Early phase drug development for treatment of chronic pain — Options for clinical trial and program design

2012 ◽  
Vol 33 (4) ◽  
pp. 689-699 ◽  
Author(s):  
Jarkko Kalliomäki ◽  
Frank Miller ◽  
Matts Kågedal ◽  
Rolf Karlsten
Keyword(s):  
Clinical Trial ◽  
Chronic Pain ◽  
Drug Development ◽  
Early Phase ◽  
Program Design

Protocol and early results of a prospective clinical trial in pediatric pancreatitis (PINEAPPLE-P – Pain IN the EArly phase of Pediatric Pancreatitis)

Pancreatology ◽  
2015 ◽  
Vol 15 (3) ◽  
pp. S62
Author(s):  
Anna Zsófia Tóth ◽  
Dóra Mosztbacher ◽  
Fanni Zsoldos ◽  
Andrea Szentesi ◽  
Gergely Tóth ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Early Phase ◽  
Prospective Clinical Trial ◽  
Early Results

Compliance with dietary guidelines and its relationship with symptoms and clinical outcomes in patients with advanced cancer in early-phase oncology clinical trials.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 199-199
Author(s):  
Goldy George ◽  
Alan J Kim ◽  
Melat Gebremeskel ◽  
Meryna Manandhar ◽  
Harsha M Pradeep ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Advanced Cancer ◽  
Early Phase ◽  
Symptom Burden ◽  
Whole Grains ◽  
Dietary Guidelines ◽  
Early Phase Clinical Trial ◽  
Dietary Guidelines For Americans ◽  
Phase Clinical Trial

199 Background: We examined compliance with the Dietary Guidelines for Americans and its association with symptom burden and clinical outcomes in patients with advanced cancer in early-phase clinical trials testing novel immunotherapeutic and targeted agents. Methods: Patients starting an early-phase clinical trial (ECOG-PS = 0-1) were recruited into a prospective, longitudinal design with assessments at baseline and at the end of Cycle 1. Diet and symptom burden were assessed using the validated National Cancer Institute Diet History Questionnaire (NCI-DHQ) and the MD Anderson Symptom Inventory, respectively. Compliance with the Dietary Guidelines for Americans recommendations was measured via the Healthy Eating Index (HEI) (a measure of dietary intake per total energy), computed from NCI-DHQ food group and nutrient scores; higher HEI scores indicate greater compliance with dietary guidance recommendations (possible range = 0–100). Statistical tests included Spearman rank correlations (rho), and Cox proportional hazards models. Results: Among early-phase clinical trial patients [N = 40; 50% female; 80% Non-Hispanic White; 80% ECOG = 1; 36% on trials including an immunotherapeutic agent and 64% on targeted therapy trials; mean age = 55y; mean BMI = 28], mean HEI was 69, compared to 59 for the US general population. The proportion of phase I clinical trial patients who met adequacy guidelines were 80% for whole fruit, 73% for total protein foods, 55% for seafood and plant proteins, 55% for total fruit, 50% for greens and beans, 28% for total vegetables, 15% for fatty acids [(PUFAs + MUFAs)/SFAs ≥2.5], 13% for dairy, and 0% for whole grains. The proportion of patients who met moderation guidelines were 28% for refined grains, 28% for added sugar, 13% for saturated fat, and 0% for sodium. Female patients had higher HEI scores than male patients (73 vs. 65, P = 0.004). Patients who were normal weight (BMI < 25) had higher scores for meeting the moderation in sugar intake guideline than overweight patients (BMI≥25) (7.7 vs. 5.5, P = 0.031). Higher intakes of cooked lean meat from beef, pork, veal, lamb, and game were linked to prolonged overall survival (HR = 0.5, 95%CI = 0.26, 0.96, P = 0.039). In immunotherapy patients, greater compliance with seafood and plant protein recommendations was associated with less fatigue at end of Cycle 1 (rho = -0.7, P = 0.008); in targeted therapy patients, higher glycemic load was associated with worse pain (rho = 0.7, P = 0.004). Conclusions: Diets of these early-phase clinical trial patients overall were congruent with recommendations in the Dietary Guidelines for Americans. However, increasing intakes of whole grains and reducing sodium intakes may be useful dietary goals for this population. Also, dietary factors may influence symptoms, such as fatigue and pain, in early-phase clinical trial patients with advanced cancer.

Ultrasound-guided Serratus Anterior Plane Block Versus Thoracic Paravertebral Block on Alleviating the Acute and Chronic Pain Following the Video-assisted Thoracic Surgery: a Prospective, Randomized, Double-blinded Non-inferiority Clinical Trial

2021 ◽  
Author(s):  
Yan Wang ◽  
Jing Hao ◽  
Simin Huang ◽  
Xiaoping Gu ◽  
Zhengliang Ma
Keyword(s):  
Clinical Trial ◽  
Chronic Pain ◽  
Thoracic Surgery ◽  
Ultrasound Guided ◽  
Video Assisted Thoracic Surgery ◽  
Video Assisted ◽  
Vas Scores ◽  
Secondary Outcomes ◽  
Double Blinded ◽  
Anterior Plane

Abstract Background: The anesthetic efficacy of ultrasound-guided serrate anterior plane block (SAPB) on alleviating postoperative acute and chronic pain has been well concerned. The present study aims to compare the efficacy between ultrasound-guided SAPB and thoracic paravertebral block (PVB) on alleviating both acute pain and chronic pain following the video-assisted thoracic surgery. Methods: It was a prospective, randomized, double-blinded non-inferiority clinical trial involving 99 patients with lung nodules receiving video-assisted thoracic surgery with ultrasound-guided SAPB (SAPB group) or PVB (PVB group) on T4 and T7 vertebra using 0.375% ropivacaine at 2 mg/kg. The Visual Analogue Scale (VAS) scores at both rest and cough at 24 h postoperatively were graded as the primary outcome. Besides, secondary outcomes included the incidence of chronic pain at 3 and 6 months postoperatively, VAS scores at rest and cough at 1, 6, 12 and 48 h postoperatively, consumptions of fentanyl and remifentanyl, and the pressing times of the patient-controlled analgesia (PCA) pump. Baseline characteristics, surgery characteristics and primary and secondary outcomes between groups were compared. Results: A total of 92 eligible patients were recruited, including 46 in SAPB group and 46 in PVB group. Baseline and surgery characteristics between groups were comparable (all P>0.05). No significant differences in VAS scores at rest and cough at 1 h, 6 h, 12 h, 24 h, 48 h, 3 months and 6 months postoperatively between SAPB group and PVB group were detected (all P>0.05). Conclusion: The anesthetic efficacy of ultrasound-guided SAPB was not inferior to PVB on alleviating postoperative acute and chronic pain following the video-assisted thoracic surgery.Trial registration number: retrospective registered in the Chinese Clinical Trial Registry (ChiCTR2100050991, http://www.chictr.org.cn, 09/09/2021, Yan Wang, MD).

Current Advances in Clinical Trials for Rare Disease Populations: Spotlight on the Patient

2021 ◽  
Vol 16 ◽  
Author(s):  
Erica Winter ◽  
Scott Schliebner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Development ◽  
Rare Disease ◽  
Rare Diseases ◽  
Statistical Analyses ◽  
Clinical Trial Designs ◽  
Novel Approaches

: Characterized by small, highly heterogeneous patient populations, rare disease trials magnify the challenges often encountered in traditional clinical trials. In recent years, there have been increased efforts by stakeholders to improve drug development in rare diseases through novel approaches to clinical trial designs and statistical analyses. We highlight and discuss some of the current and emerging approaches aimed at overcoming challenges in rare disease clinical trials, with a focus on the ultimate stakeholder, the patient.

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