Next-Generation Clinical Trials

Going into the planning for our September issue, we called this the “Status of Clinical Trials” issue. But what we

Lisa Henderson

really wanted to look at was the status of next-generation trials. The strategies that industry is currently taking to address the limitations in clinical trials such as lack of efficiencies or poor patient participation. Or technologies or business models that have advanced to again address the well-noted challenges in clinical trials. 

To support that mission, we’ve included articles from the start to the end of the clinical trials process. From using modeling and simulation in drug discovery or protocol design; to conducting drug tests not in humans, but on their cells in a dish to determine efficacy; to the advances of genetic testing that will advance research and personalized medicine and patient considerations in regard to that testing. Of course, technology has a huge role, so we explore continued use of mHealth, as well as technology uses to improve finding the right patients for the right trials.

A significant part of the patient recruitment problem continues to be education-the knowledge that everyday people have about clinical trials; location-the ability to take part in a clinical trial that is not burdensome; and trust-the ability to put your health in another person’s hands, when you usually deal with one healthcare provider. And in these areas, too, are advances in technology and business approaches.

Our first Q&A (see Clinical Trials Need to Grow In Relevance) features an interview with the executive director of Greater Gift, which offered a chance for clinical research teams to meaningfully inform the public about clinical trials in a variety of venues. In the quest to bring clinical trials closer to patients, we profiled new business models that change the site landscape, including impacts on virtual trials, specialty practice physician groups, large integrated delivery health networks, and dedicated sites (see Site Models of the Future: Finding Patients Faster). And, of course, the underlying advances for all the new models feature an aspect of technology, be they EHR integration or a network or platform to interface with patients, or technology that matches patient biomarkers and genetic information to the right clinical trial.

Reading the articles separately, the reader will hopefully come away with an appreciation for the changes that individuals and companies are bringing to improve the clinical trials process. But taken as an aggregate, you will hopefully see a moving needle, where not just one thing is going to revolutionize and improve clinical trials. Rather, you will see the promise that advancing technology and science brings to medicine-and glimpse the promise of the future.

Currently, in order to improve health or quality of life, people travel miles across countries to receive the right treatments and the right care. One of the most engaging phrases to come out of this next generation of clinical trials is its “democratization” or the action that makes something accessible to everyone. The option for a person to participate in their own health and influence their own genetic path is a reality. The option for a person to choose a clinical trial as a care option, right there at the point of diagnosis, is coming closer to reality. The option to advance science in a more personal and meaningful way, that will be the democratization of clinical trials. 

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lisa.henderson@ubm.com. Follow Lisa on Twitter: @trialsonline