Medidata
+ Cogstate

中枢神経系(CNS)適応症は非常に不均一であるため、臨床試験の測定は複雑になり、複雑な認知および行動評価が伴うことでデータのばらつきが生じやすくなります。

この課題に取り組むため、MedidataとCogstateは提携し、CNS試験向けの包括的で緊密に統合されたソリューションを提供しています。これらのソリューションは、業務を効率化すると同時に、エンドポイントデータの品質を最高水準に確保するように設計されています。

概要をダウンロード
Video transcript: Hey, Brad. Thanks for joining us. Really excited about this partnership. I can't thank you enough for what you guys have done for Medidata and helping us get into this space. But why don't you take a second and introduce Cogstate to the audience and make sure everyone knows who you guys are? Sure. So not many of you maybe have heard about Cogstate, but we've been doing this for more than twenty years now. We started the company in Melbourne, Australia with an understanding of the importance of brain health in an aging population. We originally started by, as a digital disruptor in the area of cognitive assessment, so we developed computerized cognitive assessments. We validated those extensively with over five hundred peer reviewed publications supporting that technology. Our tech's been accepted by regulators, we're a class two medical device here in the United States. In twenty twenty we were really proud to partner with Aisai. Aisai is a Japanese pharmaceutical company who's just launched the first ever disease modifying drug for Alzheimer's disease. They're taking our technology into primary care physicians' offices here in the United States to help find patients who will benefit from those drugs. So that's sort of our origin story but you know, over the course of twenty five years with a really deep bench of scientific strength, what we've done is really evolve into an endpoint data quality company. We help pharmaceutical companies to ensure that in central nervous system disease trials, the assessments are complex the complexities of training raters all over the world is difficult, we make sure that we bring both science and technology to that to ensure that data quality in small studies with biotech companies in rare disease all the way through to global phase three successful Alzheimer's disease trials. Yeah. So let's talk a little bit more about some of those service offerings around the technology. So can you talk a little bit about kind of your radar training and central review capabilities and how do you how do you help make sure that technology is used appropriately in these studies? Yeah. So it's it's really important that when you're running a global central nervous system disease trial, the idea is that most of these assessments are being developed assuming you've got a patient delivering that a doctor delivering that to a patient one on one, and we're taking that to twenty countries in thirty seven languages. And what really we wanna do is reduce the error. So training those raters to deliver that in exactly the same way is critical. And and to the extent we can reduce the error, we will increase the signal strength and therefore, you know, help to deliver a much more successful trial. But what in in doing that, we have to have, you know, people who can review that data, so other humans who essentially review that data to make sure that that's being delivered in the right way. Yep. Great. So we have a rater training program up front. We can then use the metadata application to capture all that data and execute those visits. We've got a central review process on the back end. So we think CogState and metadata together can really make that whole experience one of the best experiences out there in the market. But I think neither of us want to stop there. We really want to go beyond the current version of what's out there to support CNS studies and create something even better. So I can wonder if you talk wanna talk a little bit about how our team's been working together to kind of take some additional steps in this whole process. Yeah. So the I think the first thing is to understand the real depth of the collaboration between metadata and Cogstate. That's been really important to us. Building that infrastructure that exists now to really work seamlessly between Cogsdata and Medidata. But this is an area that's ripe for disruption. Mean, we're running these trials in the same way essentially as we've done for twenty, thirty, forty years. And we have this wealth of data and we understand what patients look like, we understand the mistakes the raters make when they're delivering these assessment. And the opportunity to build a model and and bring tech you know, bring AI and the benefit of that to that to automate error detection, and then ideally stop the error from occurring in real time. And I think that's really what the exciting opportunity is. Yeah. So our team's been working together. You can see some of the items up on the screen to try to really take this data and actually, like you said, in the moment, try to error correct and give insights to clinicians as they're executing these studies to really move way past the current paradigm. Cool. Hey, Brad, thank you so much to you for coming on stage today and for your partnership with us. We are super excited to get this joint offering out to the market. It's a pleasure. Thank you.

CNS試験実施への連携アプローチ

認定評価者

自動アクセス制御

評価者は、Cogstateの評価者向けトレーニングおよび認定プログラムを修了すると、Medidata eCOAフォームへのアクセスが自動的に付与されます。これにより、適格な評価者のみがCNS評価を実施できるようになり、試験開始時点から一貫性の確保が強化されます。

詳細はこちら

Cogstate データ品質ソリューション

認知機能測定における業界のリーダーであるCogstateは、科学的および運用上の専門知識を組み合わせ、正確で信頼性の高いCNSデータ収集を実現することで、臨床試験プロセスのあらゆる段階で高品質な結果を保証します。

CNS eCOAガイドを見る

Cogstateの科学的専門性

CNS専門家チームを擁するCogstateは、認知機能および臨床アウトカム評価のあらゆる側面に関する包括的なガイダンスを提供し、治験依頼者が正確なデータ収集のために、個別に合わせたサポートとインサイトを得られるようにします。

個別に合わせた評価者トレーニングと認定

Cogstateは、評価者の経験に合わせて設計された認定パスを提供します。これには、評価尺度や評価者によくあるエラーについて直接的な知識を持つ臨床専門家が開発したeラーニングが含まれます。多角的なトレーニングアプローチにより、効果的な学習と定着が保証され、評価者は臨床試験において高品質で信頼性の高い評価を実施できるようになります。

戦略的かつリスクベース
の中央モニタリング

Cogstateの中央モニタリングサービスは、データの最高の信頼性を確保するために、専門家による厳格なレビューを提供します。カスタムのデータ駆動型アルゴリズムを活用することで、評価者の潜在的なエラーを迅速に特定し、臨床専門家がテスト実施の的を絞ったレビューを行います。

臨床専門家による中央評価

遠隔医療を介して経験豊富な中央評価者にリモートアクセスすることで、データ品質を確保し、医療機関の負担を軽減します。また、医療機関または在宅での柔軟な患者中心の評価を提供します。

科学的に検証されたCogstate PerfO Batteries

Cogstateのデジタル認知機能評価は、これまで規制当局とのやり取りや承認取得を支援してきた実績を有しており、認知機能の測定における感度と特異度を向上させます。さらに、完全に自動化されたスコアリングにより、専門評価者を必要としません。また、これらのテストデータは、規制当局との円滑な対応や承認取得の支援にも活用されています。

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