By MATTHEW HOLT
Saturday’s New York Times portends more trouble for big Pharma. The headline is wrapped up in an examination of foreign corrupt practices, but the bigger issue is that clinical trials have hidden serious adverse events. The recent allegations that GSK hid data about heart attacks from an Avandia trial conducted abroad highlight the reality that over the last 20 years or so it’s been very hard to recruit patients for clinical trials in the US. It’s expensive to find patients, and the numbers of patients available near centers has not proved enough. The answer has been to go to places with lots of people and lower costs, like India.
One obvious consequence is that few of the significant advantages of Internet connectivity and patient community which have been developing in recent years have been adopted as part of these pre- or post market trials. Several online communities–notably PatientsLikeMe–have been running their own studies but they have typically been observational studies and haven’t had much acceptance from Pharma or regulators.
But Health 2.0 creates two opportunities to change the ground rules. First is the ability to recruit. This remains hard. My old company Harris Interactive had a database of survey recipients who said they were interested in clinical trials–but despite much effort they weren’t able to turn it into a business a decade or so ago. But last fall at the Health 2.0 conference TrialReach introduced a system that enables patients to find and approach clinical trials and for trials to advertise to them in a sort of match.com fashion. Private Access is working on developing a not too dissimilar system. It’s very early days for both these (and other) organizations, but the ability for patients to use the Internet to match themselves automatically with trials might solve the recruiting half of the puzzle.
Even more interesting is the other side of the equation. Currently you have to live near a trial center to be recruited into it, and then you have to go in regularly for testing and to answer questions. but these days the technology exists for most testing (think biometric devices or finger-stick lab tests) to be done in the home. And frankly data collection from those sources can be more accurate and more consistently gathered than from an occasional if regular doctor visit.
We know this consistent data gathering works well in clinical care, we just don’t have a sound method to pay for it. In clinical trials that’s not a problem–if you can recruit anyone into a trial and manage them remotely, the money is there to manage their activity.
Last week I saw a new company called Mytrus which is basically creating remotely managed clinical trials for patients in their own homes. It’s very early days for them too, with their first trial just starting. But Mytrus has backing from at least one major pharma and has jumped through many hoops from the FDA to show that their remote patient monitoring and online questionnaires are equivalent to dragging the patient into a clinic operating as a trial center.
So in a problematic part of the market that is vital for Pharma, the concept of at home clinical trials makes a lot of sense. If Mytrus shows some success here, we can expect that the trickle of Health 2.0 companies aiming the technologies of search, community management and consumer tools at the clinical trial problem might become a flood.
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Ah, looks like the NY Times is on it. They focused on the causes and almost ignored the unusual historical context and future implications.
Matthew, off topic, but I haven’t seen anyone blog this:
MEDICAL PRICES COME DOWN FOR FIRST MONTH IN 35 YEARS
The July report on the consumer price index from the Bureau of Labor Statistics showed that one component of consumer prices, medical prices, came down for the first month since 1975. Since the BLS started tracking medical prices as a component of the CPI in 1947, medical prices have only fallen six times in any single month. Indeed, they have increased almost twice as fast as consumer prices overall since the mid-1980s. The cost of hospital care went down in July, driving most of the decline, but the prices of drugs and medical equipment fell in July as well. Only the cost of private professional care went up.
Presumably this is mostly due to a weak economy, but even so there may be other causes at work (HIT?) and a trend may exist that starts to undermine the higher end projections for long term costs, and may bode well for health care reform.
Thank you for the post, Matthew.
The current model for clinical trials – with its complexity and cost – is unsustainable. While clinical trials are very process-driven, there is still room for innovation. Opportunities from healthcare – including health information technology, telemedicine & remote patient monitoring, and the engaged ePatient – present opportunities to repurpose trends and solutions for clinical trials (without requiring solutions to be entirely “home-grown”).
Certainly no individual solution will address all existing needs. Recruitment will require a blend of old and new methods. Likewise, there will always be complex individual trial needs or challenging geographies.
Enabling an ecosystem or toolbox of these solutions is an important step. In some cases the result will be an incrementally easier – albeit still complex – trial. In other cases there may be a composite of solutions that create a radically new model for clinical trials.
I am all for hime trials and other trials as long as they are inclusive, accurate, and unbiased. First on the list should be device trials of heart ablation and CPOE devices. The CPOE and EMR trials are important to dtermine if they can be trusted to give accurate results when testing pharma drugs.
Thanks for the interesting post.
Various comments:
1 regarding the 2.0 trial system
a) Some trials have more complex screening requirements than others and there may be some difficulties in running them all according to the home-based model for now-
b) I would think that Mytrus would encourage the patient to inform his/her physician of their intention to enter the trial.
2 regarding legal and other requirements outside the US
c) In the European Union, a trial sponsor must satisfy many official requirements and would find it difficult to make “unofficial” payments, etc.
d) Unfortunately the availability of patients for trials is often inversely proportional to the quality of and or ability to access the local health system in an affordable manner. So, some of the countries with low life expectancies generate the most willing patients for trials
3) regarding “hidden”or concealed results of trials
e) The real problem would seem to be the difficult-but not impossible to-enforce obligation for study sponsors to publish all study results in some sort of global, central repository.
More likely solution than 2.0 is overseas recruitment and management. Few recognize how hard filling trial slots is, followed only by how hard it is to keep people enrolled.
This is a serious constraint on drug development, second only to the huge gaps in scientific knowledge at the molecular level.