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    Home > Biochemistry News > Biotechnology News > Beyond the Pandemic Perspective: How to Ensure the Integrity of Clinical Trial Data for the Post-COVID-19 Period.

    Beyond the Pandemic Perspective: How to Ensure the Integrity of Clinical Trial Data for the Post-COVID-19 Period.

    • Last Update: 2020-09-18
    • Source: Internet
    • Author: User
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    The spread of the COVID-19 outbreak shows no signs of successful containment in many parts of the world.
    more subtlely, clinical trials during pandemics are becoming more visible.
    , which is continuing in the United States, is generating a steady stream of data.
    the bid must adjust their analysis and reporting strategies and adapt to the current situation.
    , data integrity is more important than ever.
    pharmaceutical companies should properly document protocol deviations and ensure data integrity around COVID-19 impact evaluation, mitigation, and monitoring visits.
    to evaluate the specific impact of the COVID-19 pandemic on clinical trials can effectively focus future work in the right direction.
    at the beginning of the pandemic, a number of pharmaceutical companies conducted large-scale impact assessments aimed at identifying sites where suspended clinical studies could be identified in an effort to minimize the impact of outbreak-related disruptions in clinical trials.
    initial impact assessment, focusing on recruitment issues and paying high attention to recruitment barriers at the research level.
    as the outbreak progresses, impact assessments become more and more detailed, focusing on the number of "affected patients" (whether or not the study is suspended).
    the next wave of impact assessments should focus on data, particularly data cleaning, management and analysis.
    this work will provide useful information for proactive impact reduction.
    impact of the assessment data will be balanced between specific clinical trial scenarios, the extent to which patients are treated, and the end of clinical trials. The main objectives of
    evaluation include: (1) determining how many patients do not have sufficient data to evaluate efficacy due to missed visits or other factors;
    impact Reduction Strategies include two aspects: (1) mitigating the risk of patients not being treated;
    possible impact reduction measures, including extending the consultation window or increasing the number of additional visits (other methods are considered in accordance with the objectives of the study).
    all clinical trial sites should explore the possibility of infusions or the mailing of oral clinical trial medications to patients' homes.
    it is important to take advantage of all available opportunities to keep patients in treatment and always put patient safety first.
    this should include training for health care providers and authorized persons on how to properly conduct revised visits, while assisting them in learning the new process.
    should organize a multidisciplinary team to discuss impact reduction and make decisions based on the specific circumstances of the specific scenario.
    , ethical issues should always be a top priority in decision-making and patient safety should always be a top priority.
    to make full use of monitoring opportunities And a flexible monitoring strategy is key to reducing the impact of COVID-19 on the research level and ensuring data integrity.
    methods available for supervision include remote supervision, centralized supervision and so on.
    remote monitoring During the COVID-19 pandemic, the use of interview techniques was particularly useful in promoting proactive measures in smaller sites with less infrastructure.
    treat each site as a separate case and consult the Coordinator for patient updates and safety updates.
    make full use of the relationship with the test site and support the test site as much as possible.
    adverse events (adverse events, AEs) reported during the pandemic may be due in part to patients' reluctance to visit the site in person.
    the test site should communicate regularly with the patient to see if all AEs need to be reported.
    the flexibility to seize the moment is also crucial.
    during the CODID-19 pandemic, bidders often did not complete eight hours of virtual remote surveillance visits per day in a day or two, but between two and three hours a week.
    the inspectors and coordinators, this approach is effective and desirable.
    can also consider virtual visits to clinical trial sites (site startion visit, SIV).
    experience before and during the pandemic has shown that virtual site start-up visits (SIV) are successful.
    make full use of the lessons learned from remote monitoring during COVID-19 to guide future monitoring strategies.
    time, the test site will become more familiar with and accept this approach.
    central monitoring to consider adopting or extending centralized monitoring to identify and identify other data integrity issues and focus on key data areas.
    now, pharmaceutical companies are more inclined than ever to adopt centralized monitoring methods.
    affected by the COVID-19 pandemic, the use of data analysis to trigger surveillance visits and identify potential signals early is becoming a broader approach across the industry.
    , however, this approach requires real-time access to data to understand appropriate key performance indicators (KPIs) and their thresholds, which may need to be adjusted under COVID-19 outbreak conditions.
    applications require dedicated in-house teams and processes, as well as appropriate skills and training.
    provides a more comprehensive view of the data, focusing on identifying trends, including trends across the data mix.
    comes from an in-depth understanding of centralized monitoring, enabling bidders to identify priority areas for monitoring and follow-up, identify training opportunities and even trigger pilot programme revisions when needed.
    to immediately conduct gap analysis to determine whether the processes implemented during a pandemic have worked and can continue to be used effectively in the future.
    often re-evaluate KPIs, thresholds, and mass tolerances (Quality Tolerance Limits, QTL) based on the results of the assessment of the collected data, and make possible adjustments.
    review some remote and centralized monitoring results in a risk-based manner, and modify the monitoring process and strategy accordingly according to the results of the review.
    maintain close contact with the Ombudsman and the premises.
    how they conducted the monitoring visit and if the Coordinator or Principal Researcher (PI) had any feedback.
    the programme deviation occurred during COVID-19 with the deviation that occurred after the on-site diagnosis and recovery.
    such an approach would allow for continued promotion of on-site surveillance visits.
    data integrity during the COVID-19 pandemic, the most common data integrity challenge was data loss due to missed visits.
    As steps are taken to continue the conversion or revision of the consultation, the Coordinator is responding to the increasing workload by contacting patients, collecting as much data as possible and entering the data into the Electronic Data Acquisition System (EDC) in the event of a missed visit.
    to ensure that data is entered in a way that provides useful and meaningful information in the future.
    the correct collection scheme bias during the COVID-19 pandemic, there was a lack of consensus in the industry to document these deviations.
    there is no need to separate the relevant deviations caused by COVID-19 from the related deviations caused by non-COVID-19, the bid party has the means to successfully report these two types of deviations.
    by the inspectors in the visit report clearly stated that the patient was treated during COVID-19.
    the manner in which deviations are recorded and, if possible and necessary, should be explicitly attributed to COVID-19.
    with the support of the FDA, the bid created an overall documentation document covering the start and end dates to address the deviation.
    note indicates that, in the face of the COVID-19 pandemic, between the X and Y dates, the bid party may deviate from the original monitoring plan or programme, but the reason for this deviation is to ensure patient safety.
    documentation should state that the host is allowed to deploy processes that are not part of the monitoring plan without having to update each individual plan.
    each individual deviation should still be recorded in the EDC report or electronic data acquisition system (EDC), if applicable, but the documentation notes give the host permission to flexibly adjust the monitoring methodology as needed.
    if, after the resumption of routine studies, inspections are still ongoing that are different from those provided for in the original CTOR plan, these separate plans should be updated to reflect changes.
    consider using a standard data acquisition method to collect information related to COVID-19, such as adding uniform COVID-19-specific data fields to the case reporting table to ensure consistency across all studies.
    before, during and after: difference assessment between different locations Accurately collect and report data affected by COVID-19 requires prior definition of "prior", "in-process" and "after-the-fact" points in time.
    , in-process and post-event schedules for identifying challenges are challenging due to regional, local, and site-related differences affected by the COVID-19 pandemic.
    recommended method is to estimate the pandemic within the scope of the experiment.
    consider setting the date at an appropriate inflection point, such as the date on which COVID-19 first affected the trial, the date on which the patient assessment can be re-evaluated, and so on.
    also need to be aware of the exact impact at these points in time.
    Since preventive measures may have been in place at each site prior to understanding the impact on the local area, the bid should work with each site to confirm the date of its impact (i.e. site closure, group suspension, change in visiting methods, etc.).
    should use these complete schedules to use the parameters around the data and provide guidance on the coding requirements for writing data analysis.
    regulator will need to look at detailed data at the site level, including the suspension/recovery date of the event.
    must be aware of the role of COVID-19 at the patient level, particularly with regard to programme deviations.
    , it is necessary to determine which deviations are due to COVID-19 and which are true site deviations.
    should still report programme deviations through their normal procedures and should work with statisticians to develop and plan strategies on how to report relevant information at the end of the trial.
    this ensures that they are able to capture and capture the right level of data and ensure data integrity.
    to grasp the reasonable intervention opportunity The bid party should carry out a summary assessment under the blind situation, detailed description of patient loss, may affect the program deviation of the assessable population, all loopholes in the data, etc.
    ideally, if the study is still ongoing, the bid should do so and if the bid decides that more patients need to be recruited, the trial will be aggregated before the recruitment stops.
    A blind review would help the bid to assess issues such as "Can the current group guarantee the end of the trial when the trial is nearly completed and then suspended" or "Should the bid undertake an in-period analysis as soon as possible when the bid is about to conduct an in-period analysis, but only a small number of patients are missing, and if recruitment is suspended due to COVID-19 and/or extremely delayed?" While much of the U.S. is still struggling with the COVID-19 pandemic, it's time for bidders to move beyond the COVID-19 pandemic and focus on strategies to assess the impact of the pandemic on data integrity and mitigation strategies.
    objective of the bid is to provide meaningful data for success during and after the pandemic, ensuring the overall data integrity, flexibility and forward-looking approach will be key to conducting research.
    in danger, from the response to the COVID-19 pandemic, we can understand and master a lot of practical knowledge, in order to deal with the crisis, to ensure the orderly progress of clinical trials, to ensure the integrity of clinical trial data, to provide useful experience.
    : Todd Johnson, Patricia Davis, Caroline Alix. Looking Beyond the Pandemic: Security Data Integrity Post-COVID-19. Jun 4, 2020. Retrieved Jun 5, 2020 from ni A Khin, Gail Francis, Jean Mulinde, et al. Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop. Clin Pharmacol Ther. 2020 Jan 20. doi: 10.1002/cpt.1794. Thomas R. Fleming, Dominic Labriola, Janet Wittes. Conducting Clinical Research During the COVID-19 Pandemic Protecting Scientific Integrity. JAMA. 2020;324(1):33-34. doi:10.10.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

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