Rationale and design of the Cancer Immunotherapy Evidence Living (CIEL) Library: A continuously updated clinical trial database of cancer immunotherapies

Background Immunotherapies for cancers are being tested in large numbers of clinical trials. It is nearly impossible for clinicians and researchers to stay current with the evidence, and traditional systematic reviews and clinical guidelines are not suited to ensure a continued overview of all trials and their results. To address this problem, we have designed a free-to-use, and publicly available database of clinical trials that aims to be continuously updated, the Cancer Immunotherapy Evidence Living (CIEL) Library. Methods We aimed to include planned, ongoing, and completed interventional trials of immunotherapies for cancer, regardless of trial design (e.g., randomization, blinding, and type of comparator). We systematically searched PubMed (for published reports) and ClinicalTrials.gov (for registered clinical trials). PubMed retrieved records were screened using the AI-assisted software ASReview and manually extracted and curated. We imported data from ClinicalTrials.gov using the Clinical Trials Transformation Initiative database which then requires further curation. The CIEL-Library is available and searchable via a web application (https://app.ciel-library.org/#/). It also contains the Match My Patient feature, a patient-centered clinical decision support system, which can filter planned, ongoing or completed trials based on four patient characteristics (disease staging, previous treatments, performance status, and location). We piloted our database with one type of cancer immunotherapy, the tumor-infiltrating lymphocytes (TIL) transfer. Conclusion The CIEL-Library offers a blueprint for a dynamic evidence synthesis infrastructure providing an exhaustive collection of clinical trials with trial characteristics and results, which can be applied across different fields, specialties, and topics. The Match My Patient search function may be very useful to implement trial research into patient-centered care by helping to find a trial for enrolment of a patient or to find results for making decisions, for example, in tumor boards. The main challenges to making a continuously updated database of clinical trials are the time and resources needed to populate it with curated and updated data. The CIEL-Library project illustrates the potential and the main limitations to designing such continuously updated trial databases that intent to be directly used in routine care. ### Competing Interest Statement RC2NB (Research Center for Clinical Neuroimmunology and Neuroscience Basel) is supported by Foundation Clinical Neuroimmunology and Neuroscience Basel. RC2NB has a contract with Roche for a steering committee participation of LGH, unrelated to this work. K.B., J.H., P.D., B.K., L.G.H. and P.J. declares no competing interest for this project. H.L. received travel grants and consultant fees from BMS and Merck, Sharp and Dohme (MSD). H.L. received research support from BMS, GlycoEra, and Palleon Pharmaceuticals. H.L. is a co-founder of Glycocalyx Therapeutics. ### Funding Statement The CIEL Project was funded the Basel Cancer League (KLbB-5577-02-2022). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors