At the 2018 DIA Annual Meeting in Boston, one of the topics I heard a lot of discussion around was China. Once known as a low-cost producer of generic drugs and pharmaceutical APIs and excipients, the country is now stepping up the quality and timeliness of its manufacturing to attract the attention of pharmaceutical companies.
I recently reported on data collected from Fitbit activity trackers. Fitbit has compiled 150 billion hours of data on the resting heart rate (RHR) of tens of millions of people around the world who used a Fitbit. Can this type of data help researchers, especially cardiologists, conduct better clinical trials on heart patients in the future?
David Pogue, a tech columnist for Yahoo Finance, notes Fitbit has collected 150 billion hours of heart-rate data from tens of millions of people all over the world. In January, Fitbit gave Pogue a deep dive into the data it collected. The finding may bode well for the use of activity trackers in future trials.
In a nearly 3,700 word missive by Scott Gottlieb, posted on August 29, 2018, the FDA commissioner attempts to bring some clarity to efforts by the agency to bring more innovation into the drug development process. Gottlieb notes innovative new technology platforms, such as digital health, targeted medicines, and regenerative medicine, including cell and gene therapies products, are helping the industry advance drug development.
ISR Reports recently published the third edition of its Clinical Development Outsourcing Models report. I spoke to Andrew Schafer, president at ISR Reports, about the report, what we can learn from the responses, and what we can expect to see in clinical outsourcing models moving forward.
Clinical trials are complex, but adding genomics to the equation has the potential to make them even more complicated. However, much of the genetic testing that is now being performed in the clinical space is done before a trial begins. That means companies need to do some thinking before adding a genetic test to the protocol.
A new brief by CB Insights focuses on AI and its potential to transform clinical trials. A makeover of the $65 billion clinical trials market is well overdue. With all of the issues that seem to be preventing more efficient trials, will AI be the technology that finally streamlines the process?
But what best practices can you employ to ensure you and your site personnel are seeing eye-to-eye? Carrie Melvin, VP of Global Clinical Operations at TESARO, addressed the topic at the 2018 Clinical Leader Forum in Philadelphia. Proper communication will help ensure monitors are properly trained, protocol deviations are prevented, and data is collected timely and accurately.
Allena Pharmaceuticals has quickly made the move from a discovery- to a clinical-stage company. Allena went public about eight months ago and already has a product (ALLN-177) that addresses a rare disease population and is also in a much broader, Phase 3 clinical trial.
The time that elapses between phases of a clinical trial can be problematic for pharma companies. Known throughout the industry as “white space”, these delays can extend the trial process, drive up the cost of studies, and delay needed medicines from reaching patients.