从其他癌症中汲取的经验教训.pdf

1、Clinical Trial Design and ExecutionLessons Learned from Other CancersVivek Subbiah,MDNashville,TN,USAMy personal perspectives on Tumor-agnostic drug developmentEvery target is a pan-target Tumors dont follow rules&are malignant snowflakes Reality-no“undruggable”targets as superior chemistry has brou

2、ght us therapies aimed at KRAS and TP53 mutationsEvery drug/target should be considered for tissue-agnostic drug developmentOnce dose is established(MTD/RP2D)organ-agnostic biomarker arm should be explored in parallel to tumor specific cohorts/trialsLearning from the past Patients cannot wait for tr

3、ials in every diseaseHuman screening trials are importantLearning from positive and negative studies VivekSubbiahMy personal perspectives on precision medicine drug developmentTumors dont follow text booksNew era of genomic medicineWe need new drugs,new mechanisms of action,better in class to best i

4、n class now!Unless a drug is approved real world patients do no have access to life saving treatments.Clinical trials are tightly controlled eligibility criteria and available in niche centersClinical trials need to go to patients not vice versaRemote screening initiative for all clinical trialsRese

5、arch should be Standard-of-care and vice-versaPatients cannot wait for years for accessEvery patient with cancer should have access to a clinical trial where they are.We need global harmonization for access to novel drugs American Association for Cancer ResearchHallmarks of Cancer:New DimensionsHana

6、han D.Cancer Discov.2022 Jan;Light microscope Light microscope Molecular Molecular microscope microscope AI era microscopeAI era microscopeEvolution in OncologyTwitter/X VivekSubbiahMoores law American Association for Cancer ResearchErooms law and drug development American Association for Cancer Res