A Modern Risk-based Monitor

Investigator fawn on her.  Coordinators call on her.
She is the very Model of a Modern Risk-based Monitor.



With a little help from Gilbert & Sullivan, Polaris describes the quintessential Risk-based Monitor.
(Sung to the tune of "I Am the Very Model of a Modern Major General.")

Operetta notwithstanding, we've been closely watching the evolution of RBM in the industry and interacting with many of the significant players from sites, sponsors, CROs, and IT solution vendors.
If you Subscribe to our Newsletter this month, we'll send you a free compilation of our articles on RBM.

No singing.

Two New RBM Papers from TransCelerate

From One, Come Two
If you follow the TransCelerate RBM initiative closely, since its July update you’ve been eagerly anticipating the availability of the paper entitled “TransCelerate BioPharma: Central Monitoring Model and Technology Specification Proposals to Enable Risk-Based Monitoring Adoption.”  Now that the paper is publically available, your patience has been rewarded twice.  TransCelerate chose to divide the single document into two, one focusing on central monitoring, the other focusing on RBM-enabling technologies.  Publishing separate documents was a good decision.  As you’ll see, each topic is certainly rich enough to warrant individual treatment.

A Curated Collection of Tweets from ACRP 2014

Some Polaris staff members attended ACRP last month in San Antonio. It was a great conference. See what we and other attendees had to say about a few key sessions here.

(This Twitter compilation was extremely easy to curate and annotate using a free service called Storify. You don’t even need to have a Twitter account to do it. In fact, you don’t even need a Twitter account to follow a conference hashtag. Feel free to contact us via our website if you’d like to learn how; we'd be glad to share!)

Risk-based Monitoring vs Traditional Monitoring: the ADAMON Project

Many clinical research professionals are RBM believers, convinced that a risk-based approach to monitoring represents an effective and more efficient alternative to the tradition of frequent on-site visits and 100% SDV.  Many others are cautiously open to the idea, and are waiting for news of successful RBM studies to start filling the industry journals and online forums.  From those same journals and forums, we know that RBM studies have been, and are currently being, conducted.  In collaboration with CluePoints, GSK Vaccines is piloting a central statistical monitoring approach.  Sanofi and Lilly are currently piloting the TransCelerate methodology published in May.  Bayer and other sponsors are using an analysis of EDC data and metadata to steer their on-site monitoring activities.  Many CROs are offering their sponsor clients alternative monitoring solutions; Quintiles has conducted upwards of 60 studies using a number of different RBM implementations, Health Decisions has had years of experience conducting trials using its adaptive monitoring approach, and ICON has just announced its ICONIK Monitoring service after several years of piloting it alongside the traditional approach.  Finally, almost every RBM webinar (RBM-inar?) I’ve attended has mentioned that government and academic clinical trials commonly employ a RBM strategy.

But it’s been quiet.  The big headlines necessary to assuage lingering doubts have not been forthcoming.  Even as we begin to hear about RBM successes, how will we know if RBM is as good as traditional techniques? 

Assessment of FDA’s Final Guidance on Risk-based Monitoring

Yesterday, FDA finalized its 2011 draft guidance on risk-based monitoring (RBM). Without preamble, here’s what has changed.

Compared with the draft version of the guidance, the final version:

• Reinforces, even strengthens, its support of RBM

• Suggests “more intensive monitoring” does not necessarily indicate on-site monitoring

• Provides specific examples of critical/non-critical data and tasks that could be accomplished remotely

• Emphasizes the importance of protocol and CRF design

• Notes that, under RBM, delegating monitoring obligations to a CRO requires more clarity, communication, and evaluation than traditional monitoring