Faro Health Inc.’s Post

It's gratifying to see what can be accomplished with the help of data-informed study design solutions. The idea of building up a study design starting with the Endpoints and Assessments that are essential to meet Study Objectives, and using analytics to optimize the design is where we need to go as an industry. It's also consistent with the "critical to quality" philosophy that underpins ICH E8 (R1) and ICH E6 (R3). The article (and the "Lean Design" approach outlined) is a great reminder of the type of focus that will really help sponsors do our most efficient work for patients.

⭕ How to Optimize Clinical Trial Design ⭕ We find that highly successful clinical development leaders who leverage a searchable, harmonized database of drug labels, pivotal trials, and AE data optimize their trial designs more effectively. This resource enables rapid analysis of historical data, identifying key correlations between study parameters and outcomes across trials and indications. By utilizing this data, teams make informed decisions on study design, enhancing protocol robustness and statistical power. This approach reduces costly amendments, accelerates timelines, and improves resource allocation, ultimately increasing the likelihood of demonstrating clinical efficacy and safety while saving time and money. If you find this topic interesting, please visit us at www.basilsys.com

What’s the secret to keeping patients engaged during a clinical trial? 📣 Transparent communication Participants want proactive outreach, access to user-friendly digital platforms, and open lines of communication from clinical research to trial completion. It’s truly that simple! As shared in a recent article from Rebecca Starkie of Advanced Clinical, the overwhelming purpose of participating in a clinical trial is to advance research and help others. Clinical trial participants have a deep desire to make a difference with innovative treatments and specialized care – and we as research organizations, pharma sponsors and healthcare professionals need to prioritize active engagement to develop meaningful treatments! Read the full article with interesting study findings here: https://bit.ly/3vrJEZK #ClinicalResearch #ClinicalTrials #Pharma

Clinical trial transformation requires us to digitize information used widely across the trial lifecycle - enabling all involved stakeholders real-time, automated access. It starts with the protocol. Check out this article I authored with Rob DiCicco at TransCelerate BioPharma Inc. #clinicaltrials #clinicalresearch #digitaltransformation

Clin. Ops - Wisdom Wednesday vol1 p.01 Fail to plan = plan to fail / let’s pave the way and plan the roadmap Running a clinical trial development program is a complex and multifaceted endeavor, especially for biotechnology companies. They face unique challenges due to size, resource limitations, funding and the critical nature of their projects. Over the years many articles have been written on the importance of having a clinical development plan, and a staged process to accompany your Therapeutic Product Profile. Drawing insights from my own lessons learned and from experts in the field, here are some of the essential plans and considerations found to be useful in preparing to run a clinical trial development program. We will never completely plan for everything as no business or industry is without change or surprises. Creating a clinical development plan allows us the opportunity to ask all the critical questions related to the characteristics of the molecule, patient populations and safety risks and debate, discuss, agree on the regulatory path and pre-clinical testing to be done. It allows the team to align the data drivers and needs for product development. In my experience companies that had a clinical development plan, whether it was a 20-page document or 1 page plan, had the following outcomes: ·        reduced time to decision making, ·        reduced meetings about objectives and direction ·        More time to focus on execution of timelines. ·        Cross-functional alignment ·        Visible objectives and key results tracking (OKRs) In the next post we will examine the essential building blocks and sections of a clinical development plan for small biotechnology companies. #oncologytrials #clinicaldevelopment #strategicplanning #clinicaltrials

👉 Clinical Trial Design Innovation Outsourcing-Pharma interviewed Samuel Salvaggio, PhD about how One2Treat is revolutionizing clinical trial designs with a patient-centric approach that dramatically reduces trial sample sizes. In the ever-evolving landscape of clinical research, One2Treat is paving the way for more efficient trials by incorporating patient-relevant outcomes into their primary endpoints. This innovative approach not only accelerates the development of new therapies but also ensures higher precision and more clinically relevant results for patients. 💡 Key Highlights of the Interview: - Involving patients from the design phase ensures a holistic assessment of efficacy, safety, and quality of life. - Leveraging more data (i.e. for each single patient) increases clinical relevance and reduces sample sizes. - Regulatory authorities are promoting innovative methodologies that leverage patient-reported outcomes in their guidance. Discover how One2Treat is driving advancements in clinical trial design. 👉 Read the full article here: https://lnkd.in/dBP4w-FZ #ClinicalTrials #DigitalInnovation #PatientCentric #ReducedSampleSize #RegulatoryCompliance

In the BEAMER project, we are partnering with Takeda, Pfizer, Uniklinik Köln, Tilburg University, Centre for Research & Technology Hellas (CERTH), FIB HNJS, empirica Communication and Technology Research and many other organizations to find an innovative way to improve adherence to treatment in both clinical research and clinical care through optimized and personalized patient support. But we do a lot more than this! Want to know how our Patient Feasibility Services can help you to achieve optimal patient experience and better efficacy and efficiency for your clinical trials? Contact Alexandra Sheren (Americas), Simon Klaasen (Europe &ROW), or Ola Hasselgren (Nordics) to learn more and discuss your specific situation and requirements. Let us know what you think and 𝗳𝗼𝗹𝗹𝗼𝘄 𝘂𝘀. #patientadherence #patientengagement #patientrecruitment #clinicaltrials #clinicaloperations #healthcareinnovations #healthcareprofessionals #patientoutcomes #patientcentricity #clinicalcare #patientexperience #healthjourney #patientjourney #patientparticipation #regulators #valuebasedpricing #valuebasedhealthcare #patientsupport

Digital protocol improvements for clinical trials can lead to reduced cycle times, reduced cost, and improvements for patients. Our life sciences expert, Kelsey Jakee, and Rob DiCicco from TransCelerate BioPharma Inc., share how to make changes that drive value with Clinical Leader ⬇️ #ClinicalTrials #ClinicalResearch #HealthcareInnovation

FDA and Duke-Margolis have great insights during their workshops. Here's a summary of the #InnovativeClinicalTrialApproaches in case you missed it. And I'm confident it's on YouTube if you want to go and watch.

How do you see decentralized trials shaping the future of healthcare and clinical research? As the FDA prepares to update its guidance on Decentralized Clinical Trials, the landscape of clinical research is set for a transformative shift. This move isn't just regulatory; it's a pivotal step towards a more patient-centric approach and sustainable future for the industry. The impact will be profound, reaching from large biopharma firms to nimble service providers. We're entering an era where clinical trials can reach rural and underserved populations across the USA, democratizing access to innovative treatments and therapies. Nexus Collaboration Partners are energized by the prospect of this evolution. It's not just about expanding trial participation—it's about empowering patients and physicians alike to engage with research, regardless of location or prior experience. Times are changing, and it's an exhilarating moment to be part of an industry poised for such meaningful transformation. Let's embrace this journey together towards a more inclusive and impactful future in clinical research! #ClinicalResearch #DecentralizedTrials #PatientCentricity #HealthcareInnovation #FDA #Biopharma #ClinicalTrials #HealthcareAccess #MedicalResearch #InnovationInHealthcare