Virtually… but not quite… there!

Featured Blog by Denni O. Day

Dave Berger has been running since college. Now in his mid-50s, Dave has slowed his pace to accommodate his aching knees. He’s noticed that Barkley, his 12-year-old Retriever, also has slowed, rarely tugging on his leash like he used to. In fact, Barkley now seems to limp a little as they walk up the driveway. Dave has thought about leaving Barkley home, but he knows that Barkley would sit by the kitchen window, barking until he returned.

One recent morning, after he and Barkley finished their run, Dave grabbed a cup of coffee and went to his study to check email. Barkley headed for his pillow next to Dave’s desk. One message was from a pharmaceutical company announcing a clinical trial for a new osteoarthritis drug. “Just what I need,” mumbled Dave. Barkley sighed in agreement. As Dave read further, he discovered that the solicitation was for a virtual clinical trial. Dave’s only experience with clinical trials had been with Barkley several years earlier, in a skin allergy study. He had visited their veterinarian seeking relief for Barkley’s incessant scratching. The study provided free treatment… plus a nice honorarium… but, since Barkley was assigned a placebo, not much relief. A diet change and some lotion prescribed by their veterinarian finally cured the problem. However, the frequent trips to the clinic over three months soured Dave on clinical trials.

But a virtual clinical trial intrigued Dave. This new drug might ease the pain he felt after each run. So, he completed the screening survey. As he waited for the results, Dave wondered whether the pharmaceutical company had a veterinary version of the new drug that might help Barkley.

“Rejected?” Dave’s reaction startled Barkley from his nap. Reading further, Dave learned that the study was being conducted in another state. “Rats!” said Dave, as he bent down to scratch Barkley’s ears. While closing down his email, Dave made a mental note to search for other virtual trials for osteoarthritis… for both himself and Barkley.

A virtual clinical trial is conducted over the internet, bypassing the need for study sites and most of the associated costs. Instead, study subjects are recruited online, trained through webinars, and virtually all data is collected electronically. Sound too futuristic for clinical research? Well, in June of last year, Pfizer conducted such a trial for an approved human drug, hoping to accelerate enrollment and reduce costs. Patients were recruited through social media and trained online. Unfortunately, the results were somewhat disappointing. Recruitment lagged, some patients were concerned about the privacy of personal information, and others were inexperienced communicating by computer. Pfizer learned many lessons from this exercise and, no doubt, will achieve better results next time. Thanks to Pfizer, the rest of us now have a road map… with some of the potholes marked.

Could a virtual trial succeed in the veterinary space? I’d expect a few challenges. First, the screening survey would have to be crafted to avoid confusion and assure compliance with the protocol’s inclusion/exclusion criteria. A follow-up phone screen might be necessary to avoid misunderstandings and ineligible subjects.

Second, each owner would need a relatively current computer, with at least dialup internet access, or a new “smart” cell phone… and reasonable proficiency in its use. These requirements could slow enrollment. Of course, whenever data are communicated over the internet, especially from varied sources of inconsistent quality, there are concerns about security, confidentiality, and data integrity. Further, limiting enrollment to owners with certain technology may introduce bias to the study data. Should the drug’s label disclose that it had been tested only in a high-tech segment of the general population?

Third, without periodic monitoring visits, how could the sponsor ensure that data were reported accurately and contemporaneously, that any adverse events were reported quickly (or at all), that test article were administered in the proper dose (e.g., does the owner have an accurate scale?), and that other protocol requirements were satisfied? Virtual clinical trials assume a lot of compliance that, in fact, might not exist. In those cases, how good are the study results? Could serious side effects go undetected until after market introduction?

Lastly, at the end of the trial, after all of the data have been collected, how will queries be resolved? How will discrepancies in test article inventories be reconciled? And, what if the regulatory authorities want to audit the study’s process and results?

There are some studies for which virtual conduct might be successful, such as palatability or food trials.

But, even in those cases, it may be a situation of implementation has not caught up with technology. Yet.