Evolving Clinical Data Strategies and Tactics in Response to Digital Transformation.

abstract：: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 pharmacovigilan...

journal_title：Therapeutic innovation & regulatory science

authors： Naik P,Umrath T,van Stekelenborg J,Ruben R,Abdul-Karim N,Boland R,Ibara M,Ekuta J,Washburn D,Stergiopoulos S

更新日期：2015-11-01 00:00:00

abstract：:Confirmation of efficacy in pediatric drug development has traditionally required large, fully powered efficacy studies that have proven to have major feasibility and ethical challenges. Extrapolation of efficacy in the framework provided by the US Food and Drug Administration and European Medicines Agency is an appro...

journal_title：Therapeutic innovation & regulatory science

authors： Leil TA,Zee P,Suryawanshi S,Male C,Portman R

更新日期：2013-09-01 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:A data monitoring committee (DMC) has special responsibilities for protecting the safety of clinical trial participants. Few guidance documents are available that address the operations and mechanics of establishing, serving on, or reporting to a DMC. This article provides a practical guide to sponsors, inst...

journal_title：Therapeutic innovation & regulatory science

authors： Bierer BE,Li R,Seltzer J,Sleeper LA,Frank E,Knirsch C,Aldinger CE,Levine RJ,Massaro J,Shah A,Barnes M,Snapinn S,Wittes J

更新日期：2016-09-01 00:00:00

abstract：:Time progression models provide a significant advantage in developing clinical trials and can also be used to elicit comparisons among therapeutic agents. The authors performed a meta-analysis to construct a time progression model for rheumatoid arthritis (RA), an area of significant interest for pharmaceutical develo...

journal_title：Therapeutic innovation & regulatory science

authors： Reeve R,Pang L,Ferguson B,O'Kelly M,Berry S,Xiao W

更新日期：2013-11-01 00:00:00

abstract：:Although much information is already available publically from information-sharing initiatives such as ClinicalTrials.gov, information about clinical programs is unstructured, inconsistent, and incomplete. Clinical research within bioscience companies, health care, academia, and governmental agencies could benefit fro...

journal_title：Therapeutic innovation & regulatory science

authors： Vasko L,Sundgren M,Bachmann P,Balinski K,Bleich N,Blom T,Eriksson H,Ferendo R,Forsberg K,King D,Mordiva A,Proeve J,Thomas L,Witch E,Simán M

更新日期：2015-01-01 00:00:00

abstract：BACKGROUND:The human papillomavirus (HPV) vaccine coverage is very low in Japan since the government suspended the active encouragement of the vaccination. We aimed to conduct a benefit-risk assessment of HPV vaccination and explore different consequent scenarios to identify potential improvements to the current Japane...

journal_title：Therapeutic innovation & regulatory science

authors： Matsumoto T,Matsumaru N,Scuffham P,Neels P,Tsukamoto K

更新日期：2021-01-01 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：:Japan's rapidly aging population has prompted a change in the country's pharmaceutical care framework from a drug-oriented to a patient-oriented approach. Pharmacies and pharmacists are expected to play central roles in this new patient-oriented approach by reconciling medication and managing polypharmacy, conducting ...

journal_title：Therapeutic innovation & regulatory science

authors： Takamura K,Tachibana K,Kihira T,Nakai K,Tsutsumi Y,Kondoh M

更新日期：2020-09-11 00:00:00

abstract：BACKGROUND:The pace of innovation, the creative engine of the pharmaceutical industry, has been variably described as stagnant, stable, or accelerating depending on the metric used for assessment or the quality of evidence. If the predominant perception holds that the speed of innovation is sluggish, pressure for chang...

journal_title：Therapeutic innovation & regulatory science

authors： Robberson M,Breder CD

更新日期：2020-08-31 00:00:00

abstract：BACKGROUND:Substance abuse research can raise ethical concerns about the comprehension and decision-making capacities of participants with drug dependence. In this study, the competence and willingness to consent to research participation were examined among patients with heroin dependence. METHODS:Twenty patients wit...

journal_title：Therapeutic innovation & regulatory science

authors： Zhao L,Shi H,Ying B,Li Q

更新日期：2020-09-01 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：BACKGROUND:The FDA Patient-Focused Drug Development Initiative was launched to ensure the incorporation of the patient voice into drug development and evaluation. Since 2017, the FDA must publish a statement outlining patient experience data (PED) considered in the approval of new drugs. This study investigated the pre...

journal_title：Therapeutic innovation & regulatory science

authors： Schultz-Knudsen K,Sabaliauskaite U,Hellsten J,Lassen AB,Morant AV

更新日期：2020-11-23 00:00:00

abstract：BACKGROUND:The number of original and supplemental ANDAs, BLAs, NDAs, and Biosimilars FDA drug/biologic approvals (Approvals) has risen dramatically in the recent years, incidentally, so has the number of issued FDA guidances (Guidances). It is hypothesized that if the structures of the two timeseries are similar and/o...

journal_title：Therapeutic innovation & regulatory science

authors： Daizadeh I

更新日期：2020-09-01 00:00:00

abstract：:The U.S. and Japan have preapproval access systems for patients who have exhausted approved treatment options. We compare the systems of both countries and discuss some ethical concerns surrounding non-trial access to investigational drugs. Notable points of comparison of the two countries' systems include cost of non...

journal_title：Therapeutic innovation & regulatory science

authors： Nakada H,Folkers KM,Takashima K

更新日期：2020-10-23 00:00:00

abstract：BACKGROUND:Patients and health care professionals receive information about pharmaceutical companies through various sources, including but not limited to print media, social media, and electronic media. The objective of this research was to benchmark the sentiment of electronic newspaper media coverage between 2014 an...

journal_title：Therapeutic innovation & regulatory science

authors： Pampulevski V,Giaquinto JR,Rametta M,Toscani M,Barone J,Nadal JC

更新日期：2020-01-01 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：:Efficient use of limited pharmaceutical product development resources requires integrating multiple attributes, such as efficacy, safety, pharmacology, and so on, to decide at any stage whether the development of a product should proceed aggressively or slowly or be terminated. The decision process proceeds most effec...

journal_title：Therapeutic innovation & regulatory science

authors： Gould AL,Krishna R,Khan A,Saltzman J

更新日期：2015-03-01 00:00:00

abstract：:Source data verification (SDV) is the process of confirming that reliable, accurate information collected from participants during a clinical trial has been reported successfully to the trial's sponsor by investigators conducting the study. Over the past 15 years or so, there has been considerable discussion in the li...

journal_title：Therapeutic innovation & regulatory science

authors： Nielsen E,Hyder D,Deng C

更新日期：2014-03-01 00:00:00

abstract：BACKGROUND:A new incentive program, "Premium Rewards for the Promotion of Innovative Drug Discovery and Resolution of Off-Label Use, etc," was introduced in Japan in 2010 and subsequently applied in 2010, 2012, and 2014. In our previous study, we reported statistical evidence regarding the attributes of drugs for which...

journal_title：Therapeutic innovation & regulatory science

authors： Shibata S,Uemura R,Suzuki T

更新日期：2016-01-01 00:00:00

abstract：:In general, similar to FDA and other health authorities, the PMDA requires clinical efficacy study(ies) to evaluate equivalence between a reference biological product and a Biosimilar product for new drug applications. Even if an identical clinical efficacy study is included in both of PMDA and FDA submissions, the co...

journal_title：Therapeutic innovation & regulatory science

authors： Asami Y,Pan J,Oh M,Sato A

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：BACKGROUND:Predictions of drug sales play an important role in setting drug prices in Japan, where drug prices are highly regulated. One of 2 primary Japanese drug-pricing methodologies-the cost calculation method- refers extensively to the prediction of drug sales in establishing drug prices. Deviations from predicted...

journal_title：Therapeutic innovation & regulatory science

authors： Shibata S,Fukumoto D,Suzuki T,Ozaki K

更新日期：2019-07-16 00:00:00

abstract：BACKGROUND:Communicating the clinical impact of immunogenicity in labeling is important for safe and effective use of certain prescription products. Current U.S. Food and Drug Administration (FDA) guidance does not provide comprehensive recommendations on the communication of clinical impact of immunogenicity in labeli...

journal_title：Therapeutic innovation & regulatory science

authors： Guinn D,Madabushi R,Wang YM,Brodsky E,Zineh I,Maxfield K

更新日期：2020-11-01 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：:In a global environment where health care costs are soaring, R&D efforts are flatlining. Meanwhile, payers are demanding more value for their money. In this environment, the traditional siloed drug development model is not sustainable. Yet innovations such as adaptive trial designs, real-world data collection, precisi...

journal_title：Therapeutic innovation & regulatory science

authors： Grignolo A,Siu A

更新日期：2019-05-01 00:00:00

abstract：:The product pipeline for diseases that disproportionately affect the developing world has considerably expanded over the last decade. Indeed, there are about 134 products for these diseases in the pipeline, including vaccines, drugs, diagnostics, microbicides, and vector control tools, and dozens of these products are...

journal_title：Therapeutic innovation & regulatory science

authors： Saidu Y,De Angelis D,Aiolli S,Stefano G,Georges AM

更新日期：2013-05-01 00:00:00

abstract：BACKGROUND:Several articles showed that statistical efficiency of multi-arm randomized clinical trials (RCTs) is much better than conventional two-arm RCTs. Multi-arm RCTs attract interest mainly when the experimental treatment regimen is not optimized or several pipelines under development exist. Breast cancer is a po...

journal_title：Therapeutic innovation & regulatory science

authors： Nomura S,Miyauchi Y,Ajisawa Y,Isogaya K,Sozu T

更新日期：2020-09-01 00:00:00

abstract：:In the current pharmaceutical regulatory environment, patients continue to benefit from great advances in medical care. Sophisticated regulatory review systems have also evolved to ensure that safe and effective medicines are approved. However, these systems are not optimized in all countries. Gaps in individual regul...

journal_title：Therapeutic innovation & regulatory science

authors： O'Brien J,Lumsden RS,Diehl DH,Macdonald JC

更新日期：2020-03-01 00:00:00

abstract：:The Asia Pacific (AP) region is diverse and dynamic. It comprises over 40 economies, with about 24 markets that are relatively more active in terms of promulgating and implementing regulations that impact the biopharmaceutical industry and advance drug development. Although many country- and territory-specific regulat...

journal_title：Therapeutic innovation & regulatory science

authors： Han FV,Weiss K

更新日期：2019-07-01 00:00:00