Evolution of the Neurosurgeon's Role in Clinical Trials for Glioblastoma: A Systematic Overview of the Clinicaltrials.Gov Database
| Autor: | Gavin J B Elias, Alireza Mansouri, Aditya Pancholi, Mathew R. Voisin, Clement T. Chow, Andres M. Lozano, Aaron Loh, Jürgen Germann, Michelle E Beyn, E. Antonio Chiocca, Alexandre Boutet, Ryan Wang, Gelareh Zadeh, Michael A. Vogelbaum |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Databases Factual Demographics Psychological intervention computer.software_genre 03 medical and health sciences 0302 clinical medicine medicine Humans Clinical Trials as Topic Neurologic Oncology Database business.industry Trial Phase medicine.disease Clinical trial Neurosurgeons Tolerability Research Design 030220 oncology & carcinogenesis Surgery Neurology (clinical) Neurosurgery Glioblastoma business computer 030217 neurology & neurosurgery |
| Zdroj: | Neurosurgery. 89:196-203 |
| ISSN: | 1524-4040 0148-396X |
| DOI: | 10.1093/neuros/nyab169 |
| Popis: | Background The therapeutic challenge of glioblastoma (GBM) has catalyzed the development of clinical trials to evaluate novel interventions. With increased understanding of GBM biology and technological advances, the neurosurgeon's role in neuro-oncology has evolved. Objective To evaluate the current landscape of procedure-based clinical trials for GBM to characterize this evolution, gain insight into past failures, and accordingly outline implications for future research and practice that may inform future studies. Methods The ClinicalTrials.gov database was searched for surgical/procedural trials in individuals with GBM. Demographics, specific intervention, trial phase, and main outcome measures were abstracted. Results A total of 224 of 2311 GBM trials (9.7%) were identified as procedural, with the majority being based in the United States (155/224, 69.2%), single-center (155/224, 69.2%), and not randomized (176/224, 78.6%). Primary and recurrent GBMs were evenly addressed. The leading interventions were local delivery of therapeutics (50.0%), surgical techniques (33.9%), such as image-guided surgery, and novel device applications (14.3%). Phase I designs predominated (82/224, 36.6%). The top primary outcome was safety/tolerability/feasibility (88/224, 39.3%), followed by survival (46/224, 20.5%). Approximately 17% of studies were terminated, withdrawn, or suspended. Fifty-two linked publications were identified, among which 42 were classified as having a positive result. Conclusion Procedural interventions comprised ∼10% of all registered GBM trials. Local delivery of therapeutics, use of surgical imaging techniques and novel device applications, predominantly through phase I designs, represent the evolved role of the neurosurgeon in neuro-oncology. Improved reporting of trial designs, outcomes, and results are needed to better inform the field and increase efficiency. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|