Do basket clinical trials in oncology increase health benefits for patients?

Session Type
Evidence synthesis innovations and technology
Strzebońska K1, Klaś K1, Zaborowska Ł1, Waligóra M1
1Research Ethics in Medicine Study Group (REMEDY), Faculty of Health Sciences, Jagiellonian University Medical College, Poland

Background: Basket clinical trials (BCTs) are novel trial designs commonly used in precision oncology. BCT is defined as a study that tests a therapeutic intervention for multiple malignancy types simultaneously under the same study protocol. Patients with different cancers recruited to BCT share specific molecular characteristics which are predictive of clinical benefit from the experimental treatment. Little is known about the risk/benefit ratio in BCTs.
Objectives: Our aim is to conduct a systematic review with meta-analysis to evaluate efficacy and safety profiles in BCTs in oncology. We also aim to compare the risks and benefits for trial participants in BCTs to the risks and benefits in other oncology clinical trials with classical design.
Methods: We systematically searched Embase, PubMed and for interventional cancer BCTs published between 1 January 2001 and 20 June 2022. We will measure the risk to trial participants by evaluating treatment-related adverse events of grade 3 or higher. We will assess the benefit by analysing objective response rate, progression-free survival, and overall survival.
Results: Of 3 890 records identified (2 627 Embase, 1 263 PubMed), we included 255 texts for full text screening. We found 260 trials through the systematic search of Two reviewers are independently performing the screening of trials according to the eligibility criteria. The results of the final analyses will be presented at the conference.
Conclusions: Our findings on the risks and benefits for trial participants in BCTs will provide a basis for discussion on clinical benefits to patients in precision oncology research. Moreover, an ethical analysis or risk/benefit profile in BCTs can contribute to the proposal of recommendations to increase the benefits for trial participants and reduce risks.
Patient, public and/or healthcare consumer involvement: No patients, the public or healthcare consumers are involved in the project.