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Filtering by Category: Clinical Research

DIA Annual Meeting Day 4: My Experience


I forgot to tell you this yesterday: I was on the escalator and turned around to eyeball the name tag of the woman behind me - never miss a networking opportunity! DIA doesn't print Twitter handles on name tags, so I had "fixed" mine. dia nametag3

"Mary D'Rozario! I know you. I follow you on Twitter."

Which is so incredibly generous, isn't it? And I didn't know her, at least I didn't think I did, so I had absolutely nothing generous to give back. "Thank you so much! I'm so sorry I didn't recognize you."

"Well 'I' don't follow you on Twitter," she clarified. "I tweet for my company and we follow you on Twitter."

So there you have it, Twitter marketing works even for an artless escalator networker such as myself.

Today was a half-day of sessions. First of all, I want to point out that Quintiles live-tweeted the FDA speaker in a session that I did not attend. This may not be the first time that Quintiles has live-tweeted someone that doesn't work for Quintiles, but it is the first time I have seen it. As the largest CRO in the world, this step forward into engagement is important for our industry. You can see some of what they are up to on the Storify they made on Day 3.

The first session I attended was on BYOD in clinical research with presentations from Chris Watson of Exco Intouch (they have some related content online), Paul O'Dononhoe of CRF Health and Stephen Joel Coons of the Critical Path Institute.

BYOD facilitation companies, it turns out, face the same problem that social media does: The concept that BYOD is "free." It of course is not free on the side of facilitating the use of the BYOD device, and there is also the cost of the device itself which is pushed off onto the patient. This caused some concern about the possibility of a future study where the inclusion criteria includes a list of devices, and what that means particularly for the poor. As the panel included xUSA speakers, I could only wonder what they thought of our clinical trials which sometimes exclude people without health insurance (not to mention the Right to Try legislation, previously discussed here, that can exclude people who cannot pay).

Benefits of BYOD are that the patient may be familiar with their device, is likely to keep it with them and keep it charged, and likely takes good care of the device that they own. Another issue is that people who have set up their devices to be adaptive for conditions such as blindness may have more opportunity to participate in clinical trials.

Negatives and difficulties make for a much longer list. One issue, discussed yesterday, is that we already have studies being evaluated by organizations like Patients Like Me from patient reported information before the studies even close. What happens when the patient has the actual study data in their position? And, if it is data that patient created on their device, and possibly on their own wearable device, who owns it? If it is exposed by the patient or by the patient's poor IT security behavior, who is liable for the exposure?

During the Q & A, a member of the audience pointed out that the FDA standard of "training and experience." How do we know a study coordinator is qualified to advise a patient on use of their BYOD device? How do we know a call center operator for the device or the app is qualified to at least know when they should not be discussing medical advice related to the device?

Another issue addressed during Q & A was the validation of survey instruments across devices. What was absolutely fascinating to me was that a member of the audience suggested a more nuanced view to how bias is controlled, the same kind of nuance that is needed in blinding. There may have been a breakthrough in the number of social media panels at this year's session, but the inescapable requirement to explain clinical research to the epatient is far bigger than just why and how to use social media. It is changing how clinical research professionals talk about clinical research in a fundamental way.

To go along with that change are new tools to implement new kinds of research. The subject of the next panel I attended was using provider EHR data and payer data (so-called Real World Information, RWI, or Real World Evidence, RWE) to solve problems in new ways.

Brett Jason Davis of ConvergeHealth by Deloitte (their RWE page) chaired the session. He pointed out that ACOs provide the incentive to collect Real World Information (RWI) and respond to it.

Bill Davis of Moffitt Cancer Center's M2Gen program presented on what they've been able to do with their opt-in database of all the health information (the EMR, 11 additional databases, and genetic information) of more than 130,000 oncology patients as well as de-identified information from all Moffitt patients since 1996. Three case examples: -Clinicians in another country thought they were seeing leukemia developing in subjects who had been on the original trial for a drug. They were able to query this database and determine that the incidence of leukemia was not related to whether people had used this drug. -Patients tended to be divided in response to a drug in that they either were found to be non-responders within the first three months, or they did will on the drug for years. Evaluating the database was able to identify the pathway that marked the different groups of patients. -Patients were pre-identify patients that would qualify for a particular clinical trial if their cancer progressed, providing 66% of all the subjects on the multi-center trial while also providing their patients with options they might have otherwise missed.

And lastly Brian Sweet from AstraZeneca's side of the Real World Evidence Health Collaboration (press release) presented three cases where data from a large provider was matched to data from a large payer and the analyzed for cost-saving solutions such as geographically targeted pre-natal interventions.

And then with my head full of the future I rushed to pack and got out of the hotel a few minutes late, then a few minutes delayed on the drive to Union Station, where I went running in desperate to find my train, and almost none of the trains on the electronic signage had their tracks lists. Once I found my train, a trek that included going the wrong way through a restricted zone that would have gotten me arrested an airport, I settled in and expressed my grudge on Yik Yak (a new social media channel that I wrote about the other day):

amtrak yak

And then a beautiful ride home. The James River, near Richmond, Virginia:

train pretty


Day 3 is posted here.


This blog post by CRP Social Media President Mary K.D. D’Rozario first published at

DIA Annual Meeting Day 3: My Experience


Day 3 for me opened with a session on returning results to clinical trial study participants. The session was on the program because this is becoming a requirement in the EU. Here in the USA, CISCRP is On It, and their stats were quoted to kick things off:

90% of clinical trial participants want the trial results 87% not only want results but what the sponsor to continue to keep them updated at least once a year A significant number demonstrate a better understanding of their knowledge of the drug when they are given this information 91% of the never hear a peep from the sponsor, results or otherwise

Businesses outside our industry will find this astonishing. They would do anything to get their customers to ask to engage with them. Meanwhile, our customers are asking. They are ready to give us permission to contact them. And our answer is, "Nah."

I linked to Marcus, The Sales Lion yesterday and I'm going to link to him again today. He wasn't at this conference, but he's famous for one thing: Answer Customer Questions Take 30 minutes and watch this awesome YouTube. No cheating- he has great points all the way to the end.

We do have complications. Not quite as many complications as are sometimes thrown at the topic, I think, but a few are real. In the EU the notification just needs to be part of the study design that was reviewed by the Ethics Committee. But here in the USA an IRB may insist on keeping the trial open until the results are communicated. This could be years.

The biggest challenge is really a broken business culture. We don't see patients as customers. (Wait until what comes next on that.) If the customer wants to give their name to the sponsor, tell me, what regulation prevents that? We don't want their names because then we would have to treat them like customers, and pharma companies may not even have a department for that. It was very striking that this and the next session were on the medical communication and writing track. There is no customer service track.

Back to the issue at hand - CISCRP, linked above, provides assistance with notifying clinical trial participants of results. The CDC has a tool to evaluate the quality of medical communication to a lay audience at http://www.cdc.ogv/ccindex. Two of the speakers were from the Multi-Regional Clinical Trials Center at Harvard, known as the MRCT, which has developed some very actionable and specific resources for interacting with patients that they call their "toolkit". I gave you the link because you'll never find it looking for "MRCT" on Google. The "toolkit" is under "resources" and requires a log-in to access.

Okay, next: customer service (we're still on the medical communication and writing track though). These presenters were doing amazing things. Joseph Gasperino, a Field Medical Director for the Pain division in Pfizer is doing analysis of "Answering Customer Questions" with zero budget. Cheekily, they actually named the program that and, because pharma people will turn anything into an acronym that they can, they call it the "ACQ Forum."

David Meluso's title is Director, Worldwide Medical Reporting and Insights Lead at BMS. He spoke about the difference between reporting and analytics, starting with the case of the 1854 cholera outbreak in London that was solved by Dr. John Snow. History of health care as an example for today's hot topics -  I am all about that! He had some very interesting things to say about "reporting" vs. "analytics." This all fits in because everyone is using analytics to try to figure out what is going on with the customer, including what questions they are asking.

"Reporting," as explained by Meluso is "describing the hay stack." It is formulaic, and as such can often be automated. It is a presentation of data.

"Analytics" is finding the needle. It is specific to the question that is asked. Now what is fascinating about this is that analytics is often presented as the end of the human and the humane, isn't it? But Meluso presented it as something that is very dependent on an analyst asking the right question and then analyzing the answer into meaning.

And then Margaret "Peg" Carrico with Eli Lilly, who has created a global voice recognition and text analytics system to answer customer questions. Her energy is just amazing and she presented a lot of great things, but here are three key business cases from the end of her presentation: Packaging - Through their analysis they discovered that when people called in about other questions they were letting slip that when the product was being re-packed by a pharmacist it was being used past the 90 days that the product was good for. Because they have this information, they are redesigning the package to give the pharmacist more cues about the 90 day usage limit. Travel - They have a product that has to be hand inspected at the airport because it cannot go through the x-ray machine. People forget all the time, of course, and then they call the company asking if the product is safe to use. All they could say was, "We don't know." Can you imagine being the customer? They were angry. They thought the pharma company was a bunch of dolts. All this was recorded in the system. Which gave the business case to pay for the study to answer the question. Training - Because they have so much information about what comes into their customer service system, they were able to prove that there was no way they were going to be able to keep up with the questions that would be generated by the launch of a new product. This enabled them to get the budget to distribute training DVDs so that health care providers wouldn't flood them with questions.

The session on social media and clinical trial blinding came next. I present on blinding because there are some serious questions about the current industry attitude of reverence toward blinding in general. Social media issues rock everyone's boat, but the questions would still be there even if social media didn't exist. Eric J. Peacock, CEO of My Health Teams, approached this issue a little hard, but frankly the patient representatives went after it even harder in the Q&A. The patient representative pointed out that patients don't question blinding because they are stupid. They question it when it isn't working for them.

Peacock pointed out the evidence that had been shown that patients go to great length to deconstruct their pills and compare them to see who is getting the drug as evidence of deafness toward what the customer wants. "How could they be voting any more with their actions?" And this is not new; this is not something invented by social media. This goes back to at the AZT trials of the 1980s (discussed in a previous blog post) and even further back than that.

He showed evidence of a project where his company had successfully recruited subjects, but then they dropped off prior to enrollment because of issues about the study. At which point he delivered a pretty spot-on zinger:

"Other than the prison industry, no other industry spends so much on an individual and never ask them upfront what they want."

Followed by:

"Patients are people who act like consumers. We're finding that works very well."

Important stuff.

Lastly I went to hear what the DIA staff had to say about speaking and publishing with DIA. First off, watch for the deadline for next year's Annual Meeting. Apparently it usually opens in August and closes in September, but they are looking at pushing that back this cycle. They really made it sound a bit like applying for college: they have to read thousands of pitches, your's gets a second. So in addition to being well written and very current and relevant, really being able to match the conference theme is something that can make your entry get noticed.

The staff pointed out that they are nice people (and they do seem like very nice people!) and that if you call them and talk to them about your pitch for a conference or for a publication, they will do what they can to help you form it in a way that is most likely to be successful.

For the Global Forum they are seeking a continual stream of very current topics about China, and they also showed 11 other preferred topic areas, one of which was communications and social media. They are having some updates coming which should make both the Global Forum and TIRS more searchable.

This tidbit I thought was fascinating: They experimented for a series of four issues of TIERS with selecting one article from each issue to have a companion podcast (available here). The expectation of course would be that this would increase text article downloads somewhat. It increased downloads 30 times over!

And then it was the end of the conference day and I ran back to my room and started trying to figure out what is going to be on my podcast that I need to start immediately.

Day 2 is posted here. This is Day 3. Day 4 is posted here.


This blog post by CRP Social Media President Mary K.D. D'Rozario first published at

DIA Annual Meeting Day 2: My Experience


If we were playing "things people say about social media bingo," today I got to mark the "social media is free" box. But after that we could put away our bingo cards because it was a really great day! Martin Harvey Allchurch from the EMA presented on WEB-RADR. This is a plan to write a definition of pharmacovigilance on social media within the next three years. Obviously there are some concerns about that, namely that we have no idea what social media is going to be in three years. While they are trying to write a definition that doesn't tie itself to any channel as it exists now, in fact the embryonic definition very much molds to Twitter, Facebook and Google+ as they exist now. We don't know what we don't know.

I do think Mr. Allchurch was probably making an error to state that "we are not confirming that social media is the next thing." That horse has done left the barn. Here is where yesterday's keynote speaker Daniel Burrus was directly on point, in that there are a lot of things about the future that just aren't up for debate. It isn't like social is going to get smaller.

On to how to do that pharmacovigilance work: Carrie Pierce of Epidemico presented some pretty amazing work. They had 50 million social media posts to review. They took 500,000 (I think I heard that right) posts and hand-coded them in a machine learning process. Their system had to learn to identify misspellings, health language terms that are used metaphorically, health words that get turned into hashtags, unusual words and more.

So now they can run these social media reviews, and they did one on Victoza as a test. They pulled in 10,433 posts and the machine identified 368 "proto-adverse events" which then humans confirmed as 158 actual adverse events. The comparison against MedWatch was very interesting: the incidences were similar EXCEPT for a condition where attorneys get involved and submit MedWatch forms. For that MedWatch had a higher incidence.

The other thing they can identified was product misuse and re-sale, and pricing concerns (which sometimes lead to the misuse). They also identified that in social media you can get more information about the context of a condition. For example, self-diagnosis not only means they might be wrong, but it also means the adverse event did not impact them as much as an adverse event that caused them to seek treatment in the ER.

At the next session, I walked in to find the Twitter handles for all of the speakers posted on the screen. I knew I was among my people! The thing that I think is difficult to grasp is that they were talking about ideas that are just givens in the social media space, but which is truly new information in the pharma space. For the people who are coming at this from the social media side, were are in a world where using customer feedback, even if it came in from phone calls, is a new concept.

Fortunately Dana Lewis, the founder of the #HCSM hashtag (I was a little star struck!) knows where she is starting. She suggested, for example, that clinical research studies could gather questions that potential research subjects ask in the office and create content that answers those questions. Do you know any clinical trials where this is happening?

Marcus Sheridan, known as "The Sales Lion" has created a career advising all kinds of businesses to do exactly this: find out the customer's questions and answer them. This is something we do for our customers. And here is a video from what fans call The Church of Marcus- he's awesome! Here is is question: Are you failing to answer your customers' questions?

"Is this problem happening in your industry? If you aren't saying yes, you aren't awake."

Watch. His. Video.

We heard an overview of PfizerLink, which looks like a really awesome website. It even has a Blue Button- the button where you download your own health information. This sets me up to talk about A. Problem. Here's the problem:

"Our app is going to solve the problem of too many apps."

Pfizer isn't saying that, because they've made a website just for Pfizer. But other organizations say that. A lot of other organizations. There is only one way an app solves the problem of too many apps: By being so awesome that the other apps curl up and die, ignored and unloved. The app that is going to make less apps has to crush it.

Vladimir Pyagay from Transperfect pointed out that we are terribly short-sighted in what we think of as a "study portal." It is a place for training. Or a place for document management. It is in no way a hatch that you swim through for complete study immersion. Pfizer obviously is trying to get closer to that.

Think of Amazon's portal into the world of household objects. Or Minecraft's portal into an entire universe. Even Apple, where I pay them for my New York Times subscription and New York Times, after some initial whining, is happy to let them do it because they know that people really do want less apps and the only way they will survive is in an app consolidation. (New York Times, having learned their lesson, is now all in on native publishing on Facebook.) No one at the conference talked about Amazon and Minecraft, this is just me riffing on the topic.

And then I heard a lot of technical stuff about the First Amendment and some potential updates to pharma marketing legislation and then I went to my hotel. There is an awesome party tonight and Buzz Aldrin is going to be there, showing up last night's party that merely had Snoop Dog, but DIA has done me in.

Day 1 can be found here. This is Day 2. Day 3 can be found here.


This post by CRP Social Media President Mary K.D. D'Rozario originally published at

DIA Annual Meeting Day 1: My Experience


My first stop was the Alliance for Clinical Research Excellence and Safety (ACRES) meeting on Sunday, before the main conference kicked off on Monday. I hesitate to characterize what ACRES is trying to accomplish because it is big. Really Big. I'm not sure I can communicate it properly. I was at the meeting because of my association with the conference company iiBIG, which is working with ACRES to host a conference in Boston on 01-02 October 2015. This meeting, called SYNERGY, is going to be a working meeting where people actually form groups and work on the issues ACRES hopes to improve. You can learn more about the meeting and sign up here. By the way, I am also working with iiBIG to bring the Clinical Study Teamwork conference to Raleigh on 19-20 November 2015. More on that later.

Two sessions were available Monday morning before the plenary and keynote. The session I attended were all about social media, naturally, and... I can't lie. Two of the seven speakers were active on Twitter. Twitter isn't the be all and end all of social media, I understand that, but if you aren't eating any of your own dog food there's a good chance you don't know from dogs. One speaker offered to give us a hashtag for the session topic, at the end of the session. I don't want to be mean, but this is what happened.

There was one Q&A interchange between someone from GSK whose name I did not get and one of the speakers, Brian David Edwards, MD, MRCP, that was at a whole different level. They brought up that the kind of information, particularly pharmicovigilance information, that was going to be collected through social media was an entirely different kind of information, and an entirely different kind of relationship. Characterizing every report as a "risk" or an "adverse event" fails to distinguish the subtleties of how communication works.

Also, if we are trying to shoehorn the communication into some replacement for a MedWatch form, it misses the entire fact that this is an interactive medium. We can ask questions and get more education about the patient experience. We could, if regulations permitted, provide education. We have opportunities to improve drug safety for which we currently have no pathways and no language. Dr. Edwards stated that this is part of what he's trying to develop through his work with ACRES.

Someone asked one of the speakers about digital clinical trials and his response was to point out that that is very cart before the horse. We (these are my words) aren't engaging people at all and then we want them to do something for us? Pharma is well on it's way (again, my words) to being the assholes stomping around on social media. We had really better not go further down that road without a course correction.

Okay, Sweta Chakraborty, PhD. She's the Associate Director of the Institute on Science for Global Policy, she can be found on Twitter, and... WOW! I tried to find a YouTube of her speaking and I'm sorry I couldn't locate one. She would like to bring Cognitive Behavioral Science to pharma communications, which means addressing the patient where they are. I wish I could quote what she had to say about TV commercials, but in short they don't address people. Mass communication inherently loses communication value (my words for what she was saying). She explained that the patient comes into the situation with their own "values" and "levels of trust" and if they aren't engaged through those lenses, the information provided to them will be meaningless. It can even be counterproductive.

Now let's talk about Paul Grant, on Twitter here. He presented an amazing engagement plan from a social media engagement project. Here's an article all about it. You should read that article.

I've never made a chart that complicated, but that is exactly what we do at my company. We think about what our goals are, and then we write out what kind of engagement we are going to do on all the channels where the brand is. Is the brand going to be on Twitter? What are we going to do if someone follows up? Some brands are really chummy and they talk to you when you follow them. They might even follow you back. For other brands that is completely the wrong thing. Add in the complications of pharma regulations and you have to work all that out before you say a peep in public.

So that's enough Very Serious Thinking about pharma and social media, time to hit the vendor floor. As usual, the vendor floor at DIA is completely wild. Someone at lunch called it "intimidating." It actually disappears over the horizon of this picture. It's that big.


My lunch table ended up being a majority of North Carolina people. It was excellent to meet everyone, but of course it was most excellent to meet people who had sat in an airplane for an hour before flying from North Carolina and gloat about having chosen the train. (Not going to the airport, worth a few bucks. Putting your feet up and watching the corn fields roll by: priceless.)


After lunch was the plenary session, featuring a choir called Selected of God.


They were quite awesome and I recorded a 15 second Instagram snippet here.

And then the keynote speaker was futurist Daniel Burrus. Look, it's easy to make fun. What he has to say is startlingly obvious, but isn't every really good business idea? Having been a business owner for about three years now, and watching and interacting with a lot of other business owners in that time, I'm starting to think that people have great ideas for business and then succeed in spite of themselves rather than because of themselves. So I can't knock obvious when we all really need to have the obvious pointed out to us. What he had to say seemed to follow the outline of his latest book pretty closely, as described on Amazon. (Disclosure: I might have that link monetized. I haven't linked to Amazon in so long that I can't remember.)

And then some people went to an awesome party, as I see on Twitter, and I sat down and wrote this. There will be a Day 2 but I'm not sure it will be as promptly written because I'm RSVP'ed for a Tuesday party.

Day 2 continues here.


This post by CRP Social Media President Mary K.D. D'Rozario was first published at

Challenging Randomized Clinical Trial Supremacy: Right to Try Legislation


A couple of weeks ago I spoke for the RTP SoCRA chapter on clinical research blinding history and current issues in clinical research blinding. You can find the slide deck here. The blinded, randomized, placebo-controlled trial, is relatively new, really only gelling into it's current form in the 1980s. It seems set in in stone, but it really recent. And the supremacy of the RTC was challenged almost from day one by the AIDS crisis. You can read more about that in And The Band Played On.

Today's challenges come from the Ebola crisis raising ethical issues about what real community consent means, an issue that has been simmering for all developing-world clinical trials, and from USA patients unsatisfied with the idea that a long testing process is necessary to protect public health, especially for terminally ill patients.

This has led to the development of Right to Try legislation at the state level. Currently 19 states have active Right to Try laws. These laws generally state that a terminally ill person can try a medication (or medical device) that has not been FDA approved if it has completed some level of testing, such as Phase I. They also generally state that the person or their insurance company can pay for the product, and that everyone involved is protected from liability. Some of them have additional restrictions such as that a clinical trial for their condition cannot be available within 100 miles of their address (Alabama).

As we have seen with other recent legislation on other issues, these laws challenge federal control. The challenge to the FDAs control of products they have not approved is obvious, but in the liability protections other challenges are necessary, including protecting treating physicians from sanction.

With Right to Try legislation, there are also questions about whether it is significantly different from the FDA's Compassionate Use program (supporters say Right to Try is more streamlined), and whether there are ethical issues with people who can pay for the product essentially "jumping the line" and possibly diverting resources from the product being developed through to FDA approval and widespread access. Again, this latter issue does not seem to be significantly different from concerns about Compassionate Use.

RAPS, the Regulatory Affairs Professionals Society, keeps a complete list of all active and draft laws. It's a fantastic resource, available here.