Citeline Clinical’s Post

Congratulations Laura Esserman on your success with the ISPY Platform Trials (for advanced and aggressive breast cancer). Here are my notes from today's Press Conference National Press Club: Randomized clinical trials (#RCT) came from agriculture more than 60-years ago. Platform trials may allow for better targeting of therapies for patients. Three problems with RCT: (1) Expensive and long time to get RTC going. Protocols and agreements are put in place (this can take more than a year) then it’s locked down and investigators can no longer update or add any new science >> Platform trials use master protocols that allow for innovative science to be more easily incorporated (2) Mean results  Everyone’s disease is different; how they respond to therapy can also be different (heterogeneity of drug effects) >> Platform trials allow for flexibility in how the patient responds to the initial therapy; if the first therapy is unsuccessful, they can pivot to another therapy offered in the trial. (3) Current trials are innovation-centered NOT patient center and results must always be compared with the standard of care (this is true for new approach methodologies (#NAMs) like #insilico) >>Platform trials allow investigators to track how the patients are getting better because ISPY is “#SMART”: Sequential, Multiple, Assigned, Randomized Trial Patients start in one block and can move to other blocks if the treatment isn’t working. They have different drugs from different companies in one trial.  Pathologic Complete Response (#PCR) – this is the tracked short-term metric Some challenges with adopting platform trials: >> still need to demonstrate causal inference - that the drug caused the change >> Platform trials require a lot of new infrastructure and training and so it’s challenging to embrace a new paradigm Still to do: - better predictive endpoints - while collecting the prelim data for ISPY trial only took 2 years; the #FDA approval can take several more years. Best wishes on this journey Dr. Esserman.

Looking forward to sharing my insights on "Standardized Measurement of Patient Experience in Clinical Trials" next week on January 17th, 12:00PM–1:00PM ET - What is experience data and how surveys help us assess the patient’s expectations with regards to clinical trial participation and measure how close we’ve come to delivering on those expectations - How psychometrically-validated survey science quantifies themes of human emotion that support patient retention and diversity in clinical trials - How standardized patient experience measures provide KPIs of patient centricity and enable comparisons to industry benchmarks to uncover areas of friction Link to register: https://lnkd.in/gs78EEGV

Gain comprehensive evidence insights for your observational study through our 360-degree view of the patient’s journey. Our Universal Patient Records encompass every provider, site, and lab your patients engage with, generating better and more informed evidence. Learn more about our data completeness: https://lnkd.in/erUw3HN4

Improvement hinges on measurement, so don’t miss our upcoming panel discussion to dive into:   ✅ Discovering the world of experience data and how surveys give us insights into patient expectations. ✅ Exploring how surveys, backed by psychometric validation, tap into human emotions, making clinical trials more inclusive and enhancing patient retention. ✅ Unveiling the power of patient experience measures – they're not just KPIs, but your key to understanding patient needs and improving their journey. Save your spot today: https://lnkd.in/gJ3pGGnA

⏳ The countdown is on for OCT New England! Visit Booth 64 to learn how Inspire is advancing both Real-World Evidence (RWE) and clinical trials by integrating patient voice data, driving research forward, and improving outcomes. #OCTNewEngland #RWE #ClinicalTrials #PatientVoice #ClinicalResearch #HealthcareInnovation #PatientOutcomes

Patient centricity is a very hot topic right now, for obvious reasons. Attend our webinar, to find out more about our efforts to place the needs of the patients central to our offerings. Happy patients = happy site staff = success.

Well worth tuning into. Some novel patient perspectives, on what's really needed within clinical trial technology

What are the operational challenges unique to adaptive multi-regional clinical trials? Find out what they are and how to address these challenges in our blog: https://bit.ly/3WMXmjF

Origins - The Patient Focused Specialists are excited to announce that the first panellist for our upcoming webinar, "Why Patient Perspectives Matter: Driving Success in Clinical Trials", is confirmed!   Join us on Tuesday, 15th October at 2pm BST as Alfred Samuels will be joining us to discuss "The Importance of Patient Involvement in Clinical Trials" – a crucial topic for driving successful outcomes.   Register now: https://lnkd.in/eNxmnQfY   Got questions? Feel free to submit them to [email protected] after you register!   #PatientInvolvement #ClinicalTrials #PatientFocused #Webinar

What are the operational challenges unique to adaptive multi-regional clinical trials? Find out what they are and how to address these challenges in our blog: https://bit.ly/471HTB7