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Clinical research blog

Explore our blog for insights into the big questions in precision medicine and clinical research.

Who tells patients when a gene therapy program pauses?

When a gene therapy sponsor pauses a clinical program, the operational machinery responds within hours. The medical monitor convenes a safety review. Regulatory...
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Operation Trailblazer and the clinical trial access gap

On June 23, 2026, the US Department of Health and Human Services launched Operation Trailblazer, a cross-agency initiative coordinated across the FDA, NCI, NCAT...
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FDA gene therapy guidance exposes patient recruitment gap

On June 2, 2026, the FDA released draft guidance that could reshape how gene therapies reach patients. The document, "Leveraging Prior Knowledge in the Developm...
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The long game: Precision trials shouldn’t start from zero every time

Precision medicine sponsors invest heavily to identify, educate, screen, consent, genotype, and support rare patients. In many programs, once a trial ends, that...
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Trust is the foundation of precision medicine

UK Biobank and similar resources have made an extraordinary contribution to biomedical research, enabling important advances across genomics, population health,...
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The psychology of kit return: What drives completion?

Genetic testing has become a core component of patient identification and stratification in modern clinical trials, particularly in rare disease and precision m...
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Patient engagement and education insights from rare disease trials

Recruiting and retaining patients in rare disease and genomic medicine research requires more than outreach. Many participants need support understanding geneti...
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Rare disease drug development requires designing for access from day one

Rare disease innovation has accelerated in recent years, particularly in cell and gene therapy (CGT). Yet for drug developers, one challenge remains persistent:...
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Barriers to long-term follow-up in cell and gene therapy

Cell and gene therapy (CGT) programs are committing to 10-15 years of follow-up – often without the infrastructure to support it. FDA guidance for certain gene ...
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From click to randomization: What truly predicts trial success?

Digital recruitment has become a standard part of clinical trial execution. Sponsors invest heavily in online outreach, patient referrals, and awareness campaig...
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