Clinical epidemiology & health care research in oncology
CEIT-cancer: Comparative Effectiveness of Innovative Treatments for cancer
Patients with cancer need treatments that improve survival and quality of life. Several programs aim to accelerate drug development and marketing approval, most recently the FDA Breakthrough program. There are increasing concerns that this acceleration restricts the knowledge on benefits and harms of novel drugs. In the Comparative Effectiveness of Innovative Treatments for cancer (CEIT-Cancer) project, we assess this early evidence described in FDA approval documents for all cancer drugs approved since 2000.
- The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs. Ladanie A, Speich B, Naudet F, Agarwal A, Pereira TV, Sclafani F, Martin-Liberal J, Schmid T, Ewald H, Ioannidis JPA, Bucher HC, Kasenda B, Hemkens LG, Trials. 2018 Sep 19;19(1):505. doi: 10.1186/s13063-018-2877-z. PubMed PMID: 30231912; PubMed Central PMCID: PMC6146631.
- How to use FDA drug approval documents for evidence syntheses. Ladanie A, Ewald H, Kasenda B, Hemkens LG. BMJ. 2018 Jul 10;362:k2815. doi: 10.1136/bmj.k2815.
- Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies. Ladanie A, Speich B, Briel M, Sclafani F, Bucher HC, Agarwal A, Ioannidis JPA, Pereira TV, Kasenda B, Hemkens LG. J Clin Epidemiol. 2019 Oct;114:49-59. doi: 10.1016/j.jclinepi.2019.05.033. Epub 2019 May 31.
Basel research team
CEIT-OLU: Contrasting evidence to reimbursement reality for off-label use in cancer care
Off-label drug use (OLU) reflects a perceived unmet medical need. This is common in oncology. OLU is frequently regulated by reimbursement restrictions, given the frequently high prices of cancer drugs that are a challenge for many healthcare systems. An evidence-based healthcare system would base reimbursement decisions on clinical evidence for treatment benefits – independent from patient or insurance factors. However, the reality of OLU reimbursement is not well explored. The association of reimbursement and the underlying clinical evidence is unknown in Switzerland. Here, we aim to investigate the relationship of reimbursement decisions with the underlying clinical evidence in an area with complex implications for health policy and practice.
- Contrasting evidence to reimbursement reality for off-label use (OLU) of drug treatments in cancer care: rationale and design of the CEIT-OLU project. Herbrand AK, Schmitt AM, Briel M, et al. ESMO Open 2019;0:e000596. doi:10.1136/esmoopen-2019-000596
- Reimbursement Reality for Off-label use in cancer care – A systematic empirical investigation. A.K. Herbrand, A.M. Schmitt, A. Hoogkamer, M. Joerger, S. Diem, U. Novak, L.G. Hemkens, B. Kasenda. Annals of Oncology (2019) 30 (suppl_5): v671-v682. 10.1093/annonc/mdz263
Basel research team
Lars Hemkens, Benjamin Kasenda