Announcements

  • This Thursday: Bioethics Community Spring Webinar!

    When:  Apr 25, 2024 from 12:00 to 13:00 (ET)

    DIA Bioethics Community Spring Webinar!

    Please join the DIA Bioethics Community for an interactive webinar to discuss two interesting topics: 

    • The ethical issues inherent in the involvement of social media influencers in communication around biopharmaceutical products (and clinical trials)
    • A preview of the DIA Global Annual Meeting agenda and planned sessions with bioethics topics
      • to help you plan your meeting schedule, if you’re attending
      • to hear what’s happening at the Meeting, if you’re not attending
      • to hear about some of the sessions we’ll come back to discuss in our summer webinar
  • Call for Abstracts: Global Clinical Trial Disclosure and Data Transparency Conference

    Call for Session, Presentation, and Short Course Abstracts

    Read Submission Guidelines| Submit

    Abstract Submission Deadline: Friday, May 10

    Notification: Week of May 20

    Final PowerPoint Presentations Due: September 13

    Meeting Dates: September 23-24

    Location: Arlington, VA

    Questions: Contact Damisha White@DIAglobal.org

    For more information

  • April CSP community call

    Once again I'm looking forward to a topical review of an important PV subject this Thursday (April 18th at 4pm UK) in the DIA CSP community call.
    I'm delighted that I'll be joining John Solomon MD of Sanofi to discuss patient centricity and engagement in PV.

    Zoom link below

    Meeting ID: 952 2731 2509

    Passcode: 760806

  • Policy 0070/PRCI/FOIA Subgroup Meeting on Apr 18

    Please note we will be meeting for a redaction discussion focused on Policy 0070/PRCI/FOIA this Thursday. I am no longer sending out calendar invitations from my email to yours. Instead, please use the link below to add this to your personal calendars so you can join us. All are welcome to attend! 

    Time: Apr 18, 2024 10:00 AM Eastern Time (US and Canada)

    Join Zoom Meeting

    https://diaglobal.zoom.us/j/99723228845?pwd=bFQ3dm8vdzgzck82d0hhMWNNK0ZDQT09

    Meeting ID: 997 2322 8845

    Passcode: 696109

    Every 2 months on the 3rd Thursday

            Jun 20, 2024 10:00 AM

            Aug 15, 2024 10:00 AM

            Oct 17, 2024 10:00 AM

            Dec 19, 2024 10:00 AM

    Please download and import the following iCalendar (.ics) files to your calendar system.

    Monthly: https://diaglobal.zoom.us/meeting/tJ0qdeqqrDMiHtFNeGwLAVvgSSXMZj3X9A7o/ics?icsToken=98tyKuChqTkpGNaduB2CRox5B4job-rzplxHgrd7shrCFAxyVBXxBdF6H4h1Q-CJ

    ---

    One tap mobile

    +13052241968,,99723228845#,,,,*696109# US

    +13092053325,,99723228845#,,,,*696109# US

    Find your local number: https://diaglobal.zoom.us/u/aepvTduLL2

  • DIA 2024 Global meeting

    Dear All,

    It will be great to connect at he DIA June 2024 Annual Meet at San Diego. I will be setting some time during the meeting for the members to meet F2F. Please share your interest if you are interested 

  • Join us on Tuesday, April 9th for our monthly conference call

    ALERT:  Log in information for the calls has been updated and a password is required!

    Our April CTD Community call features a discussion for sponsors conducting trials in the EU. We are pleased to have Grant Strachan, partner at Brodies LLP Solicitors, join us for an informative session on the impact and implications of not transitioning your trial to CTIS and the EU CTR by the January 30, 2025 deadline. Grant will provide expert insights and answer your pressing questions.

    If time allows, we will also have an open discussion on the new transparency rules in the EU and updates to CTIS planned for Q2. Topics may include what kind of post-transition submission will trigger public release of documents, how to handle transitioning trials when the new transparency rules are not yet implemented, and whether the CSR will trigger protocol publication.

    This call is an excellent opportunity to gain clarity on critical EU trial transition requirements and evolving transparency rules. Don't miss this chance to get expert advice and collaborate with peers.

    Date: Tuesday, April 9th, 2024 at 10am EST

    Join Zoom Meeting

    https://diaglobal.zoom.us/j/94448328818?pwd=NnI1UFQrSWJLOTU4RzFIRlRCbnZYZz09

     

    Meeting ID: 944 4832 8818

    Passcode: 224003

  • DIA Bioethics Community Spring Webinar!

    Please join the DIA Bioethics Community for an interactive webinar to discuss two interesting topics:

    • The ethical issues inherent in the involvement of social media influencers in communication around biopharmaceutical products (and clinical trials)
    • A preview of the DIA Global Annual Meeting agenda and planned sessions with bioethics topics
      • to help you plan your meeting schedule, if you’re attending
      • to hear what’s happening at the Meeting, if you’re not attending
      • to hear about some of the sessions we’ll come back to discuss in our summer webinar

    Date: April 25, 2024

    Time: 12 - 1 p.m. Eastern

    Register in advance for this meeting:

    https://diaglobal.zoom.us/meeting/register/tJAvc-ChqDIjGdCB7TbvJHLXGiiY5g9SHPz9

    After registering, you will receive a confirmation email containing information about joining the meeting.

  • Open Source Software for Clinical Trial Reporting and Regulatory Submissions

    Hi Everyone,

    The DIA Statistics and Data Science Community is pleased to announce a new webinar which will be held on Thursday 9th May, 2024. The "Open Source Software for Clinical Trial Reporting and Regulatory Submissions" webinar will feature presentations from industry and regulatory experts. Further details are given below. Registration for this free webinar is now open and is accessible via this web address: https://diaglobal.zoom.us/meeting/register/tJcqd-GurjkrGtwVlzPSc67AfVe58a9domMW

    Webinar Abstract: Validated proprietary software systems and packages have traditionally been the norm for statistical analyses underlying regulatory submissions for approval of new therapeutic products. While academic institutions and other industries have embraced open-source software, the pharmaceutical industry has been slower to adopt the open-source counterpart. This webinar brings in several industry and regulatory experts to share their experiences and perspectives on using open source software for clinical trial reporting and regulatory submissions.

    Webinar presentations and abstracts:

    1. Eric Nantz (Director, Eli Lilly and Company): Highlights of the Successful R-Consortium Pilot Submissions

    Abstract: Within the life sciences industry, the usage of open-source statistical software has made tremendous gains across the lifecycle of clinical studies in many organizations. One particular area that open source has encountered challenges historically is the clinical submission process. The R Consortium R Submissions working group, with representatives from industry sponsors and regulatory agencies, was created to assess the feasibility of using the R statistical programming language to create clinical submission deliverables while adhering to current guidelines used in submissions. This presentation will highlight the successful pilot submissions that cover a wide spectrum of using R to produce traditional clinical outputs, sophisticated Shiny applications, and analytical data sets. Additionally, we will highlight the ongoing efforts that aim to push the envelope even further with the use of web-assembly and container technology to distribute a Shiny application in a future pilot.

    2. Ning Leng (People and Product Leader (Director), Genentech): Embracing open source language and modernized technologies - Roche's journey in clinical trial reporting

    Abstract: In 2024, Roche embarks on a transformative journey aimed at modernizing our clinical studies by embracing cloud-based system, container and modernized version control solutions. This transition also empowers individuals to utilize the R language for generating SDTM, ADaM, and TLG outputs. This presentation will delve into Roche's transformational path, highlighting our inaugural milestone of leveraging end-to-end R solutions for pivotal readouts and filings. Additionally, we will discuss our dedication to the open-source community and our endeavors to enhance data science efficiency through the adoption of LLM.

    3. Regulatory Expert: Open-Source Software for Regulatory Submissions and Regulatory Environments

    Abstract: Regulatory submissions and regulatory computing environments have traditionally been associated with the use of proprietary software packages. While academic institutions have embraced open-source software, both industry and government have been slower to adopt open-source alternatives. I will discuss some of the challenges and issues with using open-source software in a regulatory environment, followed by some of the lessons learned in the ongoing R Consortium R Submission Pilot, as well as emerging issues

  • Join us on Tuesday, March 12th for our monthly conference call

    ALERT:  Log in information for the calls has been updated and a password is required!

    Our March CTD Community call will feature an open discussion on timely transparency topics you won't want to miss. We'll start by discussing the FDA's response to the citizen's petition filed by Universities Allied for Essential Medicines North America (UAEM). The petition calls for increased enforcement of results reporting, guidance on FDA enforcement priorities, and a public dashboard of Preliminary Notices of Noncompliance.

    Next, we'll address the initial challenges sponsors are facing with the new Catalogue of RWD studies that replaced the EU PAS/ENCePP registry. This is an opportunity to share experiences and collaborate on solutions.

    Finally, we'll delve into the challenges of identifying which regulations apply to combination drug/device products in Europe. This is a complex area where clarity is needed.

    This call is your chance to stay informed on evolving compliance, real-world evidence, and regulatory issues while working together to navigate the changing landscape. I look forward to a collaborative discussion. Don't miss out on these important topics.

    Date: Tuesday, March 12th, 2024 at 10am EST

    Join Zoom Meeting

    https://diaglobal.zoom.us/j/94448328818?pwd=NnI1UFQrSWJLOTU4RzFIRlRCbnZYZz09

     

    Meeting ID: 944 4832 8818

    Passcode: 224003

    Have a great week!

  • DIA Regulatory Policy and Intel

    DIA Regulatory Affairs Community: 

    Join us for the DIA Regulatory Policy and Intelligence meeting on March 19th at 12pm ET to hear Theresa Mullins (FDA) discuss Greater Regulatory Harmonization and Reliance Efforts.  

    Dial-in Instructions:

    Topic: Regulatory Policy and Intel Community Meeting Time: Mar 19, 2024 12:00 PM  Join Zoom Meeting https://diaglobal.zoom.us/j/92507126770?pwd=YmlEdWk4WUtkWjZwUVlCNndlK3lYUT09   Meeting ID: 925 0712 6770 Passcode: 847006
  • AI In Patient Engagement

    Come join us next Thursday, February 8 at 11 am Eastern for the next PEC-All meeting!

    We have an exciting agenda planned on the topic of artificial intelligence in patient engagement. Sridevi Nagarajan from AstraZeneca , Sanjay Bagani (Xogene) , Woo Song  (Xogene ) and Deborah Collyar from Patient Advocates In Research (PAIR) will give an overview of AI, its current applications in healthcare and research, tips for using AI wisely, and traps to be aware of. 

    Maria Paula Bautista will also provide an update on DIA's Patient Partners Program and related efforts. 

    Please check the Events tab for meeting details and log-in information and to add to your calendar. And let us know in advance if there's any specific AI-related question you'd like to have covered.

    We hope to see you next Thursday!

    From Hollie, Gloria, Sridevi & Deb

  • 1st mtg of 2024: Feb 15

    The Policy 0070/PRCI/FOIA Subgroup Mtg will not meet in January as the Zoom will not be set up by DIA in time. Instead, please join us on February 15 for lively discussions on redactions. 

  • Shared Learning: Gene therapy essentials for clinical research professionals

    Dear DIA Colleagues,

    The Clinical Research Community organises this shared learning webinar on 06 Feb 2024 at 11am EST.

    The speaker will present cell and gene therapies in the context of their recent history including clinical trials and approvals. He will provide an overview of key technologies involved, focusing on gene delivery technologies, which are at the heart of gene therapies, and their implications for clinical therapy and manufacturing. He will also provide an outlook on clinical trial activities, the progress of gene therapy in the clinic and in the market.

  • Reminder : De-Mystifying AI in Healthcare: Common Challenges AI Can Help Solve

    Happy New Year.

    Are you curious to know how AI would impact the Healthcare industry in 2024. Join us on 18th Jan 11 AM EST to know more. Registration is required.

  • De-Mystifying AI in Healthcare: Common Challenges AI

    Dear All

    Please join us by registering here for our first webinar :

     https://www.diaglobal.org/en/course-listing/webinar/2024/01/de-mystifying-ai-in-healthcare-common-challenges-ai-can-help-solve

    Jan 18, 2024 11:00 AM - Jan 18, 2024 12:00 PM

  • Interdisciplinary Safety Evaluation for Learning and Decision-Making: Education for Executives’.

    Hi Everyone,

    The final webinar of the Interdisciplinary Safety Evaluation for Learning and Decision-Making series will be taking place on 16 November at 10:00 (ET), titled ‘Interdisciplinary Safety Evaluation for Learning and Decision-Making: Education for Executives’.

    This webinar will highlight how the IND Safety Reporting Final Rule and new FDA guidelines can drive profitability, PR risk management, and culture change in clinical safety evaluations.

    It will also address the shift to innovative, interdisciplinary approaches, covering aggregate safety assessment planning, scientific techniques, FDA guideline implementation, and better collaboration with the FDA for more effective safety assessments.

    Registration and further information: https://advance.phuse.global/display/WEL/Interdisciplinary+Safety+Evaluation+for+Learning+and+Decision-Making:+Education+for+Executives?utm_source=newsletter&utm_medium=email&utm_campaign=november_news_updates&utm_term=2023-11-13

  • Utilization of Historical Trial/Registry Data in Drug Development - 17 Nov 2023, 11am EST

    The DIA Statistics and Data Science Community are pleased to announce that registrations are now being accepted for our next webinar. The Utilization of Historical Trial/Registry Data in Drug Development will be held on17 Nov 2023, 11am - 12:30pm EST and will feature presentations from Dr Melanie Quintana, Direction and Senior Statistical Scientist at Berry Consultants and Dr Tao Lui, Associate Professor at Brown University.

    The webinar is free to attend and registration can be completed using this web address:

    https://diaglobal.zoom.us/meeting/register/tJUkf--prjkoGNWkAFnDeCODPdctL_5Bg7Vs

    We hope to see you there!

    Further details on the abstracts can be found below:

    Title: Use of PRO-ACT Database in designing and analyzing clinical trials for amyotrophic lateral sclerosis (ALS)

    Speaker: Melanie Quintana, PhD; Director and Senior Statistical Scientist at Berry Consultants

    There is a growing need to learn from our past in clinical trial design and analysis.  In light of this, numerous efforts are being made to promote the creation of shared disease-specific databases with patient-level historical control and observational data.  With these efforts in mind, we discuss how we can synthesize and make better use of this historical information to design more informed and powerful clinical trials.  Throughout this presentation, we highlight the use of the shared Pooled Resource Open-Access ALS Clinical Trials Database (PRO-ACT) in designing and analyzing clinical trials for amyotrophic lateral sclerosis (ALS).  The PRO-ACT database provides patient-level longitudinal data from placebo and treatment arms from over 29 Phase II/III clinical trials and is an exemplary effort to share data and learn from past studies.  Access to rich clinical trial patient-level data within the PRO-ACT database provides many advantages in designing and analyzing trials in ALS, including informing the creation of realistic clinical trial simulations to optimize key design elements and supplementing data from randomized trials with external information.  

    Title: Emulating target clinical trials using real-world databases for treating renal cell carcinoma

    Speaker: Tao Liu, PhD; Associate Professor, Brown University 
     
    Abstract: 
    Emulating clinical trials provides an alternative approach to evaluating therapeutic values of a clinical treatment when it is practically difficult or costly to evaluate the treatment effectiveness using standard RCT.  Using the National Cancer Database, we emulated separately an index trial of patients with cT1-3cN0cM0 renal cell carcinoma (RCC), designed to resemble EORTC 30881 (“index trial emulation”), and a hypothetical trial of patients at increased risk for lymph node metastases with cT1-4cN0-1cM0 RCC (“high-risk trial emulation”). A propensity score for lymph node dissection (LND) was estimated using preoperative features (Model 1) or preoperative and pathologic features (Model 2). The impacts of LND on overall survival (OS) were estimated using Cox regression on the two emulated trials. In this presentation, I will present an overview of the study design and analyses.  The benefits and risks of emulating trials also will be discussed. 

  • Safety Evaluations - Short History of Safety Graphics - Thanks to Dale Plummer

    This is a part of Greg Ball’s webinar series: Interdisciplinary Safety Evaluation for Learning and Decision-Making. Mat Soukup has a fabulous presentation on the history of Safety Graphics with a special thank you to Dale Plummer for all of his work on CTSpedia.

    The webinar can be found here:  https://event.on24.com/wcc/r/4342324/1D129BD9D04324EA8D8FA110C0796604?mode=login

    Webinars are open to all interested parties.

    Thanks,

    Mary Banach

  • REMINDER: Register now! DIA Bioethics Community Meeting - Patient Engagement Amidst AI in Clinical R

    REMINDER! Mark your calendars and register today!

    Dear Bioethics Community Members,

    Lindsay and I are excited to host a meeting on October 23 from 12:30 - 1:30 pm Eastern to discuss patient engagement amidst AI in clinical research. We will be speaking with two experts in the field of patient engagement as we explore the implications of AI for clinical research. See the full description below. Check out the information on our event page and register at this link to get the zoom information: https://diaglobal.zoom.us/meeting/register/tJ0ldO-ppjgqHtP_TqX4OCfbXZgt5Uux_4IJ

    Can a Chatbot give true informed consent? The ethical imperative to maintain patient engagement amidst AI in clinical research

     Generative AI is being used for everything from homework assignments to reference letters to song lyrics.  A natural question is how to leverage this technology in the research and development of new drugs and therapies, including in clinical trials.  It is tempting – and in some cases appropriate - to use this new technology to gain efficiencies and to possibly remove the risk of human error or subjectivity. It is equally important to consider where human interaction remains essential, and the extent to which the technology is validated.  As we test AI use in clinical trials, we need to remember the importance of ensuring that patient voices are included in addition to reliance on tools, that appropriate human oversight is maintained, and that the datasets used to validate and develop these tools accurately reflect all patient populations we want engaged in research. 

    Please join this panel discussion, in which experts from the fields of bioethics, patient advocacy, health literacy, and drug development talk about the importance infusing patient engagement into the benefits and risks of leveraging AI in the research enterprise.  This conversation is hosted by the DIA Bioethics Community. 

    Our panelists:

    Catina O’Leary, PhD, LMSW (she/her/hers)

    Health Literacy Media

    Catina O’Leary, PhD, LMSW, is President and CEO at Health Literacy Media, a St. Louis based nonprofit that develops and distributes health literate and accessible health and science communications. Before joining HLM in 2012, as faculty at Washington University School of Medicine, Catina led large-scale, community engaged HIV prevention and substance related research trials in the U.S. and around the world. Catina is currently a member of the National Academies of Sciences, Engineering, and Medicine’s Roundtable on Health Literacy and the International Health Literacy Association’s Board of Directors, where she serves as Chair of the iHLA Council of Affiliates.  

    Deborah Collyar

    Patient Advocates In Research (PAIR)

    Deborah Collyar has been a patient engagement leader since her first cancer diagnosis. She founded Patient Advocates in Research (PAIR) international communication network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs, and delivers innovative ways to gather input from thousands of patients. Her work encompasses many diseases, programs and policies at grassroots, national and international levels and emphasizes patient issues throughout development, clinical trials, and health literate communication with providers and patients. She is a speaker, blogger, author, team member, trainer, and faculty at professional workshops.

  • RIM WG Meeting Oct 5, 2023 at 12 Eastern

    We are announcing a changing of the guard. Cary and Pat will now share the RIM WG lead role and Peter is co-lead of the RA Community along with Brooke Casselberry. This Thursday, we would like to use the meeting to brainstorm activities for both the meeting and the working group as a whole. Some ideas might be: vendor, showcases, integration with other working groups as appropriate, sharing of use cases, studies and best practices, just to name a few. 

    Please join us to help shape the future of this working group.

  • Register now! DIA Bioethics Community Meeting - Patient Engagement Amidst AI in Clinical Research

    Dear Bioethics Community Members,

    Lindsay and I are excited to host a meeting on October 23 from 12:30 - 1:30 pm Eastern to discuss patient engagement amidst AI in clinical research. We will be speaking with two experts in the field of patient engagement as we explore the implications of AI for clinical research. See the full description below. Check out the information on our event page and register at this link to get the zoom information: https://diaglobal.zoom.us/meeting/register/tJ0ldO-ppjgqHtP_TqX4OCfbXZgt5Uux_4IJ

    Can a Chatbot give true informed consent? The ethical imperative to maintain patient engagement amidst AI in clinical research

     Generative AI is being used for everything from homework assignments to reference letters to song lyrics.  A natural question is how to leverage this technology in the research and development of new drugs and therapies, including in clinical trials.  It is tempting – and in some cases appropriate - to use this new technology to gain efficiencies and to possibly remove the risk of human error or subjectivity. It is equally important to consider where human interaction remains essential, and the extent to which the technology is validated.  As we test AI use in clinical trials, we need to remember the importance of ensuring that patient voices are included in addition to reliance on tools, that appropriate human oversight is maintained, and that the datasets used to validate and develop these tools accurately reflect all patient populations we want engaged in research. 

    Please join this panel discussion, in which experts from the fields of bioethics, patient advocacy, health literacy, and drug development talk about the importance infusing patient engagement into the benefits and risks of leveraging AI in the research enterprise.  This conversation is hosted by the DIA Bioethics Community. 

    Our panelists:

    Catina O’Leary, PhD, LMSW (she/her/hers)

    Health Literacy Media

    Catina O’Leary, PhD, LMSW, is President and CEO at Health Literacy Media, a St. Louis based nonprofit that develops and distributes health literate and accessible health and science communications. Before joining HLM in 2012, as faculty at Washington University School of Medicine, Catina led large-scale, community engaged HIV prevention and substance related research trials in the U.S. and around the world. Catina is currently a member of the National Academies of Sciences, Engineering, and Medicine’s Roundtable on Health Literacy and the International Health Literacy Association’s Board of Directors, where she serves as Chair of the iHLA Council of Affiliates.  

    Deborah Collyar

    Patient Advocates In Research (PAIR)

    Deborah Collyar has been a patient engagement leader since her first cancer diagnosis. She founded Patient Advocates in Research (PAIR) international communication network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs, and delivers innovative ways to gather input from thousands of patients. Her work encompasses many diseases, programs and policies at grassroots, national and international levels and emphasizes patient issues throughout development, clinical trials, and health literate communication with providers and patients. She is a speaker, blogger, author, team member, trainer, and faculty at professional workshops.

  • Expanded Access Policies and Compliance in an Ever-Changing Environment

    Hello Bioethics Community- posting this to let you know about an upcoming FREE webinar, "Expanded Access Policies and Compliance in an Ever-Changing Environment" taking place on Friday, October 20th from 12-1pm ET via Zoom. This moderated panel will bring together experts from the fields of law, bioethics, patient advocacy, business strategy, and the biopharmaceutical industry to discuss the intent of and compliance with US regulations about expanded access (compassionate use). 

    This webinar is sponsored by the Compassionate Use and Pre-Approval Access (CUPA) Working Group based at NYU Bioethics.

  • Community FAQs

    Hello all,

    I have gotten various requests related to how to use this community site.  Please find the community FAQs that explain how you can join a community, set your email notifications so that you get community information right way, etc.

    Good luck!

  • AI in Healthcare

    The public-facing version of ChatGPT reached 100 million users in just two months. Amid the excitement surrounding generative AI since the release of ChatGPT, LLAMA, Bard, Claude, Midjourney, and other content-creating tools, CEOs are understandably wondering: Is this tech hype, or a game-changing opportunity? And if it is the latter, what is the value to my business? 

    We invite the audience in the healthcare industry to join this very happening community to benefit from co-creation of opportunities by asking the questions on the applicability of AI in the healthcare industry and data science community to discuss on the different models that could be used to answer the questions posed by the industry wide users. For example a clinician may ask, “I have this use case / problem statement.  Can someone help point me in the right direction”.  A Data scientist may post, “We are using this model or approach for this use case, can any collaborate or share an alternative approach?” 

  • New VJC Webinar: Pediatric Therapeutics Development 8th Sep 10:30 - 12:00 EST

    The DIA Statistics and Data Science Virtual Journal Club are pleased to announce a new webinar on Pediatric Therapeutics Development which will be held on 8th September 2023, 10:30am - 12:00pm EST.

    This webinar will see presentations from Thomas R. Fleming, Ph.D., Professor and former Chair of the Department of Biostatistics at University of Washington in Seattle; Robert Nelson, M.D., Ph.D., Senior Director, Pediatric Drug Development in the Child Health Innovation Leadership Department at Johnson & Johnson; and Fei Chen, Ph.D., Senior Scientific Director of Biostatistics in the Statistical Decision Sciences organization within Global Development of Janssen Pharmaceuticals.

    Dr Thomas Flemming will be discussing "Innovations in Pediatric Therapeutics Development: Principles for use of Bridging Biomarkers in Pediatric Extrapolation" (https://doi.org/10.1007%2Fs43441-022-00445-6).

    Dr Robert Nelson and Dr Fei Chen will be discussing "A Collaborative Cross-Company Pediatric Platform Trial in Pediatric Crohn's Disease Using an Innovative Bayesian Analysis" (https://doi.org/10.1007/s43441-022-00448-3).

    Registration is now open and can be accessed using the web address below:
    https://diaglobal.zoom.us/meeting/register/tJUuce-opjItH9JL8Xd4MBfLeUi5SOmzAPeg

    We do hope you will join us for this interesting session.

  • DIA Global Pharmacovigilance and Risk Management Strategies Conference: Aggregate Safety Assessment

    The DIA Statistics and Data Science Community are excited to see that our Aggregate Safety Assessment Planning (ASAP) expert Gregg Ball, PhD, is teaming up with Barbara Hendrickson, MD to deliver the ASAP training short course at the upcoming DIA Global Pharmacovigilance and Risk Management Strategies Conference, taking place on Feb 4th 2024, Baltimore MD. 

    An Aggregate Safety Assessment Planning (ASAP) process is critical to ensure collection and assessment of product level data to answer key safety questions from various stakeholders. In addition, the ASAP process strengthens safety signal detection as well as risk identification and management. The Drug Information Association–American Statistical Association Interdisciplinary Safety Evaluation (DAISE) scientific working group has proposed an ASAP template to guide sponsor teams in clinical development. This session will describe how the ASAP supports multidisciplinary safety planning, ongoing aggregate safety evaluation, IND safety reporting decisions, and evaluation of product level safety data and the Safety Topics of Interest, which have the potential to influence a product’s benefit:risk assessment.

    Registration for Live Short Course will be accepted onsite, or until capacity has been reached. Register prior to guarantee your seat.


    Learning objectives
    Upon completing this course, attendees will be able to: 

    • Identify Safety Topics of Interest (STOI) for a product and plan for their evaluation during clinical development
    • Comply with requirements for aggregate IND safety reporting
    • Scientifically evaluate accumulating program-level safety information
      • To support ongoing characterization of the product safety profile
      • To prepare for regulatory filing activities and responses to regulatory queries
    • Operationalize FDA Medical Queries (FMQs) and Standard Safety Tables and Figures

    To register please use the URL below:

    https://www.diaglobal.org/conference-listing/meetings/2024/02/global-pharmacovigilance-and-risk-management-strategies-conference/tutorials/aggregate-safety-assessment-planning-asap-process

  • Monthly Meeting

    DEI in Clinical Trials Community Meeting
    When: August 8 , 2023 11:00 AM
    Where: https://us02web.zoom.us/j/84655932054; Meeting ID: 846 5593 2054

     

    Dyan Bryson is inviting you to a scheduled Zoom meeting.

     em.

    Monthly: https://us02web.zoom.us/meeting/tZArcuyhrTkqH9ARzW99lBHrbKQOcT1FWwYs/ics?icsToken=98tyKuGsqD4vE9eXsByDRpwIBI_4Z_Pztnpfgvp8rgXSWnlfQCvkNMlzHbFLQf7n

     

    Join Zoom Meeting

    https://us02web.zoom.us/j/84655932054

     

    Meeting ID: 846 5593 2054

    One tap mobile

    +13017158592,,84655932054# US (Washington DC)

    +13126266799,,84655932054# US (Chicago)

     

    Dial by your location

            +1 301 715 8592 US (Washington DC)

            +1 312 626 6799 US (Chicago)

            +1 929 205 6099 US (New York)

            +1 253 215 8782 US (Tacoma)

            +1 346 248 7799 US (Houston)

            +1 669 900 6833 US (San Jose)

    Meeting ID: 846 5593 2054

    Find your local number: https://us02web.zoom.us/u/kbbrei3KD0

  • No RIM WG meeting August 3, 2023

    We will either reschedule for early September or reconvene in October.

  • Return of Results Webinars at MRCT

    Posting in case this is of interest to anyone in the community.  Harvard's Multi- Regional Clinical Trials (MRCT) center is running a 3-part webinar series on the return of individual results in clinical trials, a frequent topic of conversation in the bioethics space. Registration and more info at the link attached.

  • DIA PM Community Networking Event - Sunday, June 25th!

    PM Community Networking Event – Sunday, June 25th

      • 5:30 – 7:30 p.m. – Deck 12 at YOTEL Boston, 65 Seaport Boulevard
      • Join us for an informal networking event to kick off your annual meeting experience. RSVP to mkryah@ultragenyx.com by June 23; the first 20 people to RSVP will receive a pass for a complimentary beverage in exchange for their business card!
  • DIA PM Community All Hands Call: DIA Global Annual Meeting Preview

    Thanks for joining us!  Link to slides shared is below.

    Heading to the Global Annual Meeting in Boston and wondering what PM Community content and events will be available?  Join us on Friday, June 16th from 12-1pm EST for a preview and a chance to connect with other PM colleagues ahead of the event!  We are looking forward to meeting you!

  • Bioethics Sessions at DIA Global Annual Meeting

    Dear Bioethics Community Members,

    I hope to see many of you at the upcoming global annual meeting in Boston. I wanted to highlight a few sessions being led by bioethics community members and which might be of interest to you.

    Tuesday, June 27, 8:30 a.m.: Ethical Considerations for Conducting Research During Times of Disruption (Karla Childers, Lindsay McNair, Missy Heidelberg)

    Tuesday, June 27, 11:45 a.m.: Community Round Table - follow up discussion to our morning session

    Wednesday, June 28, 4:00 p.m.: Ethics by Design: Embedding Ethics into the Use of Data and Artificial Intelligence in the Pharmaceutical Industry (Matt Rotelli, Jeff Scott, Missy Heidelberg, Kelly Fitzgerald)

    Please be sure to let us know if you'll be attending and get in touch with us when you're there!

    On behalf of the Bioethics Community,
    Karla Childers

    Lindsay McNair

  • Statistics and Data Science Virtual Journal Club

    Date and Time: Thursday 10th August, 10:30am - 12:00pm EST
    Title: Pediatric Therapeutics Development

    The Statistics and Data Science Virtual Journal Club is organizing a webinar on Pediatric Therapeutics Development to be held on 10th August 2023.

     Dr. Tom Fleming will present the principles for the use of bridging biomarkers in pediatric extrapolation. Dr. Robert Nelson and Dr. Fei Chen from Johnson & Johnson will jointly present the role of master protocols in pediatric drug development

    Please use the link below to register for this meeting

  • PSI Journal Club: Propensity Scores

    The PSI Journal Club is hosting an event on Thursday 22nd June, 4-5 BST on Propensity Scores where Lilly Yue (FDA) and Jixian Wang (Bristol Myers Squibb) will present their recent work.

    There will be a 20 minute presentation by each author followed by a 10 minute discussion.

    To register please use the link below

  • Exciting Events Of Interest Across DIA

    There are a couple of upcoming events of that our community most surely would be interested in - just wanted to be sure folks were aware.  

    1) Short course at the Global Annual Meeting (June 25th) on "Ecosystem of Digital & Data Innovation Partnerships: Generating Regulatory Grade Evidence in Divers Patient Populations"  (http://https://www.diaglobal.org/en/conference-listing/meetings/2023/06/dia-2023-global-annual-meeting/tutorials/ecosystem-of-digital-data-innovation-partnerships-generating-regulatory-grade-evidence-in-diverse-patient-populations)

    2) Virtual Meeting (June 5th) on "Digital Health Technology and Meaningful Change"  (https://www.diaglobal.org/en/course-listing/webinar/2023/06/digital-health-technology-and-meaningful-change?mkt_tok=MzQ5LVNWSi0wNjgAAAGLvvcHLtog6PNN5zjF5GdJ90eWPbEyDPB3J1nF5N2XvZqF6LVKVkkSvLbMzCU_3XjjZwPJhnG3OM40jPNsCEsEFd61AGCwxJi2uES1Pfo)

  • DEI in Clinical Trials Community Meeting

    DEI in Clinical Trials Community Meeting
    When: May 9 , 2023 11:00 AM
    Where: https://us02web.zoom.us/j/84655932054; Meeting ID: 846 5593 2054

     

    Dyan Bryson is inviting you to a scheduled Zoom meeting.

     em.

    Monthly: https://us02web.zoom.us/meeting/tZArcuyhrTkqH9ARzW99lBHrbKQOcT1FWwYs/ics?icsToken=98tyKuGsqD4vE9eXsByDRpwIBI_4Z_Pztnpfgvp8rgXSWnlfQCvkNMlzHbFLQf7n

     

    Join Zoom Meeting

    https://us02web.zoom.us/j/84655932054

     

    Meeting ID: 846 5593 2054

    One tap mobile

    +13017158592,,84655932054# US (Washington DC)

    +13126266799,,84655932054# US (Chicago)

     

    Dial by your location

            +1 301 715 8592 US (Washington DC)

            +1 312 626 6799 US (Chicago)

            +1 929 205 6099 US (New York)

            +1 253 215 8782 US (Tacoma)

            +1 346 248 7799 US (Houston)

            +1 669 900 6833 US (San Jose)

    Meeting ID: 846 5593 2054

    Find your local number: https://us02web.zoom.us/u/kbbrei3KD0



    ------------------------------
    Thomasina Bailey MD
    Gaithersburg MD
    ------------------------------