A drug developer wants to shake up the clinical trial process through crowdsourcing as well as using telemedicine and greater data transparency. It believes implementing these together can cut the cost of doing clinical trials by 50 percent in the next two years.
Transparency Life Sciences is a New York-based startup that was founded by CEO Tomasz Sablinski, also currently the head of development at Celtic Therapeutics , and Marc Foster, Transparency’s chief operating officer, who previously worked at FoldRx Pharmaceuticals before it was acquired by Pfizer (NYSE:PFE). The company plans to develop refocused compounds before embarking on novel drugs. Foster spoke about the company’s plans in a phone interview with MedCity News.
Crowdsourcing. “What’s wrong with the current system is clinical trials are mostly designed by a small group of opinion leaders who are experts in their fields, so we’re getting a very limited perspective of how these trials should be designed. [Clinical trials] suffer from that because they are not taking in a broad enough range of ideas from the field,” Foster said. He said his company wants to adopt something like what Topcoder has popularized in the technology sector — offering ways to design and implement a project in the form of “challenges.” Individuals submit ideas to create an efficient version of what a company wants and get a monetary award.
InnoCentive has taken a broader approach and includes companies in the biomedical sector. One recent challenge posted on the site offers $30,000 to develop an efficient protocol to recover bacillus spores from swabs. “It’s about tapping into a global web of brainpower,” Foster said. “All we are doing is taking that concept and applying it to the design of clinical trials.”
Foster points out that with more people contributing ideas, it would speed up the design process compared with the current approach. “We view this as a way to drastically streamline the process by putting these protocol challenges out for all the world to see.”
Patient input. So often the problem is that patients’ opinions are not taken into account in developing a clinical trial, Foster said. “Patients often have a super-detailed appreciation for how they take medicine and are acutely aware of the effect of a given indication of a drug — so much so that they are often an excellent source of information.” As Foster notes, patient-centric drug development is hardly a new concept. Indeed, it was the focus of a conference earlier this week where the corporate launch of the company took place.
Telemedicine. Foster says working with patients within the comfort of their homes will lead to better data. “One of the things you see a lot these days is researcher bias, where a doctor or clinician is taking data in a clinical setting their involvement can bias the results of a clinical trial. If people are at home in their most natural setting, the ability to take their data remotely we think would be more uniform.”
Telemedicine is not exactly a foreign concept for pharmaceutical companies. Pfizer used this approach in a phase 4 trial last year. Although initially the company plans to target specific geographies where it has a principal investigator, Foster said once the technology is proven it could provide a way to broaden a clinical trial’s geographic reach. He also pointed to a mobile app in which clinicians can monitor the progression of Parkinson’s disease based on the voice of the user.
Data transparency. One of the core aims of the company is greater data transparency. Foster notes that currently, most drug companies do not publish negative results. One reality of the pharmaceutical industry is that companies are competing with each other to develop some of the same drugs. If they published negative results, then other companies could either retool the parameters of the study or take a different tack, which would create greater efficiency in the system. Foster notes that some aspects of a clinical trial would remain private, such as patient identities and blind trials.
He observes that the company has had support from the U.S. Food and Drug Administration in their efforts to improve the design of clinical trials and points out that the U.S. regulator has been open to new ideas and encouraging of what the company is doing.
“We’re trying to get more drugs on the market for people who need them, crushing the cost burden and working with the FDA. … They feel the heat and see that new approaches are necessary and as long as these approaches can be done without sacrificing patient safety, these approaches will be acceptable.”
[Photo from flickr user jjelenbaas]
IMO - the most important aspect that decides the outcome of a clinical trial is point # 4 - data transparency. somehow we - the humans - are so much hooked on to success that we forget to even look at the things the way they are. A result is a result and will remain to be one. Whether we like it or not has nothing to do with it at all. It just is. Sadly among the race to top, to success, we tend to overlook it, sometimes unintentionally, but often times we just "learn" to ignore it. Glad to find that efforts like this are coming out there. Great idea.
RE: Foster said. “Patients often have a super-detailed appreciation for how they take medicine and are acutely aware of the effect of a given indication of a drug — so much so that they are often an excellent source of information.” Qualify that with "SOME" PATIENTS have super-detailed bla-bla-bla"....and add to that a heavy patrolling of the website by both FDA and the pharm/drug maker for "plants"--those who are paid to post positive comments and/or stir up controversy-- and this can probably work. But...can/will FDA and the pharm/drug maker want to take on those kinds of responsibiliteis? And, also, what will the freedom of speech folks say? eb, Cle, OH