Pillar 2 - Breast Cancer, page-100

Hi @RaceOncology here's a consolidated memory jogger containing wombat's list and my list, plus some new ones.

Let it not be said that shareholders aren't willing to teach / remind management how to suck eggs (or chickens).

Clinical Trial Execution errors - consolidated post

·paperwork necessary to commence a trial not completed correctly

·wrong indications (could impact recruitment because of competition for patients)

·wrong biomarkers chosen

·patient selection criteria wrong, either inclusion criteria or exclusion criteria

·drug dosing protocol wrong

·endpoints wrong, either primary or secondary

·failure to specify joint primary endpoints when applicable

·wrong selection of blinded vs open label

·trial sites wrong (could impact recruitment)

·clinician recruitment too slow

·patient recruitment too slow

·insufficiently powered for low Type II error. Overly powered is expensive, but penny wise can be pound foolish

·inefficient ratio of sample sizes in treatment arm and control arm. Need good chance of not getting placebo to attract clinicians and patients

·wrong treatment in control arm, e.g. wrong interpretation of Standard of Care

·failure to discuss trial design with regulatory authority

·do discuss trial design with regulatory authority, but fail to follow their hints or advice

·do discuss trial design with regulatory authority, and do follow their hints or advice. Later, when theregulatory authority is assessing the new drug application, the old staff have left and the new staff have different ideas

·leaks from DSMB

·unskilled people running the trial / lab errors.