Scientific Publications

Peer-reviewed publications written and co-authored by our biostatistics and clinical data experts, sharing research and practical insights from across the field.

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

Multicentre Phase 1 study of the bispecific EpCAM/CD3 BiTE solitomab in refractory solid tumours.

2024-11-06
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Anti-C5a antibody IFX-1 treatment versus best supportive care for patients with severe COVID-19

Trial comparing anti-C5a antibody IFX-1 with best supportive care in patients with severe COVID-19.

2024-11-06
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Assessing health-related quality of life in patients with Parkinson's disease in a prospective longitudinal study

Prospective longitudinal assessment of health-related quality of life in Parkinson's disease.

2024-11-06
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Bispecific T-cell engager (BiTE) antibody construct blinatumomab for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma: final results from a phase I study

Final Phase I results for the BiTE construct blinatumomab in relapsed/refractory non-Hodgkin lymphoma.

2024-11-06
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Cabergoline versus levodopa monotherapy: a decision analysis

Decision-analytic comparison of cabergoline versus levodopa monotherapy in Parkinson's disease.

2024-11-06
Publication

Cost of illness and its predictors for Parkinson's disease in Germany

Cost-of-illness study and predictors for Parkinson's disease in Germany.

2024-11-06
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Cost of illness in Parkinson disease. A retrospective 3-month analysis of direct costs

Retrospective 3-month cost-of-illness analysis of direct costs in Parkinson's disease.

2024-11-06
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Costs of drug treatment of neurologic diseases: Parkinson disease, dystonia, epilepsy

Analysis of drug-treatment costs across Parkinson disease, dystonia and epilepsy.

2024-11-06
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Costs of treating dystonias and hemifacial spasm with botulinum toxin A

Cost analysis of treating dystonias and hemifacial spasm with botulinum toxin A.

2024-11-06
Publication

Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis

Economic evaluation of maintenance tacrolimus 0.1% ointment in adults with moderate-to-severe atopic dermatitis.

2024-11-06
Publication

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

Study of Ep-CAM expression in chronic inflammatory liver disease and hepatocellular carcinoma.

2024-11-06
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

Long-term haematologic relapse-free survival follow-up from a Phase 2 study of blinatumomab in B-lineage ALL with MRD.

2024-11-06
Publication

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

Long-term follow-up of serum immunoglobulin levels in blinatumomab-treated MRD-positive B-precursor ALL patients.

2024-11-06
Publication

Long-term relapse-free survival in a phase 2 study of blinatumomab for the treatment of patients with minimal residual disease in B-lineage acute lymphoblastic leukemia

Phase 2 study reporting long-term relapse-free survival with blinatumomab in MRD-positive B-lineage ALL.

2024-11-06
Publication

Phase II trial of the anti-CD19 bispecific T cell-engager blinatumomab shows hematologic and molecular remissions in patients with relapsed or refractory B-precursor acute lymphoblastic leukemia

Phase II trial of blinatumomab showing haematologic and molecular remissions in relapsed/refractory B-precursor ALL.

2024-11-06
Publication

Principles and recommendations for incorporating estimands into clinical study protocol templates

Practical principles and recommendations for embedding the ICH E9(R1) estimand framework into protocol templates.

2024-11-06
Publication

Prophylaxis of migraine with oral magnesium: results from a prospective, multi-center, placebo-controlled and double-blind randomized study

Prospective, multicentre, placebo-controlled, double-blind RCT of oral magnesium for migraine prophylaxis.

2024-11-06
Publication

SAE reporting in EDC trials

Practical perspectives on serious adverse event reporting within EDC-based clinical trials.

2024-11-06
Publication

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

Dose-response findings after PQ Grass immunotherapy assessed by conjunctival provocation testing.

2024-11-06
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

Blinatumomab in chemotherapy-refractory MRD B-lineage ALL, showing high response rates and prolonged leukaemia-free survival.

2024-11-06
Publication

The anti-C5a antibody vilobelimab efficiently inhibits C5a in patients with severe COVID-19

Pharmacodynamic evidence that vilobelimab efficiently inhibits C5a in patients with severe COVID-19.

2024-11-06
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The economic impact of Parkinson's disease. An estimation based on a 3-month prospective analysis

Estimation of the economic impact of Parkinson's disease from a 3-month prospective analysis.

2024-11-06
Publication

Twice-weekly treatment with tacrolimus 0.03% ointment in children with atopic dermatitis: clinical efficacy and economic impact over 12 months

Clinical efficacy and 12-month economic impact of twice-weekly tacrolimus 0.03% ointment in children with atopic dermatitis.

2024-11-06
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Vaccinations in recurrent urinary tract infections — an observation study relating to health economy

Observational health-economics study of vaccination in recurrent urinary tract infections.

2024-11-06
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Validation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies

Validation of a menstrual pictogram and daily bleeding diary as efficacy measures in uterine fibroid treatment studies.

2024-11-06
Publication

Vilobelimab in combination with tocilizumab or baricitinib dramatically improves mortality in critically ill COVID-19 patients: a subgroup analysis

Subgroup analysis of vilobelimab combined with tocilizumab or baricitinib in critically ill COVID-19 patients.

2024-11-06
Publication

Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy

RCTs characterising the dose-response relationship for Pollinex Quattro Birch allergoid immunotherapy.

2024-10-27
Publication

Vilobelimab in combination with tocilizumab may synergistically improve mortality in critically ill COVID-19 patients: a post-hoc analysis of the Phase III PANAMO study

Post-hoc analysis of the Phase III PANAMO study examining vilobelimab combined with tocilizumab in critically ill COVID-19 patients.

2024-10-27
Publication

Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial

The pivotal multicentre, double-blind, randomised, placebo-controlled Phase 3 PANAMO trial of vilobelimab in mechanically ventilated COVID-19 patients.

2024-10-26