Introduction to the EQIPD quality system (original) (raw)
Related papers
Author response: Introduction to the EQIPD quality system
2021
While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Supported through the European Union's Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers, and collaboration partners such as peers in a multi-site research project. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to userspecific needs and following a user-defined trajectory. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e. performance standards) and provides examples of how such measures can be developed and implemented. However, it does not prescribe any predetermined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system and assessment services for those research units that successfully implement the quality system and seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting nonregulated preclinical research, by helping them generate reliable data that are fit for their intended use.
Current Trends in Quality Assurance of Clinical Research
Clinical Research is an investigation in humans anticipated to decide or confirm the effects of a drug or to identify any adverse reactions with an intention of ascertaining its safety and efficacy. Quality of clinical Research relies on data consistency and subject safety. Quality control and quality assurance are part of quality management systems. There is an increasing focus on having quality systems in place throughout the planning stages of clinical Research. The regulatory outline for clinical Research has altered in recent years with the addition of thorough controls to guarantee patient protection and data dependability. There is a clear requisite to execute the principles of planned quality management in health research to avoid failure, take full advantage of the utilization of offered resources and guarantee reliability and integrity of results. Ideally, all clinical Research ought to have a Clinical Research Quality Management Plan (CRQMP) describing the tools that will be used to guarantee study quality. Adoption of quality-by-design (QbD) and quality risk management methods for clinical Research management is the current mantra at FDA.
Defining “Quality” With Respect to Study Conduct, Science, and Contract Research Organizations
Journal of Pharmaceutical and Pharmacological Sciences
Quality is a common point of discussion in the preclinical evaluation process of new drug candidates, however this can be a very subjective topic. While there is no universally accepted definition of "Quality", under the US Food & Drug Administration's Good Laboratory Practice Guidelines it is most often used to describe study performance, scientific validity, reliability and rigor, and last but not least-documentation. It can be a challenge for the CRO industry to fully appreciate the practical constraints of operating in a typical preclinical research setting as it relates to quality and quality management systems. This overview highlights some of the basic issues defining "Quality" with respect to GLP-compliant research generated as part of the drug development process.
2016
Quality disciplines have been widely used for decades in industrial and business fields. It is only in recent times, however, that Quality management and approaches have received proper attention in life science. In particular, the need for Quality standards in nonregulated research is a matter of considerable current debate inside international research community. The Quality and Project Management OpenLab (qPMO) is a research network involving 5 different Institutes and two Departmentes of the Italian National Research Council (CNR), aimed at realizing a Total Quality Management (TQM) model for Life Sciences laboratories. This TQM OpenLab model will act as a uniform environment in which strong, innovation-oriented research projects can be designed and developed according to international Quality standards and with the planning of Horizon 2020. Our experience demonstrates that Quality management tools can strongly support the management of scientific research through disseminating knowledge, best practice and interoperability and enhance of the economic value of project and research outcomes.
Molecular Therapy - Methods & Clinical Development, 2020
Advanced therapy medicinal products (ATMPs) comprising cell therapy, gene therapy, and tissue-engineered products, offer a multitude of novel therapeutic approaches to a wide range of severe and debilitating diseases. To date, several advanced therapies have received marketing authorization for a variety of indications. However, some products showed disappointing market performance, leading to their withdrawal. The available evidence for quality, safety, and efficacy at product launch can play a crucial rule in their market success. To evaluate the sufficiency of evidence in submissions of advanced therapies for marketing authorization and to benchmark them against more established biological products, we conducted a matched comparison of the regulatory submissions between ATMPs and other biologicals. We applied a quantitative assessment of the regulatory objections and divergence from the expected data requirements as indicators of sufficiency of evidence and regulatory flexibilty, respectively. Our results demonstrated that product manufacturing was challenging regardless of the product type. Advanced therapies displayed critical deficiencies in the submitted clinical data. The submitted non-clinical data packages benefited the most from regulatory flexibility. Additionally, ATMP developers need to comply with more commitments in the post-approval phase, which might add pressure on market performance. Mitigating such observed deficiencies in future product development, may leverage their potential for market success.
2006
Research ratings based on: (i) Research quality measured on a five-point scale. (ii) Research impact measured on a three-point scale. Funding allocation based on: (i) RQF ratings should be used to distribute 100% of the Institutional Grants Scheme (IGS), at least 50% of the Research Training Scheme (RTS) and 100% of additional funding. (ii) The Expert Advisory Group believes that it may not be possible to achieve the full impact of the RQF without the distribution of additional funds. (iii) Institutions will retain discretion to internally allocate RQF-driven research block funding. (iv) Funding will take into account the size of the institution. ◆ 2 UK Research Assessment Exercise (RAE) 2008summary of methodology Universities: (i) To nominate research unit of assessment (UoA). (ii) Each submission to include researchers' evidence portfolios (comprising up to four research outputs undertaken during a 6year assessment period), individual staff details, data on research student numbers and studentships, research income and research environment and esteem. UK-RAE Assessment Panel: (i) 15 main expert panels, 67 disciplinary subpanels. (ii) Each panel comprising 12-15 academic and expert reviewers to assess research groupings and provide ratings. Research Quality Profile based on: (i) Research outputs. (ii) Research environment and esteem indicators. (iii) Publication of a "quality profile" showing the number of staff submitted for assessment and the proportion of research activity that falls into five categories from unclassified to four-star quality (according to degree of excellence).
2020
The reproducibility crisis in science is a multifaceted problem involving practices and incentives, both in the laboratory and in publication. Fortunately, some of the root causes are known and can be addressed by scientists and authors alike. After careful consideration of the available literature, the National Institutes of Health identified several key problems with the way that scientists conduct and report their research and introduced guidelines to improve the rigor and reproducibility of pre-clinical studies. Many journals have implemented policies addressing these same criteria. We currently have, however, no comprehensive data on how these guidelines are impacting the reporting of research. Using SciScore, an automated tool developed to review the methods sections of manuscripts for the presence of criteria associated with the NIH and other reporting guidelines, e.g., ARRIVE, RRIDs, we have analyzed ~1.6 million PubMed Central papers to determine the degree to which article...
Quality of clinical trials: A moving target
Perspectives in Clinical Research, 2011
Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.
F1000Research, 2018
Stakeholders in healthcare are increasingly turning to real world evidence (RWE) to inform their decisions, alongside evidence from randomized controlled trials. RWE is generated by analysing data gathered from routine clinical practice, and can be used across the product lifecycle, providing insights into areas including disease epidemiology, treatment effectiveness and safety, and health economic value and impact. Recently, the US Food and Drug Administration and the European Medicines Agency have stated their ambition for greater use of RWE to support applications for new indications, and are now consulting with their stakeholders to formalize standards and expected methods for generating RWE. Pharmaceutical companies are responding to the increasing demands for RWE by developing standards and processes for each stage of the evidence generation pathway. Some conventions are already in place for assuring quality, whereas other processes are specific to the research question and data sources available. As evidence generation increasingly becomes a core role of medical affairs divisions in large pharmaceutical companies, standards of rigour will continue to evolve and improve. Senior pharmaceutical leaders can drive this change by making RWE a core element of their corporate strategy, providing top-level direction on how their respective companies should approach RWE for maximum quality. Here, we describe the current and future areas of RWE application within the pharmaceutical industry, necessary access to data to generate RWE, and the challenges in communicating RWE. Supporting and building on viewpoints from industry and publicly funded research, our perspective is that at each stage of RWE generation, quality will be critical to the impact that RWE has on healthcare decision-makers; not only where RWE is an established and evolving tool, but also in new areas that have the potential to disrupt and to improve drug development pathways.