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!)

Questions All Auditors Should Ask: the Use and Misuse of Audit Checklists

There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist. It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all important question: "Why?"  How can you develop the best checklists possible and avoid relying on them too heavily?

On the Quality of Vendor/Supplier Audit Responses

The Compliance Perspectives post this month was written by guest blogger, John Janeri, an independent contractor working with Polaris.

After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.  I’ve done many of these solo audits, and I’ll admit that I've often wondered who at the Sponsor* company would communicate the findings to the Auditee and review their responses.  But no matter, I've completed the contracted assignment and I'm now off doing something else, right?  Not so much anymore.

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?