scholarly journals PMH52 EVALUATING CENTRAL NERVOUS SYSTEM DRUG LABELS FOR PATIENT-REPORTED OUTCOMES CLAIMS

2009 ◽  
Vol 12 (3) ◽  
pp. A182
Author(s):  
S Viswanathan ◽  
EK Gemmen ◽  
M Bharmal
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Patient Reported Outcomes ◽  
Central Nervous System Drug ◽  
Patient Reported

EPID-24. TRANSCRIPT: A cenTRAl NERVOUS SYSTEM CANCER CLINICAL tRIals PostmorTem

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi91-vi91
Author(s):  
Yeonju Kim ◽  
Terri Armstrong ◽  
Mark Gilbert ◽  
Orieta Celiku
Keyword(s):  
Central Nervous System ◽  
Overall Survival ◽  
Clinical Trials ◽  
Nervous System ◽  
Brain Tumor ◽  
Objective Response ◽  
Survival Rates ◽  
Maximum Tolerated Dose ◽  
Secondary Outcome ◽  
Patient Reported

Abstract BACKGROUND Despite the growing number of neuro-oncology clinical trials, there have been limited advances in the treatment of malignant primary central nervous system tumors. We surveyed the landscape of past, ongoing, and planned trials to assess trends in their interventions, outcomes, and design considerations to guide future studies. METHODS Data on interventional trials on ClinicalTrials.gov were accessed programmatically using AACT and R. Neuro-oncology trials were isolated using primary malignant brain tumor classification terms. Instrument names from PROQOLID were used to identify clinical outcome assessment (COA) use. Linear regression was used to assess chronological trends; power analyses utilized CBTRUS survival rates among trials investigating overall survival. RESULTS We identified 3039 interventional brain tumor trials that started between 1966 and 2025. Trials were most frequently phase II (43%), completed (40%), non-blinded (92%), single-group assignment (65%), non-randomized (51%) studies targeting glioblastoma (45%). Planned outcomes were reported by 93% of trials; this included adverse event or toxicity (54%), overall/x-year survival (44%), progression free survival (43%), maximum tolerated dose (16%), and objective response rate (14%). Evaluating the anticipated and actual trial enrollment, we estimate that only 10% and 8% of trial arms, respectively, were sufficiently powered to assess overall survival endpoints. 21% of trials mentioned the use of a COA (first trial initiated in 1992), majority of which were patient-reported outcomes. Among these, 25% and 58% reported COA as a primary or secondary outcome, respectively. The rate of COA use increased linearly over time at 1.1%/year but remained less than 5 trials per year until 2003. Ongoing work is investigating treatment mechanisms of actions and evidence of preclinical efficacy among brain tumor studies. CONCLUSIONS Low randomization rates and underpowered trial design may impede interpretability of efficacy. Increasing trends in COA use suggests cumulative influence of advocacy efforts to holistically evaluate net clinical benefit of interventions.

scholarly journals Defining Desirable Central Nervous System Drug Space through the Alignment of Molecular Properties, in Vitro ADME, and Safety Attributes

2010 ◽  
Vol 1 (6) ◽  
pp. 420-434 ◽  
Author(s):  
Travis T. Wager ◽  
Ramalakshmi Y. Chandrasekaran ◽  
Xinjun Hou ◽  
Matthew D. Troutman ◽  
Patrick R. Verhoest ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Molecular Properties ◽  
Central Nervous System Drug ◽  
Safety Attributes

Central Nervous System Drug Consumption Depending on the Time between Symptom Onset and the Diagnosis of Alzheimer’s Disease: An Analysis by the Registry of Dementias of Girona

2012 ◽  
Vol 33 (2-3) ◽  
pp. 104-110 ◽  
Author(s):  
Laia Calvó-Perxas ◽  
Secundino López-Pousa ◽  
Joan Vilalta-Franch ◽  
Oriol Turró-Garriga ◽  
Michael Blankenburg ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Symptom Onset ◽  
Drug Consumption ◽  
Central Nervous System Drug

NCOG-42. SYMPTOM ONSET TO TIME OF DIAGNOSIS IN PRIMARY CENTRAL NERVOUS SYSTEM TUMOR PATIENTS: A REVIEW OF FINDINGS FROM THE NOB-NHS

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi161-vi161
Author(s):  
Matthew Lindsley ◽  
Elizabeth Vera ◽  
Alvina Acquaye ◽  
Nicole Briceno ◽  
Anna Choi ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Healthcare Providers ◽  
Healthcare Setting ◽  
Tumor Location ◽  
Low Grade ◽  
Central Nervous System Tumor ◽  
Tumor Patients ◽  
Patient Reported ◽  
Reported Data

Abstract Prior reports suggest the low prevalence of primary central nervous system (PCNS) tumors and the healthcare setting where patients seek care can contribute to diagnostic delays, potentially affecting prognosis. This descriptive report highlights findings from patient-reported data at presentation collected from a sample of 623 PCNS tumor patients. Participants were White (88%), males (56%), median age at diagnosis 41 (2-79) with high grade (HG) (66%) brain tumors (BT) (89%). Among BT patients, 30% reported ≥ 3 concurrent symptoms at presentation including headaches (40%), seizures (30%), and memory problems or difficulty with balance/walking (20% each). Over half (57%) had symptoms for < 6 months before diagnosis and 60% presented to the Emergency Room. Sixty-five percent of HG BT patients had symptoms for < 6 months prior to diagnosis compared to low grade (LG) tumors (40%) and had surgery in < 1 month from presentation (68% vs 51%, p < 0.01). More HG BT patients presented with weakness in the arms/legs than LG BT (14% vs 8%). Among spine tumor (ST) patients, 45% reported ≥ 3 concurrent symptoms at presentation including back pain (65%), sensory changes (45%), and weakness (40%). Almost half (46%) were symptomatic for > 1 year before diagnosis, presented in an outpatient clinic (64%) with 41% having surgery < 1 month from presentation. Younger (40% vs 16%) and HG ST patients (56% vs 21%) more often reported symptoms for < 6 months before diagnosis. HG ST patients more often presented to Emergency Rooms (67% vs 25%) and had surgery < 1 month from presentation (60% vs 36%). Further analysis of symptom presentation and clinical course is ongoing. Tumor location, grade, patient age and healthcare setting were associated with the time from clinical presentation to diagnosis. Development of aids providing guidance on diagnostic evaluation/treatment to front-line healthcare providers is warranted.

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