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Generational Value Differences Affecting Public Perceptions of and Willingness to Participate in Clinical Trials
Conclusions: Preliminary results indicate that members of Generation Y are less willing to participate in clinical studies and that these differences are truly generational and not simply age related. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Nelson, A. M., Martin, I. G., Getz, K. A. Tags: Special Populations Source Type: research

Partnering With Patients in the Development and Lifecycle of Medicines: A Call for Action
The purpose of medicines is to improve patients' lives. Stakeholders involved in the development and lifecycle management of medicines agree that more effective patient involvement is needed to ensure that patient needs and priorities are identified and met. Despite the increasing number and scope of patient involvement initiatives, there is no accepted master framework for systematic patient involvement in industry-led medicines research and development, regulatory review, or market access decisions. Patient engagement is very productive in some indications, but inconsistent and fragmentary on a broader level. This often ...
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Hoos, A., Anderson, J., Boutin, M., Dewulf, L., Geissler, J., Johnston, G., Joos, A., Metcalf, M., Regnante, J., Sargeant, I., Schneider, R. F., Todaro, V., Tougas, G. Tags: Special Populations Source Type: research

National Drug Information Sharing in the Thailand Health Care Supply Chain
Conclusions: Due to fragmented data and information and lack of data standard problems, the study purposes the information sharing system by constructing a national drug information database. The database contains information needed by all players in health care supply chain. A conceptual network of web-based services is presented to facilitate drug information sharing among health care supply chain members as well nationwide implementation. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Muangchoo, S., Kritchanchai, D. Tags: Global Perspectives Source Type: research

The Relationship Between Development Start Lag and Approval Lag in Oncology Drug Development in Japan
Conclusions: Shortening the DSL is important for reducing large AL, but it is not necessary to eliminate the DSL completely for the purpose of minimizing the AL. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Nakajima, K., Dagher, R., Strawn, L., Urushidani, J., Kurokawa, T., Chiba, K. Tags: Global Perspectives Source Type: research

Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality
Conclusions: It is recommended that SDV, rather than just focusing on key primary efficacy and safety outcomes, focus on data clarification queries as highly discrepant (and the riskiest) data. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Tantsyura, V., Dunn, I. M., Fendt, K., Kim, Y. J., Waters, J., Mitchel, J. Tags: Clinical Trials Source Type: research

Quantitative Methods for the Identification of Signals for Individual Case Safety Reports in India
Conclusions: The proposed methods may help in the identification of new signals in Indian individual case safety reports. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Vivekanandan, K., Tripathi, A., Saurabh, A., Kumar, R., Kumar, R., Prasad, T., Singh, G. N. Tags: Product Safety Source Type: research

Improved Label and Liver Warning for Nonprescription Acetaminophen Products
Conclusion: Findings support revision of acetaminophen ODFLs to improve liver damage warnings and to optimize labeling likely to be useful in prevention of and response to overdose. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Soller, R. W., Ho, T., Lightwood, J. M. Tags: Product Safety Source Type: research

The Phosphate Content of Prescription Medication: A New Consideration
Conclusion: Commonly prescribed drugs may contain clinically important levels of phosphate. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Sherman, R. A., Ravella, S., Kapoian, T. Tags: Product Development and Innovation Source Type: research

Managing Team Innovation in the Research and Development (R&D) Organization: Critical Determinants of Team Effectiveness
Conclusions: This research offers key insights for managers when forming and staffing teams. One is an emphasis on coaching. It is imperative for senior managers to assign individuals to teams who liaise with broader management that are capable of offering coaching and availability for team members to enhance their skills. This is particularly important in a growing hypercompetitive environment that is witnessing continuous strategic change. A second area of emphasis is on TMS, in an expertise-centered organization. As this is a central driver to team performance, it is imperative to improve adaptation skills of team membe...
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Krishna, R., He, H. Tags: Product Development and Innovation Source Type: research

An Examination of eClinical Technology Usage and CDISC Standards Adoption
Conclusions: The results of the study indicate that increasing use of standards could translate into improvements in time, costs, and overall approval rates. The study also observed an uptake in the use of eClinical technologies that could potentially create efficiencies and streamline operational processes. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Lamberti, M. J., Kush, R., Kubick, W., Henderson, C., Hinkson, B., Kamenju, P., Getz, K. A. Tags: Product Development and Innovation Source Type: research

Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity
The field of oligonucleotide (OGN)–based therapeutics has been growing dramatically in the past decade, providing innovative platforms to develop agents for the treatment of a wide variety of clinical conditions. OGN agents have unique physicochemical properties and pharmacokinetic/pharmacodynamic characteristics. This review considers findings from the literature and information on new molecular entities submitted to the US Food and Drug Administration as OGN-based therapeutics. In addition, the article discusses several challenging issues from the perspective of clinical pharmacology, emphasizing the potential of i...
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Wang, J., Lon, H.-K., Lee, S.-L., Burckart, G. J., Pisetsky, D. S. Tags: Product Development and Innovation Source Type: research

Are Phase 3 Clinical Trials Really Becoming More Complex?
Conclusions: In general, there is limited evidence for significant increases in the study and protocol design and execution of phase 3 clinical trials sponsored by pharmaceutical companies. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Glass, H. E., DiFrancesco, J. J., Glass, L. M., Tran, P. Tags: Product Development and Innovation Source Type: research

Regulatory Definitions and Good Pharmacovigilance Practices in Social Media: Challenges and Recommendations
Social media presents new challenges to the biopharmaceutical industry for conducting pharmacovigilance activities. The authors reviewed worldwide regulatory guidance documents related to monitoring of adverse events posted on social media sites and identified gaps in current regulatory definitions for pharmacovigilance. Points to consider for addressing these gaps are made to offer standards for industry consideration and a potential framework for guidance from global health authorities. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Naik, P., Umrath, T., van Stekelenborg, J., Ruben, R., Abdul-Karim, N., Boland, R., Ibara, M., Ekuta, J., Washburn, D., Stergiopoulos, S. Tags: Regulatory Science Source Type: research

An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals
Conclusion: While no one size fits all, the need to include an IRC depends on the subjectivity of the primary endpoint, the therapeutic area concerned, the clinical trial design, the need to assess reliability of marginal positive events, or if a critical assessment is required for adverse event accuracy. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Krumholz-Bahner, S., Garibbo, M., Getz, K. A., Widler, B. E. Tags: Regulatory Science Source Type: research

Overcoming Organizational Challenges of Integrating Patient-Reported Outcomes in Oncology Clinical Trials
Patients with cancer frequently experience multiple symptoms that may cause significant distress and may impair physical, emotional, and social functioning and health-related quality of life. Drug development in oncology is characterized by a high attrition rate of new compounds, faster development times encouraged by the regulatory process, studies that are often open and single-arm, and emphasis on survival-related endpoints, creating unique challenges for the inclusion of patient reported outcomes (PROs). These challenges to include PRO-related endpoints in oncology research are further exacerbated by downward pressure ...
Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: Gnanasakthy, A., DeMuro, C. Tags: Special Section on Clinical Outcome Assessments Source Type: research