VHIO’s statistics unit implements innovative biostatistical methodologies to optimise study design, clinical-molecular data analysis and its subsequent interpretation to enhance its clinical and pre-clinical research.
The unit collaborates with the different research groups, both in clinical trials and observational studies, throughout the project life cycle: from study design and methodology to statistical analysis, graphic representation and publication of the study. Areas of work include sample size calculation, complex analyses with survival endpoints and competitive risks, multi-state models and the conduct of systematic reviews and meta-analyses.
In recent years, the Biostatistics Unit has worked on the design and subsequent publication of the results of various phase I, II and III studies led by VHIO researchers. It has also worked on the validation of new biomarkers created by the institution in clinical and pre-clinical contexts.
Some of the short-term strategic objectives include: i) facilitating the design and execution of more VHIO researcher-led studies; ii) implementing new adaptive designs in phase I/II studies; iii) maximising the value of real-world data to generate new evidence outside the context of clinical trials; and iv) validating the prognostic and predictive value of new tests and biomarkers.
The unit also collaborates on European and Spanish projects dedicated to the creation and implementation of new statistical designs. It does so with a view to enhancing new designs in dose-escalation studies aimed at maximising the likelihood of selecting the optimal dose level for the subsequent development of the drug. It also seeks to evaluate the real potential of using synthetic controls as comparative groups in single-arm trials.
Guillermo Villacampa
Head of Unit
Biosketch
- Designing phase I-II and phase II-III trials to accelerate the evaluation of the efficacy and safety of new treatments.
- Implementing adaptive designs in dose-escalation studies aimed at maximising the likelihood of selecting the optimal dose level for the subsequent development of the drug.
- Building prognostic and predictive models for the validation of biomarkers in oncology.
- Conducting systematic reviews and meta-analyses in cancer research settings where questions remain unanswered.
- Producing multi-state models, survival analyses and competitive risk assessments.
- Enhancing the efficacy of using synthetic controls as comparative groups in single-arm trials.
- Establishing an automated data processing, statistical analysis and results reporting structure in the different clinical and pre-clinical research projects carried out at VHIO.
Group lead
Guillermo Villacampa
Biostatistician
Victor Navarro
Lorenzo Carità
Most relevant scientific publications
- Villacampa G, Tung NM, Pernas S, et al. Association of HER2DX with pathological complete response and survival outcomes in HER2-positive breast cancer. Ann Oncol. 2023;34(9):783-795. doi:10.1016/j.annonc.2023.05.012
- Villacampa G, Cresta Morgado P, Navarro V, Viaplana C, Dienstmann R. Comprehensive evaluation of surrogate endpoints to predict overall survival in trials with PD1/PD-L1 immune checkpoint inhibitors plus chemotherapy. Cancer Treat Rev. 2023;116(March):102542. doi:10.1016/j.ctrv.2023.102542
- Villacampa G, Matikas A, Oliveira M, Prat A, Pascual T, Papakonstantinou A. Landscape of neoadjuvant therapy in HER2-positive breast cancer: a systematic review and network meta-analysis. Eur J Cancer. 2023;190(xxxx):1-12. doi:10.1016/j.ejca.2023.03.042
- Villacampa G, Patel D, Zheng H, et al. Assessing the reporting quality of early phase dose-finding trial protocols: a methodological review. eClinicalMedicine. 2023;60:102020. doi:10.1016/j.eclinm.2023.102020
- Villacampa G, Papakonstantinou A, Fredriksson I, Matikas A. Impact of Primary Breast Surgery on Overall Survival of Patients With De Novo Metastatic Breast Cancer: A Systematic Review and Meta-Analysis. Oncologist. 2023;(August 2023):1-7. doi:10.1093/oncolo/oyad266
- Oaknin A, Gladieff L, Martínez-García J, et al. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial. Lancet. 2023;403:31-43. doi:10.1016/s0140-6736(23)02405-4
- Iacoboni G, Navarro V, Martín-López AÁ, et al. Recent Bendamustine Treatment Before Apheresis Has a Negative Impact on Outcomes in Patients With Large B-Cell Lymphoma Receiving Chimeric Antigen Receptor T-Cell Therapy. J Clin Oncol. Published online 2023. doi:10.1200/jco.23.01097
- Coakley M, Villacampa G, Sritharan P, et al. Comparison of circulating tumor DNA assays for Molecular Residual Disease detection in early-stage triple negative breast cancer. Clin Cancer Res. 2023;011(1):1-9. doi:10.1158/1078-0432.ccr-23-2326
- Serrano C, Rothschild S, Villacampa G, et al. Rethinking placebos: embracing synthetic control arms in clinical trials for rare tumors. Nat Med. 2023;29(11):2689-2692. doi:10.1038/s41591-023-02578-z
- Villacampa G, Tolosa P, Salvador F, et al. Addition of immune checkpoint inhibitors to chemotherapy versus chemotherapy alone in first-line metastatic triple-negative breast cancer: A systematic review and meta-analysis. Cancer Treat Rev. 2022;104(January). doi:10.1016/j.ctrv.2022.102352
- Villacampa G, Falato C, Paré L, et al. Pre-operative ribociclib plus letrozole versus chemotherapy: Health-related quality of life outcomes from the SOLTI CORALLEEN trial. Eur J Cancer. 2022;174(2022):232-242. doi:10.1016/j.ejca.2022.07.028
- Remon J, Villacampa G, Facchinetti F, et al. Immune checkpoint blockers in patients with unresectable or metastatic thymic epithelial tumours: A meta-analysis. Eur J Cancer. 2023;180(2023):117-124. doi:10.1016/j.ejca.2022.12.005
- Tolaney SM, Tarantino P, Graham N, et al. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial. Lancet Oncol. 2023;24(3):273-285. doi:10.1016/S1470-2045(23)00051-7
- Elez E, Ros J, Fernández J, et al. RNF43 mutations predict response to anti-BRAF/EGFR combinatory therapies in BRAF V600E metastatic colorectal cancer. Nat Med. 2022;28(10):2162-2170. doi:10.1038/s41591-022-01976-z
- Ros J, Matito J, Villacampa G, et al. Plasmatic BRAF-V600E allele fraction as a prognostic factor in metastatic colorectal cancer treated with BRAF combinatorial treatments. Ann Oncol. 2023;34(6):543-552. doi:10.1016/j.annonc.2023.02.016
- López-Fernández A, Villacampa G, Grau E, et al. Patients’ and professionals’ perspective of non-in-person visits in hereditary cancer: predictors and impact of the COVID-19 pandemic. Genet Med. 2021;23(8):1450-1457. doi:10.1038/s41436-021-01157-2
- Llop-Guevara A, Loibl S, Villacampa G, et al. Association of RAD51 with homologous recombination deficiency (HRD) and clinical outcomes in untreated triple-negative breast cancer (TNBC): analysis of the GeparSixto randomized clinical trial. Ann Oncol. 2021;32(12):1590-1596. doi:10.1016/j.annonc.2021.09.003
- Matos I, Villacampa G, Hierro C, et al. Phase I prognostic online (PIPO): A web tool to improve patient selection for oncology early phase clinical trials. Eur J Cancer. 2021;155:168-178. doi:10.1016/j.ejca.2021.05.040
- Villacampa G, Dienstmann R, Bosch F, Abrisqueta P. Combination of novel molecular targeted agent plus R-CHOP-based regimen versus R-CHOP alone in previously untreated diffuse large B-cell lymphoma (DLBCL) patients: a systematic review and meta-analysis. Ann Hematol. 2021;100(12):2969-2978. doi:10.1007/s00277-021-04623-8
- Iacoboni G, Villacampa G, Martinez-Cibrian N, et al. Real-world evidence of tisagenlecleucel for the treatment of relapsed or refractory large B-cell lymphoma. Cancer Med. 2021;10(10):3214-3223. doi:10.1002/cam4.3881
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