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Defining Regions in Multiregional Clinical Trials: An Analytical Approach to Considering Impact of Intrinsic and Extrinsic Factors
Conclusion: Using a checklist to identify intrinsic/extrinsic factors that might lead to differences in treatment effect allows one to scientifically define more meaningful regions from the identified factors, which will help with estimating the relative treatment outcome as well as exploring appropriate regional sample size. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Tanaka, Y., Buchanan, A., Lipsius, S., Ibia, E. O., Rabbia, M., Binkowitz, B. Tags: Global Perspectives Source Type: research

Efficient Source Data Verification Using Statistical Acceptance Sampling: A Simulation Study
Conclusion: Our results suggest that major reductions in workload can be achieved, while maintaining acceptable data quality levels. However, the results also indicate that the proposed strategy is conservative and further improvement is possible. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: van den Bor, R. M., Oosterman, B. J., Oostendorp, M. B., Grobbee, D. E., Roes, K. C. B. Tags: Global Perspectives Source Type: research

Studies of Product Structure Adjustment Routes for Chinas Pharmaceutical Industry: A View From the New Healthcare Reform Targets
Conclusion: The fundamental drug system and medical insurance system, which the New Healthcare Reform focuses upon, are closely related to the pharmaceutical product structure. For entities in which structural adjustment is not autonomous, changes can be achieved through sound coordination between organizational structure, technical structure, and repeated evaluation of consistency of drug product quality and overseas technical license. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Luo, W., Sun, L., Wang, G. Tags: Global Perspectives Source Type: research

Comparison of Treatment Effects Between US and Non-US Study Sites in Multiregional Alzheimer Disease Clinical Trials
Conclusions: It appears that there is no clear evidence to suggest that MRCTs should not be used to study AD. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Luan, J. J., Mani, R., Hung, H. M. J. Tags: Global Perspectives Source Type: research

Factors That Affect the Acquisition of Reward Premiums for Promotion of Innovative Drug Discovery in Japan
Conclusions: These findings suggest that orphan drugs and drugs with specific Anatomical Therapeutic Chemical (ATC) classifications such as N and L are likely to receive rewards. We can verify that this incentive program works well in Japan, launching truly innovative drugs that meet high medical needs. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Shibata, S., Uemura, R., Suzuki, T. Tags: Global Perspectives Source Type: research

Impact of Premium Rewards for the Promotion of Innovative Drug Discovery on the Japanese Pharmaceutical Market: An Analysis by Therapeutic Area
Conclusion: Our study suggests that this system has been working according to its original aim of promoting the development of innovative drugs in Japan. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Shibata, S., Uemura, R., Suzuki, T. Tags: Global Perspectives Source Type: research

Innovation of Medical Products: The Evolution of Regulatory Science, Research, and Education
We present a commentary on the international aspects of the evolution of regulatory science as a multidisciplinary, multistakeholder academic discipline of education and applied research emphasizing the need for seamless interaction between stakeholders such as regulatory authorities, the pharmaceutical industry, universities, payers, and patient organizations. Regulatory science is the science of developing new tools, standards, and approaches to evaluate the efficacy, safety, quality, and performance of medical products in order to assess benefit/risk and facilitate a sound and transparent regulatory decision making thro...
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Spindler, P., Bach, K. F., Schmiegelow, M., Bedlington, N., Eichler, H.-G. Tags: Global Perspectives Source Type: research

Practical Considerations for the Use of Clinical Outcome Assessments (COAs) in Pediatric Clinical Research: Examples From Pediatric Gastroenterology
Clinical outcome assessments (COAs), including patient-reported outcome (PRO) measures, are routinely used in drug development and other clinical research initiatives to assess the impact of treatment on patient health and well-being. The FDA Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (2009), the European Medicines Agency’s Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life Measures in the Evaluation of Medicinal Products (2005), and the International Society for Pharmacoeconomics and Outcomes Research P...
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Kovacs, S. M., Turner-Bowker, D. M., Calarco, G., Mulberg, A. E., Paty, J. Tags: Special Section on Clinical Outcome Assessments Source Type: research

Establishing Equivalence of Electronic Clinician-Reported Outcome Measures
Conclusions: In many respects, the migration of a ClinRO to electronic administration is similar to that of a PRO. This article has explored the ways in which there might be special considerations for ClinROs that have not been elaborated for PROs. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Fuller, R. L. M., McNamara, C. W., Lenderking, W. R., Edgar, C., Rylands, A., Feaster, T., Sabatino, D., Miller, D. S. Tags: Special Section on Clinical Outcome Assessments Source Type: research

Interpreting Change in Scores on Patient-Reported Outcome Instruments
Interpreting change in scores on patient-reported outcome instruments is a key aspect of instrument development. Without interpretation guidelines, the clinical meaning of significant improvements observed within a treatment group cannot be ascertained. While the field has contemplated this topic for several decades, there remains inconsistency in terminology, methods, and application. Careful selection of methods can result in determining when change is meaningful, but researchers must keep an open mind to the methods that best fit their study and instrument. In many cases, anchor-based methods are appropriate, but the st...
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Coon, C. D., Cappelleri, J. C. Tags: Special Section on Clinical Outcome Assessments Source Type: research

Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations
Conclusions: TransCelerate recommends the creation of an integrated, multifaceted approach to proactively detect data quality issues. Detection methods should include a strategy tailored to the characteristics of the study. Some sponsors are taking advantage of more advanced methods and integrated processes and systems to proactively detect and address issues, relying on advances in technology to more efficiently review data in real time. Further research is underway to assess statistical data quality detection methodology in clinical trials. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Knepper, D., Fenske, C., Nadolny, P., Bedding, A., Gribkova, E., Polzer, J., Neumann, J., Wilson, B., Benedict, J., Lawton, A. Tags: Sponsored Special Section by TransCelerate BioPharma Source Type: research

Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharmas Approach, Part 2
Conclusions: One of the primary issue detection methods of central monitoring is the proactive identification of areas of focus through the use of risk indicators. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Gough, J., Wilson, B., Zerola, M., Wallis, P., Mork, L., Knepper, D., Achenbach, H. Tags: Sponsored Special Section by TransCelerate BioPharma Source Type: research

DIA Japan Meeting: Thoughts on Global Collaboration
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Spielberg, S. P. Tags: Editorial Source Type: research

Statistical Considerations on the Evaluation of Imbalances of Adverse Events in Randomized Clinical Trials
This article highlights key aspects that need attention and statistical analysis approaches that could be helpful for screening and evaluation of signals generated from imbalances of AEs in moderate or large RCTs. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Ma, H., Ke, C., Jiang, Q., Snapinn, S. Tags: Biostatistics Source Type: research

Clinical, Ethical, and Socioeconomic Considerations for Prescription Drug Use During Pregnancy in Women Suffering From Chronic Diseases
In conclusion, treatment guidelines need to be developed in the future; additionally, better insight into the economics of pregnancy for women with chronic diseases will improve value for money in obstetric care. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Tzouma, V., Grepstad, M., Grimaccia, F., Kanavos, P. Tags: Special Populations Source Type: research