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Do Patients Use a Headline Section in a Leaflet to Find Key Information About Their Medicines? Findings From a User-Test Study
Conclusion: The research suggests there does not appear to be any negative impact from including a headline section in a PIL, and it is a technique that is highly valued by the consumers of medicines information. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Dickinson, R., Raynor, D. K., Knapp, P., MacDonald, J. Tags: Product Development and Innovation Source Type: research

A Patient Centricity Team Tool to Enable Patient-Focused Drug Development
In order to better understand and advance the field of patient-focused drug development, a multifunctional patient affairs team developed and piloted a Patient Centricity Team Tool (PCTT) within a large pharmaceutical organization. The tool is a computer-based survey designed to interrogate the frequency of team efforts in 20 areas of patient centricity across 4 dimensions: people, purpose, process, and actions. Results from a pilot with a Phase III product team indicate a spectrum of team activity of different frequencies related to patient-focused drug development. Given the lack of tool validation, interpretation of res...
Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Ashkenazy, R., Schneider, R. F. Tags: Product Development and Innovation Source Type: research

Survey of Health Care Practitioners Preferences for Medical Information: Collective Insights for Impacting Patient Care
Conclusions: These findings provide information regarding the utility of medical information services while providing insights on the informational needs of health care professionals today. MI departments provide an important service to health care professionals that impart confidence for making treatment decisions. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Fung, S. M., Chang, D. Y., Patel-Romero, R., Suchodolski, M. Tags: Policy Source Type: research

Improving Information Processing: The Effect of Label Format Among Current and Potential Over-the-Counter Medication Users
Conclusion: Our label format improved information processing among consumers but only when warning placement was placed at the end in the Drug Facts panel, giving an opportunity for the FDA to consider revising the format of the OTC Drug Facts panel, to improve patient understanding and reciprocally enhance patient safety. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Bhansali, A. H., Fleming, M. L., Sherer, J. T., Sansgiry, S. S. Tags: Policy Source Type: research

A Theory on the Relativity of Factors Impacting the Utilization of Medical Information Services From the Pharmaceutical Industry
Health care providers have many options for obtaining answers to their questions about pharmaceutical products. These options include drug information curators and aggregators such as ePocrates, WebMD, and Wikipedia, as well as professional journals. However, drug information obtained directly from a pharmaceutical company is arguably the best source of information regarding that company’s medicine. This is because medical information (MI) professionals from the pharmaceutical industry have the product expertise, technical skills, and access to relevant information that enable current, evidence-based, and scientifica...
Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Albano, D., Soloff, A., Heim, K., Mavila, S. Tags: Policy Source Type: research

Patient Engagement at a Tipping Point--The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, "Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products"
This article discusses insights gleaned from the DIA conference, "Patient Engagement in Benefit-Risk Assessment throughout the Life Cycle of Medical Products" (September 2015). It highlights the changes that will need to occur within the patient, medical-product sponsor, and regulatory cultures in order for patient engagement to become integrated into the medical-product development process and life cycle maintenance. Furthermore, it emphasizes that reaching the desired future state will require a conscious commitment from all stakeholders to work collaboratively to develop shared solutions and to map a common path forward...
Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Smith, M. Y., Hammad, T. A., Metcalf, M., Levitan, B., Noel, R., Wolka, A. M., Michaels, D. L., Johnson, F. R. Tags: Policy Source Type: research

A Knowledge Management Framework and Approach for Clinical Development
A knowledge management (KM) framework enhances knowledge gathering, sharing, application, and retention within clinical development and enables the effective and successful implementation of a clinical quality management system (QMS). The goal of managing knowledge is to improve organizational performance by getting the right information to the right people at the right time. The concepts of KM have been around for decades but, to date, have not been widely adopted within the clinical development arena. Implementing a structured approach and strategy to managing knowledge can enable more timely and informed decision making...
Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Salzano, K. A., Maurer, C. A., Wyvratt, J. M., Stewart, T., Peck, J., Rygiel, B., Petree, T. Tags: Sponsored Special Section by TransCelerate BioPharma Source Type: research

TransCelerates Clinical Quality Management System: Issue Management
Issue management is one of the elements of the TransCelerate clinical quality management (QMS) conceptual framework. Effective issue management benefits clinical development organizations by allowing them to focus efforts on those issues that materially impact patient safety, rights, and well-being; data integrity and/or scientific rigor; compliance with regulatory requirements; or trust in the clinical research enterprise, which have been defined as "Issues that Matter." Issue management begins with a triage of issues to identify those issues that materially impact as defined above, which are then handled by an end-to-end...
Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Callery-DAmico, S., Sam, L. M., Grey, T. H., Greenwood, D. J. Tags: Sponsored Special Section by TransCelerate BioPharma Source Type: research

Progress on Behalf of Children
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Spielberg, S. P. Tags: Editorial Source Type: research

Erratum
Gnanasakthy A, DeMuro C. Overcoming organizational challenges of integrating patient-reported outcomes in oncology clinical trials. Therapeutic Innovation & Regulatory Science. 49(6):822-830. (Original DOI: 10.1177/2168479015608413) In the above article, the introductory text of the funding statement was incorrect. The phrase "The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: ..." should read "The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article:...
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Tags: Erratum Source Type: research

Institutional Review Boards as Arbiters of Expanded Access to Unapproved Drugs: Time for a Change?
Institutional review boards (IRBs) are one of the bodies charged with prospectively reviewing compassionate use, the hopefully therapeutic use of an unapproved drug in a seriously ill or dying patient who has no other treatment options. However, there are ethical issues in assigning this role to a body whose primary purpose is to review research proposals. The role of IRBs with regard to compassionate use must be examined and potentially revised. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Redman, B. K., Bateman-House, A. S. Tags: Policy Source Type: research

Process Innovation Improves Trial Operation Efficiency
Conclusions: The initiatives were effective in reforming trial operational efficiency. Additional studies to address the cause of operational delay and modifiable factors influencing subject enrollment are needed to further improve operational efficiency. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Choi, Y. J., Kim, K.-p., Park, S., Park, M., Kim, S., Kim, Y., Bae, K.-S., Beck, S.-H., Choi, K.-E., Chung, J. W., Lim, Y.-S., Kim, T. W. Tags: Product Development and Innovation Source Type: research

Using Contour Plots to Assess the Sensitivity of Clinical Trial Design Assumptions
Conclusions: Contour plots are a useful tool for the study team in designing clinical trials, and they can be included in study documents to better communicate the rationale for sample size for clinicians and regulators. Contour plots provide greater transparency as to the uncertainty of the currently available information, and can be useful in deciding whether to consider adaptive designs. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Zink, R. C., Jiang, X. Tags: Statistics Source Type: research

Quality of Regulatory Decision-Making Practices: Issues Facing Companies and Agencies
Conclusions: The findings of this study support the need to further characterize and assess the practices and behaviors of individuals and organizations. Furthermore, the barriers, mainly relating to the influence of biases, should be addressed by developing the general principles of a formal quality decision framework and identifying quality decision-making practices in order to ensure that structured decisions are made throughout the life cycle of medicines. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Bujar, M., McAuslane, N., Salek, S., Walker, S. Tags: Regulatory Science Source Type: research

Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency
Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results. In the United States, trial sponsors generally require investigators to complete GCP training prior to participating in each clinical trial to foster GCP and as a method to meet regulatory expectations (ie, sponsor’s responsibility to select qualified inves...
Source: Therapeutic Innovation and Regulatory Science - June 26, 2016 Category: Drugs & Pharmacology Authors: Arango, J., Chuck, T., Ellenberg, S. S., Foltz, B., Gorman, C., Hinrichs, H., McHale, S., Merchant, K., Seltzer, J., Shapley, S., Wild, G. Tags: Regulatory Science Source Type: research