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Unique Challenges in Development, Psychometric Evaluation, and Interpretation of Daily and Event Diaries as Endpoints in Clinical Trials
This article provides an overview of key methodological, statistical, and clinical considerations for implementation of patient diaries with a regulatory perspective in mind. Approaches and solutions covered in this article include (1) techniques to establish content validity based on obtaining qualitative insights in naturalistic settings and real-life experience of diary completion, (2) demonstration of psychometric properties with respect to day-to-day variability, and (3) aggregation of data from multiple days/events to move from items to endpoints. The importance of the patients’ engagement is highlighted in ord...
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Gater, A., Coon, C. D., Nelsen, L. M., Girman, C. Tags: Special Section on Clinical Outcome Assessments Source Type: research

Advances in the Evaluation of Longitudinal Construct Validity of Clinical Outcome Assessments
We describe a sample of these methods and provide considerations and recommendations for designing a thoughtful longitudinal construct validity evaluation of clinical outcome assessments. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Williams, V., McLeod, L., Nelson, L. Tags: Special Section on Clinical Outcome Assessments Source Type: research

Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials: The Case of Patient-Reported Endpoints
The objective of this paper is to describe study site-, subject-, and technology-related factors that may lead to deviations from the planned electronic collection of PRO data (eg, defaulting to paper-based data collection) and to provide recommendations aimed at preventing potential problems or quickly resolving problems once they occur. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Fleming, S., Barsdorf, A. I., Howry, C., O'Gorman, H., Coons, S. J., on behalf of the Patient-Reported Outcome (PRO) Consortium and the ePRO Consortium at the Critical Path Institute Tags: Special Section on Clinical Outcome Assessments Source Type: research

Considerations for Requiring Subjects to Provide a Response to Electronic Patient-Reported Outcome Instruments
This article provides guidance on the circumstances under which allowing a subject to opt out of responding to ePRO items may be appropriate. Three main scenarios are discussed: (1) requiring subjects to complete all items in all the instruments in the study, (2) allowing subjects to opt out of at least some selective items that do not support key primary or secondary endpoints, and (3) allowing subjects to opt out of responding to any or all items in the study. For either of the 2 scenarios allowing the subject to opt out of responding to an item, the use of programmed edit checks is highly recommended to confirm that the...
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: O'Donohoe, P., Lundy, J. J., Gnanasakthy, A., Greene, A., on behalf of the Patient-Reported Outcome (PRO) Consortium and the ePRO Consortium at the Critical Path Institute Tags: Special Section on Clinical Outcome Assessments Source Type: research

"Bring Your Own Device" (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials?
Field-based patient-reported outcome (PRO) assessments, including measures of signs, symptoms, and events that are administered outside of the research clinic, can be critical in evaluating the efficacy and safety of new medical treatments. Collection of this type of data commonly involves providing subjects with stand-alone electronic devices, such as smartphones, that they can use to respond to assessments in their home or work environment. Although this approach has proven useful, it is also limited in several ways: For example, provisioning stand-alone devices can be costly for sponsors, and requiring subjects to carry...
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Gwaltney, C., Coons, S. J., O'Donohoe, P., O'Gorman, H., Denomey, M., Howry, C., Ross, J., on behalf of the ePRO Consortium Tags: Special Section on Clinical Outcome Assessments Source Type: research

Advances in Clinical Outcome Assessments
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Cappelleri, J. C., Spielberg, S. P. Tags: Editorial Source Type: research

Evaluation of an Adaptive Maximizing Design Study Based on Clinical Utility Versus Morphine for TRV130 Proof-of-Concept and Dose-Regimen Finding in Patients With Postoperative Pain After Bunionectomy
Conclusions: Based on this evaluation of performance characteristics of the AMD versus a traditional study design, the AMD was selected for this proof-of-concept and dose-regimen finding study of TRV130. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Bolognese, J. A., Subach, R. A., Skobieranda, F. Tags: Biostatistics Source Type: research

Implementing the Principle of the 3Rs Through the Indian Pharmacopoeia
This article details the Indian Pharmacopoeia Commission’s initiative to implement the 3Rs through the Indian Pharmacopoeia. Explored are the deletion of animal tests, such as the abnormal toxicity test at final lot for biologicals; the replacement of in vivo methods by in vitro methods; the reduction in the number of animals used where deletion of the animal test is not possible; and the refinement of tests to cause minimal suffering to the animals. In Indian Pharmacopoeia 2014, pyrogen testing using rabbits has been replaced by the bacterial endotoxin test in the majority of biological monographs—keeping in v...
Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Rastogi, S., Kalaivani, M., Bhatia, A. K., Prakash, J., Singh, G. N. Tags: Global Perspectives Source Type: research

Establishing Return-on-Investment Expectations for Patient-Centric Initiatives
This article offers insights and suggestions for organizations looking to establish ROI expectation and evaluation of their patient-centric initiatives. The article is based on ideas and concepts that have been shared and discussed among stakeholders throughout the clinical research enterprise. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Getz, K. A. Tags: Product Development and Innovation Source Type: research

Bowel Preparations for Colonoscopy: A Regulatory Perspective
Agents indicated for cleansing of the colon as a preparation for colonoscopy (bowel preps) are among the most frequently prescribed drugs for otherwise healthy patients. Better bowel preparation has been shown to translate into higher adenoma detection rates. Therefore, safety and efficacy standards need to be high. Clinical trials can be designed to show superiority or non-inferiority, and there are 3 different types of relevant New Drug Applications. Current endpoint instruments rely on clinician reporting, and more than 1 endpoint instrument may be required to ensure a valid appraisal of efficacy. Future trials that stu...
Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Gottlieb, K., Turner, J. R., Gillespie, B. S., Hussain, F. Tags: Product Development and Innovation Source Type: research

Incentivizing Quality in the Manufacture of Pharmaceuticals: Industry Views on Quality Metrics and Ratings
Conclusions: Industry is an important stakeholder in the development of metrics. The concerns of industry must be recognized and addressed if policies related to metrics and ratings are to be effective in building an industry-wide quality culture. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Medina, C., Richmond, F. J. Tags: Product Development and Innovation Source Type: research

A Model Data Management Plan Standard Operating Procedure: Results From the DIA Clinical Data Management Community, Committee on Clinical Data Management Plan
Conclusion: The model DMP SOP produced addresses most data management issues that are present in any phase clinical trial while providing a flexible framework. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Brand, S., Bartlett, D., Farley, M., Fogelson, M., Hak, J. B., Hu, G., Montana, O. D., Pierre, J. H., Proeve, J., Qureshi, S., Shen, A., Stockman, P., Chamberlain, R., Neff, K. Tags: Product Development and Innovation Source Type: research

Topic of Timely Interest--Decision Criteria for Negative QT Assessment Using Exposure Response Analysis of Data From Early-Phase Clinical Studies: Letter to the Editor
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Darpo, B., Ferber, G., Garnett, C., Liu, J., Stockbridge, N. Tags: Product Safety Source Type: research

Identifying and Quantifying the Accuracy of Product Name Attribution of US-Sourced Adverse Event Reports in MedWatch of Somatropins and Insulins
Conclusions: The completion and accuracy rates of FAERS data on biologics observed in this study are consistent with those observed in earlier studies and suggest that traceability in adverse event reports can be improved through more consistent use of brand names or other product specific identifiers and through more frequent inclusion of lot numbers. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Stergiopoulos, S., Brown, C. A., Grampp, G., Felix, T., Getz, K. A. Tags: Product Safety Source Type: research

An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees
Conclusion: The DMC guidance has had a net positive economic impact on the clinical trial enterprise. However, noneconomic factors need to be evaluated. ClinicalTrials.gov could be further leveraged to explore further noneconomic benefits and costs of DMCs. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Seltzer, J. Tags: Regulatory Science Source Type: research