Better Systems for Clinical Data Collaboration

Innovation in Systems and Software

In my last two posts, I wrote about the need for more liquidity in clinical research data.  As a foundation for sharing this new more-liquid clinical research data, we need more patient-centric systems, where patients can create, consume and maintain relevant medical information.

However, in the average hospital, most patient data is generated and organized in the clinic, and typically stored in a variety of different legacy hospital systems.  Pretty illiquid by definition. Therefore, we need fresh approaches to sharing that data across hospital systems  ― and then across multiple hospitals.  

Fortunately, innovation in systems and software is beginning to happen on this front.

Several organizations ― including Dana-Farber Cancer Institute, the LIVESTRONG Foundation, and Boston Children’s Hospital ― are working to build a reference implementation.  This is a technology model that would describe how a hospital could publish the information contained in its systems easily, securely and efficiently to other institutions. 

Another very interesting technology is the SMART Platform, developed under the leadership of Dr. Zak Kohane and Dr. Ken Mandl at Children’s Hospital in Boston.  The SMART Platform and i2b2 Analytical tool are truly a step in the right direction.   

These new technical approaches provide the ability to build cool new apps very quickly – apps that combine data reported by the patient in an interface like the LIVESTRONG Cancer Guide and Tracker iPad app alongside data collected by traditional clinical systems. Using the same approach, we can build apps for physicians and many other use cases and simultaneously make the apps accessible via browser-based applications.

Let’s think about what else we can do as an industry – and encourage many people and companies to start writing new apps quickly.  

In my next post, I’ll talk about big remaining challenge to the liquidity of clinical research data – patient consent – and how we win patient trust and cooperation.

This blog post came out of a presentation that I recently delivered at Rev Forum, a conference sponsored by Lance Armstrong’s LIVESTRONG Foundation and Genentech. I have worked with LIVESTRONG and various biopharmaceutical companies on new health care information products and apps that take advantage of data liquidity to help patients combat cancer and other difficult diseases.

Improving Data Liquidity in Clinical Research

Empowering Patients and Doctors

In my last post, I wrote about the need for data liquidity in clinical research – and the need for biopharmaceutical companies and healthcare institutions to take the lead by freeing up data about their studies, clinical trials and drugs.

To accelerate clinical research efforts for diseases like cancer, we need two things.  First, stakeholder institutions (like biopharmaceutical companies and healthcare institutions) need to free up their data.  Second, we need new systems and software that can share and manage that data – securely and at scale – across our complex healthcare ecosystem. 

Start-ups are being formed every day that are pushing the envelope on applications and technologies that take advantage of health care data liquidity. In Boston/Cambridge alone, we have three start-up incubators dedicated to health information technologies, each with 10+ start-ups.  That’s more than 30 top-tier, vetted start-ups focused on health information technologies being developed at any given point and time. For example, check out:

Rock Health
Health Box
AthenaHealth Accelerator

 

Pharma companies have long been proponents of “free your data” – as long as it means freeing data from patients, from claims clearinghouses, from pharmacies and so on.  Pharma companies have been less enthusiastic about freeing their own data, about their studies, clinical trials and drugs.  But the logjam is starting to break.

As I mentioned in my previous post, recently GlaxoSmithKline (GSK) publicly announced it would make detailed data from clinical trials available to researchers.  The company’s detailed patient data (data that forms the basis of trials of approved drugs as well as discontinued investigational drugs) would be made accessible to researchers.  Researchers’ requests for access will be reviewed by an independent panel of experts, and the patient data will be anonymous.

  

Last year, one of the large biopharmaceutical companies – in collaboration with the electronic health record company Cerner – began an initiative to build an open interface that will enable sponsors of clinical research studies such as Novartis, Genentech, GSK or Pfizer to publish inclusion/exclusion criteria about their clinical studies to specific clinical partners – in much greater detail than what’s available on the National Institutes of Health's ClinicalTrials.gov today.  

The goal of this project is to create a electronic mechanism to ensure that all eligible patients are identified for appropriate studies via their doctors.  This mechanism would be able – without changing any data privacy – to flag patients’ records when they are diagnosed or when new studies or updates to studies become available; and to dynamically notify doctors and match patients with new or evolving studies based on patients' clinical profiles and the inclusion/exclusion criteria of the trial.

Under this new electronic standard for study information, study eligibility criteria are expressed in a standardized, machine-readable format. Any EHR system can ingest the study data automatically as new studies are created and as existing studies change.  With this more-liquid data, providers can then match the inclusion/exclusion criteria against the health records in their systems.

A provider configures its systems to flag records of potentially qualifying patients using a form of research-study-recommendation engine. The provider runs and tunes this engine so that the next time a clinician pulls up a patient’s health record (or the patient’s health record changes), the EHR system will suggest to the doctor that his patient may qualify for a clinical trial – both local and not-so-local trials (think truly global patient recruitment with little or no extra effort). 

In addition, when a new trial is published, doctors with patients can be notified that there is a new trial of possible interest and eligibility for specific patients.

Through this type of simple standard for study information exchange – one that empowers doctors and is run by providers – doctors and patients could be automatically made aware of trials regardless of where the study is being run or when a new study starts.

Using this simple standard, Cerner has worked with various large biopharmaceutical companies to build and test end-to-end Proofs of Concept –  in the process successfully demonstrating that this approach can work very well with relatively little extra effort on the part of the study sponsors, the providers or the biopharmaceutical companies.   There is no additional risk of information privacy, since these criteria have been published previously to the providers, and the patient data does not have to be shared at all. The standard just enables getting better data on studies to providers in a more targeted way.

In short, starting to improve liquidity of clinical research data just requires leadership from pharma companies and cooperation from health care providers to prime the pump and adopt  standards – and perhaps the encouragement of trusted brokers such as LIVESTRONG to bring the parties together. 

Increasing the liquidity of data in ways like this could improve enrollment in studies, especially for rare diseases with small patient populations. Doctors and patients would have a proactive monitoring system that reminds them about all relevant research studies – especially new studies in rare indications – regardless of geography or the distractions in their daily lives.

This blog post came out of a presentation that I recently delivered at Rev Forum, a conference sponsored by Lance Armstrong’s LIVESTRONG Foundation and Genentech. I have worked with LIVESTRONG and various biopharmaceutical companies on new health care information products and apps that take advantage of data liquidity to help patients combat cancer and other difficult diseases.

The Need for Data Liquidity in Clinical Research

Much of the content in the next few posts was developed jointly with my close friend and trusted colleague Joris Van Dam.  Joris is truly a superstar and is doing fantastic work around the world related to eHealth and improving the liquidity of data in healthcare.  

In the course of creating new drugs and therapies, organizations in the biopharmaceutical and healthcare industries amass huge amounts of clinical trial data.  Unfortunately, much of that data remains locked up in individual IT systems, making key data unavailable to the many of the participants in clinical trials: physicians and their patients.  As our society intensely seeks cures for cancer and other diseases, this is nuts – and completely unnecessary.  It's time for a change.  The data required to empower researchers can be shared securely and appropriately.  

In the Information Age where we can do so much via the web, our smartphones, our iPads and the "Cloud," we shouldn’t accept word of mouth as the best tool for patients to find the right studies.  It’s clearly not.  Nor should we accept data illiquidity as an obstacle to timely, broad availability of information about clinical trials. 

The Story of Melissa

Meet Melissa.  Melissa isn’t her real name and that isn’t her real picture above, but this is a true story.

Earlier this year Melissa was diagnosed with one of the deadliest forms of cancer.  Despite her predicament, Melissa is one of those patients (like many of those involved in the LIVESTRONG community) who decided to take an active interest in her own care. 

She wanted to proactively explore any and all kinds of treatment opportunities, including experimental treatment in a clinical research study.

Melissa was smart enough to understand that clinical trials offer no guarantee of improving her condition, let alone a cure.  But the opportunity to participate in a clinical trial would give her hope. It would give her the ability to fight, and the satisfaction, that through her disease, she might be able to contribute to better treatment and ultimately perhaps even a cure, if not for herself then potentially for others like her. It would give her the feeling that her pain and suffering mattered and that she could make a difference in the world.

Melissa believed that it was important for her to have the opportunity to join a clinical research study. So she spent a lot of time on the Internet, educating herself about her disease and treatment opportunities. One day, using the U.S. National Institutes of Health’s Clinicaltrials.gov, she found a study for which she appeared to qualify ― one being run not too far from her home.

Unfortunately, Clinicaltrials.gov didn’t list the name or contact number for the investigative site.  It just said that it was a  study being run by a large biopharmaceutical company and that she could call the main switchboard number. She called and they really couldn’t help her ― so Melissa was stuck.  Next, she turned to a clinical-trials matching web site and asked if there was anything they could do to help her.

Fortunately, by chance the team at the research group of the large biopharmaceutical company happened to know the person who runs that matching web site. That person connected Melissa with someone who offered to help coordinate.

The folks at the biopharmaceutical company went into their clinical trials database to identify the study manager. Then, they contacted the study manager, who went to the matching web site asking if it was okay to share their contact details with Melissa.  A few weeks and many phone calls later, Melissa finally had a screening appointment at the clinic. Within a short time Melissa ― through her own perseverance and a lot of luck ― was screened and enrolled in the study.

Now the shocker in this story is that... 

....the study investigator was Melissa’s own doctor!  

This was the very doctor who had diagnosed Melissa just a few months earlier.

It’s tempting to think that this doctor dropped the ball.  But in fact he hadn’t. He’s an extremely competent and compassionate physician, not to mention a great study investigator.  He just had a lot going on, and the timing of the start of the trial had been off a bit with the timing of Melissa’s diagnosis. 

It might also be tempting to say that the biopharmaceutical company was at fault for not listing the investigator’s contact details on Clinicaltrials.gov. But the clinic in question is based in Europe, where regulations are such that pharmaceutical companies have to obtain explicit consent from each individual investigative site before its contact details can be listed on Clinicaltrials.gov.  The company just hadn’t dealt with all that red tape yet and there are no systems set up for information to flow more easily.

So, this situation was no one’s fault in particular, but rather a matter of circumstances, bad timing and the lack of data liquidity.

Time for Big Pharma and Healthcare Institutions to Step Up to the Plate

Clinicaltrials.gov was an important milestone and a catalyst when it was launched. On the back of clinicaltrials.gov emerged a slew of applications that help patients and doctors navigate the data, and find studies that are particular to a condition.

These include:

• The Fox Trialfinder for Parkinson's Disease from the Michael J. Fox Foundation
• Corengi for diabetes
• YourTreatmentChoices.com

More recently, there are new smartphone apps such as TrialX and CoActive.

This is what data liquidity is all about:  Making data appropriately available to encourage an ecosystem of applications that help patients and physicians ― and ultimately help drive down the cost of health care and improve outcomes. 

But Clinicaltrials.gov was launched 12+ years ago ― 7 years before the first iPhone.  We now need to go much further and faster in liberating clinical research data, and I believe that the large biopharmaceutical companies and healthcare institutions have the opportunity to take the lead. 

GlaxoSmithKline (GSK) recently announced that it will open up access to its clinical trial data as appropriate to support open collaboration among researchers.  (You can read more about this decision in this Wall Street Journal article here.)

To accelerate clinical research efforts, we also need new systems and software that can improve liquidity of clinical trial data across the complex healthcare ecosystem.

By increasing the liquidity of clinical trial data this way, we could both improve the lives of patients and reduce overall health care costs. 

The information technologies exist.  Attitudes toward information-sharing are changing.   And cost reduction and better outcomes are compelling motivators. 

In my next posts, I'll talk about some specific initiatives that could have a big impact on the liquidity of data in the healthcare industry as well as a number of issues related to consent, where my great friend John Wilbanks is leading the charge. Check out his TED talk.

This blog post came out of a presentation that I recently delivered at Rev Forum, a conference sponsored by Lance Armstrong’s LIVESTRONG Foundation and Genentech. I have worked with LIVESTRONG and various biopharmaceutical companies on new health care information products and apps that take advantage of data liquidity to help patients combat cancer and other difficult diseases.

RISD Entrepreneur Mindshare Celebrates Artrepreneurship

Encouraging Entrepreneurship for Artists

My wife Amy Palmer and I were honored to sponsor the 2nd annual RISD Entrepreneur Mindshare.  RISD President John Maeda has provided incredible leadership and thoughtful guidance in developing the next generation of top-tier "Artrepreneurs," and the event was truly inspiring.

This year's conference had more than 150 participants including RISD students, alumni and faculty as well as folks from the Providence and Boston entrepreneurial communities.

The conference kicked off with Joe Gebbia RISD '05/ID/GD, Co-Founder of Airbnb,  who gave a profound talk about how to be successful as an artrepreneur.  

There was some great press coverage of the event:

RISD Joe Gebbia says to "take the next step"

At RISD, Design Meets 'Scrappy' to Create Artrepreneurship

RI School of Design holds innovation conference

Joe was followed by a two-day visit by Enrique Allen, co-founder of The Designer Fund, who met one-on-one in small groups with RISD students and alumni.  RISD students were the first audience given access to the brand-new free e-book published by the Designer Fund, Designer Founders.

The next big event at RISD is the Artrepreneur Bootcamp in collaboration with the New York Foundation of the Arts in January followed by a full-day hands-on Art of Business Bootcamp in April.

There is a vibrant and visible student entrepreneurial community at RISD, thanks in large part to the support of RISD President John Maeda as well as the entire RISD Staff – especially Greg Victory, who is the voice of entrepreneurship at RISD.  GREAT JOB, GREG!

Upstart is in Beta - Check It Out

Help Support the Next Generation of Entrepreneurs

I posted previously about a great new company called Upstart that I’ve been helping to get off the ground. Now Upstart is in Beta. I’ve already backed more than a dozen outstanding Upstarts – and you should consider doing the same.

Upstart is Kickstarter for people: a crowd-funding platform that allows college grads to raise capital in exchange for a small share of their personal income over 10 years.  It aims to make it easier for grads to pursue what they really want instead of following a traditional job path, by matching the Upstarts with mentors and giving them a modest amount of economic freedom (to retire student debt or fund the first step of their dreams).  

At this point, Upstart has launched its first pilot class of funded students (that's one of them, Ian Shakil, above), and also attracted more than 30 leading universities into the Upstart network.  The company has also generated a great deal of positive press for its approach to addressing a major problem.

Now that Upstart is featuring its next batch of profiles, I wanted to invite you to join me in supporting the next generation of great entrepreneurs.

You can invest as little as $100 in an Upstart. I’d recommend diversification by spreading your investment among five or more Upstarts to maximize risk/return.  The great part about this is that you get returns that are better than T-Bills AND you are supporting specific young people who are pursuing alternative career paths – the kind of paths that usually lead to the most value creation in our economy (NOT investment banking or consulting).

You can browse some of the new Upstart profiles here:  https://beta.upstart.com/upstarts

You can register to be a backer here:  http://beta.upstart.com/register?code=b4d9ad169139872384acd56b10a9ff1d

About Upstart

Upstart was founded earlier this year by my close friend Dave Girouard, who was president of Google Enterprise for eight years (cloud apps, Gmail, Calendar, Google Docs, etc). Dave brought over a few members of his team from Google. Upstart was seed-funded by Kleiner, NEA, Google Ventures, First Round, and Mark Cuban, and the company and its team are off and running.

You can find some recent press on Upstart here:

   

Upstart - Empowering The Next Generation of Entrepreneurs

Today the team at Upstart announced what we’ve been up to over the past three months. 

The Upstart mission is inspiring (see Founder/CEO Dave Girouard's blog post here), the team is world-class, and the culture of the company is…well…a ton of fun.  I’m especially thrilled to be joined as a “Backer” by two close friends and trusted colleagues in Boston, Frank Moss and Jim Dougherty.  Their leadership in supporting young people who want to turn their passions into careers as entrepreneurs is exemplary.  I’m also thrilled to be working yet again with the fantastic partners at Kleiner Perkins, NEA and Google Ventures. 

Briefly, Upstart is a new approach to funding and mentorship. Using a crowdfunding model, it allows college grads/would-be entrepreneurs in virtually any field to raise capital in exchange for a small share of their income over a 10-year period.   Upstart aims to provide a modest amount of risk capital, paired with guidance and support from experienced backers, to help grads pursue less-traditional and more-inspiring careers.  

I believe that Upstart has the potential to supercharge the US Innovation Economy - as Dave says "When politicians say we need more entrepreneurs, what they mean is that we need more people creating jobs, rather than taking them." I couldn't agree more - it's time to do the heavy lifting required to create more entrepreneurs so that they can do the heavy lifting required to drive job growth over the next two decades. Upstart believes that one of the key factors in creating more entrepreneurs is early intervention in their career development. Some of the key principles that are driving us include:

●       Innovative and ambitious young people should be empowered to pursue their passions when they are young.  If we don’t empower them when they are young, they risk being numbed by the bureaucracy of the larger organizations that they often join for lack of a viable alternative path as entrepreneurs. It’s not that big companies are bad. It’s just that young people who have a high risk/return profile can quickly lose their edge and passion as they succumb to the broader interests of a large organization vs. pursuing something that they care about deeply.  65% of our job growth over the past 2 decades has come from companies with less than 500 people - over the next 2 decades it's the Millennials/Generation Y that will create those companies and create the bulk of jobs that our country needs so desperately - we need to empower them as much as possible.  It's time to bet on Generation Y.

●        It’s fundamentally valuable for our economy to balance the recruiting machines of large organizations with a social networking-based system that facilitates young people who want to follow more independent, highly individual paths.  This generation just wants to connect with people who could be their mentors in pursuing their interests and passions. Mentors just want to connect with inspiring young people. Upstart makes those connections easy and automatic. 

●        Not every young person has a high risk/return profile, but many more young people will pursue entrepreneurial interests if they have a little bit of  financial flexibility at the right time.  Modest amounts of financial support as young people graduate from school, along with some strong support and encouragement from great mentors, can go a long way.  I know because I've had fantastic support from many great mentors during my career.  

●        Mentorship is just as rewarding for the mentor as for the mentee – if only we can make the right connections. What’s been missing is a system to connect potential mentors and mentees around shared interests and affinities.  I’m a software guy who is interested in the life sciences, so I’m naturally prone to want to mentor smart, young, enthusiastic people who share those interests.  But I’m also passionate about rugby, so anyone who is involved in rugby always gets more of my time than those who don’t ;)  When young people who share my interests ask for my help - I'm compelled to help them - because I get way more back than I give.

●        Most mentors who have the financial resources – when provided with the opportunity to earn a return similar to bonds – would be thrilled to invest their own money in promising young people with similar passions and interests. Upstart matches mentors with the young talent who will power the growth of our economy over the next 20+ years – and does this at scale.  I can't think of a better investment - definitely better than T-Bills.

●        To scale entrepreneurship in the US, we need to scale our ability to empower and coach young people who are capable of taking risks and executing on their passions. I’ve spent a lot of time starting companies from scratch. In my experience, the older and more successful people get, the more they are prone to take for granted the value of a small amount of coaching and financial resources early in the career of a budding entrepreneur.  Small amounts of time and money directed strategically and without friction at scale, can have a huge positive effect on our economy.

●        Most entrepreneurs need help, coaching and advice in order to achieve their missions. Most people are not the kind of superstar entrepreneurs that the media popularizes every day:  Steve Jobs, Bill Gates, and so on.  At the same time, these young people contribute the bulk of the job creation through the number of companies they start and the never ending flow of their ideas, energy, passion. A big part of what Upstart provides to young entrepreneurs is a network that can fill the gaps in their experience, knowledge and contacts so they can reach their full potential.

I’m honored to be partnering with my great friend and trusted colleague Dave Girouard as the Founding BOD Member at Upstart and thrilled to be the #1 Backer. 

Let’s take the “post-industrial reins” off our brightest, ambitious young people and empower them to leverage the Information Economy to change the world for the better.  Our country was founded on a core principle of rugged individualism. Let’s coach our young people to take control of their own careers, professional lives and interests and pursue their passions.  We will benefit as an economy and a society in ways that we can't begin to imagine. 

Steve Blank on Demystifying the Start-Up Culture

In his remarks yesterday at the closing session of the National Governors Association Annual Meeting, author, successful entrepreneur and educator Steve Blank did a great job of articulating in layman’s terms how the start-up ecosystem in Silicon Valley works, why start-ups are different and require specific expertise, and why embracing start-up culture and expertise is so critical.  I believe Steve's work is going to be a primary driver of innovation at scale for our country. It’s BRILLIANT.  

If you care about start-up/founder culture or start-ups, you should watch his talk in its entirety.  

Steve mentions the importance of researchers who focus not only on world-class research going on inside of their respective academic institutions, but also on the application of their research at scale in the public and private sectors.  Some of my favorite role-model researchers in Cambridge include:  

George Church 
Eric Lander
Bob Langer
Marvin Minsky
Mike Stonebraker

These innovators have done not just one or two start-ups each, but many dozens of start-ups. It's this combination of world-class academic research and commercial innovation that creates exponential value in our economy and in society.  

Here is a quick summary of Steve's talk and some highlights that really hit home with me.

A Quick Summary  

Four lessons: 

• Different types of start-ups
• What a start-up ecosystem looks like
• How to make start-ups fail less
• Can we actually teach what we now know?

Types of start-ups: 

• Lifestyle start-up - small businesses that serve known customers with known products and feed the family
• Scalable start-ups – which are designed to grow big (“We’re going to build a company that will take over the universe!”)
• Buyable start-ups – which have low capital requirements and can be very valuable very quickly
• Large companies that focus on “sustaining innovation.” They innovate on core products but cycle time is compressing, creating pressure for large companies to innovate faster

Important Highlights

Referring to the Nokia Board of Directors’ reaction to the iPhone on day of launch – “It's a toy. Why should we worry about this?” – Steve said: “To a big company, a disruptive innovation always looks like a toy on day 1.”

“The secret history of Silicon Valley” [another great video]

“The first venture capital was an unintended consequence of Sputnik”

“We want the engineering department at Stanford to face outward as well as inward”  

“Recognize that 90% of start-ups fail”

“Failure = Experience. We understand that these are the risks”

“Start-up culture is not just about the great entrepreneurs. It's about the ecosystem. Building this ecosystem is critical in getting any cluster off the ground.”

"Start-ups are not just small versions of big companies" - Steve Blank

“Embrace failure as part of the process”

“95% of start-ups fail because they didn't find customers or markets”

“We now know that start-ups search for something and large companies execute...The difference between search and execution are not just words...it's actually the difference in how we build these things”

“On day one, start-ups just have guesses...A start-up is a faith-based enterprise.. You want to turn the faith into facts as quickly as possible”

“What we now know is that no business plan survives first contact with customers”

“A start-up is a temporary organization”

“A start-up is designed to search for something that is repeatable and scalable”

“In the Customer Development Process, everything you know or think you know is a guess"

“In a start-up, it used to be when you failed you fired the VP of Sales, then fired the VP of Marketing, then the CEO.  We know now that start-ups go from failure to failure…Pivot says that this is going to happen all the time.”

And, I love the fact that he was the only dude not in a suit. Now there’s a lesson in itself :)