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Consider your Patient population – already in early phase 👨👨👧👦 The FDA has released “Diversity Action Plans” as draft guidance: “Participants in clinical trials should be representative of the patients who will use the medical products,” said #FDA Commissioner Robert M. Califf, M.D.,[1] and sums up the intention of these recommendations. Clinical trials shall… 🔹Enroll representative populations with respect to specific demographic factors (e.g., #race, #ethnicity, #sex, #age group). 🔹Aim to increase #diversity in clinical studies (e.g., broadening of eligibility criteria) when scientifically appropriate.   This guidance is applicable for efficacy and safety studies, but already in early phase these principles are worth considering! We at SocraTec R&D are experts in study design and we love to support your trials - from planning to conduct and reporting! 💙     👉 find the FDA announcement here [1] https://lnkd.in/eT5AhNTP #clinicaltrials #earlyphase #clinicalresearch

The U.S. Food and Drug Administration had issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically under-represented populations to help improve the data the agency receives about the patients who may potentially use the medical product.  Enhancing diversity within clinical studies not only facilitates broader applicability of results across a broad spectrum of patient populations, but also enhances understanding of the disease or medical product under study, thus providing valuable insights to inform the safe and effective use of the medical product among patients. #clinicaltrials #diversity #FDA

What’s new in the world of ISF and pharmacy clinical trial binders? Imperial found a way to create and produce binders centrally to take the “binder burden” away from your #clinicaltrial sites. Learn more about our quick and flexible solution for these essential #studystartup materials. https://lnkd.in/gt5TbP6n

Today, the FDA issued: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies – DRAFT Guidance June 2024 This draft guidance describes the form, content, and manner of diversity action plans, the applicable medical products, and clinical studies for which a diversity action plan is required, the timing and process for submitting diversity action plans, and the criteria and process by which FDA will evaluate sponsors’ requests for waivers from the requirement to submit a Diversity Action Plan. It replaces the draft guidance for industry entitled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” published April 14, 2022. https://lnkd.in/eTEEMKv7

Strategic alignment between clinical and field medical teams brings many upsides. Here are two ways this collaboration helps: Insights from MSLs on local clinical trends, patient needs and potential investigators / sites enable data-driven decision making by clinical study teams. Data shared by CRAs, such as on-site visits, give MSLs a 360-degree view of interactions with their KOLs and helps strengthen relationships. Learn how to get started on connecting medical with clinical: https://bit.ly/3MiOptM #medicalaffairs #clinicaltrials #pharma

Bridging Gaps that impact study start up & finding ways to help clients navigate complex challenges with Study Binders is something we at Imperial are committed to. We developed a flexible solution that has reduced the burden on the site teams. Click the link below to read more about it.

Check out the latest in our series on diversity guidance for clinical trials: https://lnkd.in/gCDna5FE This week we spotlight the #FDA's 2022 #diversity guidance and Congress' very recent mandate for clinical trial sponsors. Learn about the history of FDA diversity efforts, key aspects of the current recommendations, and what the future holds. We also highlight #implementation challenges and advanced methods that can help As Congresswoman Eschoo said, “fixing this issue [of underrepresentation] is not only fair and just, its good science.” #ClinicalTrials #FDAUpdates #Regulations

You likely heard about #Congress passing mandates for diversity action plans in clinical trials. Check-out the latest #CCS newsletter for details on #FDA recommendations and discussion of how we can work with #patients and other stakeholders to help close the implementation gap. #Implementation #DiversityEquityInclusion #FDARegulations #ClinicalTrials #PatientEngagement

🌍 Yesterday marked Clinical Trials Day 2024. Dive deeper into the FDA's efforts and the future of #ClinicalTrials in our latest blog post! And remember to check out the upcoming webinars on clinical trials at Xtalks.com to learn about the latest clinical trial innovations from leading industry service providers. Read more here: https://buff.ly/4bsVh2f #ClinicalResearch

Decentralized clinical trials are in the news after FDA's recently-finalized guidance. https://lnkd.in/dPgRwZPw Here's an interesting summary of a "siteless" trial - not "siteless" as much as "site visit-less" - with lots of operational details about how it's being run. https://lnkd.in/dxCN4Z9H