By Michael Goodman

June 7, 2016 | Since its founding in 2010, Transparency Life Sciences (TLS) has been on a mission: to build a culture and a platform for moving clinical trials out of the existing healthcare system. It plans to accomplish this via new methods for designing and executing clinical trials through the use of  crowdsourcing and digital technology.

Founder and CEO Tomasz Sablinski is a 20-year veteran of Novartis’ clinical development organization, and more recently was managing director and head of Celtic Therapeutics Development, the development arm of the private equity firm Celtic Therapeutics (rebranded in 2013 as Auven Therapeutics). His decades of experience in clinical trials gave rise to the idea behind TLS: to democratize the planning of clinical trials by bringing in other voices, and to make trials more efficient and easier on patients by conducting them at the homes of study subjects via the use of telemonitoring.

The Old Way of Doing  Clinical Trials is Broken

In a world where sponsors and key opinion leaders (KOLs) dominate the development of trial protocols, Sablinski’s idea was to solicit the views of patients and care givers through an online crowdsourcing application called Protocol Builder. Protocol Builder is also used to evaluate patients’ comfort level in participating in a clinical trial at their home.

The traditional process for developing protocols is first to design it internally at the sponsor. Then it goes to an external pool of 5-10 KOLs that the industry feels comfortable with. KOLs tend to have preconceived notions based on their own experience. The protocol then goes before regulators.

A entrenched conservatism is embedded into the process. The result is that there is little variation; the same trial design, often insensitive to the needs of patients, keeps being put forward for the same indication. Sablinski says that regulators, contrary to their reputation, are keen to introduce innovation into clinical trials. The sticking point is industry. “Pharma is used to absorbing compound risk,” he says, “but they avoid methodological change.”

There are two obstacles to implementing the digital clinical trial throughout industry: the first is culture; the second is the adaptation of technology—e.g., telemonitoring or the use of mobile sensors—to regulations such as HIPPA and other privacy laws. The second obstacle can be surmounted, says Sablinski, “but it takes time and a different skill set than typically exist in pharma or in CROs.”

Patient Centricity Through Crowdsourcing and Telemonitoring

Sablinski divides the crowd into two categories: patients and caregivers. Some indications—e.g., pediatric diseases or Alzheimer’s, or acute care conditions—aren’t good candidates for crowdsourcing. TLS instead focuses on the 90% of trials in the chronic disease space. These patients are typically well-informed about their disease and have strong views on what they want to be measured.

For instance, most MS patients recognize that MRI tests to measure brain lesions are important to gauge the progress of the disease. But MRI is not top of mind to the typical MS patient. Instead, they are more likely to want clinical outcomes that are meaningful to them, like tests to measure how fatigued they are today vs a month ago. This is where crowdsourcing meets technology, says Sablinski. “We can actually design algorithms to measure overall fatigue.”

TLS also gets feedback from health care professionals: MDs, basic researchers, physical therapists. These individuals are usually not involved in clinical trials sponsored by pharma, but many conduct their own trials and analyze their own data. Echoing the experience of technology crowdsourcers like Innocentive Inc., TLS finds its most valuable input from individuals typically not accessed by industry or CROs.

In its trial testing the generic antihypertensive lisinopril as adjunctive therapy in MS, TLS has adapted the 20 ft. measured walk test to be administered at home using remote monitoring and video technology by patients or their caregivers. Walk tests—which are currently an infrequently administered snapshot—are notoriously variable depending on the patient’s state. Telemonitoring means patients don’t need to go to an investigative site and clinical staff has greater flexibility in its scheduling. Also the data is of higher quality because patients can video the test at a set time, e.g. early in the morning, in the evening, etc. TLS is planning to roll out GPS and accelerometry tools for near continuous monitoring of energy expenditure.

TLS is at an inflection point, Sablinski says. He is in active talks with investors, and the outcome will likely determine TLS’s corporate structure and growth strategy.

He estimates it will take industry 10-20 years to integrate crowdsourcing and telemonitoring into clinical trials. But he’s not daunted. In December 2012, FDA cleared a TLS IND for a trial of lisinopril based on a crowdsourced protocol. It is currently in talks with FDA around a second IND, this one for an NCE in pulmonary sarcoidosis, not a repurposed generic. TLS is managing the trial through a collaboration with Auven Therapeutics. Sablinski expects an announcement in the coming months.