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.
- The Fox Trialfinder for Parkinson’s Disease from the Michael J. Fox Foundation
- Corengi for diabetes
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.