A short pre-surgery drug window as the default early test of new agents
Between diagnosis and surgery there are usually a few weeks. Giving a new drug in that window and comparing the tumour before and after surgery shows whether it hits its target in real people, quickly and cheaply.
Window-of-opportunity trials give a short course of an investigational agent between diagnostic biopsy and definitive surgery, with paired tissue for pharmacodynamic, proliferation (Ki-67) and immune readouts, and ctDNA dynamics. The proposal is to make a window study a standard early step for agents with a tissue biomarker, with cancer centres maintaining a standing window-trial pathway (consent, scheduling, sample handling) that any agent can slot into.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
- The valley of death between lab and product · Most academic discoveries die before anyone tests them in people because nobody funds the middle step.
- Biomarkers are not validated or standardised · Tests that decide who gets a drug are often not validated prospectively and are measured differently in every lab.
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not linked directly; found by shared links- IdeaSMART designs to test treatment strategies, not just single drugs
Shares Circulating tumour DNA (ctDNA), Trial design, endpoints and cost, Prostate cancer.
- IdeaCirculating tumour cell clearance as the phase 2 gate for anti-metastatic drugs
Shares Circulating tumour DNA (ctDNA), Biomarkers are not validated or standardised, Prostate cancer, HR-positive / HER2-negative breast cancer.
- IdeaA pragmatic trial network for intraoperative margin tools, paid on margin reduction
Shares The valley of death between lab and product, Head and neck squamous cell carcinoma, Prostate cancer, HR-positive / HER2-negative breast cancer.
- IdeaPre-consented cohorts that can be randomised to future trials (TwiCs)
Shares Trial design, endpoints and cost, Prostate cancer, HR-positive / HER2-negative breast cancer.
- InstitutionApollo Hospitals (Apollo Cancer Centres)
Shares Head and neck squamous cell carcinoma, Prostate cancer, HR-positive / HER2-negative breast cancer.
- IdeaTake the blood test, and give the drug, at the right time of day
Shares Circulating tumour DNA (ctDNA), Biomarkers are not validated or standardised, HR-positive / HER2-negative breast cancer.
- IdeaA regulatory endpoint for drugs that block spread, not tumours
Shares Trial design, endpoints and cost, Prostate cancer, HR-positive / HER2-negative breast cancer.
- IdeaAdd a cheap-drug factorial arm to every cooperative-group adjuvant cancer trial
Shares Neoadjuvant / adjuvant / perioperative, Trial design, endpoints and cost.