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 Persisting with an outdated and ineffective approach to trial design has to end,” commented Dr Gen Li, CEO and Founder at Phesi.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
01. 16. 2023
New Phesi global analysis sees breast cancer retain position as most studied disease area in 2022 Read more
11. 30. 2022
Number of collagen clinical trials more than doubled since 2010, Phesi analysis shows Read more
10. 14. 2022
Phesi launches AI-driven Trial Accelerator™ to enable simulated trials and deliver comprehensive view of the patient throughout clinical development and commercialization Read more
10. 06. 2022
Almost half of Ukraine’s clinical trials to find new therapies are still recruiting patients despite ongoing conflict, Phesi analysis shows Read more
09. 21. 2022
New Phesi Analysis of 117,000 Alzheimer’s Patients Highlights Need for Preventative Approach that Includes Younger Participants Read more
06. 23. 2022
48% of US cancer clinical trials have no Hispanic or Latin American representation, and 42% do not include a single Black patient, Phesi analysis reveals Read more