FDA gives green light to remote monitoring in clinical trial
■ The agency also approves a drug company’s techniques aimed at getting more physician and patient input through the use of online tools.
The Federal Drug Administration has approved a clinical drug trial that is unique for two reasons. It used crowdsourcing, including physicians, for the design of the trial. And it’s using telemonitoring to track patient data.
The FDA granted new drug status to a proposal by drug development company Transparency Life Sciences to conduct a phase II study of the effect of a widely used hypertension drug, lisinopril, in patients with multiple sclerosis. The trial was designed using feedback from an online crowdsourcing system, the first clinical drug trial of its kind to use crowdsourcing in its design.
“What we aim to do is get physicians involved with the design of these trials more systematically,” said Marc Foster, co-founder and chief operating officer of TLS. The company wants a broader set of ideas when it comes to clinical trial design. It is opening up the process through an online system where both physicians and patients can submit ideas.
The company will use telemonitoring to collect patient data rather than requiring patients to see clinical trial personnel. Telemonitoring not only will reduce the number of in-person visits to two, but it also will bring the cost of the clinical trial down to an estimated $1.5 million, compared with the $5 million to $10 million that a phase II study typically costs.
“When we speak with patients, and when patients are involved in conversations about clinical trials, time and time again they talk about the inconvenience of having to take off chunks of the day to go in and have data collected in a hospital or clinic setting,” Foster said. “And with telemonitoring we can put a lot of this data collection into patients’ homes, so we very much anticipate this will be an incentive for more patients to participate in clinical trials.”
The company partnered with AMC Health, a developer of telehealth technology, for the trial. John Holland, senior vice president for research and business development for AMC, said there is increasing recognition that the high price of clinical trials keeps companies from taking new medications to market.
He said a shift in FDA policy also has opened the door for telemonitoring to be used. More than a year ago it changed its policy of requiring 100% verification of every data point as a way of detecting fraud. It has developed other ways of looking for fraud, he said.