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Therapeutic Innovation & Regulatory Science
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#1Matthew J. Coleshill (UNSW: University of New South Wales)H-Index: 1
#2Eindra Aung (UNSW: University of New South Wales)H-Index: 7
Last. Richard O. Day (UNSW: University of New South Wales)H-Index: 60
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Gout is the most common form of inflammatory arthritis in men, yet both patients and the public often do not recognise gout as a form of arthritis. Instead, due to historical misconceptions, gout is typically seen as a lifestyle disease caused by poor diet. In reality, there are a number of risk factors that contribute to gout, including genetic factors. Views of gout as precipitated by lifestyle alone can lead to stigma, and maladaptive beliefs that it should be treated primarily through dietar...
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#1J. Jason LundyH-Index: 9
#2Cheryl D. CoonH-Index: 9
Last. Vivek Pawar (Merck Serono)
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As patient-reported outcome (PRO) measures are being included more frequently in oncology clinical trials, regulatory and health technology assessment agencies have begun to request long-term, post-treatment PRO data to supplement traditional survival/progression endpoints. These data may be collected as part of cohort extension or registry studies to describe long-term outcomes of study participants after concluding their cancer treatment. While post-treatment PRO data may be expected to satisf...
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BACKGROUND Approval of regulated medical products in the USA is based upon a rigorous review of the benefits and risks as performed by the US Food and Drug Administration (FDA) staff of scientists and is summarized in a descriptive and qualitative format called the FDA's Benefit-Risk Framework (BRF). This present method highlights the key factors in regulatory decision-making, but does not clearly define the reason for its final approval. METHOD This study proposes a quantitative version of FDA'...
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This commentary is authored by several industry real-world evidence (RWE) experts, with support from IQVIA, as part of the 'RWE Leadership Forum': a group of Industry Leaders who have come together as non-competitive partners to understand and respond to RWD/E challenges and opportunities with a single expert voice. Here, the forum discusses the value in bridging the industry disconnect between RTCs and RWE, with a view to promoting the use of RWE in the RCT environment. RCT endpoints are explor...
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Incorporating patient perspectives into clinical studies is recognized as important to the development of high-quality, safe, and effective fit-for-patient medicines. However, no widely accepted methodology to help design more patient-centered studies has been established systematically. TransCelerate Biopharma Inc., a non-profit organization promoting collaboration across biopharmaceutical companies, organized a Patient Experience (PE) Initiative to create tools to intentionally include the pat...
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BACKGROUND The certificate of pharmaceutical product (CPP) was implemented to accelerate the availability of new drugs in developing countries by providing evidence of the quality of products and reducing the time to market through reliance on a prior trusted analysis. However, the CPP format, issuing process and use have not been revised since 1997 and there are significant differences among countries in regard to requirements for CPP timing, terminology, and format. We sought to determine curr...
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Background Oral inhalation drug products (OIDPs) are combination products comprising two components, i.e., a device and the corresponding formulation, and are manufactured with ‘patient use’ being the key consideration. The formulation is designed to be compatible with the device, as the device and formulation have to work in tandem for the intended effect of the drug to be imparted to the patient. OIDPs are generally categorized into three sections: pressurized metered dose inhalers (pMDIs or M...
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#1Maria Apostolaros (Pharmaceutical Research and Manufacturers of America)H-Index: 1
#2David BabaianH-Index: 1
Last. Penny RandallH-Index: 1
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Background Traditional clinical trials are often expensive, inefficient, include selected populations, and can create significant participant burden via travel and other logistical demands. Using new technologies and methodologies to promote a decentralized approach has the potential to improve the efficiency of clinical trials. The Clinical Trials Transformation Initiative (CTTI)—a public–private partnership to improve clinical trials—launched a multi-stakeholder Decentralized Clinical Trials (...
1 CitationsSource
#1Meguru Watanabe (Pharmaceuticals and Medical Devices Agency)
#2Hiroki Nishikawa (Pharmaceuticals and Medical Devices Agency)
Last. Tatsuya KondoH-Index: 3
view all 7 authors...
Adverse drug reaction (ADR) relief system in Japan is comprehensively described in this article. Particularly, review process during ADR relief evaluation is focused from clinical perspective. The significance of clinical review process and roles of a physician medical reviewer in the ADR relief system in Japan are also discussed. The current ADR Relief Service in Japan requires criteria for compensation eligibility including the “proper” use of the medication associated with the adverse event, ...
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The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre- and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the...
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