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Sometimes a treatment must be designed for a single patient. Agreeing in advance what evidence and safety checks are needed would make that fast, fair and learnable.
Bespoke antisense oligonucleotides and personalised gene therapies have been given to individual patients with ultra-rare disease under case-by-case regulatory arrangements, and regulators have begun issuing platform-oriented guidance. Oncology has the same need for bespoke neoantigen products, personalised oligonucleotides and unusual repurposing. A published framework (pre-agreed manufacturing standards, ethics route, mandatory registry submission and shared outcome reporting) would turn one-off heroics into cumulative knowledge.
Shares ClinicalTrials.gov, Regulatory divergence between regions.
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Shares Regulatory divergence between regions, Rare and paediatric cancers without markets.
Shares ClinicalTrials.gov, Regulatory divergence between regions.
Shares ClinicalTrials.gov, Failures are hidden.
Shares ClinicalTrials.gov, Failures are hidden.
Shares ClinicalTrials.gov, Failures are hidden.
Shares ClinicalTrials.gov, Failures are hidden.