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Comparative Analysis Between the Top-Selling Drugs in the Japanese Pharmaceutical Market and Those in the United States, the United Kingdom, France, and Germany
Conclusions: These results suggest that the Japanese market will rival overseas markets in the near future. Pharmaceutical companies should seriously consider operating within Japan, whose market is currently transitioning to a global market. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Shibata, S., Uemura, R., Suzuki, T. Tags: Global Perspectives Source Type: research

Profit Evaluations When Adaptation by Design Is Applied
Conclusions: CSSE can be adopted in many different statistical problems, and consequently the profit evaluations proposed here can be widely applied. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: De Martini, D. Tags: Drug Development Source Type: research

The Score Card Approach: A First Step Toward an Evidence-based Differentiation Assessment for Tablets
Conclusion: The score card is a first step in the assessment of adequate differentiation of tablets and can be used for the design of tablets that promote safe use of medication. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Pekari, K., Fürst, T., Gössl, R., Dudhedia, M. S., Segretario, J., Sommer, F., Watson, P. Tags: Product Development and Innovation Source Type: research

CBERs Experience With Adaptive Design Clinical Trials
We present an up-to-date summary of adaptive design proposals seen in CBER and provide an overview of our experiences. We share our concerns regarding the statistical issues and operational challenges raised during the review process for adaptive design trials. We also provide general recommendations for developing proposals for such trials. Our motivation in writing this paper was to encourage the best study design proposals to be submitted to CBER. Sometimes these can be adaptive, and sometimes a simpler design is most efficient. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Lin, M., Lee, S., Zhen, B., Scott, J., Horne, A., Solomon, G., Russek-Cohen, E. Tags: Product Development and Innovation Source Type: research

Statistical Analysis of Cumulative Serious Adverse Event Data From Development Safety Update Reports
Conclusions: The method provides a systematic and objective approach to analysis of cumulative SAE data that could help to identify potential risks that need further investigation by a regulatory authority or sponsor. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Davis, B., Southworth, H. Tags: Product Safety Source Type: research

Community Opinions on the Collection and Use of Historical Control Data in Nonclinical Toxicity Studies
Conclusions: Community-supported projects to increase the availability of well-annotated and scientifically curated collections of historical control data appear to be of most interest. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Mihalcik, L. M., Bausman, M., Brown, P., Everds, N., Feldmann, J., Henck, J., Potenta, D., Sims, J., Zandee, J. Tags: Product Safety Source Type: research

Who Said It Better? A Test of Wording Differences in the MedWatch "Toll-Free Statement" for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements
Conclusions: Findings suggest that the FDAAA toll-free statement wording is superior to that of the TFNR. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Aikin, K. J., ODonoghue, A. C., Sullivan, H. W., Betts, K. R., Squire, C. Tags: Product Safety Source Type: research

Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring
The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variabili...
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Stewart, J., Breslin, W. J., Beyer, B. K., Chadwick, K., De Schaepdrijver, L., Desai, M., Enright, B., Foster, W., Hui, J. Y., Moffat, G. J., Tornesi, B., Van Malderen, K., Wiesner, L., Chen, C. L. Tags: Clinical Trials Source Type: research

Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct
Conclusions: We recommend a cross-functional, collaborative approach to statistical monitoring that can adapt to study design and data source and use a combination of statistical screening techniques and confirmatory graphics. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Knepper, D., Lindblad, A. S., Sharma, G., Gensler, G. R., Manukyan, Z., Matthews, A. G., Seifu, Y. Tags: Sponsored Special Section by TransCelerate BioPharma Source Type: research

Quite a Third Birthday
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Spielberg, S. P. Tags: Editorial Source Type: research

Incorporation of a Benefit-Risk Assessment Framework Into the Clinical Overview of Marketing Authorization Applications
Conclusions: Ultimately, such an approach that lends further support to quality decision making would be beneficial to patients who would be treated with new pharmaceutical products. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Wolka, A., Warner, M., Bullok, K., Wang, J., Radawski, C., Noel, R. Tags: Product Safety Source Type: research

Benefits of Centralized ECG Reading in Clinical Oncology Studies
Conclusions: While on average ECG machine–measured QTcF values were very similar to the central core lab measurements; there were very significant discrepancies which will have important implications for patient recruitment for clinical oncology trials as well as for patient safety during dosing with new oncologic agents. Reliance on ECG machine QTc measurements during clinical oncology trials may lead to unnecessary exclusion of patients as well as unneeded treatment interruptions. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Kleiman, R., Litwin, J., Morganroth, J. Tags: Clinical Trials Source Type: research

Extended Risk-Based Monitoring Model, On-Demand Query-Driven Source Data Verification, and Their Economic Impact on Clinical Trial Operations
Conclusions: (1) High-risk sites (identified via analytics) do not necessarily require a higher percent SDV. While high-risk sites require additional resources to assess and mitigate risks, in many cases these resources are likely to be allocated to non-SDV activities such as GCP, training, etc. (2) It is not necessary to combine SDV with the GCP compliance monitoring. Data validation and query management must be at the heart of SDV as it makes the RBM system more effective and efficient. Thus, focusing SDV effort on queries is a promising strategy. (3) Study size effect must be considered in designing the monitoring plan ...
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Tantsyura, V., Dunn, I. M., Waters, J., Fendt, K., Kim, Y. J., Viola, D., Mitchel, J. Tags: Clinical Trials Source Type: research

Implementation of the European QRD Template in Package Leaflets of Centralized Approved Medicines
Conclusions: Limitation to mandatory contents through stricter use of the QRD template’s bracketing convention, which would reduce package leaflets’ text without loss of essential information, is suggested. In addition, making the current QRD template more concise is strongly recommended. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Wolf, A., Fuchs, J., Schweim, H. G. Tags: Global Perspectives Source Type: research

Risk Management Plans in the European Union: Nonclinical Aspects
This article provides information to aid in the decision making of appropriate nonclinical content in the RMP and highlights the most common nonclinical endpoints discussed in published RMP summaries both as Identified or Potential Risks and as Planned Studies to further evaluate the risk. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Baldrick, P., Reeve, L. Tags: Global Perspectives Source Type: research