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To Share or Not to Share Failed Genetic Screening Results with Patients

Worldwide Clinical Trials

When using genetic screening to identify clinical trial volunteers, a sponsor’s obligations for further testing and disclosure of results to patients and families are unclear, especially when the results have no impact on medical management. Guidance in this area is much needed. Read the full article!

Genetics 130
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Large-Scale Study Shows Guardant360 Liquid Biopsy Accelerates Clinical Trial Enrollment Compared to Tissue Biopsy

BioTech 365

Nature Medicine Publication Reports that Liquid Biopsy More Than Doubles Clinical Trial Enrollment Rate Compared to Tissue Biopsy REDWOOD CITY, Calif.–(BUSINESS Despite advances in precision oncology, progress is slowed by the limitations of tissue genotyping, … Continue reading → Nasdaq: GH).

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US FDA approves Vertex’s Orkambi for cystic fibrosis in children

Pharmaceutical Technology

The treatment is indicated for CF patients who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The latest approval for use in children aged 12 to below 24 months is based on an open-label, multicentre Phase III clinical trial for 24 weeks.

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Partnership to advance personalised treatments for long Covid

Drug Discovery World

The partners will first develop and validate genotypic diagnostics that provide clinicians with an accurate view of a patient’s risk of disease; then, using the molecular profile of their underlying disease mechanisms, report back effective prescribing decisions and drug discovery opportunities to improve patient outcomes.

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EU OKs paediatric use of Gilead's Epclusa

The Pharma Data

The decision allows use of the therapy in the EU in children as young as six years of age and weighing at least 17kg, regardless of HCV genotype or liver disease severity. Source link.

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Why early participant engagement is now a top priority in genetic disease research

pharmaphorum

Pharmaceutical companies and biotechs are also adapting their approaches, launching patient finding and engagement programmes that can start years before clinical trials begin and allow them to run ‘recontact by genotype’ studies that the Resilience Project would have liked to do. Giving participants something in return.

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Cancer, genomics and personalised medicine: Modelling the future of oncology

pharmaphorum

What are the implications from these changes for clinical trials? How the shift towards cancer as a phenotype/genotype is being applied in clinical trials and how they are run •What are co-clinical trials and why could they hold the key to answering unmet need in cancer treatment and beyond into broader drug development?