Follow the (Clinical Trials) Money

This post was originally featured on HIStalk.

A New York Times article, Do Clinical Trials Work?, describes how modern clinical trials are broken since drugs for most of the complicated modern diseases only work for X percent of the population.

It’s widely understood that many drugs only work for people with certain genetic traits and comorbidities. The challenge is in determining which traits and conditions affect outcomes while controlling for a range of factors, including: age, sex, medical history, disease, stage of the disease, and confounding with other diseases, to name a few.

The clinical trials business is undergoing serious changes. As the NYT article suggests, trials need to be smaller and targeted to patients with more narrowly defined inclusion / exclusion criteria. The issue is that existing methodologies driven by mass-media marketing for identifying and recruiting patients for more specific criteria aren’t effective, hence all the trial delays.

Simply taking existing trials and breaking them up into smaller trials doesn’t sound particularly difficult. Why hasn’t it been done? There’s always a single answer to that universal question: follow the money.

Recruiting patients into trials is already an extremely expensive proposition. There are cancer studies in which the cost of finding and recruiting each patient exceeds $50,000. Mass media marketing is expensive. Additionally, 80 percent of trials are delayed, and the average delay is almost five months. These financial and time costs kill people who aren’t receiving market-approved treatments as cheaply or as quickly as they otherwise could have.

Marketing larger numbers of smaller trials and recruiting patients into them is cost prohibitively expensive. The more trials, the more marketing dollars required. The challenge is not in trial design, but the ability to find the right patients and recruit them into the right trials.

A handful of startups and well-established vendors are trying to solve the patient recruitment problem.

CenterWatch is an established company that maintains a database of clinical trials and allows patients to use powerful search tools to find trials that they’re interested in. Once a patient finds a trial that they are interested in, they provide the patient with the contact information and additional details for the trial. The service is straightforward and the filtering tools are robust, but overall it feels very Web 1.0 to me. It requires a lot of clicking and navigation. They could be ten times more successful if they could automate and simplify the user experience.

Emerging Med is another industry veteran that is focused on cancer trials. Emerging Med claims to have guided 170,000 patients through a search for clinical trials over the last 13 years. Their service is remarkably similar to CenterWatch’s. The presence of two companies that do almost the same thing clearly validates the market and indicates that it’s sufficiently large.

ePatientFinder (ePF) works with pharmaceuticals, device manufacturers, and CROs (contract research organizations) to match trials with a nationwide network of referring physicians. Working with EHR vendors, ePF runs analytics to de-identify patients who meet trial inclusion / exclusion criteria. This partnership network enables more targeted searches and allows ePF to compensate its EHR vendor partners, many of which are struggling. ePF is trying to invert the entire patient recruitment process. Their model is radically different from the traditional industry practices. Historically, patients have been recruited through expensive mass media marketing campaigns. ePF finds patients cost effectively by working with physicians to accurately target patients based on EHR data. They may have found a great application of analytics technologies, which have been overhyped for years (I’m guilty!).

TrialReach has compiled a database of clinical trials and uses a survey tool to help filter patients for these trials. They are based in the UK and are focused on European trials. TrialReach posts ads online to direct patients to TrialReach’s website, where patients are asked to answer a few questions. If the patient passes the survey, their information is sent to the CRO. TrialReach’s secret sauce is its placement of advertisements through the use of proprietary tracking algorithms and a network of ad distribution partners.

I’m actually a bit surprised there aren’t more companies actively pursuing the clinical trials space. The analytics space is overhyped, overfunded, and overcrowded, and most of the analytics companies aren’t making the kind of money they told their investors they would (similar to the startup EHR market). There have been a few breakouts though, such as Ayasdi, that are doing well.

The biggest flaw in the NYT article was its title. It paints a reasonably accurate picture of the current state of clinical trials and begins discussing some of the more advanced concepts such as personalized medicine, comorbidities, etc. It fell short of explaining why trials are structured the way they are and most certainly didn’t investigate existing or up and coming commercial solutions to the problems they pointed out. It’s always easier to pull down than push up. Unfortunately, if you follow the money, you’ll quickly realize that the NYT needs eyeballs to feed itself, hence the sensationalist title.

Selling a Dream

We're lucky. We spent a remarkably short period of time answering the existential startup question. We found surgeons, anesthesiologists, and seasoned healthcare IT executives that believed in our dream, and were willing to fund and pilot it.

We're among the most atypical startups on Earth:

• We have a billion dollars of free marketing (thanks Google)
• No one expects us to or holds us to having market traction
• We are competing in a green field (which we'll burn in our wake)
• Paradoxically, legacy health IT vendors have already validated the market for us, despite the fact that we're competing in a green field
• The CEO writes for what's widely recognized as the leading blog in the industry, HIStalk

The combination of all of the above empowered us to get off the ground faster than the vast majority of startups.

The moral of the story is that selling a dream is 10x more powerful than selling traction. That's why Amazon is worth $50B even though they don't make money. Jeff Bezos is probably the greatest dream salesman of all time.

The Genius of the Glass Explorer Program

I see four distinct forms of genius in the design of the Glass Explorer #ifihadglass program.

1) Ensure that Explorers love Glass.

I've interacted with over 100 Explorers. I've noticed some unique patterns and trends. These aren't unilaterally true, but apply to the overwhelming majority of those that I've talked to.

Explorers seem to love Glass blindly and whole-heartedly. There're lots of negative reviews of Glass the Internet, but the reviewers have incentives to be negative and sensationalist to drive web traffic. The average non-influential explorer has no such incentive. I've found that they're deeply in love with Glass.

Why?

Because Google created arbitrary scarcity, and made Explorers feel special for being chosen in a public contest in which 90% of applicants didn't get chosen. Additionally, Google arbitrarily raised the price of Glass to $1500, even though Glass will be priced at no more than $400 upon release.

http://blog.pristine.io/blog/2013/7/10/kjbs75or8znukxz8wndkfw9dcdpi3j

Who wants to admit that they spent $1500 on a silly product? That inherently implies a lack of intelligence on behalf of the consumer. There've been lots of studies that show that people will justify and rationalize purchases with higher price tags. It's the same psychology that drives flame-wars on the Internet, particularly in the gaming community.

2) Give Glass to the most influential people

How does the world's ultimate data company go about determining the 8000 most influential people in the country? Easy. Just quantify everyone's social media presence, and use that as a proxy for influence.

This also explains how some people won Glass for entries such as  "cut a bitch." Google later revoked those invitations, but the fact that they were handed out to begin with suggests that most of the posts were never actually read by a human.

http://arstechnica.com/gadgets/2013/03/proposal-to-cut-a-bitch-gets-selected-for-google-glass-program/

The combination of these first two traits has been a potent marketing tool.

3) Distribute Patents

The smartphone era induced a massive web of patent battles. Apple sued Samsung and Motorola. There were many others.

Google wants to crowd source every idea, and let the entrepreneurs patent everything as fast as possible so that no single company hordes the patents to sue everyone else.

4) Kickstart development for the app store

Google of course wants to get Glass in the hands of developers so that Glass can launch with lots of fun and interesting apps.

Blogging and Signalling

Blogging was one of the best decisions I've made in my life. It's one of the best signalling mechanisms.

I had a hunch going into 2013 that I would want to start a company, raise capital, attract talent, and ultimately ask for money from customers. In order to do that, I knew that I would have to showcase my brain. No one wants to give money to, work for, or be associated with an idiot. This challenge is even more pronounced in healthcare IT, in which my age works against me.

Blogging is one of the best ways to showcase one's brain in a format that anyone can digest and understand on their own time. Blogging is simple, universally accessible, and still incredibly powerful.

In addition to signalling, I've also discovered that blogging helps me collect and organize my thoughts, improve all facets of written and verbal communications, and calm my nerves. For the first time in my life, I carry fiduciary responsibilities. I am accountable to my investors, and I will do anything and everything to ensure that I return their capital 10x. That responsibility creates real pressure to perform. Since I don't watch TV or play video games anymore, I relax by writing and working out.

Thank you to everyone who's helped me get my writing career off the ground. I want to give special thanks to:

Dr. Robert Marcus, who's edited almost every post I've written since the start of the year.

Tushar Jain, who's held me accountable via stickk.com every week, and provided insightful, honest feedback on many posts.

Ryan Hoover, who's provided inspiration and given crucial feedback on a few key posts.

Dr. Travis Good, who's provided excellent guidance and mentorship as a fellow HIStalk blogger.

Tim, aka Mr. HIStalk, who's provided access to the best writing outlet and publication platform in healthcare IT on the Internet, HIStalk.

Battle of the App Stores: Athena vs. Greenway

This post was originally featured on HIStalk. 

Greenway and athenahealth are two of the more forward-thinking companies in health IT. Although they do have some older technologies in the background, they’ve adopted most of the newer tech stacks when and where possible.

Most importantly, both companies view themselves as platforms on which other apps can be built. They see themselves as app platforms and distributors, similar to the Apple and Google model and their respective iOS and Android app stores.

An app platform exposes application programming interfaces (APIs) that allow other apps to integrate with the core functions that the platform itself provides. Two fundamental types of APIs exist: data APIs and logical APIs. Data APIs expose data to third-party services. Logical APIs allow third-party services to be logically integrated into existing workflows.

A common example of a data API is when a third-party iPhone or Android app pulls up your contact list. A common example of a logical AP is integrating camera functionality into an app. In both examples, Google and Apple performed an enormous amount of work to build contact lists and a camera. They exposed the data and logic behind each function so that developers could integrate those functions into their own apps.

Let’s take a look at the athena and Greenway platforms.

It’s important to note that athena hasn’t actually launched anything of substance. Its current "release" is a soft launch that was timed for HIMSS13. The athena app store won’t be live for another few months at least.

Greenway beat athena to the market by a mile and finished the marathon before anyone else even started. Greenway launched its app store for HIMSS12. It has provided a few updates API updates since then, though I haven’t seen any remarkable jumps forward since the initial launch.

Next, let’s look at technology. Athena is only exposing modern, RESTful APIs. Athena isn’t exposing any logical APIs, only data. That’s not necessarily a bad thing, as data is more important, but it means that third-party apps can’t plug into athena’s existing workflows. All athena third-party apps must exist as standalone, independent entities.

For developers, RESTful APIs are awesome to work with. In many cases, they require just 1-2 lines of code to get a data back in a predefined, Web standards compliant structure (usually JSON).

Greenway doesn’t provide any logical APIs either. Unfortunately, they live on an older tech stack, so not all of their data APIs are RESTful. Many of them use the older SOAP format, which is much more cumbersome for developers to work with. Additionally, some of Greenway’s documentation is lacking. To be fair, that’s still better than athena, which provides no documentation at all since nothing has actually launched.

Both Greenway and Athena hired Mashery to help build their application platforms. Mashery helps technology companies build application platforms and expose APIs. It helps them make decisions about when and where to expose data, how to structure APIs, how to write documentation, and how to evangelize and entice developers to write on top of their platforms. Mashery is widely considered to be the best in the API management business, so it’s no surprise that both athena and Greenway turned to them. Neither company had experience building an application platform, so it was smart to bring in outside help.

Let’s take a quick look at business practices and models. Greenway’s model is not particularly friendly towards startups. They told my company to come back when we had customers, and more importantly, revenue. Greenway only wants to work with established companies that have real customers and real revenue.

From Greenway’s perspective, if they can’t monetize the relationship on Day One, it’s not worth pursuing. While I respect that logic, that defeats the entire premise of an app store — self-proclaimed "innovation at lightning speed." Quite a few pre-revenue companies innovate much faster than those with customers who slow them down.

Greenway also told me explicitly that if the company ever decides that it wants to be in my business (or any other developers’ business), it will gladly copy and steamroll me. Although I disagree with its thinking, it aligns with its business model: selling software as a service. Sell more modules and charge more money. I think the best thing Greenway can do is to grow the app store as fast as possible and create developer and customer lock-in. Stickiness is more valuable than marginal revenue.

Athena on the other hand is much more like Apple and Google. They don’t play favorites with their developers. Whether you’re a guy in a garage living on ramen or a $50M company, they treat you the same. This model reflects athena’s business model: give away software for free to sell administrative services and take money off the back end.

Athena doesn’t care if you replicate every function they offer and do it 10 times better. As long as the practice is an athena customer, athena is monetizing the billing and collections at the end of the day, not the use of any particular function of its many first-party apps. Athena’s interests are more aligned with those of its developers and customers.

I should make a grand statement of which app store is better, but that’s silly. Athena’s isn’t even out yet and I’m inherently biased against Greenway since they told me to go away. I would rather level the playing field, make knowledge public, and encourage all of the EHR vendors to learn from both the successes and the mistakes of athenahealth and Greenway. Hopefully other EHR vendors can learn to make better decisions on behalf of their customers and third-party developer partners.

EHR vendors, please, for the love of God, open up your platforms. It’s in your long-term best interest. EHR churn is rampant and only getting worse. Stickiness is way more valuable than marginal revenue. You’ve already built a castle, now build a moat. I’m especially looking at you, Epic, Cerner, Meditech, and McKesson.