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Open AccessChallenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees
In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know ...
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Prognostic Scores for Patients with Chronic Myeloid Leukemia under Particular Consideration of Disease-Specific Death
Prognostic scores are used to predict the outcome for individual patients. In chronic myeloid leukemia (CML), the Sokal, the Euro, the EUTOS, and the EUTOS long-term survival (ELTS) score are prognostic scores...
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Article
Open AccessCorrect use of non-indexed eGFR for drug dosing and renal drug-related problems at hospital admission
Two to seven percent of the German adult population has a renal impairment (RI) with an estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2. This often remains unrecognized and adjustment of drug thera...
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Article
Open AccessRedundant trials can be prevented, if the EU clinical trial regulation is applied duly
The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions...
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Erratum zu: Arzneimittelprüfung an nicht einwilligungsfähigen Erwachsenen: Kritische Bewertung der neuen gesetzlichen Regelung durch medizinische Ethikkommissionen in Deutschland
Erratum zu:
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Article
Open AccessThe EUTOS long-term survival (ELTS) score is superior to the Sokal score for predicting survival in chronic myeloid leukemia
Prognostic scores support clinicians in selecting risk-adjusted treatments and in comparatively assessing different results. For patients with chronic-phase chronic myeloid leukemia (CML), four baseline progno...
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Article
Arzneimittelprüfung an nicht einwilligungsfähigen Erwachsenen: Kritische Bewertung der neuen gesetzlichen Regelung durch medizinische Ethikkommissionen in Deutschland
In Deutschland wurde 2016 das 4. Arzneimittelrechtsänderungsgesetz (AMG) verabschiedet, welches auch die Arzneimittelforschung an nicht einwilligungsfähigen Erwachsenen regelt. Erstmalig sollen an ihnen aussch...
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Article
Open AccessDefining therapy goals for major molecular remission in chronic myeloid leukemia: results of the randomized CML Study IV
Major molecular remission (MMR) is an important therapy goal in chronic myeloid leukemia (CML). So far, MMR is not a failure criterion according to ELN management recommendation leading to uncertainties when t...
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Erratum to: Ethical aspects of clinical trials in rare diseases
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Systematic review and meta-analysis of standard-dose imatinib vs. high-dose imatinib and second generation tyrosine kinase inhibitors for chronic myeloid leukemia
Most randomized clinical trials evaluating second generation tyrosine kinase inhibitors (TKI) for the first-line treatment of Chronic Myeloid Leukemia used as comparator the ‘standard’ dose of 400 mg imatinib ...
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Article
Factors influencing adherence in CML and ways to improvement: Results of a patient-driven survey of 2546 patients in 63 countries
Optimal adherence to CML therapy is of key importance to maximize treatment effectiveness. Two clinical studies (ADAGIO and Hammersmith) have proven a clear correlation between adherence and achieving optimal ...
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Article
No influence of BCR-ABL1 transcript types e13a2 and e14a2 on long-term survival: results in 1494 patients with chronic myeloid leukemia treated with imatinib
The genomic break on the major breakpoint cluster region of chromosome 22 results in two BCR-ABL1 transcripts of different sizes, e14a2 and e13a2. Favorable survival probabilities of patients with chronic myel...
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Article
Improved survival boosts the prevalence of chronic myeloid leukemia: predictions from a population-based study
Due to prolonged survival, there will be many more chronic myeloid leukemia (CML) patients alive in the future. The aims of this work were to estimate the current prevalence of CML by using routine data and to...
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Chapter
Prognostic Scores for Patients with Chronic Myeloid Leukemia Under Particular Consideration of Disease-Specific Death
Prognostic scores are used to predict the outcome for individual patients. This chapter provides a general definition of prognostic scores and explains their meaning. In chronic myeloid leukemia (CML), the Sok...
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Article
Impact of unbalanced minor route versus major route karyotypes at diagnosis on prognosis of CML
Major route additional cytogenetic aberrations (ACA) at diagnosis of chronic myeloid leukaemia (CML) indicate an increased risk of progression and shorter survival. Since major route ACA are almost always unba...
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Article
A multi-state model approach for prediction in chronic myeloid leukaemia
Multi-state models support prediction in medicine. With different states of disease, chronic myeloid leukaemia (CML) is particularly suited for the application of multi-state models. In this article, we tried ...
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Article
Open AccessPrescribing of long-acting beta-2-agonists/inhaled corticosteroids after the SMART trial
After the SMART trial evaluating the safety of salmeterol (long-acting beta-2-agonist (LABA)) in asthma patients, regulatory actions were taken to promote a guideline-adherent prescribing of LABA only to patie...
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Article
Prognostic scores for patients with chronic myeloid leukemia under particular consideration of competing causes of death
Nowadays in many fields of medicine, prognostic scores are used to predict the outcome for individual patients. In chronic myeloid leukemia (CML), the Sokal, the Euro, and the EUTOS score are established progn...
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Article
Equivalence of BCR-ABL transcript levels with complete cytogenetic remission in patients with chronic myeloid leukemia in chronic phase
Chronic myeloid leukemia (CML) patients are monitored by both cytogenetic and molecular assessments, although present guidelines appear to switch from cytogenetic to molecular criteria. Due to the increasing u...
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Sources of European drug consumption data at a country level
This study aimed at outlining the characteristics of nationwide administrative databases monitoring drug consumption in Europe.
