Only 14% of breast cancer trials reached optimal enrolment targets in 2021, despite being the most studied indication globally

Date: 02. 03. 2022

Phesi data highlight the critical need for protocol design optimization to improve clinical trial outcomes

Boston, USA, February 3rd, 2022: Despite being the most studied indication globally in 2021, only 14% of breast cancer trials reached optimal enrolment targets according to analysis by Phesi, provider of patient-centric analytics. The data emerges following a major global study of all clinical trials conducted in 2021, including more than 25,000 investigator sites running breast cancer trials. The Phesi model predicts that this trend will continue in 2022. The data highlight the huge challenges facing clinical development as trial recruitment continues to miss protocol targets.

“Clinical development is under increasing pressure to reduce costs, reduce cycle times, and improve success rates – but the industry will not achieve these goals if it doesn’t take advantage of big data. Persisting with an outdated and ineffective approach to trial design has to end,” commented Dr Gen Li, CEO and Founder at Phesi. “That such a small number of breast cancer trials reached their recruitment target, despite being the most studied disease area of the last 12 months, underlines this fact. Even taking into account the competition for patients, the real challenge in recruitment is caused by inadequate planning and poor study design. This has to change so companies can stop hoping their clinical trials will work out and start knowing.”

In many clinical programs, trial planning still does not integrate or analyze data from previous and current trials, protocols and related amendments. This means studies are launched despite many unanswered questions that exist at the planning stage. These include selecting inclusion/exclusion criteria, outcome measures, and accurately modelling baseline patient characteristics. Inevitably, this leads to costly and time-consuming protocol amendments, prolonged cycle times and even the eventual failure of development candidates that could have provided benefit to patients if the trial process had been optimized.

“The bottom line is that patients are waiting for biopharmaceutical companies to deliver,” commented Dr Paul Chew, Chief Medical Officer, Phesi. “The data exist today that — with the right analysis — can pre-emptively optimize all clinical trials to help answer key questions across the development cycle. Predictive protocol design analytics can solve the challenges that exist in trial planning today. From understanding the competitor landscape to identifying where a synthetic trial arm or digital twin can be deployed, patient-centric data analytics deliver better trials that will accelerate the speed of drug development and deliver faster cures.”

Dr Gen Li will be presenting at SCOPE Summit for Clinical Ops Executives 2022 on “Unlocking the power of integrated, patient-centric data science to answer the biggest questions in clinical development”. Stand #219, 4.05pm, February 8 (Room: Gatlin A4).

To find out more about Phesi, visit

Related news
05. 14. 2024
Phesi launches predictive Patient Burden Score to improve trial efficiency, patient experience and investigator site performance Read more
05. 08. 2024
Phesi Q1 2024 Business Update Read more
02. 12. 2024
Phesi announces AI-driven Trial Accelerator™ hits critical milestone with data from 100 million patients Read more
01. 16. 2024
Phesi releases 2023 analysis of clinical development; breast cancer remains most studied disease area for third year Read more
10. 15. 2023
Phesi launches Health Check and Trial Rescue Service to save at-risk trials and bring drugs to market faster Read more
09. 07. 2023
Phesi and Krystelis collaborate to launch new Diversity, Equity, and Inclusion Data Service for clinical development Read more