WALL STREET JOURNAL – Medical startups are pushing to modernize what many see as an unwieldy clinical trials system that holds back promising new medications.
The rising cost and complexity of medical studies is forcing patients to wait longer for new therapies and threatens to keep them from benefiting fully from an explosion of medical innovation, experts say.
“The clinical trial system is broken,” said Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, which regulates prescription and over-the-counter drugs.
Drug companies compete to recruit patients into studies and often struggle to enroll them, adding time and cost to a development process that often stretches out a decade or more.
Drugmakers are exploring strategies to overcome recruitment struggles and are turning to startups with technologies that promise to make trials more efficient. Venture capitalists have funded at least a dozen software startups in this market so far this year, according to Dow Jones VentureSource.
The struggle to enroll clinical studies remains a chief obstacle for drug developers. As many as 86% of clinical trials don’t reach recruitment targets within their specified timeframe, according to a study published this year in the journal Contemporary Clinical Trials.
Many patients are unaware of trials open to them or face obstacles to participating, such as living too far away from study sites. Patients may also be less willing to join clinical trials of new medicines if treatments for their disease already exist.
“There are lots of drugs that may not be getting the attention they should because the patients are not available for testing,” said Rachel Humphrey, chief medical officer of cancer drug developer CytomX Therapeutics Inc. “The problem is particularly acute now because the science is so good and the opportunities so much better than they were 20 years ago.”
Another barrier to trial enrollment is that physician practices that want to be clinical trial sites must acquire technology systems to send data electronically and invest in training staff on these systems, according to John Potthoff, chief executive of startup Elligo Health Research Inc. When practices see lulls in clinical trial activity, these costs become more difficult to maintain, he said.
Austin, Texas-based Elligo provides these practices with the technology, personnel and services they need to serve as study sites for their patients.
Services include pre-qualifying people for studies and scheduling treatment appointments for trial participants. The company, whose investors include Hatteras Venture Partners, works with more than 50 physician practices across the country, Dr. Potthoff said.
Another startup, TriNetX, whose backers include MPM Capital, says it has developed a network of health-care organizations across 16 countries that can help pharmaceutical companies find medical centers with large numbers of patients who qualify for their studies.
This helps them avoid adding sites with few or no potential participants, said Gadi Lachman, CEO of the Cambridge, Mass., startup, which works with companies including Sanofi SA .
“They’re avoiding locations where they have no patients, which saves money, time and embarrassment,” Mr. Lachman said.
Meanwhile, startups such as Los Angeles-based Science 37 Inc. and ObvioHealth, of Singapore and Orlando, Fla., aim to make trials more accessible to patients by enabling them to join studies without leaving home.
Science 37, whose investors include GV and Sanofi’s venture-capital arm, brings study medications to patients and has developed a mobile platform to support these trials.
ObvioHealth, meanwhile, has developed an app that enables studies to be run using mobile devices. Data from smart devices such as a Bluetooth blood pressure monitor can integrate with the app, according to the company, which earlier this year raised a $3 million Series A round led by life sciences venture fund TKS I.
“If people do not have to drive to a brick-and-mortar study site,” said ObvioHealth CEO Bryan Silverman, “you take away [one] of the biggest barriers that gets in the way of recruitment.”