LitCovid-sentences  

PMC:7536913 / 3719-8681 JSONTXT 6 Projects

Annnotations TAB TSV DIC JSON TextAE

Id Subject Object Predicate Lexical cue
T26 0-55 Sentence denotes TRANSFORM REGULATORY FRAMEWORKS TO STREAMLINE PROCESSES
T27 56-242 Sentence denotes First, it is imperative to increase the use of existing electronic‐based tools and accelerate modern digital efforts to improve efficiency of operations for both regulators and industry.
T28 243-415 Sentence denotes Outdated technical infrastructure and lack of contemporary digital capabilities present a challenge across many regulatory authorities, regardless of the level of maturity.
T29 416-448 Sentence denotes COVID‐19 exposed this shortfall.
T30 449-624 Sentence denotes Faster and better‐informed regulatory decisions, coupled with enhanced platforms to enable collaboration and reliance activities among regulators, 6 are critical for success.
T31 625-759 Sentence denotes We discuss the following recommendations, recognizing that certain areas are more practiced, while others require further examination.
T32 761-814 Sentence denotes Virtual clinical trials and digital health technology
T33 815-959 Sentence denotes By far, the biggest innovation emerging from the COVID‐19 crisis is the virtualization of many aspects of clinical trials by digital enablement.
T34 960-1140 Sentence denotes By utilizing various digital health technologies, patients can participate in one or more aspects of a trial without visiting a clinical site as part of “routine” drug development.
T35 1141-1322 Sentence denotes We commend the regulators for developing much needed guidance during the pandemic, allowing for remote monitoring and other alternatives to help sponsors continue to conduct trials.
T36 1323-1682 Sentence denotes While decentralized clinical trials and digital health technologies have been critical during the current pandemic, the increased use of telemedicine creates opportunities to reform the clinical trial paradigm by implementing digitally enabled tools in areas such as patient screening, informed consent, telemedicine‐facilitated visits, and remote monitoring.
T37 1683-1952 Sentence denotes The International Council for Harmonization (ICH) is currently revising the E6 Guideline Good Clinical Practice, and we believe this is an ideal opportunity to support the development of a responsive guideline with stakeholders’ perspectives and advances in technology.
T38 1953-1954 Sentence denotes 7
T39 1956-2002 Sentence denotes Alternatives to on‐site regulatory inspections
T40 2003-2131 Sentence denotes The idea of a virtual regulatory inspection seemed reserved for the next generation of regulatory professionals, until COVID‐19.
T41 2132-2289 Sentence denotes Our experience with remote Good Clinical Practice and pharmacovigilance inspections by regulators during the pandemic has been both positive and encouraging.
T42 2290-2430 Sentence denotes The challenges of COVID‐19 underscore the importance of achieving process efficiency while at the same time ensuring high‐quality standards.
T43 2431-2637 Sentence denotes To date, the remote inspections have demonstrated efficiencies for regulators and sponsors by eliminating travel, enhancing document management systems, and fostering disciplined and focused communications.
T44 2638-2969 Sentence denotes We recognize the broader practice of virtual inspections is untested, but it’s an area worth exploring, where regulatory inspections of investigator sites and sponsors are digitally enabled (e.g., secure video conferencing), allowing inspectors to interview personnel, review procedures, and validate data against source documents.
T45 2971-3037 Sentence denotes A global platform to accelerate real‐time data and insight sharing
T46 3038-3180 Sentence denotes The pandemic has galvanized a renewed call for knowledge and voluntary data sharing as researchers race to find solutions to end the pandemic.
T47 3181-3369 Sentence denotes While stakeholders are committed to facilitating effective data sharing of COVID‐19 research findings, the types of data and the methods of sharing should be harmonized, where appropriate.
T48 3370-3616 Sentence denotes Forums such as ICH and the International Coalition of Medicines Regulatory Authorities can play an important role in convening stakeholders to navigate the various challenges and avoid the emergence of fragmented, potentially conflicting systems.
T49 3617-3839 Sentence denotes Beyond data sharing to accelerate development, cloud‐based systems have the potential to accelerate and streamline regulatory review and enhance regulatory decision making, encompassing parallel agency review and reliance.
T50 3840-3841 Sentence denotes 8
T51 3843-3900 Sentence denotes Universal acceptance of electronic regulatory submissions
T52 3901-4037 Sentence denotes As noted above, we have seen a wide range of flexibility by regulators to avoid delays in patient access to new and existing treatments.
T53 4038-4271 Sentence denotes Regulators around the world have permitted electronic files for Certificates of Pharmaceutical Products and Good Manufacturing Practices, and accepted all regulatory filings electronically (e.g., meeting packages and annual reports).
T54 4272-4485 Sentence denotes This reduction in administrative burden—without reduction in quality of information being provided—has simplified regulatory processes while maintaining compliance, and facilitated more efficient use of resources.
T55 4486-4604 Sentence denotes Moreover, COVID‐19 has revealed the advantages to having real‐time and accurate product information for all countries.
T56 4605-4750 Sentence denotes Electronic labeling provides the opportunity to immediately share with patients and healthcare providers changes in approved product information.
T57 4751-4960 Sentence denotes While we recognize many regulators have already taken steps toward implementing electronic labeling, it is important to do so in a consistently accessible manner, seeking standards and interoperable solutions.
T58 4961-4962 Sentence denotes 9