Testing https://evidenceaccelerator.org/ en Evidence Accelerator Model – A Critical Catalyst Towards A Learning Health System https://evidenceaccelerator.org/blog/evidence-accelerator-model-critical-catalyst-towards-learning-health-system <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--title--blog-post.html.twig x field--node--title.html.twig * field--node--blog-post.html.twig * field--title.html.twig * field--string.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--node--title.html.twig' --> <span class="field field--name-title field--type-string field--label-hidden">Evidence Accelerator Model – A Critical Catalyst Towards A Learning Health System </span> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--node--title.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-date--blog-post.html.twig * field--node--field-date.html.twig * field--node--blog-post.html.twig * field--field-date.html.twig * field--datetime.html.twig x field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field.html.twig' --> <div class="field field--name-field-date field--type-datetime field--label-hidden field__item"> <!-- THEME DEBUG --> <!-- THEME HOOK: 'time' --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/time.html.twig' --> <time datetime="2021-04-23T12:00:00Z" class="datetime">Friday, April 23, 2021</time> <!-- END OUTPUT from 'core/themes/classy/templates/field/time.html.twig' --> </div> <!-- END OUTPUT from 'core/themes/classy/templates/field/field.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--uid--blog-post.html.twig x field--node--uid.html.twig * field--node--blog-post.html.twig * field--uid.html.twig * field--entity-reference.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--node--uid.html.twig' --> <span class="field field--name-uid field--type-entity-reference field--label-hidden"> <!-- THEME DEBUG --> <!-- THEME HOOK: 'username' --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/user/username.html.twig' --> <span>webmin</span> <!-- END OUTPUT from 'core/themes/classy/templates/user/username.html.twig' --> </span> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--node--uid.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--created--blog-post.html.twig x field--node--created.html.twig * field--node--blog-post.html.twig * field--created.html.twig * field--created.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--node--created.html.twig' --> <span class="field field--name-created field--type-created field--label-hidden">Fri, 04/23/2021 - 16:23</span> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--node--created.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-authors--blog-post.html.twig * field--node--field-authors.html.twig * field--node--blog-post.html.twig * field--field-authors.html.twig x field--text-long.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--text-long.html.twig' --> <div class="clearfix text-formatted field field--name-field-authors field--type-text-long field--label-hidden field__item"><p>Amy Abernethy, MD, PhD</p></div> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--text-long.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--body--blog-post.html.twig * field--node--body.html.twig * field--node--blog-post.html.twig * field--body.html.twig x field--text-with-summary.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--text-with-summary.html.twig' --> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><p class="paragraph"><em><span><span><span><span><span>Dr. Amy Abernethy reflects on the work accomplished through the Evidence Accelerator as well as its potential for the future as she ends her tenure as Principal Deputy Commissioner of Food and Drugs at the FDA.   </span></span></span></span></span></em></p> <p class="paragraph"> </p> <p><img alt="Amy Abernethy, MD, PhD" data-entity-type="file" data-entity-uuid="2d183477-a7c4-4e38-ab4d-aaf3bd95ff46" height="264" src="/sites/default/files/inline-images/Amy_Abernethy.jpg" width="223" class="align-right" loading="lazy" /></p> <p class="paragraph"><span><span><span><span><span>Many of you are aware that my career has had some unique and unexpected turns – including time in academia, clinical research, international care delivery, health tech, and most recently in government service. While each of these “stops” along the way offer distinct lenses and opportunities, my core focus, the ‘north star’ that compels me each day, is the need to take care of the patient sitting in front of me. When practicing in my oncology clinic, treating melanoma patients, I envisioned a time when I could walk into the room (or today through a virtual platform) and know that the care and decisions would be informed by similar individuals with melanoma who came before, while also tailored to the patient’s individual needs and characteristics. This model and aspirational system is what we refer to as a learning health system. In this system each individual’s experience is collected through data that is curated and continuously put to use for a variety of tasks, while also respecting personal privacy and fostering trust.</span></span></span></span></span></p> <p class="paragraph"><span><span><span><span><span>Our national and global shared experience with COVID-19 crystallized the criticality of near real-time, real-world data (RWD) to generate insights and actionable information; and the imperative to drive towards a learning health system. The Reagan-Udall Foundation, in close collaboration with Friends of Cancer Research, brought their strength as a public-private convener to aid in this important effort creating the COVID-19 Evidence Accelerator. Each one of you has contributed to this effort in a meaningful way.  </span></span></span></span></span></p> <p class="paragraph"><span><span><span><span><span>You all know well what this community has accomplished together and how novel this endeavor has been. As I reflect today, just a year past our first official ‘lab meeting’ on April 16, 2020, I am heartened, humbled, and energized by what is possible. "Way back in April 2020” (!), we thought we would be furiously working into the summer – sprinting as we used to say – and then doing a lot more scientific work into the fall and maybe focusing on vaccines and getting back to “normal.” Predicting the future is hard! Moving on to the marathon, the </span></span><span><span><a href="https://evidenceaccelerator.org/">Evidence Accelerator</a></span></span><span><span> community adapted and continued to bring forward challenges, digging into the parallel analyses, expanding our spheres of focus, spanning boundaries and evolving as we continue to learn. This has all been done in part by subscribing to a set of principles that guide these efforts, with ruthless transparency at the fore.  </span></span></span></span></span></p> <p class="paragraph"><span><span><span><span><span>The </span></span><span><span><a href="https://evidenceaccelerator.org/">Evidence Accelerator</a></span></span><span><span> model has created a </span></span><span lang="EN" xml:lang="EN" xml:lang="EN"><span><span><span>mechanism for engagement with diverse stakeholders to build and create solutions for the future. Critical to this has been a belief that we are better when we have all voices at the tables, listening to each other and learning together. For example, we intentionally included data and tech experts since they are often missing from the design phase of these projects; the goal is to ensure new ideas and solutions have a (virtual) ‘seat at the table’ to partner with the broader scientific community. Such an approach is key to unlocking the vast streams of data in service of solving critical questions in COVID-19.</span></span></span></span> </span></span></span></p> <p class="paragraph"><span><span><span><span><span>The <a href="https://evidenceaccelerator.org/">Evidence Accelerator</a> is a force for progress – spend time  taking stock of the community, how the conversations have moved forward, and what we have learned.  Critical to this has been the share of voice and offering an equal seat at the table to a community of stakeholders willing to work together to address the pandemic, including data/tech, regulatory, academia, clinicians, patients, analysts, and more. Harness this diversity – think about what seat might be missing – draw upon the energy and shared experience of COVID-19 to continue that important work, and envision the ways it can be replicated, refined, and scaled. There are many problems to be solved beyond COVID!</span></span></span></span></span></p> <p class="paragraph"><span><span><span><span><span>I am an ardent champion for the transformative promise of data and the application of a variety of data sources to contribute to the totality of the evidence. There are myriad drops, streams, and rivers of data including data that are passively collected from within the ecosystem of care delivery, patient-generated health data like symptom information or sensors in our watches, social and environmental data, and biological data from laboratory tests or discovery sciences. We need to learn to leverage all types of available data in a responsible way, to create a system where data translates to improvement in health. </span></span></span><span><span>We need to keep improving the datasets themselves. </span></span><span><span><span>We need to keep advancing the rigorous scientific methods to generate insights from these datasets. And more! There is so much to do and addressing critical COVID-19 questions together has helped to chart the path of the possible. </span></span></span> </span></span></p> <p><span><span><span><span><span>As I close-out my official post at FDA, know that I will continue to cheer on the work you are doing in the Evidence Accelerator community.  Remember, hard things are hard, but doable when we are addressing important tasks, and doing the work together.  </span></span></span></span></span></p> <p><span><span><span><span><span>A huge and hearty thank you.  </span></span></span></span></span></p> <p> </p></div> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--text-with-summary.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-blog-tags--blog-post.html.twig * field--node--field-blog-tags.html.twig * field--node--blog-post.html.twig * field--field-blog-tags.html.twig x field--entity-reference.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> <div class="field field--name-field-blog-tags field--type-entity-reference field--label-hidden field--entity-reference-target-type-taxonomy-term clearfix field__items"> <div class="field__item"><a href="/taxonomy/term/35" hreflang="en">data analytics</a></div> <div class="field__item"><a href="/taxonomy/term/36" hreflang="en">real world evidence</a></div> <div class="field__item"><a href="/taxonomy/term/30" hreflang="en">FDA</a></div> </div> <!-- END OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-topic--blog-post.html.twig * field--node--field-topic.html.twig * field--node--blog-post.html.twig * field--field-topic.html.twig x field--entity-reference.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> <div class="field field--name-field-topic field--type-entity-reference field--label-above field--entity-reference-target-type-taxonomy-term clearfix"> <div class="field__label">Topic</div> <div class="field__items"> <div class="field__item"><a href="/taxonomy/term/20" hreflang="en">Data/data analytics</a></div> <div class="field__item"><a href="/taxonomy/term/23" hreflang="en">Real world evidence</a></div> <div class="field__item"><a href="/taxonomy/term/25" hreflang="en">Testing</a></div> </div> </div> <!-- END OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> Fri, 23 Apr 2021 20:23:04 +0000 webmin 100 at https://evidenceaccelerator.org Guidance on Evaluating Impact of Viral Mutations on COVID-19 Tests and Lessons Learned Thus Far https://evidenceaccelerator.org/blog/guidance-evaluating-impact-viral-mutations-covid-19-tests-and-lessons-learned-thus-far <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--title--blog-post.html.twig x field--node--title.html.twig * field--node--blog-post.html.twig * field--title.html.twig * field--string.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--node--title.html.twig' --> <span class="field field--name-title field--type-string field--label-hidden">Guidance on Evaluating Impact of Viral Mutations on COVID-19 Tests and Lessons Learned Thus Far </span> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--node--title.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-date--blog-post.html.twig * field--node--field-date.html.twig * field--node--blog-post.html.twig * field--field-date.html.twig * field--datetime.html.twig x field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field.html.twig' --> <div class="field field--name-field-date field--type-datetime field--label-hidden field__item"> <!-- THEME DEBUG --> <!-- THEME HOOK: 'time' --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/time.html.twig' --> <time datetime="2021-04-02T12:00:00Z" class="datetime">Friday, April 02, 2021</time> <!-- END OUTPUT from 'core/themes/classy/templates/field/time.html.twig' --> </div> <!-- END OUTPUT from 'core/themes/classy/templates/field/field.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--uid--blog-post.html.twig x field--node--uid.html.twig * field--node--blog-post.html.twig * field--uid.html.twig * field--entity-reference.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--node--uid.html.twig' --> <span class="field field--name-uid field--type-entity-reference field--label-hidden"> <!-- THEME DEBUG --> <!-- THEME HOOK: 'username' --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/user/username.html.twig' --> <span>webmin</span> <!-- END OUTPUT from 'core/themes/classy/templates/user/username.html.twig' --> </span> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--node--uid.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--created--blog-post.html.twig x field--node--created.html.twig * field--node--blog-post.html.twig * field--created.html.twig * field--created.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--node--created.html.twig' --> <span class="field field--name-created field--type-created field--label-hidden">Fri, 04/02/2021 - 16:21</span> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--node--created.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--body--blog-post.html.twig * field--node--body.html.twig * field--node--blog-post.html.twig * field--body.html.twig x field--text-with-summary.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--text-with-summary.html.twig' --> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"> <!-- THEME DEBUG --> <!-- THEME HOOK: 'filter_caption' --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/content-edit/filter-caption.html.twig' --> <figure role="group" class="caption caption-img align-right"><img alt="Dr. Timothy Stenzel" data-entity-type="file" data-entity-uuid="450aa1ab-3292-4f3a-9058-8f50bb5888ef" height="200" src="/sites/default/files/inline-images/stenzel_trimmed.jpg" width="175" loading="lazy" /><figcaption>Dr. Timothy Stenzel</figcaption></figure><!-- END OUTPUT from 'core/themes/classy/templates/content-edit/filter-caption.html.twig' --><p><em><span><span><span><span>As part of our March 18 COVID-19 Diagnostics Evidence Accelerator Collaborative meeting, Dr. Timothy Stenzel, Director of FDA’s Office of In Vitro Diagnostics and Radiological Health detailed the impact of viral mutations on COVID-19 testing and answered key questions posed by meeting participants. In light of new FDA guidance </span></span></span></span></em><em><span><span><span><span>on monitoring and responding to emerging variants and diagnostic test performance, his insight is particularly informative. Below are highlights from that discussion.</span></span></span></span></em></p> <p> </p> <p><span><span><span><span>Dr. Stenzel began with an overview of the impact of viral mutations on testing and then answered questions from Accelerators.</span></span></span></span></p> <ul><li><span><span><span>Viral mutations present a risk to the effectiveness of diagnostic tests and vaccines. If vaccines lose their effectiveness against variants, diagnostic testing (and test performance) becomes more important in the pandemic response. </span></span></span></li> <li><span><span><span>At the beginning of the pandemic, developers were encouraged to develop multitarget assays. However, due to the shortage of tests, the recommendations for a multitarget assay were modified to allow for a single target assay. Because the FDA expected mutations in the virus, the Agency asked manufacturers to conduct an analysis of known viral mutations at the beginning of the pandemic, and now developers focus on the US primarily, to assess whether the test will perform with the known mutations. </span></span></span></li> <li><span><span><span>With the growing number of variants and access to the primers and probe sequences for Emergency Use Authorized tests, the FDA conducted their own analysis to see if the variants had an impact on the test. This led the FDA to release safety communications where they described three tests that are impacted by viral mutations. </span></span></span></li> <li><span><span><span>In  <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-evaluating-impact-viral-mutations-covid-19-tests">guidance released on February 22, 2021</a>, FDA describes working with developers where they will consider current and future mutations that may impact their tests and develop new tests as needed. Also, the guidance described the ongoing efforts to monitor the current tests and describe improvements that can be made to existing and new tests. [<a href="https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests">See also additional information published by FDA on March 30, 2021</a>.]</span></span></span></li> </ul><p><strong><span><span><span><span>Questions and Answer Session</span></span></span></span></strong></p> <p><span><span><span><span><strong>Question:</strong> Are there any questions or feedback that the FDA/CDRH has been getting from test developers about the new guidance?</span></span></span></span></p> <p><span><span><span><span><strong>Answer:</strong> Developers have been engaged in the public comment aspect of the new guidance. The guidance was issued to make the process for developers clear and transparent about what the FDA/CDRH wants to do. </span></span></span></span></p> <p><span><span><span><span><strong>Question:</strong> Will the results report be required to include “sensitivity” to known major variants?</span></span></span></span></p> <p><span><span><span><span><strong>Answer:</strong> To date, there is no significant decrease in overall test sensitivity, therefore there is no need to report sensitivity to variants, though EUA labeling is usually updated with relevant information. Increased occurrence of false negative results will trigger further investigation. In the event of a false negative, it will be important to know whether the patient was exposed to a variant. FDA/CDRH has prioritized sequencing based assays and will begin prioritizing genotyping based assay. This will be important to evaluate diagnostic testing, therapeutics, and vaccines.</span></span></span></span></p> <p><span><span><span><span><strong>Question:</strong> What incentives are in place to have developers review performance of their assays for different variants?</span></span></span></span></p> <p><span><span><span><span><strong>Answer:</strong> There are no defined incentives. However, developers want to ensure that their test continues to perform well, which motivates them to continue to review performance of their assay for different variants. FDA is interested in helping assure that test performance remains high. As such, we work with diagnostic companies to facilitate assay tests for new variants. </span></span></span></span></p> <p><span><span><span><span><strong>Question:</strong> Test developers are sequencing; however, they are struggling to decided what to report out. Should they report out on the spike variant or the lineage? </span></span></span></span></p> <p><span><span><span><span><strong>Answer:</strong> The value of sequencing is for public health planning and action. For FDA/CDRH, the prevalence of variants, particularly variants of concern, provides context for trends in COVID-19 presentation and transmission. There is limited evidence that mutations need to be reported for patient care; though this may be needed in the future. The FDA is accepting submissions for tests that will allow genotyping information to be collected and reported. The FDA encourages such advancements to fight the pandemic. </span></span></span></span></p> <p><span><span><span><span><strong>Question:</strong> Do you see a role for multi-target testing and variant calling in a distributed setting, or do you feel that sequencing will continue to be the tool to track prevalence of variants?</span></span></span></span></p> <p><span><span><span><span><strong>Answer:</strong> The FDA is open to the genotyping strategy. Challenges arise with additional variants of the virus. The concern is that genotyping assays will not be as useful as sequencing. We want to capture what mutations and variants are possible and design assays for those variants that will prove to be beneficial. </span></span></span></span></p> <p><span><span><span><span><strong>Questions:</strong> Development requires samples of the different kinds of variants, spiking works for the variant testing but is not necessary for the immune response - are there sample repositories that can be used for development?</span></span></span></span></p> <p><span><span><span><span><strong>Answer:</strong> This is part of the Pandemic response to partner with other governmental agencies. However, the challenge that occurs is the identification of which samples to put in the repositories. The FDA is ready to engage stakeholders to address this. </span></span></span></span></p></div> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--text-with-summary.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-blog-tags--blog-post.html.twig * field--node--field-blog-tags.html.twig * field--node--blog-post.html.twig * field--field-blog-tags.html.twig x field--entity-reference.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> <div class="field field--name-field-blog-tags field--type-entity-reference field--label-hidden field--entity-reference-target-type-taxonomy-term clearfix field__items"> <div class="field__item"><a href="/taxonomy/term/14" hreflang="en">Diagnostics</a></div> <div class="field__item"><a href="/taxonomy/term/37" hreflang="en">Variants</a></div> </div> <!-- END OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-topic--blog-post.html.twig * field--node--field-topic.html.twig * field--node--blog-post.html.twig * field--field-topic.html.twig x field--entity-reference.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> <div class="field field--name-field-topic field--type-entity-reference field--label-above field--entity-reference-target-type-taxonomy-term clearfix"> <div class="field__label">Topic</div> <div class="field__items"> <div class="field__item"><a href="/taxonomy/term/25" hreflang="en">Testing</a></div> <div class="field__item"><a href="/taxonomy/term/26" hreflang="en">Vaccines</a></div> <div class="field__item"><a href="/taxonomy/term/27" hreflang="en">Variants</a></div> </div> </div> <!-- END OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> Fri, 02 Apr 2021 20:21:25 +0000 webmin 99 at https://evidenceaccelerator.org