Therapeutic Innovation and Regulatory Science This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Implementing Adjusted Imaging Metrics Within Roche With the Metrics Champion Consortium: Experiences and Outcome
Conclusions: Imaging metrics in clinical trials are a useful tool in improving timeliness and quality of imaging data, enhancing trial processes, and governing sponsor/provider relationships. It increases the transparency in the business relationship and in the different clinical trial–related process steps. The use of metrics highlights critical topics, such as reading and adjudication, and enables parties to take actions to improve performance. Disease area–related reporting needs more data for specific improvements. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: McDonald, A., Zahlmann, G. Tags: Product Development and Innovation Source Type: research

Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND
Due to investigators’ complaints about the volume and limited interpretability of expedited safety reports received in Investigational New Drug (IND) studies, the authors surveyed industry sponsors in late 2009 about their reporting practices. An Internet-enabled survey was submitted to 51 industry sponsors. Ten (20%) complete surveys were returned, 9 of which came from large pharmaceutical/biotechnology companies. Although the response rate in this study was low, considering the consolidation present in this sector, the preponderance of responses from large pharmaceutical companies provides a useful description of t...
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Sethi, S. S., Kramer, J. M., Gagnon, S., Nadzan, G., Vega, J. M. Tags: Product Safety Source Type: research

Timeliness of a Signal Detection Process as a Component of Effectiveness Assessment in a Drug Safety Department of a Large Pharmaceutical Company: Review Over a 5-Year Period
In conclusion, the signal detection process at Novartis Pharmaceuticals could detect at least 9 of 10 signals prior to them being detected by health authorities. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Bapatla, K. B., Close, P., Sharma, G., Naidu, M., Valliappan, R. Tags: Product Safety Source Type: research

Risk Evaluation and Mitigation Strategies With Elements to Assure Safe Use: Alignment of the Goals With the Tools to Manage Risk
The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require drug sponsors to submit a risk evaluation and mitigation strategies (REMS) program for those medicines with serious risks such that failure to effectively manage these risks would tip the benefit-risk balance. As of August 8, 2013, the 34 distinct individual and shared REMS programs that have specific elements to assure safe use (ETASU) were reviewed to ascertain the types of risks managed, the goals of the REMS, and the tools that were employed targeting prescribers, health care facilities, pharmacists, and particular conditions ...
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Cronin, M., Berger, S., Seligman, P. J. Tags: Product Safety Source Type: research

Current Practice in Japan for the Prevention and Treatment of Missing Data in Confirmatory Clinical Trials: A Survey of Japanese and Foreign Pharmaceutical Manufacturers
This study aims to survey the current practice in Japan for the prevention and treatment of missing data in clinical trials since the publication of regulatory guidelines on missing data issues. A web-based questionnaire was conducted among 65 member companies of the Japan Pharmaceutical Manufacturers Association in 2013. Responses were obtained on 187 clinical trials from 55 companies, including 42 based in Japan and 13 based in other countries. Missing data were most frequent in trials involving the central nervous system (65.2% had ≥10% missing data). Overall, last observation carried forward (LOCF) was the most popu...
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Tanaka, S., Fukinbara, S., Tsuchiya, S., Suganami, H., Ito, Y. M. Tags: Global Perspective Source Type: research

Evaluation of the Gulf Cooperation Council Centralized Procedure: The Way Forward
The aim of the study was to evaluate the Gulf Cooperation Council (GCC) centralized regulatory review process. Regulatory review times—including submission and application dates for new active substances (NASs) and existing active substances (EASs) using a standardized template for the period of 2006 to 2010—were collected directly from the GCC office located in Riyadh, Saudi Arabia. A total of 413 products (96 NASs and 317 EASs) were approved during the period, with an overall significant increase in the EASs (P < .001). The median approval times increased from 107 calendar days in 2006 to 265 in 2010 (P &l...
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Al-Rubaie, M. H., Walker, S. R., Salek, S. S. Tags: Global Perspective Source Type: research

Competitive Strategies for Japanese Clinical Trial Sites: A New Approach to Quality
In Japan and other major East Asian countries in the global drug development scene, trial sites play a major role in conducting clinical trials by intervening between sponsors and investigators. The recent globalization of clinical development has been intensifying competition among the regions, trial sites, and investigators in terms of cost, speed, and quality. The quality of clinical trials—the key factor for competitiveness—is now being defined with a risk-based approach. Within this backdrop, Japanese trial sites now assume a new role in attaining the necessary amount of quality with increased efficiency. ...
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Tominaga, T. Tags: Global Perspective Source Type: research

Insights Into the Decision Making of Advisory Groups to the Italian Medicines Agency
The Italian Medicines Agency (AIFA) is enhancing a strong transparency-oriented policy to improve information exchange and decision making with stakeholders. To this end, a questionnaire titled "Survey AIFA 2013" was sent to the 72 selected contacts on February 17, 2013 (closing date April 3, 2013), to assess influence on committees and secretariats’ opinions and decisions. The survey was divided into 2 sections (17 questions) with a 10-minute time limit. The results show that external resolutions have little influence on internal advisory groups, whereas internal ones carry more weight. So-called intellectual bias n...
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Marangi, M., Cammarata, S. M., Pani, L. Tags: Global Perspective Source Type: research

Does the Essential Medicines Policy Succeed in China? Empirical Study on Rational Medicine Use in Primary Health Care Institutions
This study investigated outpatient prescription medicines use in primary health care institutions to evaluate the impact of the essential medicines policy on rational medicines use. Data were collected from primary health care institutions in 4 province-level areas of different socioeconomic status in China. Around the policy implementation, the numbers of various medicines used per prescription were compared by t test and 1-way analysis of variance, and the proportions of prescriptions with antibiotics, injections, or hormones were compared by chi-square test. After the policy implementation, the numbers of all medicines ...
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Yin, S., Song, Y., Bian, Y. Tags: Global Perspective Source Type: research

New Governmental Regulatory System for Stem Cell-Based Therapies in Japan
Regenerative medicine using stem cells is expected to provide tools for the replacement or repair of damaged tissues, opening up the possibility of treating many diseases that cannot otherwise be effectively treated. To promote the development of and access to regenerative medicine, it is important to take a balance of expedited provision of innovative therapies and appropriate steps to ensure safety and efficacy. While most developed countries have various regulatory frameworks for clinical trials and medical treatments involving stem cells, the Act on the Safety of Regenerative Medicine and the Revised Pharmaceutical Aff...
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Hara, A., Sato, D., Sahara, Y. Tags: Global Perspective Source Type: research

Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials
This article assesses the value of SDV in clinical trial monitoring via a literature review, a retrospective analysis of data from clinical trials, and an assessment of major and critical findings from TransCelerate member company internal audits. The results support the hypothesis that generalized SDV has limited value as a quality control measure and reinforce the value of other risk-based monitoring activities. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Sheetz, N., Wilson, B., Benedict, J., Huffman, E., Lawton, A., Travers, M., Nadolny, P., Young, S., Given, K., Florin, L. Tags: Sponsored Special Section by TransCelerate BioPharma: Challenging the Value of Source Data Verification Source Type: research

Whence a Journal...
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Spielberg, S. P. Tags: Editorial Source Type: research

The Impact of the Great East Japan Earthquake on Research Activity in a Disaster-Stricken Area
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Narimatsu, H., Sugawara, Y., Morita, T., Hayashi, E., Kami, M. Tags: Letter to the Editor Source Type: research

Serialization: Benefits Beyond Regulatory Compliance
As pharmaceutical and biotech markets continue to globalize, there are increasing concerns for ensuring the safety and legitimacy of pharmaceutical products. An efficient network in which the supply chain is secure and patients are safe is of great importance to the reputation of the industry in today’s global marketplace. Consequently, systems and processes for identifying products through the supply chain are being put into place to meet new regulations. These same systems and processes offer the industry an opportunity to move beyond compliance and reap additional benefits affecting overall performance and patient...
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Greenberg, M. A. Tags: Special Section on Medical Communications Source Type: research

Medical Information Services: How Are We Trending?
As the pharmaceutical and biotechnology industry continues to undergo transformative changes with mergers and acquisitions, loss of patent exclusivity, increased collaborations, and health care reform, Medical Information departments have changed as well. A total of 25 companies were asked to participate in a telephone survey to better understand the trends and adaptations over the last 5 years. Of these, 21 companies participated; the response rate was 84%. The survey focused on 5 key areas: operations and demographics, outsourcing, diversity of responsibilities, value, and health care reform. Results from this survey ind...
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Bordoloi, P., Gažo, A., Savulich, D., Verzosa, C. Tags: Special Section on Medical Communications Source Type: research