Regulatory agencies today are looking for Phase 3 trials to demonstrate a reduction in mortality as well as greater patient mobility. Unfortunately, Phase 3 trials also cost a lot of money to run, making them a challenge for small biotech firms.
Andreas Koester, MD, Ph.D., global head, R&D operations innovation at Janssen, discusses how the company is attempting to make patient data available to participants while a clinical trial is underway.
Often when we think about inefficiencies in the clinical trial process, we focus on the role of the sponsor or CRO, a particular aspect of the value chain, or new technologies that promote data sharing and faster decision making. While these are critical aspects that drive day-to-day operations, there is another aspect of the value chain that we may be neglecting: the patient side.
With wearables, we now have the means to innovate the “where” and the “how” of patient data capture, creating a 24-hour digital map of physical behaviors.
Bert Hartog, Ph.D., innovation leader, in R&D Operations Innovation at Janssen Research & Development, has a plan in place to make trials more patient-friendly. Janssen’s goal is to incorporate the patient voice into clinical research, make patients a partner in the research process, and ensure all future collaborations are a two-way street.
When you talk to Dr. Mireille Gillings, the founder and executive chair of HUYA Bioscience International, her enthusiasm and passion for drug development is clearly evident.
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.