Technology Considerations to Enable the Risk-Based Monitoring Methodology.

abstract：:Agents indicated for cleansing of the colon as a preparation for colonoscopy (bowel preps) are among the most frequently prescribed drugs for otherwise healthy patients. Better bowel preparation has been shown to translate into higher adenoma detection rates. Therefore, safety and efficacy standards need to be high. C...

journal_title：Therapeutic innovation & regulatory science

authors： Gottlieb K,Turner JR,Gillespie BS,Hussain F

更新日期：2015-09-01 00:00:00

abstract：BACKGROUND:Medical information (MI) departments across pharmaceutical companies respond to medical inquiries about a company's products to healthcare providers, payors, patients, and caregivers. Responses provided are constructed to be relevant, accurate, scientifically balanced and delivered in a timely manner. Benchm...

journal_title：Therapeutic innovation & regulatory science

authors： Byun J,Jong JA,Gangat A,Flowers T,Gazo A,Shah I

更新日期：2020-11-01 00:00:00

abstract：BACKGROUND:Although a large number of clinical trials have been conducted, the types of clinical trials that are scientifically influential, frequently utilized by society, and contribute to the progress of evidence-based medicine (EBM) have not been studied. Thus, we aimed to investigate the relationship between the c...

journal_title：Therapeutic innovation & regulatory science

authors： Noguchi Y,Kaneko M,Narukawa M

更新日期：2020-11-01 00:00:00

abstract：BACKGROUND:Several regulatory guidelines recommend that assessments of endpoints supporting drug approval should be verifiable by applicants and the regulatory agencies to minimize the potential for bias. This becomes especially critical when assessments are not based on measurable data but are derived from the interpr...

journal_title：Therapeutic innovation & regulatory science

authors： Krumholz-Bahner S,Garibbo M,Getz KA,Widler BE

更新日期：2015-11-01 00:00:00

abstract：BACKGROUND:This study compared the timing, regulatory marketing authorization decisions, and the final labeling for products submitted to Swissmedic to those submitted to European Medicines Agency (EMA) and the US Food & Drug Administration (FDA). METHODS:The Centre for Innovation in Regulatory Science (CIRS) conducte...

journal_title：Therapeutic innovation & regulatory science

authors： Dörr P,Wadworth A,Wang T,McAuslane N,Liberti L

更新日期：2016-11-01 00:00:00

abstract：:This study aimed to determine the potentially severe chemical properties of drugs that can cause adverse drug reactions (ADRs) such as erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) by using a data mining method. The study data were extracted from the Adverse Event Repor...

journal_title：Therapeutic innovation & regulatory science

authors： Shirakuni Y,Okamoto K,Uejima E,Inui S,Takahara JI,Ohgaru T,Yamasaki H,Tian Y,Kawashita N,Inoue R,Yasunaga T,Takagi T

更新日期：2013-03-01 00:00:00

abstract：BACKGROUND:The influence of patient advocates on FDA regulatory decision making has increased. Despite enhanced engagement with FDA, there remain challenges to achieving the regulatory goals of patients within FDA's regulatory framework. Gaps exist between patient advocates' knowledge of the agency's processes and FDA'...

journal_title：Therapeutic innovation & regulatory science

authors： Kuehn CM

更新日期：2018-09-01 00:00:00

abstract：:The regulatory agencies all over the world have defined the pathway and regulations for the approval of simple small-molecule generics. In addition, the agencies are striving to form perspicuous regulatory frameworks for the approval of biosimilars. In this view, there are no defined regulations for the approval of co...

journal_title：Therapeutic innovation & regulatory science

authors： Lunawat S,Bhat K

更新日期：2020-09-01 00:00:00

abstract：BACKGROUND:Safety data are continuously evaluated throughout the life cycle of a medical product to accurately assess and characterize the risks associated with the product. The knowledge about a medical product's safety profile continually evolves as safety data accumulate. METHODS:This paper discusses data sources a...

journal_title：Therapeutic innovation & regulatory science

authors： Izem R,Sanchez-Kam M,Ma H,Zink R,Zhao Y

更新日期：2018-03-01 00:00:00

abstract：:After nearly a decade of discussion, analysis, and development, the Medicines Adaptive Pathways to Patients (MAPPs) initiative is beginning to see acceptance from regulators, industry, patients, and payers, with the first live pilot project initiated under the guidance of the European Medicines Agency in 2014. Althoug...

journal_title：Therapeutic innovation & regulatory science

authors： Schulthess D,Baird LG,Trusheim M,Unger TF,Lumpkin M,Hoos A,Garner S,Gavin P,Goldman M,Seigneuret N,Chlebus M,Van Baelen K,Bergstrom R,Hirsch G

更新日期：2016-05-01 00:00:00

abstract：:Meta-analyses are increasingly influencing clinical practice, but significant methodological flaws have been reported. The purpose of this study was to evaluate the quality of search strategies utilized by anti-infective meta-analyses. The Embase database was searched for meta-analyses evaluating anti-infective drug t...

journal_title：Therapeutic innovation & regulatory science

authors： Marler JL,Curry KY,Suda KJ

更新日期：2014-05-01 00:00:00

abstract：BACKGROUND:The design and sample size of a phase III study for new medical technologies were historically determined within the framework of frequentist hypothesis testing. Recently, drug development using predictive biomarkers, which can predict efficacy based on the status of biomarkers, has attracted attention, and ...

journal_title：Therapeutic innovation & regulatory science

authors： Takazawa A,Morita S

更新日期：2020-09-01 00:00:00

abstract：:Adaptive designs are increasingly used in clinical trials. The Drug Information Association's Adaptive Design Scientific Working Group (ADSWG) works to foster collaboration among regulatory agencies, academia, and pharmaceutical and biotech companies to further the science of adaptive clinical development. The ADSWG S...

journal_title：Therapeutic innovation & regulatory science

authors： Morgan CC,Huyck S,Jenkins M,Chen L,Bedding A,Coffey CS,Gaydos B,Wathen JK

更新日期：2014-07-01 00:00:00

abstract：: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...

journal_title：Therapeutic innovation & regulatory science

authors： Walker S,McAuslane N,Liberti L,Leong J,Salek S

更新日期：2015-01-01 00:00:00

abstract：BACKGROUND:Prescription drug labeling is an authoritative source of information that guides the safe and effective use of approved medications. In many instances, however, labeling may fail to be updated as new information about drug efficacy emerges in the postmarket setting. When labeling becomes outdated, it loses i...

journal_title：Therapeutic innovation & regulatory science

authors： Shea MB,Stewart M,Van Dyke H,Ostermann L,Allen J,Sigal E

更新日期：2018-11-01 00:00:00

abstract：:The DIA Study Endpoints Community Working Group on Mobile Sensor Technology (MST) series addresses considerations that may be useful for selecting MST for use in a clinical trial. This article describes considerations regarding the selection of MST for clinical trials including expectations around technology specifica...

journal_title：Therapeutic innovation & regulatory science

authors： Russell C,McCarthy M,Cappelleri JC,Wong S

更新日期：2021-01-01 00:00:00

abstract：BACKGROUND:(1) A growing number of pharmaceutical and biotechnology organizations are engaging patients, their support networks, and clinical trial site staff at various touchpoints along the clinical research development spectrum to solicit feedback on how to reduce the burden of clinical trial participation and admin...

journal_title：Therapeutic innovation & regulatory science

authors： Gregg A,Getz N,Benger J,Anderson A

更新日期：2019-05-22 00:00:00

abstract：:The American Statistical Association and DIA have created an interdisciplinary working group of drug safety experts from academia, industry and regulatory backgrounds to explore the future direction for safety monitoring. This introduction to the series explains the background and rationale for this special section. ...

journal_title：Therapeutic innovation & regulatory science

authors： Seltzer JH,Li J,Wang W

更新日期：2019-03-29 00:00:00

abstract：BACKGROUND:Package leaflets of medicines distributed within the European Union should use the template headings and standard texts created by the Working Group on the Quality Review of Documents (QRD). The following study investigated how the QRD template is implemented in this patient information. METHODS:All English...

journal_title：Therapeutic innovation & regulatory science

authors： Wolf A,Fuchs J,Schweim HG

更新日期：2016-01-01 00:00:00

abstract：:A growing number of organizations-including pharmaceutical and biotechnology companies, foundations and associations-are routinely implementing patient advisory boards (PAB) given their high reported value for minimal relative investment. Organizations are typically implementing PABs to solicit patient voices and pers...

journal_title：Therapeutic innovation & regulatory science

authors： Anderson A,Getz KA

更新日期：2018-07-01 00:00:00

abstract：:Attention deficit hyperactivity disorder (ADHD) is the most common neurobiological disorder in children, with a prevalence of ~6-7%1,2 that has remained stable for decades2. The social and economic burden associated with patients3, families, and broader systems (healthcare/educational) is substantial, with the annual ...

journal_title：Therapeutic innovation & regulatory science

authors： Connolly JJ,Glessner JT,Elia J,Hakonarson H

更新日期：2015-09-01 00:00:00

abstract：BACKGROUND:The coherence between the relationship of QTc and drug plasma concentration (this relationship is measured through the slope) and ICH E14 findings based on hundreds of QT study reports was studied. RESULTS:Based on ICH E14 analysis, our findings indicate that if the slope was not positive, in most cases (86...

journal_title：Therapeutic innovation & regulatory science

authors： Zhang J,Chen H,Tsong Y,Stockbridge N

更新日期：2015-05-01 00:00:00

abstract：:The Tufts Center for the Study of Drug Development and Medidata Solutions Inc analyzed data from 9737 protocols and 130,601 investigative site contracts associated with these protocols to derive updated benchmarks characterizing protocol complexity. The results of the study indicate that protocol design complexity con...

journal_title：Therapeutic innovation & regulatory science

authors： Getz KA,Campo RA

更新日期：2018-01-01 00:00:00

abstract：:Recently, it is becoming increasingly difficult to develop innovative drugs. Thus, the role of regulatory science research in drug development and postmarketing settings has become more important. In this article, the authors discuss the roles of regulatory science research at the Pharmaceuticals and Medical Devices A...

journal_title：Therapeutic innovation & regulatory science

authors： Asahina Y,Tanaka A,Uyama Y,Kuramochi K,Maruyama H

更新日期：2013-01-01 00:00:00

abstract：BACKGROUND:Obtaining assent from children participating in clinical trials acknowledges autonomy and developmental ability to contribute to the consent process. This critical step in pediatric drug development remains poorly understood, with significant room for improving the clarity, efficiency, and implementation of ...

journal_title：Therapeutic innovation & regulatory science

authors： Lombardi D,Squires L,Sjostedt P,Eichler I,Turner MA,Thompson C

更新日期：2018-01-01 00:00:00

abstract：BACKGROUND:Self-management can be considered a way of dealing with oneself and relates to actions undertaken to create order, discipline, and control. The concept is closely linked to concepts of self-efficacy and self-regulation but can be distinguished from these. The Self-Management Self-Test (SMST) is a 5-item asse...

journal_title：Therapeutic innovation & regulatory science

authors： Wehmeier PM,Fox T,Doerr JM,Schnierer N,Bender M,Nater UM

更新日期：2019-07-14 00:00:00

abstract：BACKGROUND:Contending with a continuously expanding volume and variety of clinical data poses challenges and opportunities for the industry and clinical data management organizations. METHODS:Tufts CSDD conducted an online survey aimed at further quantifying and understanding the magnitude and impact that expanded dat...

journal_title：Therapeutic innovation & regulatory science

authors： Harper B,Wilkinson M,Indupuri R,Rocchio S,Getz K

更新日期：2020-09-14 00:00:00

abstract：: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,...

journal_title：Therapeutic innovation & regulatory science

authors： Cronin M,Berger S,Seligman PJ

更新日期：2014-11-01 00:00:00

abstract：:The authors consider a statistically valid method that has little concern caused by down weighting in stage 2 or slight loss in efficiency and possibly improves power performance for a trial design that allows for adaptation of statistical information. In addition to the need for a priori sound data-based planning tha...

journal_title：Therapeutic innovation & regulatory science

authors： Wang SJ,Hung HMJ

更新日期：2014-01-01 00:00:00

abstract：BACKGROUND:Increasing generic drug price competition by facilitating abbreviated new drug applications (ANDA) submission may help patients have access to affordable care. This study examined factors associated with first ANDA submission for the brand drug to be copied [the "reference listed drug" (RLD)]. METHODS:This ...

journal_title：Therapeutic innovation & regulatory science

authors： Wittayanukorn S,Rosenberg M,Schick A,Hu M,Wang Z,Babiskin A,Lionberger R,Zhao L

更新日期：2020-11-01 00:00:00