Real world evidence https://evidenceaccelerator.org/ en A Community of “Accelerators” https://evidenceaccelerator.org/blog/community-accelerators <!-- 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">A Community of “Accelerators”</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="2021-09-01T12:00:00Z" class="datetime">Wednesday, September 01, 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>mmcnamara</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">Wed, 09/01/2021 - 11:03</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><strong>Authors:</strong><br /><em>Aloka G. Chakravarty, PhD, </em>Senior Statistical Advisor, Office of the Commissioner, U.S. Food and Drug Administration<em> <br /> Tamar Lasky, PhD, FISPE, </em>Senior Advisor for Real-World Evidence, Office of the Commissioner, U.S. Food and Drug Administration <em>    </em><br /><span><span><em>Amar Bhat, PhD</em></span></span>, Chief Operating Officer, Reagan-Udall Foundation for the FDA</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><span><span><span>In June of 2021, the Therapeutics Parallel Analysis (TxPA) work group of the COVID-19 Evidence Accelerator paused to conduct a retrospective or “retro”. For those of you who are unfamiliar with the expression, a retro is an opportunity to review the work of a previous cycle or “sprint” in Agile terminology. A retro allows the Evidence Accelerator community the opportunity to step back and see how far we have come, what went well, and where we could make improvements. </span></span></span></p> <p><span><span><span>The retro revealed a few themes which we plan to discuss in some detail in a series of blog posts.  This first article examines the development of “Community” in the Evidence Accelerator. </span></span></span></p> <p><span><span><span>Our first TxPA workstream focused on the question of hydroxychloroquine use in COVID-19 patients concluded in the fall of 2020 resulting in our first </span><a href="https://doi.org/10.1371/journal.pone.0248128"><span>publication</span></a><span>.  The TxPA work group has made significant progress since the Fall of 2020, focusing on our two current workstreams: Natural History of Coagulopathy and Remdesivir. The questions that we chose to tackle were developed collaboratively between FDA and the broader Evidence Accelerator community, specifically: </span></span></span></p> <ul><li><span><span><span>What is the natural history of coagulopathy in COVID-19 patients?</span></span></span></li> <li><span><span><span>Can we assess the effectiveness of remdesivir in hospitalized COVID-19 patients?</span></span></span></li> </ul><p><span><span><span>To address these questions, we worked with a community of volunteer groups known collectively as “Accelerators” with access to datasets, tools, and/or methodologies to build a robust and credible real-world evidence-base. Each group (Table 1) chose which question set they would like to tackle, based on their own interests and available resources. By working with groups willing to conduct these analyses in parallel using a common analytical plan, our goal was to gather quick insights into the management and treatment of patients with COVID-19. </span></span></span></p> <img alt="table 1" data-entity-type="file" data-entity-uuid="5f31d974-f48e-4e75-bcb2-7263b12d063e" height="310" src="/sites/default/files/inline-images/retro%20chart%203.jpg" width="606" class="align-center" loading="lazy" /><p> </p> <p><span><span><span>Each member of this newly formed community came to the group with different motivations; the wish to contribute to addressing the public health emergency, a desire to learn from peers regarding how they would tackle common problems, or an opportunity to showcase and sharpen their skills and expertise applying the most recent methods of real-world evidence. Below are some of the lessons learned from this process from the perspective of the community. </span></span></span></p> <ol><li><span><span><span><strong>Agreeing on a common analytical plan takes time.</strong> The TxPA community has substantial skills and expertise in designing and executing observational studies using real-world data. The teams authoring the analytical plans needed to iterate with others within the community to develop common plans, one for each question set. The newness of this disease, combined with the still-evolving methods and the varied level of expertise of those in the community meant that we needed to spend time to develop and refine these analytical plans and protocols. Over the course of several weeks, the groups reviewed multiple drafts and weighed the costs and benefits of different statistical approaches and methodologies. </span></span></span></li> <li><span><span><span><strong>Each dataset presents its own unique challenges.</strong> By sharing experiences, the community was able to accelerate and share learnings amongst themselves. Groups with one type of dataset, e.g., electronic health records, appreciated hearing about the challenges and solutions of using different types of data, e.g., Chargemaster data or insurance claims. An example was medication use definitions, i.e., how did various groups identify the medications used in their analysis, whether medications of primary interest, e.g., remdesivir, or concomitant medications such as anticoagulants. While some groups used NDC codes, others used RxNORMS, or simple text searches. See our <a href="https://www.evidenceaccelerator.org/blog/covid-19-evidence-accelerator-workgroup-coordinate-medication-use-definitions-across-evidence">January 28, 2021 blog</a> for more on this particular challenge.</span></span></span></li> <li><span><span><span><strong>Contributors vary in how much time and resources they can devote.</strong> Along the way, some groups had to drop out or divert personnel as they realized that their other obligations precluded them from continuing. Lack of funding for the groups may have also been a factor for other groups, although other factors were certainly at play. Bandwidth concerns also impacted the speed with which results were generated and analyzed. As a result, the groups shared their results over a wider timeframe than originally anticipated. This was a particularly useful insight which we will need to consider when planning future research activities.</span></span></span></li> </ol><p><span><span><span>One reoccurring theme was the value of community, and having a venue for an exchange of ideas, knowledge, and even problems. In the fast-paced world of scientists responding to a fast-moving pandemic, access to fellow scientists doing different work, and approaching problems in varied ways was exciting, inspiring and invaluable.</span> <span>We will look to incorporate these and other lessons as we evolve the Evidence Accelerator and plan future research activities. </span></span></span></p> <p><span><span><span>Additional lessons learned from the retro, grouped along other themes, will be explored in future posts. Stay tuned!</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/15" hreflang="en">Therapeutics</a></div> <div class="field__item"><a href="/taxonomy/term/30" hreflang="en">FDA</a></div> <div class="field__item"><a href="/taxonomy/term/33" hreflang="en">Hydroxychloroquine</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> </div> <!-- END OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> Wed, 01 Sep 2021 15:03:12 +0000 mmcnamara 95 at https://evidenceaccelerator.org Working Toward Data Interoperability https://evidenceaccelerator.org/blog/working-toward-data-interoperability <!-- 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">Working Toward Data Interoperability</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="2021-06-16T12:00:00Z" class="datetime">Wednesday, June 16, 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">Tue, 06/15/2021 - 16:24</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><img alt="Dr. Micky Tripathi" data-entity-type="file" data-entity-uuid="6dd9cdac-f96d-43fb-9d34-a8237069e23b" height="143" src="/sites/default/files/inline-images/Micky-Tripathi-web_1.jpg" width="104" class="align-right" loading="lazy" /></p> <p><span><span><span><em>Micky Tripathi, PhD, MPP, H</em></span></span></span><span><span><span><em>HS National Coordinator for Health Information Technology (HHS/ONC) </em></span></span></span><span><span><span><em>joined the Evidence Accelerator’s regular biweekly meeting to discuss data interoperability and working toward solutions to produce more useful data to address health questions. The following provides an overview of the conversation with Dr. Tripathi.</em></span></span></span></p> <p> </p> <p> </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><strong><span><span><span><span><span>Seeing interoperability issues? Look for misalignment</span></span></span></span></span></strong></p> <p><span><span><span><span><span>When talking about data interoperability, researchers should understand that most data issues can be traced back to a lack of alignment. Data is merely a byproduct of a process; no one produces data for its own sake, so if the information being produced has nothing to do with anyone’s day to day, it won’t </span></span></span></span></span><span><span><span><span><span>be good data. </span></span></span></span></span></p> <p><span><span><span><span><span>Lack of alignment can be a significant problem in healthcare because it is one of the most fragmented sectors of the economy.  It’s a complex value chain, so achieving as much standardization as possible is necessary to eliminate a source of problems. One way to approach the issue is for individual organizations to start thinking about what can be done to improve standardization. </span></span> <span><span><span><span>This will be a challenge for many healthcare organizations, not only did the pandemic sidetrack interoperability advancements, but it also revealed the depth of healthcare’s data-sharing deficiencies. Fortunately, awareness about interoperability limitations is increasing and there is a trend among regulators, providers, vendors and others to make inroads toward greater interoperability.</span></span></span></span> <span><span>Industry and electronic health record vendors are critical partners in this space. State and local Health Information Exchanges log millions of transactions every day, in a fragmented world, they are in a majority the market so if they start building interoperability, everyone else will follow. </span></span></span></span></span></p> <p><strong><span><span><span><span><span>Driving change? Drive the leaders</span></span></span></span></span></strong></p> <p><span><span><span><span><span>Another way to approach solving the problem is to look at the industry, the players who drive the industry and who has the authority to change standards. Apply the “80-20 rule,” to identify inputs that are potentially the most productive and make them the priority. Take insurers, for example, insurers will tell providers, ‘I literally will not pay you if you don’t use the correct codes’ when filling out paperwork. So, when insurance companies come out with new codes, everyone figures out how to deal with it. It may be worthwhile to focus a greater portion of energy into a dialogue with insurers about the value of data interoperability, recognizing the influence they have, as catalysts of change on the healthcare system. </span></span></span></span></span></p> <p><span><span><span><span><span>There’s a unique role the government can play in this space. Government can be a driver towards better coordination. CDC, HHS, ONC, and other agencies can make this coordination a priority, not to establish the standards, but to work with standards development groups and incorporate [standards] into those systems. </span></span></span></span></span></p> <p><span><span><span><span><span>Another factor to consider is to think more broadly about ‘what’ it is necessary to standardize. For example, ONC should be adding more social determinants of health data, it’s a natural thing for them to do. But in many healthcare settings, this is difficult information to get; it’s hard to start asking questions about race and sex, and it creates a burden for clinicians as well as patient hesitancy. So then, what about demographic data obtained by payers? The healthcare and research communities can bring that data in to inform the kinds of data we want. It’s vital to start giving more consideration to bringing other data sets together to get higher quality data. If the goal is to have more complex interactions, more patient-driven cases, there are apps for that. We should think about more creative ways to use those for interoperability. </span></span></span></span></span></p> <p><span><span><span><span><span>Reflecting on the past year and a half and the massive challenges COVID-19 presented for our healthcare system, one thing that became clear is the importance of building a more connected, and more equitable system. That means discovering alignment in what our priorities are about the data we collect and how we collect it, as well as getting cooperation from healthcare influencers who can drive the change we want to achieve.   </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/30" hreflang="en">FDA</a></div> <div class="field__item"><a href="/taxonomy/term/36" hreflang="en">real world evidence</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> </div> <!-- END OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> Tue, 15 Jun 2021 20:24:06 +0000 webmin 101 at https://evidenceaccelerator.org 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