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Advancing neurofibromatosis and schwannomatosis clinical trial design: Consensus recommendations from the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration
Clin Trials. 2023 Sep 29:17407745231201345. doi: 10.1177/17407745231201345. Online ahead of print.NO ABSTRACTPMID:37776044 | DOI:10.1177/17407745231201345 (Source: Clinical Trials)
Source: Clinical Trials - September 30, 2023 Category: Research Authors: Vanessa L Merker Andrea M Gross Brigitte C Widemann Scott R Plotkin Source Type: research

A critique on "A randomized evaluation of on-site monitoring nested in a multinational randomized trial"
Clin Trials. 2023 Sep 30:17407745231204803. doi: 10.1177/17407745231204803. Online ahead of print.NO ABSTRACTPMID:37776253 | DOI:10.1177/17407745231204803 (Source: Clinical Trials)
Source: Clinical Trials - September 30, 2023 Category: Research Authors: Reem AlSowaiegh Alastair O'Brien Nicholas Freemantle Source Type: research

Potential endpoints for assessment of bone health in persons with neurofibromatosis type 1
Clin Trials. 2023 Sep 29:17407745231201338. doi: 10.1177/17407745231201338. Online ahead of print.ABSTRACTNeurofibromatosis type 1 is a genetic syndrome characterized by a wide variety of tumor and non-tumor manifestations. Bone-related issues, such as scoliosis, tibial dysplasia, and low bone mineral density, are a significant source of morbidity for this population with limited treatment options. Some of the challenges to developing such treatments include the lack of consensus regarding the optimal methods to assess bone health in neurofibromatosis type 1 and limited data regarding the natural history of these manifesta...
Source: Clinical Trials - September 29, 2023 Category: Research Authors: Andrea M Gross Scott R Plotkin Nelson B Watts Michael J Fisher Laura J Klesse Andr és J Lessing Miranda L McManus A Noelle Larson Beverly Oberlander Jonathan J Rios Herb Sarnoff Brittany N Simpson Nicole J Ullrich David A Stevenson Source Type: research

Controls, comparator arms, and designs for critical care comparative effectiveness research: It's complicated
CONCLUSION: Flawed critical care comparative effectiveness research trial designs can lead to unsound trial conclusions, compromise informed consent, and increase risks to research subjects, undermining the major goal of comparative effectiveness research: to inform current practice. Well-constructed control and comparator arms comprise indispensable elements of critical care comparative effectiveness research trials, key to improving the trials' safety and to generating trial results likely to improve patient outcomes in clinical practice.PMID:37615179 | DOI:10.1177/17407745231195094 (Source: Clinical Trials)
Source: Clinical Trials - August 24, 2023 Category: Research Authors: Verity J Ford Harvey G Klein Robert L Danner Willard N Applefeld Jeffrey Wang Irene Cortes-Puch Peter Q Eichacker Charles Natanson Source Type: research