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Clinical Trial Protocol (clinical + trial_protocol)
Selected AbstractsVariation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical TrialACADEMIC EMERGENCY MEDICINE, Issue 6 2001Thomas O. Stair MD Abstract. Multicenter clinical trials require approval by multiple local institutional review boards (IRBs). The Multicenter Airway Research Collaboration mailed a clinical trial protocol to its U.S. investigators and 44 IRBs ultimately reviewed it. Objective: To describe IRB responses to one standard protocol and thereby gain insight into the advantages and disadvantages of local IRB review. Methods: Two surveys were mailed to participants, with telephone follow-up of nonrespondents. Survey 1 was mailed to 82 investigators across North America. Survey 2 was mailed to investigators from 44 medical centers in 17 U.S. states. Survey 1 asked about each investigator's local IRB (e.g., frequency of meetings, membership), whereas survey 2 asked about IRB queries and concerns related to the submitted clinical trial. Results: Both surveys had 100% response rate. Investigators submitted applications a median of 58 days (interquartile range [IQR], 40-83) after receipt of the protocol, and IRB approval took an additional 38 days (IQR, 26-62). Although eight applications were approved with little or no changes, IRBs requested an average of 3.5 changes per site. Changes involved study logistics and supervision for 45%, the research process for 43%, and the consent form for 91%. Despite these numerous requests, all eventually approved the basic protocol, including inclusion criteria, intervention, and data collection. Conclusions: The IRBs showed extreme variability in their initial responses to a standard protocol, but ultimately all gave approval. Almost all IRBs changed the consent form. A national, multicenter IRB process might streamline ethical review and warrants further consideration. [source] Do motor and nonmotor symptoms in PD patients predict caregiver strain and depression?MOVEMENT DISORDERS, Issue 9 2008Julie H. Carter MS Abstract Our objective was to understand the impact of motor and nonmotor symptoms of patients with early and middle stage Parkinson's disease (PD) on their spouses' caregiver strain and depression. A sample of 219 spouse caregivers of PD patients participating in a clinical trial was evaluated for six dimensions of caregiver strain and depression using the Family Care Inventory. Motor and nonmotor (i.e., psychological) clinical symptoms collected from PD patients as part of the clinical trial protocol were used as predictors. Seven hierarchical regression analyses were used to determine the contribution of the motor and nonmotor clinical symptoms in explaining variation in each of the seven caregiver-dependent variables. Clinical symptoms explained 9,16% of the variance in caregiver strain and 10% of depression. Motor symptoms explained 0,6% of the variance and nonmotor psychological symptoms explained 7,13% of the variance in caregiver strain. Comparing our findings with literature that is deemed clinically relevant for patient symptoms that predict caregiver strain, we concluded that PD patient symptoms are important predictors of caregiver strain and depression. Patient nonmotor psychological symptoms have a much greater impact on caregiver strain and depression than patient motor symptoms. © 2008 Movement Disorder Society [source] Acute Otitis Externa: Efficacy and Tolerability of N-Chlorotaurine, a Novel Endogenous Antiseptic Agent,THE LARYNGOSCOPE, Issue 5 2004Andreas Neher MD Abstract Objective: The study's objective was to test the tolerability and efficacy of the endogenous antiseptic N-chlorotaurine (NCT) in comparison with a standard clinical treatment according to a phase IIb clinical trial protocol. Study Design: The antimicrobial agent NCT was compared with the antibiotic component drops Otosporin (containing neomycin, polymyxin B, and hydrocortisone) for topical treatment of acute otitis externa in a randomized and rater-blinded clinical study. Methods: Fifty patients suffering from acute otitis externa were divided into two groups according to a randomized list. The test group was treated with 1 mL of 1% aqueous NCT solution, the reference group with 1 mL of Otosporin. The substances were applied to the external ear canal at one daily session until the signs of infection disappeared. Efficacy and tolerability were evaluated daily by visual analogue scale and a six-step infection score. In addition, smears were analyzed to identify the causative pathogens. Results: Both medications were equally well tolerated by the patients. The treatment was successful for all patients of the NCT group, whereas in one patient from the reference group, the infection did not disappear. The inflammation score improved more rapidly in the NCT group, which resulted in an earlier termination of the therapy. This difference became highly significant on days 4 to 7 (P < .01 each). Time needed for disappearance of inflammation (score 0) was 5.6 ± 1.6 (mean ± SD, range 3,9) days in the NCT group and 7.4 ± 1.6 (range 4,10) days in the Otosporin group (P < .001). As expected, micro-biologic cultures from ear swabs revealed Pseudomonas aeruginosa (58%) followed by Staphylococcus aureus (18%) as the main causative pathogens. Conclusions: NCT appears to be well tolerated and more effective than the therapy using antibiotic component drops. Because of its endogenous nature and its higher efficacy, NCT appears to be a good choice for topical treatment of acute otitis externa. [source] Diagnostic Accuracy of the Gail Model in the Black Women's Health StudyTHE BREAST JOURNAL, Issue 4 2007Lucile L. Adams-Campbell PhD Abstract:, The Gail model is used to predict the risk of breast cancer in women of diverse race/ethnic groups for clinical trial protocols. However, this model has only been validated in US white women. Using a nested case-control study design, we evaluated the diagnostic accuracy of the original Gail model (GM) and that of the revised Gail model algorithm for blacks/African-Americans (GM-B) in the Black Women's Health Study (BWHS). Risk profiles were derived via a self reported questionnaire at the time of enrollment into the BWHS in 1995. Biennial questionnaires were obtained from the participants to determine the incident cases of breast cancer. The study of 725 breast cancer cases and 725 controls revealed that the 5-year risk of breast cancer based on the GM ranged from 0.2% to 15.4% among cases and 0.2% to 13.6% among the controls. Based on the GM-B, the 5-year risk of breast cancer ranged from 0.2% to 8.7% among cases and 0.2% to 7.2% among the controls. The sensitivities of the GM and GM-B model with the standard cutoff of 1.7% were 17.9% (95% CI: 15.9,19.9%) and 4.1% (95% CI: 3.0,5.2), respectively. Both the original and the modified version of the Gail model underestimate the risk of developing breast cancer in African-American women. More importantly, the modified Gail Model (GM-B) does a worse job at predicting the development of breast cancer for blacks than the original model (GM). 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