On Biostatistics and Clinical Trials

 As the field of oncology moves from systemic cytotoxic chemotherapies to targeted agents and immunotherapies, the paradigm for dose selecti...

In a previous blog post "Protocol amendment in clinical trials", I discussed the impact of protocol amendments on the clinical tri...

Tipping point analysis (TPA) is a key sensitivity analysis mandated by regulatory agencies like the FDA to assess the robustness of clinic...

Earlier this month, FDA issued its guidance " Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND an...

In the era of highly effective therapies for may diseases, clinical researchers are increasingly encountering a "good" problem in ...

When trials don’t use a traditional control — What the FDA guidance says In the usual drug-development pathway, regulators expect a trial w...