Scientific evaluation of modern clinical research: we need a new currency!

Büchler, Markus W.; Weitz, Jürgen

doi:10.1007/s00423-011-0842-3

Cited by 10 publications

(4 citation statements)

References 15 publications

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“…Since 2004 the SDGC was able to successfully contribute to surgical clinical research by performing several high-quality multicentre trials and systematic reviews. While new pharmacological products justifiably already require phase I to III randomized controlled trials by law, non-pharmacological therapies such as surgical techniques should likewise be subject to safety and efficacy assessment according to the criteria of EBM [20]. To this extent, the Balliol Collaboration presented the IDEAL concept for evaluation of surgical innovations in 2009 [6].…”

Section: Discussionmentioning

confidence: 98%

The Study Centre of the German Surgical Society: current trials and results

Knebel

Kühn

Ulrich

et al. 2012

Langenbecks Arch Surg

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Section: Discussionmentioning

confidence: 98%

The Study Centre of the German Surgical Society: current trials and results

Knebel

Kühn

Ulrich

et al. 2012

Langenbecks Arch Surg

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“…For Europe, the Regulation (EC) no 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products (ATMPs), which is an optional classification procedure, and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 is available on http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32007R1394&from=EN. Well‐organised preclinical, clinical studies, especially multicenter, randomised clinical trials, although very challenging (Büchler et al 2011; Ergina et al 2009; Lyman et al 2016) are extremely costly by all means. However, this is the robust way to study whether there is an evidence that regenerative tissue engineering solutions can be favoured over comparator treatments for targeted clinical conditions or not.…”

Section: Facing the Current Challengesmentioning

confidence: 99%

Orthopaedic regenerative tissue engineering en route to the holy grail: disequilibrium between the demand and the supply in the operating room

et al. 2018

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Orthopaedic disorders are very frequent, globally found and often partially unresolved despite the substantial advances in science and medicine. Their surgical intervention is multifarious and the most favourable treatment is chosen by the orthopaedic surgeon on a case-by-case basis depending on a number of factors related with the patient and the lesion. Numerous regenerative tissue engineering strategies have been developed and studied extensively in laboratory through in vitro experiments and preclinical in vivo trials with various established animal models, while a small proportion of them reached the operating room. However, based on the available literature, the current strategies have not yet achieved to fully solve the clinical problems. Thus, the gold standards, if existing, remain unchanged in the clinics, notwithstanding the known limitations and drawbacks. Herein, the involvement of regenerative tissue engineering in the clinical orthopaedics is reviewed. The current challenges are indicated and discussed in order to describe the current disequilibrium between the needs and solutions made available in the operating room. Regenerative tissue engineering is a very dynamic field that has a high growth rate and a great openness and ability to incorporate new technologies with passion to edge towards the Holy Grail that is functional tissue regeneration. Thus, the future of clinical solutions making use of regenerative tissue engineering principles for the management of orthopaedic disorders is firmly supported by the clinical need.

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“…Nicht umsonst wird deshalb eine ,,neue Währung'' für die Beurteilung von Publikationen aus dem Formenkreis der klinischen Studien gefordert [4].…”

Section: Akademische Karriereunclassified