Background: Basket clinical trials (BCTs) are novel trial designs commonly used in precision oncology. A 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 BCTs 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 with the risks and benefits in other oncology clinical trials with classical designs.
Methods: We systematically searched Embase, PubMed and ClinicalTrials.gov 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 and 1,263 PubMed), we included 255 texts for full text screening. We found 260 trials through the systematic search of ClinicalTrials.gov. 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: None.