Related Experiment Video
Updated: Feb 28, 2026
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
PROSPECT-LUNG: A National Clinical Trials Network Trial Advancing Pragmatic Innovation in Cancer Clinical Trials
Allison Booth1, Shauna Hillman1, Kristina Laumann1
1Alliance Statistics and Data Management Center, Mayo Clinic Department of Quantitative Health Sciences, Rochester, Minnesota.
Introduction:
Clinical trial designs marked by extensive data collection, restrictive eligibility, and lengthy protocols create inefficiencies, increase costs, and hinder accrual. These are further compounded by staffing shortages and operational burdens. By incorporating pragmatic features, including simplified eligibility criteria, streamlined protocol, and data collection, the PROSPECT-Lung trial, CTIU2317-A082304-S2402 Perioperative versus Adjuvant Systemic Therapy in Patients with Resectable NSCLC, paves the way forward as a model for enhancing clinical trial efficiency and feasibility, while maintaining scientific rigor.
Methods:
PROSPECT-Lung (CTIU2317-A082304-S2402) is a pragmatic, phase III, open-label, randomized trial comparing 3-year real-world event-free survival and overall survival using approved perioperative and adjuvant immunotherapy-based treatment strategies in patients with resectable NSCLC. Protocol length and data collection elements were compared with Alliance A081801, Integration of Immunotherapy into Adjuvant Therapy for Resected NSCLC: ALCHEMIST CHEMO-IO (ClinicalTrials.gov Identifier: NCT04267848), a phase III trial in the same disease setting, to quantify streamlining efforts.
Results:
Relative to A081801, PROSPECT-Lung achieved major reductions in trial complexity. Protocol length decreased from 88 to 30 pages (65%), and data fields per patient were reduced from 2523 to 438 (82.6%), driven by streamlined summary versus cycle-by-cycle data collection. These efficiencies translate to estimated site workload reductions from 210 hours per patient in A081801 to 36.5 hours in PROSPECT-Lung. At full accrual, this equates to more than 190,000 hours saved in chart review, data entry, documentation, and quality control.
Conclusion:
By broadening eligibility and streamlining logistics, PROSPECT-Lung reduces burden for patients, investigators, and sites while preserving scientific integrity. This pragmatic approach, when appropriate and possible, provides a replicable model for future cancer trials, promoting efficiency, accessibility, and real-world relevance.
Gov Identifier:
NCT06632327 (CTIU2317-A082304-S2402).
Insights
The PROSPECT-Lung trial significantly streamlined clinical trial design for resectable non-small cell lung cancer. This pragmatic approach reduced protocol length and data collection, saving substantial site hours and enhancing feasibility.
Area of Science:
- Oncology
- Clinical Trial Design
- Translational Research
Background:
- Traditional clinical trials face inefficiencies due to extensive data collection, restrictive eligibility, and lengthy protocols.
- These factors increase costs, hinder patient accrual, and are exacerbated by staffing shortages and operational burdens.
- There is a need for more efficient and feasible clinical trial designs without compromising scientific rigor.
Purpose of the Study:
- To evaluate the PROSPECT-Lung trial as a model for enhancing clinical trial efficiency and feasibility in resectable non-small cell lung cancer.
- To compare the protocol length and data collection elements of PROSPECT-Lung with a traditional trial (Alliance A081801) in the same disease setting.
- To quantify the streamlining efforts and their impact on trial complexity and site workload.
Main Methods:
- PROSPECT-Lung is a pragmatic, phase III, open-label, randomized trial comparing immunotherapy-based treatment strategies.
- The trial focuses on 3-year event-free survival and overall survival in patients with resectable non-small cell lung cancer.
- Protocol length and data fields were compared against Alliance A081801 to assess streamlining.
Main Results:
- PROSPECT-Lung achieved significant reductions in trial complexity compared to A081801.
- Protocol length decreased by 65% (88 to 30 pages), and data fields per patient were reduced by 82.6% (2523 to 438).
- Estimated site workload reduced from 210 hours per patient to 36.5 hours, saving over 190,000 hours at full accrual.
Conclusions:
- The PROSPECT-Lung trial demonstrates that broadening eligibility and streamlining logistics reduce burden for patients, investigators, and sites.
- This pragmatic approach maintains scientific integrity and offers a replicable model for future cancer trials.
- The PROSPECT-Lung model promotes efficiency, accessibility, and real-world relevance in oncology research.
More Related Videos
06:28E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
04:04Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
Published on: February 12, 2017
Related Concept Videos
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...
01:11Clinical Trials: Overview
02:57Targeted Cancer Therapies
There are several types of targeted therapies against...
02:56Treatment Resistant Cancers