COTA

COTA and Memorial Sloan Kettering Cancer Center will present new research at the American Society of Hematology Annual Meeting (ASH) next month. The joint-research explores the implication of treatment urgency and end-of-life care patterns for older patients with Diffuse Large B-Cell Lymphoma (DLBCL). It provides new findings that demonstrate the potential for RWD to improve cancer care for older adults - an often ignored patient demographic. Read more in Clinical Trials Arena. Link in comments ?? #ash24 #ash2024 #oncologyresearch #RealWorldData #RWD

COTA and Memorial Sloan Kettering Cancer Center will present the findings from their research collaboration on Diffuse Large B-Cell Lymphoma (DLBCL) studies in older patients at the upcoming American Society of Hematology Annual Meeting (ASH) next month. The joint-research explores the implication of treatment urgency and end-of-life care patterns for older DLBCL patients and provides new findings that demonstrate the potential for RWD to improve cancer care plans for an older, often ignored patient demographic. Key takeaways: ?? DLBCL is a blood cancer that is commonly diagnosed in the elderly ?? Survival rates drop dramatically with advancing age ?? Age, comorbidities, risk and physical ability may prevent older individuals from participating in clinical trials? ?? This exclusion means we lack clear insight into the care and outcomes of older individuals ?? RWD offers critical insights into treatment patterns for older patient populations ?? RWD sheds new light on older patients’ response to emerging treatments and how best to manage end-of-life care and outcomes Key research findings: ?? Older adults with DLBCL who initiated treatment immediately after diagnosis had worse outcomes and shorter overall survival rates compared to patients who had a longer interval between diagnosis and first-line therapy ?? Only a minority of older adults with DLBCL had a documented hospice or palliative care referral ?? There is a need for additional research to understand the value of (or lack thereof) care delivered near the end-of-life for these patients According to C. K. Wang, MD., chief medical officer at COTA: “Clinical trials have largely excluded the elderly population which has resulted in uncertainty as to the right treatment approaches for this patient population. Additionally, we know that hospice care tends to be under utilized in the US, especially in cancer patients. Using technologies powered by real-world data, we can bridge this gap to ensure that older adults receive evidence-based care during a critical time in their life.” According to Paul Hamlin, MD, Medical Director, David H. Koch Center for Cancer Care, and Attending, Lymphoma Service - Division of Hematologic Malignancies at Memorial Sloan Kettering Cancer Center: “The incorporation of real-world data to assess outcomes in older patients is an invaluable resource, given their general decreased representation in clinical trials. The data being presented as ASH 2024 regarding the DTI interval (Diagnosis to Treatment Interval) and the utilization of hospice/palliative care referrals can help inform future trials and identifies ongoing gaps in our knowledge/practices.” Read the full announcement on our website: cotahealthcare[dot]com #ASH2024 #ASH24 #RWD #RealWorldData #OncologyResearch #CancerResearch #DLBCL #MSK

Recently, the Clinical Research Data Sharing Alliance (COTA is a member ??) published a white paper about the power of platforms to accelerate the use of high quality RWD for clinical research. In the paper, they provide a series of recommendations for how data platforms can and should evolve to support future research driven by non-traditional sources: 1?? When re-using prior clinical trial data, platforms should focus on trials that have been previously submitted to health authorities for regulatory review, since these trials are likely to already follow established guidelines for regulatory submissions. If the platform also includes trials not previously submitted, they should clearly label each type to make it easier for sponsors to discuss the implications with regulators. 2?? When collecting RWD from disparate sources, platforms should follow clearly defined and documented processes for curating the data.? Explicability and clear provenance are key for demonstrating quality and reliability of data for submissions.?All RWD datasets should include documentation of changes, alterations, deletions, or transformations performed.? If the data is to be used for a regulatory submission, sponsors and data platforms should discuss requirements for data format (i.e.,? SDTM format). 3?? RWD platforms, in particular, should engage in robust quality assurance processes, including audits and inspections, and make insight into their processes open and available to audit by regulatory authorities if necessary.? Transparency will be crucial for supporting the development of a secondary use community built upon a foundation of quality and trustworthiness. ???? more highlights on our blog ?? cotahealthcare[dot]com (link in comments) #rwd #RealWorldData

What's the value proposition for integrating real-world data into the clinical trial process? Miruna Sasu, President and CEO of COTA reminds the room of why the challenges are worth working through. Watch the full conversation, including Former FDA Commissioner Andrew von Eschenbach M.D; Laura Wallace, Head of Global Integrated Evidence, Boehringer Ingelheim; Alastair Thomson, Acting Director Data Innovation, Advanced Research Projects Agency for Health (ARPA-H); and Datavant Clinical Trials Scientific Lead, Kathleen Gavin, PhD here: https://hubs.ly/Q02X7jBR0 #FOHD2024 #healthcare #innovation #RWD

How are pharma leaders adapting to a ChatGPT world? The path forward seems clear: Either we learn very quickly to harness this new way of working – within our company, with our partners, and with our customers – or we fall behind. Read more from Miruna Sasu in MedCity News (link in comments??)

The COTA team was out in full force with The Leukemia & Lymphoma Society to celebrate, honor and remember those touched by cancer at the annual 'Light the Night' walk in Manhattan. The COTA Hedgehogs have raised nearly $25,000 this year to help the The Leukemia & Lymphoma Society fund life-saving research and provide support to blood cancer patients and their families. Please check out our fundraising page (link in comments) and help us surpass our goal - and consider participating in a 'Light the Night' walk near you. #bloodcancer #bloodcancerawareness #LLSlightthenight

?? The latest publication from the Clinical Research Data Sharing Alliance including insights from COTA's research leaders Andrew Belli and Laura Fernandes is now available. Learn more about the recommendations for sponsors, regulators, and data platforms to achieve regulatory acceptance of supplemental and externally controlled clinical trials in this new white paper. #realworlddata #realworldevidence #pharma

My team at COTA is hiring! We're looking for a senior associate to join our Life Science Ops team. If you or someone you know is interested, please reach out! Job posting is here:

AI models need to be trained & validated on high-quality, fit-for-purpose data to produce trustworthy, accurate, & consistent results.? Increasingly, this data is being drawn from real-world data sources, many of which require careful curation to get to the point of being usable for these purposes. So what’s really involved in this process, & how will it change in the future as our understanding of both AI & RWD evolve? We asked one of COTA’s product leads, Nick Ritter, to help us answer some key questions. 1?? What data quality metrics have proven effective in identifying & mitigating biases in AI models developed from real-world-data?? Mitigating biases in models developed from RWD starts by mitigating any biases in the datasets themselves.? We would rely on quality metrics such as data completeness & representativeness, appropriate sample sizes, the recency of data to ensure the RWD & resulting AI-based products would perform with minimal biases. 2?? Given the current limitations of data standardization, how can we ensure that AI models trained on heterogeneous RWD maintain high predictive accuracy across different healthcare settings? The answer lies in collaboration across the industry & across settings where AI models are being deployed.? Developers & users need to create high-quality data standards – & push themselves & others to conform to those standards.? Users of AI models also need to do their part by understanding which datasets & standards their models are based on so they can make the right choices about how to use the results & provide meaningful feedback to developers.? At COTA, we’ve developed a data model based on the type of high-quality standards we’d like to see across the industry, & we’re subsequently building our AI applications based on those standards. 3?? What’s your 3-to-5 year prediction about the dynamic between human data curation & AI’s ability to perform the same functions? While we’re excited about the potential use of AI for the purpose of curation, we know there’s currently a gap between AI’s maturity in this space & the imperative to ensure that researchers have access to the highest quality RWD.? That being said, COTA is currently developing products where AI shows the most opportunity to provide assistance.?We’re staying focused on the extremely high standards these models have to meet in order to replace or assist experienced humans in these tasks. In the next few years, I suspect we’ll see certain data elements that can be reliably curated by technology, given the nature of how they’re documented & discussed among healthcare teams.? But we can’t lose sight of the value that human intelligence & organic clinical knowledge can bring to the curation process, especially around complex health data. #RWD #AI #Healthcare

Quarterly wellness days are an important part of the COTA experience. These are days when our only job is to prioritize our wellbeing - and it's no coincidence the most recent wellness day landed in the same week as World Mental Health Day. The news about increasing rates of stress and anxiety at workplaces globally is concerning. And while we can't fix it with wellness days alone, at COTA we strive to create a workplace that is rewarding, meaningful, kind, and fun. Thank you to our talented and hard working team members. We are so pleased to see you enjoying another COTA Wellness Day! ?? #WorldMentalHealthDay #MentalHealthMatters