Richard Tao’s Post

Global clinical research is essential to ensure efficient drug development. FDA must evaluate if the results of clinical development programs inclusive of multiregional clinical trials are applicable to the intended use population in the U.S. and U.S. standard of care. With the release of this draft guidance FDA has provided sponsors with insights as to their expectations regarding factors that must be considered when assessing the appropriateness of including MRCTs in a clinical development program. Some of the factors highlighted include patient-related, disease-related, healthcare system, and socio-cultural factors that may influence clinical outcomes and potentially impact applicability to the US population. The draft guidance also recommends sponsors prospectively plan the distribution of clinical sites in a MRCT to achieve enrollment of a population that adequately represents the U.S. population affected with the cancer indication being studied. FDA recommends a strategic allocation of study participation on the basis of major geographical regions (Africa, Asia, Europe, N America) with equal allocation of participants across regions for cancers that are common in the U.S. and proportional allocation for cancers less common in the U.S. compared to other regions. FDA has been questioning the decreasing proportion of U.S. participants included in oncology clinical trials for some time now. The regulatory expectation has clearly been that the evidence generated in a clinical development program should be derived from study populations that enable the results to be interpretable in the context of U.S. patients with the disease or condition and U.S. medical practice. This draft guidance gives a nice overview of what FDA expects in terms of prospective planning and consideration that could be helpful in justifying clinical development plan decisions.

Great! FDA just issued draft guidance focusing on multiregional oncology clinical trials (MRCTs), offering clearer recommendations for pharmaceutical companies conducting global cancer drug trials. The aim is to ensure that data from these international trials can be applied to U.S. patients and meet the standards of U.S. oncological care. This is important because cancer treatment often involves international collaboration, and harmonizing these efforts is key to speeding up the availability of life-saving therapies. For patients, this means better access to new treatments and faster regulatory approval. By ensuring that trial data from different regions is relevant to U.S. patients, it improves the chances of having effective drugs available sooner. The draft guidance emphasizes designing and conducting trials that take U.S. medical practices and patient characteristics into account, improving the quality of evidence and safety evaluations. Pharmaceutical companies will need to adapt by paying even more attention to how trial designs can meet both international and U.S. regulatory requirements. They'll also need to continue to focus on aligning clinical trial data with the needs of diverse patient populations - something everyone talks a lot about doing - ensuring the drugs being developed globally are effective for diverse American patient populations. This step forward in international collaboration promises better outcomes and more rapid advancements in oncology care. Thank you FDA for the draft guidance to ensure that clinical trial results from global cancer research can apply to U.S. patients, speeding up the availability of life-saving treatments! At Global Healthy Living Foundation (GHLF), we stand behind this important step forward. #Oncology #ClinicalTrials #FDA #CancerCare #PatientAdvocacy #GlobalHealth #Innovation Roche Novartis Merck Pfizer Bristol Myers Squibb Johnson & Johnson AstraZeneca AbbVie Sanofi GSK Genmab Genentech

Head And Neck Cancer Diagnostics Market Share And Growth Analysis 2024-2033 It will grow to $3.32 billion in 2028 at a compound annual growth rate (CAGR) of 16.7% Read More @ https://lnkd.in/g85B6zhg #marketresearchreport #marketresearch #CancerDiagnostics

Honored to speak in this webinar, where I’ll share the latest evidence on #Quitting #Smoking After a #Cancer Diagnosis: Key to Better #Survival and #Treatment Outcomes. More details & registration 👇: https://lnkd.in/d_F7TTVi

#ICYMI Here is the link to the webcast replay of yesterday's Q3 conference call: https://bit.ly/4hOUhZR Press Release: https://bit.ly/3YREp0g #Nasdaq #Earnings #Pharma #Oncology #RareDisease #Patients #HealthCare #Cancer #Radiotherapeutics #ClinicalTrials #PSTV $PSTV

While #RandomizedClinicalTrials remain the “gold standard” for evaluating medicines, real-world evidence (RWE) can provide understanding of the use and outcomes of a treatment in everyday clinical practice. This can be particularly important in diseases like #BreastCancer, where some communities remain underrepresented in clinical research. Pfizer is a leader in RWE generation, exemplified by our breast cancer program which includes real-world data from over 20,000 people globally. Learn more about the ways RWE can help expand on the learnings from clinical research: https://lnkd.in/ebxPtZA6

We know that the survival window for HGG patients can be short due to the limited treatment advancements over the past few decades. That's why we created 3D Predict™ Glioma. This test offers a new way forward by identifying individual responses to standard-of-care treatments like temozolomide (TMZ) before treatment begins. It will show with 98% certainty which chemo will (or won't) kill a patient's cancer cells so different treatment possibilities may be considered — whether it's: 🩺 An alternative chemotherapy, 🏥 clinical trial, or 🏡 no treatment at all. See how our functional precision oncology test prospectively identifies patients' response to TMZ in this recent study: go.nature.com/3XrcTpF #Kiyatec #3DPredict #FunctionalPrecisionOncology #Temozolomide #RadiationTherapy #OncologyInnovation #StandardOfCare #SurvivalRate #PatientAdvocacy #PatientSupport #PatientCare #QualityOfLife

What knowledge, skills, and attitudes are required by oncology pharmacists in Canada? On Tuesday, October 1, CAPhO will unveil the Competencies for Oncology Pharmacists in Canada document. Stay tuned to learn how these competencies will shape the future of cancer care and enhance our profession! #CAPhO #ACPhO #CAPhOCompetencies #OncologyCompetencies

There are currently five classes of immunotherapies (ICIs) available for over 20 #cancer types. Some examples of ICIs are: 💊 Atezolizumab (Tecentriq) 💊Durvalumab (Imfinzi) 💊Ipilimumab (Yervoy) 💊Nivolumab (Opdivo) 💊Pembrolizumab (Keytruda) There is a lack of #biomarkers to treat each #patient precisely though, which results in thousands of patients not responding to their given #ICI treatment. This is the clinical issue we are working to overcome at OncoHost. Learn more about PROphet® here: https://bit.ly/4cgNODS #cancerimmunotherapymonth #cancerimmunotherapy #precisiononcology

💫 FDA Fast Track 💫 🌟 Fast Track Designation from the U.S. FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer 👉 In the 6 mg/kg dose group, 13 subjects with CLDN18.2 1/2/3+≥60% had at least one post-baseline tumor assessment, of which 5 achieved PR with an ORR of 38.5% (95%CI: 13.9-68.4) and a DCR of 84.6% (95% CI：6-98.1). Among the 10 subjects with advanced PDAC in this subgroup, the ORR was 40% (95% CI: 12.2-73.8). DoR and PFS data are not mature yet. 🔗 https://buff.ly/4eoYJNc #OncEd #ONCOnews #OncoAlert