Rob Rittberg, Marketing Communications Manager - Clinical Informatics, PerkinElmer
The most powerful aspect of the latest ICH E6 (r2) guidance is the enormous weight given to trial quality – in fact, 16 addendums out of 26 total are dedicated to it. Section 5.0 [Quality Management] of the guidance highlights trial process, design, management, data, risk elements, QA/QC, technology, etc. for sponsors, CROs and clinical teams alike.
The most significant Section 5 statement is:
“Sponsors should focus on trial activities essential to ensuring human subject protection and the reliability of trial results.” (section 5, page 21) Note that human subject protection appears first. Although this is obvious to most, the guidance itself and clinical research activities should all be predicated on that primary focus.