data can be captured on a continuous basis in the patient’s own environment (at rest, before/after meals, etc.) as opposed to a single point in time in an unfamiliar setting. Not only is this approach more cost-efficient, it also provides a much more comprehensive data set upon which to base insights. Remote monitoring technology is advancing at a galloping pace, and will become increasingly feasible over time. The fact that FDA cleared the TLS lisinopril protocol, which primarily relies on telemonitoring, sends a strong signal that regulators are ready to consider this novel methodology in appropriate situations.
Industry Collaboration
TLS’s contributions to positive changes in clinical trials are complemented by the work of a recently formed biopharmaceutical consortium, TransCelerate Biopharma. The formation of TranCelerate, a group of 10 of the world’s largest biopharmaceutical companies, sends another clear signal of a new, open mindset in clinical development. TransCelerate’s mission is to accelerate drug development by first focusing on streamlining the clinical trial process where longstanding challenges exist.
It’s no secret that clinical trial teams, even within the same company, collect and manage data differently; and tend to reinvent the wheel with every development program. TransCelerate has said that one of its first efforts will be to standardize how clinical data is recorded in order to minimize human error, enable the use of data across trials and generally manage data more efficiently. Another program aims to standardize qualification of trial sites and investigator training, all with the goal of increasing efficiency and quality.
While the TransCelerate project is still in its early stages, the promise of its mission is exciting. In a competitive industry where information is held close and rarely shared, this new willingness to communicate and collaborate is a major step forward.
Regulatory Hurdles
Innovation calls for change, and change calls for different, uncharted circumstances which haven’t been previously encountered or regulated. With the new techniques and technologies presented by innovative groups like TLS and TransCelerate, there is always the question of which methods, technologies and methods will be accepted by regulatory bodies.
Transparency Life Sciences began its journey with a repurposed drug that already had a known safety profile. Still, the regulatory clearance of its crowdsourced protocol and the authorization of remote monitoring technology in the trial is a significant advancement. TLS’s successful filing should encourage others to push the envelope, take the road less traveled, and re-think traditional processes. The very real issues facing pharmaceutical drug development demand no less. The life sciences thrive on progress and innovation, and industry leaders should be ready to capitalize on opportunities to be a trailblazer and catalyze positive change. TLS’s Sablinski is clear and direct when he advises the best approach to introducing new methods and technologies in clinical development: be open to new ideas, seek input from outside your comfort zone, involve regulators early on in the study design process, be bold but reasonable and, of course, be transparent.
