John Anthony Laczin - Comment

I welcome the opportunity to comment on the FDA’s Docket No. FDA-2012-N-0170, Modernizing the Regulation of Clinical Trials and Approaches to GCP. My observations are from the perspective of an M.D. Pathologist and Director, Medical Affairs in one of the world’s largest global central laboratories exclusively dedicated to serving clinical trials. There is no global guideline or requirement for uniform identification of patients and specimens for clinical trials. Thus, local agencies or organizations create their own scheme for identification. The trend we see over the years is to have fewer identifying elements, along with increasing use of surrogate elements, such as partial birthdates (where only the patient’s year of birth is authentic, but no month or day is given) and the use of alias initials (where all patients from a given country use the same initials, often reflecting that country). With increasing frequency, only one unique identification element is supplied, an assigned number, with no collaborating identification elements. Statistically, such schemes defeat the concept of reliable specimen identification, promote errors, and create a fertile opportunity for research fraud. In contrast, patient confidentiality and defensible specimen identification are mutually compatible, and can be achieved. Therefore, a defined set of identification elements is essential to maintain the integrity and reliability of the data used and should be specified in detail.