Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-19 01:30 CEST (UTC+2h)

2017-07-06 22:59

Posting: # 17513
Views: 1,661

 Centralized monitoring for BE? [GxP / QC / QA]

Hi all,

with the new R2 revision of ICH E6 the issue of centralized monitoring is becoming a hot topic.
It is my understanding that CM is a process that is well accomplished in trials involving electronic data capture in devices that are regularly "phoning home" to deliver a load of data and progress indicators, or in multicenter trials where individual centers are communicating froma distance about their enrollment status.
EDC wizardry is still rare in BE. I have come across CM a few times the past year or two where honestly CM seemed to be mere excuses for not being on site, possibly due to a desire to avoid the logistical expenses. I have yet to see CM in an obviously meaningful manner for traditional BE. But perhaps it is just me overlooking some important points (that has happened so often before).

Could anyone here comment? Are you experts out there introducing CM in ordinary BE trials involving specialised CROs? How? How are risks identified and ranked in those case where CM is being scheduled?

Have a good day and thanks so much in advance for any input.:-)

if (3) 4

Best regards,

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

2017-07-13 18:29

@ ElMaestro
Posting: # 17539
Views: 1,259

 Centralized monitoring for BE?

Dear ElMaestro,

This thread has generated so many comments from enthusiastic crowds that I can't resist adding my twopence.

I think that just like most of the rest of ICH E6, the few bits and pieces on central monitoring were written with Phase 2-3 trials in mind. Or at least, multicentre studies using eCRF (not necessarily EDC systems for patient reporting outcome, such as these nice e-diaries where you can so easily see that all data from a 3-month period were entered on the day before the next visit to the Doc, or even while at the trial site because the Study Nurse is not happy).

I don't quite see the applicability to BE trials. Particularly considering the way the monitoring of BE trials is often organised in my experience: visits during the trial conduct, which are half-way between monitoring and in-process auditing, and quite different from the way they are done in Phase 2-3.


2017-07-14 18:24

@ ElMaestro
Posting: # 17549
Views: 1,283

 Centralized monitoring for BE?

Hi all,

This is surely not my field of experience nor interest.

Nevertheless, I have been "colaborating" recently in centralized/risk-based monitoring for phase III trials, by providing the monitoring team with pre-defined reports for them to identify centers and forms to SDV. From my perspective, this approach will be more common and effective in the near future for this kind of trials. As regards to bioequivalence, I don't think this will be the case. I can't see how centralized monitoring can be used in this context. Only in the case of units that have eSource implemented and monitoring will be mostly performed on the data available on the eSource system. But in this case, what is the purpose of monitoring? Wouldn't the data management review and medical review "catch" every issue that a monitor could possibly identify?

Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,384 posts in 3,905 threads, 1,172 registered users;
online 19 (1 registered, 18 guests [including 12 identified bots]).

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

BEBAC Ing. Helmut Schütz