Speed of Change is Accelerating in Clinical Trials

Craig Lipset, Former Head of Clinical innovation for Pfizer Inc., Industry Consultant

Fasten your seatbelts, clinical trial practitioners, because you’re about to encounter some turbulence in the friendly skies. Whether it’s new regulatory demands, evolving patient expectations, or navigating a bewildering array of technologies promising to be the next big thing, the speed of change in the clinical trial industry has perhaps never been faster than it is right now. That’s the take shared by thought leaders at ACRP’s Southeast Regional Conference in North Carolina today (October 3).

“If ever an industry was in need of change, it’s ours,” said Paul Evans, PhD, president and CEO of Velocity Clinical Research. “We’re inefficient” and need to do a better job of getting new drugs and devices to the patients that need them, he told attendees of the event, being held today and tomorrow in Durham in conjunction with the ACRP Research Triangle Park Chapter.

“We live in a period where there’s a very rapidly changing environment—probably faster than any of us have ever experienced in this industry,” Evans said.

Visionaries David Vulcano and Craig Lipset offered expert analysis of several looming technology trends poised to change the face of the clinical trial landscape over the next several years.

Clinical trial practitioners understandably feel “overwhelmed and overburdened” by the plethora of new tools that sometimes feel forced upon them, added Vulcano, LCSW, MBA, CIP, RAC. He’s vice president for research compliance and integrity at HCA Healthcare.

Lipset, former head of clinical innovation for Pfizer Inc and now an industry consultant, said we might see an increase in the use of storage technologies like blockchain to help with supply issues and the proper sharing and overall integrity of personal health data as a kind of “shared neutral space.” Vulcano added he foresaw some role for blockchain in the informed consent process. Neither, however, expected blockchain to have a huge impact on clinical trial operations in the near term.

Vulcano predicted an uptick in so-called “smart contracts,” where patients electronically set up the means to share their health data online with entities of their choice. Lipset noted that leveraging those contracts and storing them on blockchain will allow patients to see who asked for and who received access to their personal health information in a transparent way.

Turning to “super cool” possibilities in virtual trials and augmented reality, Lipset foresaw heavier use on the pharmacy side than in clinical trials for the foreseeable future. Noting augmented reality could be effective in some forms of patient education, he warned it could become “overkill” if it was leveraged too often and freely in the informed consent realm.

Both thought leaders predicted an increased role for artificial intelligence (AI) in clinical trials. Vulcano noted it had already been effective in trials where machines were able to use algorithms in clinical trials involving retinopathy.

Lipset applauded some “cool and exciting” uses for AI in chart protocol interfaces, data management, and using the technology to turn data from a trial into study safety narratives. Both Vulcano and Lipset cautioned that AI has limits, especially in the area of ethics.

“How we train on [AI] and use it [can] create ethical conundrums,” Lipset said. For example, if an application is being used only on Caucasian skin without regard for other skin tones, it won’t promote patient diversity.

Vulcano noted voice recognition and other forms of AI are already playing an active part in risk-based monitoring and establishing inclusion/exclusion criteria.

Lipset urged audience members to embrace virtual trials and telemedicine. As an early proponent of virtual trials at Pfizer, he stressed it was “never my intent to remove clinicians” from studies. “Patients want choice within the study,” he said, and that often includes basic human interaction and the desire to travel to a site or clinic in person rather than doing everything remotely.

“The people in this room are doing an amazing job, and we don’t want to take away that choice from patients,” Lipset said.

Author: Michael Causey