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About us
Whitepapers and Publications

Whitepapers and Publications

We invite you to gain a first-hand insight into the work and knowledge of our Data Science Specialists:

Below you will find our whitepapers on specific topics from the world of biostatistics and data management, just as a list of publications to which the METRONOMIA team has contributed.

Would you like to hear the voice of our customers directly?
Contact us for references!

Publication

Anti-C5a antibody IFX-1 treatment versus best supportive care for patients with severe COVID-19

Publication

Strong dose response after immunotherapy with PQ grass using conjunctival provocation testing

Publication

A multicenter phase 1 study of solitomab (MT110, AMG 110), a bispecific EpCAM/CD3 T-cell engager (BiTE®) antibody construct, in patients with refractory solid tumors

Publication

Long-term follow-up of serum immunoglobulin levels in blinatumomab-treated patients with minimal residual disease-positive B-precursor acute lymphoblastic leukemia

Publication

Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL

Publication

Targeted therapy with the T-cell-engaging antibody blinatumomab of chemotherapy-refractory minimal residual disease in B-lineage acute lymphoblastic leukemia patients results in high response rate and prolonged leukemia-free survival

Publication

Assessing health-related quality of life in patients with Parkinson's disease in a prospective longitudinal study

Publication

Expression of epithelial cellular adhesion molecule (Ep-CAM) in chronic (necro-)inflammatory liver diseases and hepatocellular carcinoma

Publication

Cabergoline versus levodopa monotherapy: a decision analysis

whitepaper

Benefits of Bayesian Optimal Interval (BOIN) Design for Early-phase Oncology Trials

Early-phase oncology trials, particularly Phase I trials, typically determine the maximum tolerated dose (MTD) to ensure patient safety. While the traditional 3+3 design is common for its simplicity, the Bayesian Optimal Interval (BOIN) design offers greater flexibility and efficiency. This white paper explores the advantages of the BOIN design and compares it to the 3+3 approach using practical examples.

Case study

Driving Innovation: The Metronomia-Medidata Partnership

Medidata Provides Metronomia with The Tools and Expertise to Deliver Excellence for Customers

Case study

Rescue Services: A Global Phase II Study in Dermatology

Metronomia successfully took over Clinical Data Management and Biostatistics for a global Phase II
study in dermatology because of deficiencies in the performance of the previous CRO.

Case study

ISS/ISE Package in Immunology

Metronomia successfully assisted a biopharmaceutical company in preparing an Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) by integrating data from 11 heterogeneous clinical trials, of which five studies had legacy data formats. By standardizing data formats, harmonizing endpoints, recoding medical terminology, and applying advanced statistical methodologies, we delivered a comprehensive ISS/ISE package on schedule, ensuring a smooth regulatory submission and strengthening our partnership with the sponsor.

Case study

Rescue Services: A Pivotal Phase III Study in Oncology

Metronomia successfully rescued a delayed Phase III oncology study by automating data transfers,
enhancing data cleaning and reconciliation, and streamlining the data pipeline. This turnaround
restored confidence in the outcome of the study and led to further collaboration with the sponsor.