Summary of TransCelerate’s Update to its Risk-based Monitoring Position Paper

The 7-page document provides an update on TransCelerate’s Risk-based Monitoring (RBM) initiative.  It includes a list of lessons learned, shares FDA feedback on RBM pilot studies, and provides links to RBM training developed by TransCelerate (TCB) member companies.  It also outlines 2014 publishing plans.

The Plain Writing Act of 2010: Lessons for Industry

FDA and other federal agencies are bound by the Plain Writing Act of 2010 to use “clear government communication that the public can understand and use.”  It seems ridiculous that we’d need legislation for such a thing, since “understandable” and “useful” are such obvious and fundamental attributes of communication.  There’s even a companion document, the 118-page Federal Plain Language Guidelines (FPLG).

Be us not, in industry, too smug.

Strategic Partnerships in Big Pharma: Implications for Small and Mid-sized Sponsors

Traditionally, large biopharmaceutical companies have outsourced clinical study responsibilities to a wide variety of external vendors, distributing the work across many service providers.  For their part, large CROs have routinely provided services to both large and small biopharmaceutical companies to keep their top-notch resources utilized to capacity and add to their bottom line.

Over the past several years, large sponsors and CROs have been trading in these transactional, fee-for-service business relationships for longer-term, tightly-integrated strategic partnerships.  And the trend is only accelerating.

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? 

Finding Clinical Trials During Government Shutdown

As a result of Congressional impasse, almost half of the approximately 15,000 FDA employees are subject to furlough.  In “15 Things to Know About FDA’s Operation During the Shutdown,”  Regulatory Focus editor Alexander Gaffney reports, “ClinicalTrials.gov, which is run by NIH, is being maintained by ‘minimal staffing,’ meaning that registering a trial may be difficult even if FDA does approve a trial to go forward.”

Over the past few months, I’ve been assembling a list of clinical trial finders for use in a future blog post.  I had planned to provide as complete a list of websites as I could, highlight benefits, draw comparisons, and include some details of operation.  I’m not close to that yet, but even though my research is incomplete, what I currently have may help someone now who is looking for very up-to-date clinical trial information.  So, without a passable transition sentence, here’s what I have.  I hope it turns out to be useful to someone.

(Note that some of these sites get their information, in part, from clintrials.gov, but they also use other sources that would hopefully be unaffected by the shutdown.)

What If You Needed SOPs to Run Your Household?

Last week I traveled to Phoenix to videotape a presentation for Natural Products INSIDER’s upcoming Digital Summit.  The 45-minute presentation, entitled “A Guide to SOPs and Compliance for Dietary Supplement Distributors,” goes into  much more detail than our February blog post on the same subject (which you can read here: http://bit.ly/YGTQWd).

Rosanne Sylvia-Heeter, Director of cGMP Compliance at Polaris, is always chanting the FDA compliance mantra, “If it’s not documented, it didn’t happen.”  As I worked on the blog post with her last winter, I was struck by the amount of documentation actually needed to comply with 21 CFR Part 111 distribution regulations.  As we worked on the Digital Summit presentation this summer, I was struck by something else.  In the course of simply maintaining a residence, members of my household actually perform a lot those Part 111 activities.  And so do yours.

The big difference is that we don’t have to write it all down.

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