Our expert panel predicts mobile technologies are poised to gain traction in clinical trials next year. Other hot trends in the clinical space include more focus on patient-centricity and greater adoption of risk-based monitoring and EHRs.
Eileen Daniel, executive director of clinical operations at Nektar Therapeutics, always felt there were ways the clinical trial planning process could be improved.
In 2013, TransPoC, Inc. (Translational Proof of Concept) was formed to solve a serious problem: the diminishing number of new drug therapies resulting from oncology research. This problem has become more challenging given the overwhelming volume of genomic data available since the completion of the Human Genome Project in 2003.
Expanded access (compassionate use) clinical trials aren’t as straightforward as they seem, and applications to expand access for cannabinoid drug trials are even more complicated.
There is a growing movement by some researchers and regulators to increase disclosure of clinical trial results.
Having spent more than 11 years at Genentech, Joling Mew has heard a lot of industry discussion about patient-centric trials. Mew is development excellence leader in product development and also works closely with the Strategic Innovation Group.
What a difference a year makes. Last year, beginning in September, we ran a series that addressed the challenges and opportunities of using new agents to rally the immune system against cancer. In most cases, we were talking about the checkpoint blockers such as ipilimumab and tremelimumab, inhibiting the checkpoint CTLA-4, and nivolumab, pembrolizumab, and pidilizumab, which have a multimodal effect on another target, PD-1. Checkpoints are proteins expressed on immune cells that normally “check” the immune system from attacking the body’s own cells. But tumors can hijack the checkpoints to keep the immune cells inactive and thus prevent an immune response.
“When I got ill, it was completely by surprise,” says Dr. Jan Vesseur. The former general practitioner who now works as a civil servant for the Netherlands Ministry of Health was on a skiing trip in France when a fall forever changed his life. “My daughter, also a doctor, was with me,” he recalls. “The fall was very soft, and we couldn’t believe it was anything other than some low-back pain.”
Flipping the off switch in rare, chronic inflammatory diseases.
Restorative Sleep and a Second Pathway to Pain Control
People don’t think twice to pay bills on a smartphone, share experiences on social media, and even monitor sleep habits on wearable activity trackers. But when it comes to participating in a study to test a new therapy or medical device, we might as well be standing in line at the bank to deposit a paper check.