Requirements For Approval Research Articles

Barriers and hurdles delaying governance approval for an ethically approved nationwide clinical trial in pancreatic cancer.

Streamlined, expedited clinical research is fundamental to rapidly test, translate and implement novel treatments into routine care to improve patient outcomes. The National Mutual Acceptance (NMA) scheme was designed to expedite the ethics approval process, however, growing concerns exist about the fragmented time-consuming governance process needed to actually commence clinical research in Australia. This study reports hurdles and barriers encountered while seeking governance approval for the SCANPatient trial. SCANPatient is a nationwide multi-centre trial comparing standard narrative radiological reporting of CT scans for suspected pancreatic ductal adenocarcinoma. with an alternative structured approach. SCANPatient was approved by a national Human Research Ethics Committee under the NMA. The documents, time, costs and platforms required to obtain governance approval and open the trial at 30 participating hospitals were analysed. Wide variation exists in research governance office (RGO) requirements for local approval, resulting in extra costs (>$117 000), delays of up to 4 months in commencing the trial at some participating sites, unplanned adjustment of the study design, and ultimately the loss of several potential sites. There were inconsistencies among RGOs minimum requirements and processes across jurisdictions and sites, with delays in obtaining approval signatures, time-consuming processes, differing platforms used to submit governance reviews and inflexibility of RGO processes all contributing to delays in progressing the trial and obtaining governance approval. The current governance process is time- and cost-consuming and undermines the NMA scheme's efforts to streamline the clinical trials review process.

The Effects of Removing the Requirement for Prior Reimbursement Approval on Anticoagulant Use in Ireland: A Cross-Sectional Study.

Prior approval for reimbursement is a policy of cost containment while ensuring oversight and governance of medicines. It has been employed in Ireland to address financial challenges due to the shift from warfarin to direct oral anticoagulants (DOACs). Studies assessing the effectiveness of this policy are limited. Thus, we aimed to examine the effectiveness of prior approval for reimbursement of DOACs (apixaban, rivaroxaban) as a cost containment policy in Ireland. The Irish Health Service Executive-Primary Care Reimbursement Service database was used in this cross-sectional study. We examined the prescribing frequencies and associated costs of the oral anticoagulants; [(OACs) apixaban, rivaroxaban and warfarin] listed in the top 100 most frequently prescribed drugs, between 2018 and 2021. Time series negative binomial regression was used to assess the impact of removing the approval requirement of apixaban in September 2019 followed by the other DOACs in November 2020. The prescribing frequency of OACs increased by almost 20% from 2018 to 2021. This study showed there were significant differences in the proportion of OACs prescribed among the Community Drug Schemes. A statistically significant decreased use of apixaban (< 1%, p < 0.05) occurred when prior approval was removed for all DOACs. The removal of prior approval for reimbursement of DOACs in Ireland had a minimal impact on the prescribing frequency trends of the OACs. Future use of these potentially useful policies by healthcare systems requires careful consideration of drug type, approval criteria and length of time the policy remains in place to minimise any negative effects associated with their use.

Roadmap for Linking Registry Data with Health Services Data to Support Evidence-Informed Decision-Making.

ApproachAs part of a learning period to optimize the use of RWE for decision-making for drugs for rare diseases, the [organization name removed to allow for blind review] conducted an environmental scan to map real-world data in patient registries. Over 400 patient registries were identified, signaling the potential wealth of untapped information to support decision-making by linking registry data with health services data. To better understand the challenges faced by registry holders hoping to link registry data with health services data sources available in Canada, a series of interviews were conducted with several Canadian rare disease registries. In addition, a literature review was completed, and Canadian experts in epidemiology, privacy, record linkage, registry science, and health services research were consulted to inform the development of a roadmap to meet various stakeholder needs. ResultsThe resulting roadmap consists of 8 specific steps covering topics related to registry purpose, informed consent, ethical approval, participant privacy, governance, data linkability, participant identifiability and jurisdictional requirements. ConclusionThe roadmap is currently undergoing pilot testing by a pan-Canadian rare disease registry. A final [organization name] report and an accompanying roadmap in a checklist format to facilitate implementation will be finalized, disseminated across key stakeholders, and made publicly available. ImplicationsWhile developed for registries, the roadmap applies to the linkage of clinical trial or cohort study data, or other systematically gathered patient-level data to health services data.

Accelerated Approval for Cancer Drugs in the United States and the Clinical Evidence Required for Conversion to Regular Approval

PurposeOncology products often leverage accelerated approval program to seek earlier launches in the United States. Little is known about how the Food and Drug Administration (FDA) has been balancing evidence and access, and the factors that may characterize post-accelerated approval requirements. The present study aimed to obtain insights on how accelerated approval is determined by investigating the balance between pre-accelerated approval and supplemental clinical evidence required for future regular approval.MethodsThe product properties, pre-accelerated approval evidence, rationale, post-accelerated approval requirements, and prior regulatory designations for oncology accelerated approvals were summarized based on public databases. Regression analyses were performed to investigate factors that may have been associated with the post-accelerated approval requirements.ResultsHundred fifty-seven accelerated approvals were granted between 1992 and 2021. An increase in the number of pre-accelerated approval trials by one trial resulted in a 20% decrease in supplemental trials. The endpoint for the post-accelerated approval trial tended to be more robust when products were indicated for common cancers, while less robust when products had been used to treat fewer subjects, when products were indicated for respiratory and skin cancers, or when less malignant cancers were targeted.ConclusionsAccelerated approvals for oncology products were often based on the response rate of a noncomparative trial. However, considerable variation was observed in the post-accelerated approval requirements. Factors such as the quality and quantity of pre-accelerated approval evidence, regulatory designations, and operational feasibility may have been considered when determining the accelerated approvals and post-accelerated approval requirements.

Virtual clinical simulation as a paedagogical strategy in healthcare learning: Evidence and Gap Map protocol

IntroductionVirtual clinical simulation involves creating and applying scenarios using technology like computers or virtual reality. This method provides a secure experiential learning environment, encouraging active student participation and stimulating clinical,...

Development and implementation determinants of competency frameworks for mental health clinicians and service providers working with youth: a scoping review protocol

IntroductionDespite high prevalence, access to mental healthcare for Canadian youth is limited, with less than 20% receiving adequate treatment. Marginalised and at-risk youth face particular challenges, including cultural misunderstandings, long...

Biosimilar Medicines: From Development Process to Marketing Authorization by the EMA and the FDA

Biosimilars are a new category of medicines that have revolutionized the treatment of patients with life-threatening conditions, such as cancer and autoimmune diseases. A biosimilar is a biological product that is very similar to an already approved biological medicine that is used as its reference. These medicines go through less clinical studies than their reference product and therefore the cost of their development process is significantly lower, giving patients access to them more quickly and at a more affordable price. However, due to the structural complexity and inherent degree of variability of these products, it is very difficult to develop biosimilar medicines that are exactly the same as the reference product. Thus, it is extremely important to define strict controls to guarantee that these minor differences are not clinically significant in terms of safety and efficacy. Like any other medicine, biosimilars have to go through a complex approval process, which involves a thorough assessment by regulatory authorities to ensure these products meet the necessary standards of quality, safety, and efficacy before being placed on the market. Due to their nature and complexity, the approval process of biosimilar medicines contains some unique and specific considerations. This review aims to address the regulatory framework of biosimilar medicines, their development process and the approval requirements by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).

Strategic Developments in Polymer-Functionalized Liposomes for Targeted Colon Cancer Therapy: An Updated Review of Clinical Trial Data and Future Horizons.

Liposomes, made up of phospholipid bilayers, are efficient nanocarriers for drug delivery because they can encapsulate both hydrophilic and lipophilic drugs. Conventional cancer treatments sometimes involve considerable toxicities and adverse drug reactions (ADRs), which limits their clinical value. Despite liposomes' promise in addressing these concerns, clinical trials have revealed significant limitations, including stability, targeted distribution, and scaling challenges. Recent clinical trials have focused on enhancing liposome formulations to increase therapeutic efficacy while minimizing negative effects. Notably, the approval of liposomal medications like Doxil demonstrates their potential in cancer treatment. However, the intricacy of liposome preparation and the requirement for comprehensive regulatory approval remain substantial impediments. Current clinical trial updates show continued efforts to improve liposome stability, targeting mechanisms, and payload capacity in order to address these issues. The future of liposomal drug delivery in cancer therapy depends on addressing these challenges in order to provide patients with more effective and safer treatment alternatives.

Pharmaceutical Market Access in Latin America: Analyzing Approval Requirements in Three Key Nations: Ecuador, Dominican Republic and Nicaragua

: This article presents a comprehensive and comparative analysis of the regulatory frameworks governing the approval of pharmaceuticals in the Dominican Republic, Ecuador, and Nicaragua. It delves into the intricate scientific terminology and complex procedures inher-ent in these regulatory systems, shedding light on the demanding requirements that pharmaceu-tical companies must fulfil to secure market access in these countries. Employing a comparative approach, the article explores both the analogy and differences in the approval processes, focus-ing on factors such as safety standards, efficacy assessments, clinical trial prerequisites, post-marketing surveillance, and overall transparency. The findings contribute to a deeper under-standing of the scientific accuracy and ongoing efforts towards regulatory harmonisation within the pharmaceutical industry across these countries. Furthermore, this study aims to define the regulatory requirements for drug approval in the LATAM region, explicitly emphasising the Dominican Republic, Ecuador, and Nicaragua. It provides insights into the current pharmaceuti-cal market landscape in Latin America, compares the regulatory requirements for drug approval in these three countries, and offers guidance on preparing dossiers for obtaining authorisation of pharmaceutical drug products. By examining the similarities and differences in regulatory stand-ards, this article facilitates a comprehensive understanding of the stringency ratios between these countries and assists companies in navigating the specific regulatory landscapes to achieve suc-cessful drug approvals

Analysis of post-marketing requirements for oncology drug conditional approvals in the United States and China

BackgroundConditional approvals, also known as accelerated approvals, have been introduced by many pharmaceutical regulators around the world, allowing innovative drugs to enter the market earlier on the basis of limited evidence. This research aims to systematically analyze and compare the post-marketing requirements for conditional approvals of oncology drugs in China and the United States. By collecting and categorizing different types of post-marketing requirements, this study seeks to elucidate how these requirements are proposed and discern the underlying logic and patterns. MethodsThis study delved into oncology drug approvals, encompassing FDA accelerated approvals (up to December 31, 2022) and NMPA conditional approvals (from 2017 to December 31, 2022). Leveraging review documents from FDA and NMPA, comprehensive data on product characteristics, all post-marketing commitments and requirements, and especially those related to confirmatory requirements were extracted. The analysis incorporated descriptive statistics, visualizations such as Upset plots, and thorough examination of confirmatory requirement timeframes. FindingsThis study examined 168 FDA accelerated approvals and 41 NMPA conditional approvals for oncology indications. Post-marketing requirements displayed diversity: FDA emphasized confirmatory studies, clinical pharmacology studies, and more, while NMPA predominantly focused on confirmatory studies. Confirmatory requirement timeframes indicated higher FDA-required completion times for new confirmatory trials compared to continued completion of original pivotal trials. In contrast, NMPA's requirement patterns were comparatively singular, with relatively fixed timeframes. FDA's evolving trend showed decreasing timeframes over time, suggesting an increasing demand for timely confirmatory data. InterpretationConditional approvals offer a unique approach to bring potentially life-saving drugs to the market faster, despite limited supporting evidence. Our analysis of oncology drug conditional approvals in the U.S. and China reveals diverse post-marketing requirement patterns. This study provides valuable insights for regulatory decision-making in a dynamic pharmaceutical landscape. Balancing the risks and rewards of conditional approvals is crucial in ensuring both patient safety and timely access to innovative treatments.

Characteristics of mental skills interventions in dance: a mixed methods systematic review protocol

IntroductionDancers are expected to navigate major challenges in their careers that might take a toll on their physical and mental health. To address underlying factors that might increase dancers’ mental...

ADAPTING TO THE DIGITAL ERA: KEY SKILLS FOR FUTURE ACCOUNTING PROFESSIONALS

Unemployment can be considered as global challenge faced by almost all countries. However, further analysis by the Department of Statistics of Malaysia (DOSM) revealed a worrisome detail in which the rate of skill-related underemployment graduates continues to rise up recording 33.9 per cent in 2021 as compared to 31.2 per cent in 2020. Skill-related underemployment graduates is identified as occupation mismatch taking into consideration their educations, knowledge and skills were not fully utilised to their current work. Occupation mismatch may be worsened with the rapid growth of information and communication technology (ICT) and accounting graduates is no exception. Accounting profession is notified to also be highly at risk of being digitalised and automated in the near future. Accounting graduates with top academic credentials may still possibly failed to secure jobs because employers may view certificate and approval requirements are not enough. Instead, they require more incremental benefits such soft skills, communication skills, leaderships skills and ability to work in team. Importantly, students need to be aware of the employment needs and equipped themselves with skills beyond classroom learning before they finally graduated. To address this issue, this study will be carried out with the purpose to identify the important of accounting skills required for employment in accounting profession. A group of accounting students will be identified to participate this research. This research employs qualitative approach utilizing structured interviews which will be conducted through several medium of communication namely, phone calls and online questionnaires distributed through instant messaging application using Google form. The findings from this study are hoped to provide some suggestions of programs, activities, or new approaches on improving and enhancing accounting graduates’ skills that would transform them into highly marketable graduates.

Group arts therapies for patients with schizophrenia: a protocol of systematic review and meta-analysis

IntroductionSchizophrenia, a chronic mental problem, significantly impacts cognition, emotion and social functioning. Conventional pharmacotherapy faces challenges including numerous side effects, low adherence to medication and substantial costs. In this context,...

Financial Toxicity of Withdrawn Poly (Adenosine Diphosphate Ribose) Polymerase Inhibitor Indications for Ovarian Cancer

ObjectivesWe sought to quantify exposure to and financial impacts of poly (adenosine diphosphate ribose) polymerase inhibitor (PARPi) treatments for eventually withdrawn ovarian cancer indications. MethodsWe identified in Optum’s deidentified Clinformatics® Data Mart database 1695 patients with ovarian cancer diagnoses who received olaparib, rucaparib, or niraparib between January 2015 and September 2021. We describe PARPi use and out-of-pocket, total healthcare, and PARPi spending among patients with ovarian cancer with 3 or more previous lines of therapy. ResultsOf the 1695 patients who received PARPi, 254 were estimated to have been heavily pretreated and exposed to eventually withdrawn indications. Cumulative total medical and pharmacy costs for these patients were $53 392 184; PARPi costs accounted for 34%. Median PARPi cost per patient was $43 347. Cumulative out-of-pocket costs totaled $533 281. ConclusionsPotential patient harm, including financial toxicity, might have been mitigated through more stringent drug approval requirements.

Car-trailer coupling devices - description of requirements and overview of flexible and static load measuring solutions

The article presents an overview of the current normative, national, and international documents, containing in their content the requirements for devices coupling a car with a trailer in terms of technical conditions that these devices must meet to confirm proper performance and ensure the possibility of safe use during exploitation before will go on sale. Attention was paid to the division of coupling devices of motor vehicles and trailers into classes according to Regulation 55 of the UN/ECE and the resulting requirements. The principles according to which it should be accepted that couplings meet the approval requirements are discussed, and the meaning and way equipment manufacturers determine the characteristic values of the indicated coupling parameters are explained. Requirements for the minimum and maximum loads exerted by the trailer on the coupling device are presented. Particular attention was paid to the existing technical solutions (including patent claims in the Patent Office of the Republic of Poland or in the European Patent Office) regarding coupling devices characterized by the possibility of measuring the static vertical force on the coupling and couplings with vertical flexibility (compliance), which can potentially reduce dynamic loads on the coupling device. Calculations focused on two practical applications are planned using the article's content and simulation. The first is the ability to assess the impact of introducing vertical compliance to the coupling device on its durability. The second is the ability to assess the impact of the value of the static vertical load of the coupling device (resulting from the trailer load and the longitudinal position of its center of mass) on the length of the braking distance of the combination: towing vehicle - trailer.

Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals

This cross-sectional study evaluates the use of the US Food and Drug Administration’s Real-Time Oncology Review (RTOR) program in confirming the effectiveness of cancer drugs.

Association between hypertensive disorders and Bell’s palsy in pregnancy: protocol for a systematic review and meta-analysis

BackgroundBell’s palsy is an idiopathic peripheral nerve palsy involving the facial nerve. Pregnancy, diabetes mellitus and hypertension are the risk factors for Bell’s palsy. However, the association between hypertensive disorders...

La scuola estimativa italiana, gli International Valuation Standard (IVS) e il Codice delle valutazioni immobiliari: i problemi di natura metodologica e applicativa

In some Anglo-Saxon countries, such as Australia and the United States, initiatives have already emerged to promote standardized evaluation practices. However, in Italy, this process is still evolving. Since 1994, the International Valuation Standards Committee (IVSC) has been working on various documents to establish uniform evaluation practices globally. These International Valuation Standards (IVS) are gradually gaining recognition in Italy. Through the efforts of organizations like ABI, Tecnoborsa, the Revenue Agency, and professional associations, IVS are being integrated into evaluation practices for credit approval and public administration requirements.

Comparative analysis and classification of measurement procedures and procedures for transferring of unit of quantity as elements of metrological traceability chain of measurement results

The article analyzes types of measurement procedures and procedures for transferring a unit of quantity, such as: primary reference measurement procedures, reference measurement procedures, calibration procedures, validation procedures, end-user measurement procedures and measurement procedures. The article discusses requirements for developing the presented procedures, their research and approval. The article presents a classification of procedures depending on their place in metrological traceability chain, type of determined metrological characteristics and their application in the field of regulation. Based on the results of the analysis of regulatory documents, a table that describes basic requirements for development and approval of measurement procedures and procedures for transferring a unit of quantity is presented. The article also discusses requirements established for conformity assessment procedures for measurement procedures and procedures for transferring а unit of quantity, such as certification, validation and verification of procedures. The article presents definitions and scope of application for conformity assessment of measurement procedures and procedures for transferring a unit of quantity. Based on the analysis of requirements for conformity assessment of procedures, a flowchart for selecting appropriate conformity assessment procedure is presented. Due to this scheme, laboratories will be able to unambiguously choose one or another conformity assessment procedure to approve the required measurement method or method of transferring a unit of value. In particular, in preparation for accreditation for compliance with the requirements of ISO/IEC 17025-2017 “General requirements for the competence of testing and calibration laboratories.” The proposed scheme of choosing a procedure for conformity assessment of a specific measurement procedure eliminates ambiguity of the requirements of regulatory documents.

Regulatory requirements for approval and Registration Procedure of Biosimilar in US and European Union (EU)

The market for biotechnology-derived medicinal products is evolving rapidly with the imminent entry of biosimilars. The development and approval of biosimilars represent a critical pathway to expanding access to biological therapies while maintaining high standards of safety, efficacy and immunogenicity profile because biosimilars are made in living organisms there may be some minor differences from the reference medicines.&#x0D; In the US, biosimilars are regulated under the Biologics Price Competition and Innovation Act (BPCIA), which is part of the Affordable Care Act. The regulatory pathway emphasizes a stepwise approach, involving analytical studies, preclinical assessments, and comparative clinical trials to establish biosimilarity with a reference product. The FDA assesses the totality of evidence provided by the biosimilar applicant to make a determination on safety, purity, and potency.&#x0D; In the EU, the approval process for biosimilars is governed by the European Medicines Agency (EMA). The regulatory framework relies on a robust comparability exercise, emphasizing extensive analytical studies and well-designed clinical trials to establish biosimilarity. The EMA assesses the comprehensive data package submitted by the biosimilar applicant, considering the totality of evidence before granting marketing authorization.&#x0D; While the overall approach is similar, there are nuanced differences in the regulatory processes. The US typically requires a more prescriptive approach to clinical trials, with the expectation of conducting at least one confirmatory comparative clinical trial. In contrast, the EU may allow for a more tailored approach to clinical development, recognizing that the need for extensive clinical trials may vary depending on the nature of the biosimilar and the reference product.&#x0D; As the biosimilar landscape continues to evolve, ongoing collaboration and harmonization efforts between regulatory authorities aim to streamline global access to high-quality ,cost-effective biologic therapies.