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Effective Drug Supply for Adaptive Clinical Trials: Recommendations by the DIA Adaptive Design Scientific Working Group Drug Supply Subteam
During the past decade, there has been increasing interest in adaptive clinical trials in pharmaceutical drug development as a means to improved decision making, better dose selection, and reduction in cost and time to market. Nevertheless, the operational challenge of drug supply continues to be a barrier preventing greater uptake of adaptive designs. Such studies require the ability to quickly accommodate changes in treatment allocation while maintaining the integrity of the blind. The DIA Adaptive Design Scientific Working Group formed a subteam to discuss solutions to the drug supply dilemma. In this paper, the subteam...
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Burnham, N., Quinlan, J., He, W., Marshall, M., Nicholls, G., Patel, N., Parke, T., Wong, L. B. Tags: Clinical Trials Source Type: research

Incorporating Historical Data in Bayesian Phase I Trial Design: The Caucasian-to-Asian Toxicity Tolerability Problem
Following phase I dose-finding oncology trials completed in Western countries, Asian investigators often conduct further phase I trials to determine the maximum tolerated dose for Asian patients. This may be due to concerns about possible differences in treatment tolerability between Caucasian and Asian patient groups. Our proposed approach aims to appropriately borrow strength from a previous Caucasian trial to improve the maximum tolerated dose determination in an Asian population of patients. We design an Asian phase I trial using the Bayesian continual reassessment method. First we analyze toxicity data from a Caucasia...
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Takeda, K., Morita, S. Tags: Product Safety Source Type: research

Inferences Beyond a Study Design's Grasp: A Cautionary Case Study From the Recent Renal Sympathetic Denervation Literature
During the past 6 years, the technique of renal sympathetic denervation has been proposed as a treatment for drug-resistant hypertension, and several studies have been published that claimed to provide supportive evidence of its efficacy. There is no question that resistant hypertension is a major medical concern: hypertension has been authoritatively designated as the greatest threat to the global burden of disease, and approximately 8% of hypertensive individuals have resistant hypertension. However, the first studies reporting the efficacy of renal sympathetic denervation were not methodologically capable of supporting ...
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Turner, J. R., O'Brien, E. Tags: Product Safety Source Type: research

Valacyclovir-Induced Acute Kidney Injury in Japanese Patients Based on the PMDA Adverse Drug Reactions Reporting Database
Conclusions: There were many reports of AKI involving valacyclovir and females, particularly in the 70- to 79-year age group in Japan. The results suggest that these patients were most likely to develop AKI after valacyclovir treatment. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Kitano, A., Motohashi, H., Takayama, A., Inui, K.-i., Yano, Y. Tags: Product Safety Source Type: research

Reduction in Medication Errors: The Fentora Case Study
Fentora (fentanyl citrate) is an analgesic opioid used in the management of breakthrough pain in adult cancer patients. Numerous reports of medication errors had been reported since the product’s launch in 2006, 74% of which were prescribing errors. Subsequent to the initiation of a risk evaluation and mitigation strategy (REMS) by FDA and the sponsor in 2011, reports of prescribing errors dropped rapidly. It is likely the REMS had a significant impact on the safe use of this important product. While further data from subsequent years would be needed to confirm this hypothesis, this is one of the first reports of an ...
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Palvatla, G. R., Martin, I. G. Tags: Product Safety Source Type: research

Methods and Issues to Consider for Detection of Safety Signals From Spontaneous Reporting Databases: A Report of the DIA Bayesian Safety Signal Detection Working Group
This article provides recommendations for using information from postmarketing spontaneous adverse event reporting databases to provide insight into risks of potential harm expressed by safety signals and offers guidance regarding appropriate methods, both frequentist and Bayesian, to use in various situations as a function of the objective of the analysis. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Gould, A. L., Lystig, T. C., Lu, Y., Fu, H., Ma, H. Tags: Product Safety Source Type: research

Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes
In December 2008, the US Food and Drug Administration (FDA) issued a guidance for industry requiring sponsors to demonstrate that a new antidiabetic therapy being developed to treat type 2 diabetes does not increase cardiovascular (CV) risk to an unacceptable extent. CV events reported during phase 2 and phase 3 trials should be prospectively and independently adjudicated. Before submission of a new drug application or biologics license application, sponsors should compare the incidence of major CV events occurring with the investigational agent versus the control group to show that the upper bound of the 2-sided 95% confi...
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Geiger, M. J., Mehta, C., Turner, J. R., Arbet-Engels, C., Hantel, S., Hirshberg, B., Koglin, J., Mendzelevski, B., Sager, P. T., Shapiro, D., Stewart, M., Todaro, T. G., Gaydos, B. Tags: Product Safety Source Type: research

A Survey of Key Opinion Leaders to Support Curriculum Development in Advanced Medical Science Liaison Training
This report describes a survey of key opinion leaders (KOLs) to identify MSL skills most highly valued and those in need of enrichment with the objective of designing an advanced training curriculum for experienced MSLs. A total of 66 MSLs representing diverse therapeutic areas verbally administered a 9-question survey at the conclusion of a routine MSL-KOL interaction. There were 296 surveys completed, with most respondents (239 of 281; 82%) indicating that they meet with MSLs from other companies. Ninety-five percent (218 of 230) responded that the value provided by MSLs was comparable to that offered by other companies....
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Moss, R. J., Smith, E. B., Anderson, G., Rozenfeld, V., Evangelista, C., Trahey, C., Venuti, C., Weiner, E. J. Tags: Policy Source Type: research

Development and Use of Reprints Tracking Reporter (RTR(C)) as a Medical Information Web-Based Tool for Compliance with the Physician Payments Sunshine Act
Dissemination of full-article references in connection with medical information responses from pharmaceutical industry medical information departments (PIMID) has both copyright and Physician Payments Sunshine Act (PPSA) compliance requirements. A complex of data must be aggregated from multiple databases, which presents a challenge in efficiently distributing articles and reporting the metrics. Using contemporary programming methods that any PIMID can duplicate and that is described herein, the authors developed a web-based tool (Reprints Tracking Reporter [RTR © ]) to meet this nee...
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Fuentes, R. J., Idowu, K., Sahoo, S. K. Tags: Policy Source Type: research

Funding of Cancer Research: Do Levels Match Incidence and Mortality Rates?
The incidence and mortality rates of the ten most prevalent cancers types in the US were compared with the National Cancer Institute’s funding of clinical studies in 2012. Additionally, a sampling of print and broadcast media coverage of these ten cancer types were gathered for the same year. While funding per case and per annual death broadly matched cancer prevalence, significant exceptions existed. Breast cancer research is funded at the highest level on both a per-case and a per-death basis. Funding far exceeds that of any other cancer regardless of the measure examined. While second in prevalence in the US, actu...
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Martin, I. G., Mallela, S. Tags: Policy Source Type: research

An Assessment of Future Clinical Pharmacy Service Delivery in the Patient-Centered Medical Home
Two health care reform initiatives—patient-centered medical home (PCMH) and payment reform—in combination have the potential to increase clinical pharmacy involvement in patient care. However, the effects of these reforms on clinical pharmacy are highly uncertain. In particular, which clinical pharmacy services will be provided, how the services will be requested and delivered, and in what practice settings the services will be provided are not known. To gain insight into future clinical pharmacy service delivery in the PCMH, the authors examined current clinical pharmacy service delivery models at 4 sites in M...
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Gettens, J., Hudd, T. R., Henry, A. D., Brown, T., Santarelli, C. Tags: Policy Source Type: research

A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward?
A universal framework for the evaluation of the benefit-risk assessment of medicines during development by pharmaceutical companies and in the regulatory review by regulatory authorities is considered of value, as it would result in the systematic structured approach to support transparency in decision making. Several organizations have developed frameworks over the past few years, including those recommended by pharmaceutical companies such as the PhRMA BRAT (Pharmaceutical Research and Manufacturers of America Benefit-Risk Action Team) and the BRAIN (Benefit-Risk Assessment in New and Old Drugs) as well as frameworks adv...
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Walker, S., McAuslane, N., Liberti, L., Leong, J., Salek, S. Tags: Policy Source Type: research

Patient Engagement by Pharma--Why and How? A Framework for Compliant Patient Engagement
Engagement is increasingly recognized as a decisive factor for health-related outcomes in people living with a medical issue. It is their experience that drives this engagement. Therefore, providers who seek to develop better solutions, including medicines, must gain a deeper understanding of the patient experience. Beyond pathology, such understanding requires direct engagement with patients, something that has been historically avoided in the pharmaceutical industry. Whereas clear and comprehensive engagement frameworks are in place for direct engagement with health care professionals, such guidance does not yet exist fo...
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Dewulf, L. Tags: Policy Source Type: research

2015 and Beyond
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Spielberg, S. P. Tags: Editorial Source Type: research

The Life Cycle and Management of Protocol Deviations
Clinical trials are designed to evaluate the efficacy, safety, or other characteristics associated with medical products. Trials are usually complex and require a large group of professionals to follow a clinical trial protocol, standard operating procedures, and study-specific manuals, guidelines, and plans. Clinical trial protocols prospectively describe the background and rationale for conducting the trial, the objectives of the trial, the trial design, the equipment to be used, the procedures to be performed, and the statistical methods on how the trial data are to be analyzed. Deviations from the protocol can result i...
Source: Therapeutic Innovation and Regulatory Science - October 30, 2014 Category: Drugs & Pharmacology Authors: Mehra, M., Kurpanek, K., Petrizzo, M., Brenner, S., McCracken, Y., Katz, T., Gurian, M. Tags: Clinical Trials Source Type: research