial simulation, patient profiling, protocol design and digital control arms available to support life sciences companies in accelerating drug development and commercialization. Find out more about Phesi and the Phesi Trial Accelerator™ platform.
About Phesi
Phesi is a global provider of AI-powered patient-centric data analytics, and clinical development products and solutions to the biopharmaceutical industry. The company’s integrated offerings cover the entire clinical development process — from patient profiling and development planning to protocol design optimization, investigator site selection and trial implementation management. Phesi has the world's largest and most dynamic real-time clinical development database; delivering patient-centric data science that enables biopharmaceutical companies to predict and optimize clinical development outcomes in any indication. Its database integrates data from 90,000 sources; consisting of records from 120+ million patients, 485,000+ curated clinical trials, 604,000 completed research projects, 4.2 million physicians, 600,000 investigator sites in 195 countries, and over 4,000 indications. Phesi delivers data, insights and answers, enabling smarter trials and faster cures.
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