How to protect the study blind with unblinded site staff and monitoring.

Study blinding is a complex topic administratively, scientifically, psychologically and philosophically.  The double-blind is the "gold standard" of clinical research, but often for reasons of persuasion and sales as much as for reasons of scientific exactitude. Meanwhile, the growing body of information and network effects available to both medical personnel and patients makes blinding more difficult than ever, and a growing variety of products, especially biologics, are more difficult to to successfully blind.

In 2009, I created a presentation for the SoCRA Annual Convention that year that was half philosophy and history overview and half administrative advice for how to protect blinding by segmenting off unblinded study staff and unblinded monitors and study management. Attached is a SoCRA Source article that I wrote after the 2009 presentation, and the current slide set from a more recent iteration of the presentation.

I think this presentation continues to be requested because dealing with complex blinding protections continues to be a footnote to clinical research administration.  The textbooks from my MSCR program did not mention it, and I know of no widely used clinical research management programs for sites or sponsors which included task support for unblinded study management.  Future blog posts will touch on why this might be.

The documents:

Article PDF: D'Rozario, MKD. (2011, February). Unblinded monitoring programs: Design and Education. SoCRA Source. 70-75

Unblinded Monitoring Programs from Mary D'Rozario (Select "Slideshare" to get the option to download the slides in Powerpoint format.)

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Post by Mary D'Rozario originally posted to the CRP Blog.

Blog Interview at BBK Worldwide

If you were at DIA 2012, BBK Worldwide was the company that took over with their awesome T-shirt give away. You can buy the t-shirts off their website for other events- "These HIPAAs don't lie" and others.  And I got paid absolutely nothing to tell you that. This is a company that knows how to mobilize excitement and interest, so I was thrilled when they invited me to do a blog interview about the challenges and successes of clinical research sites.  You can read the interview here.  And those t-shirts?  Here.

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Originally posted by Mary D'Rozario on the CRP Blog.

Police department horror story illustrates why your practice needs text messaging.

Recently a practice manager expressed a frustration about her staff.  They were using their personal phones to text message with patients about appointment scheduling.  No matter how many times she told them to stop, they wouldn't listen. Meanwhile, she wasn't listening to the message her patients were giving: they wanted to be able to schedule their appointments via text messaging. The practice had not provided any way to do this, so the staff were going behind her back to make the patients happy.  The good news is that this is solvable.  The bad news is that it needs to be solved quickly for all of the obvious HIPAA and legal protection reasons, as well as the simple factor of providing one clear professional voice from the practice to the public.

A recent example from law enforcement provides a compelling image of why a medical practice needs to control their own communication:

When 30- year-old Ricky Lamb died, Clayton County Police Department detectives were unable to locate his mother.  One detective eventually sent her a message on Facebook from his personal account to notify her of the death, as reported on Today.  Because the detective had no relationship with the mother in Facebook, the message went to the infamous "other" folder.

When the mother did see the message she showed it to her daughter.  The message came from account with an image of rapper TI as the profile picture, so they didn't think it could possibly be serious.  It was only when Mr. Lamb continued to be missing that his mother called the phone number on the unprofessional Facebook profile.

Now there were some other problems here, like why the police could not find a woman who lived such a stable life that she had had the same job for more than a decade. But the Clayton County Police Department has learned some lessons. They have realized that they need to take control of how their staff communicates with the public and they are going to set up their own Facebook page and their own social media review policies.

Your staff is more likely to use their personal phone to text message a patient than their personal Facebook, so the medical application of this story is on text messaging.

A New York Times article from last year provides some great examples of pediatricians using texting and social media to connect with their patients.  Several solutions exist to access text messaging via a computer workstation and logging text messages. Clinical Research Performance, Inc. can work with your practice or research program to assist in developing your texting solution.  Give us a call at 919-890-5513.

--- Originally posted by Mary D'Rozario on the CRP Blog. Photo by hugovk used under Creative Commons licence.

One Tiny Change Saves Time and Aggravation When Answering Queries

If I could help study coordinators absorb just one take-away from my MAGI West presentation on data management for sites it would be this:

Solve the query, THEN answer the query.

Did you know that a lot of automatic queries will simply disappear if you do this?  That's right, you won't ever have to answer them at all.

There are other good reasons to make this process update, starting with the fact that the study coordinator is the subject matter expert on their subjects.  The query is merely a red flag- it can cite unexpected data or inconsistent data, but it can't tell a study coordinator or investigator what the correct data are.  Only the subject source record and the judgment of the investigator can tell you this.

So solve the problem first, then respond to the query with a good explanation of what you did.  Solving the query before you answer the query will increase the likelihood you have given a full, complete and correct response to the query.  It will decrease the number of re-queries.  It will increase the quality of communication between the study coordinator and the data managers.

One way this works is by returning the focus from the communication in the query to the data on the page.  Query communication causes a lot of difficulties because study coordinators and data managers are coming from very different places, not just in terms of professional experience but often in terms of fundamental personality differences.  They see the world differently, so conflicts are inevitable when they try to partner to simplify a real-world interaction into a data listing.

It's impossible to beat this one improvement for return-on-investment (it's such a tiny change!), however there are additional process improvements which will improve the site's experience of data management.  Some of these improvements are about increasing data quality to start with, and others are about understanding some hidden rules in what data managers are looking for.

Here is the expanded Slideshare version of the MAGI West presentation (and all my Slideshare presentations are Creative Commons licensed for use in entirety and with attribution- so you can copy and use this presentation wherever you like):

Strategies for Dealing with the CRF from Mary D'Rozario

Is the patent cliff going to ruin my life?

This is the question a lot of clinical research professionals keep asking themselves. The bad news is clear: the most valuable set of drug patents in history will expire in 2013, major pharma will lose 90% of that revenue, and there are no new blockbuster drugs to fill in the gap. Meanwhile, clinical research is getting more complex and more expensive, and to top it all off the Affordable Care Act is anticipated to result in a short-term reduction of the remaining revenue of drugs under patent of around 10%.

So how about some good news:

• We are at least half-way through the patent cliff already.

• The long-term stock price may not be irrational. Because we are waiting for the sky to fall, it can seem like major pharma stock prices have not accounted for the patent cliff. But what if stock prices did account for it, just over the 20 year patent life instead of all at once? Go to Yahoo and run an all-history of the top four pharma and you will see the possibility.

• Pharmaceutical stocks have a comparatively low price-to-earnings ratio, making them attractive compared to other sectors.  This attractiveness is especially relevant in the case of an economic downturn sparking a flight to value.

• The largest pharmaceutical companies have enormous cash reserves- on the same scale as the total patent cliff.

• Pharmaceutical development remains an attractive bet. The investment pool and the people associated with it who already took their loss on pharma may not be back, but there is an endless line of people right after them. If you could take a flier on being a multi-billionaire, would you? So would a lot of other people.

It isn’t possible to predict the future, but as we try to assess the health of the industry we do well to remember that the “plus” column is not empty.