When I first started reading about virtual clinical trials (see links to articles below), the first thing that struck me was the use of the word virtual.
From the Free Dictionary online,
When virtual was first introduced in the computational sense, it applied to things simulated by the computer, like virtual memory that is, memory that is not actually built into the processor. Over time, though, the adjective has been applied to things that physically exist and are created or carried on by means of computers.
With all the technology available, it seems only natural to question, why wouldn’t we do virtual trials? But there are many factors to consider before you jump into doing a virtual trial – and exactly how virtual do you want it to be?
- Indication/phase: The first item to consider is the study indication or therapeutic area. Will it lend itself to a virtual clinical trials or does a healthcare provider need to actually see the patient a few times during the trial? Along with indication, you need to consider the phase of the trial the investigational product in and if that will lend itself to a virtual environment.
- Type of investigational product: It would need to be a medication that can be self-administered. That would knock many trials out of being completely virtual.
- Technology: How much, how savvy? Exactly how much technology and how virtual do you want the trial? Pfizer went whole hog with the entire trial virtual and found some speed bumps. They did all of their recruiting for the trial online. Did they not consider how savvy the customer was going to be? OAB is generally an older woman’s condition. While some older women embrace technology, others do not. If the patients are being recruited on websites they must first be on the website to see the advertisement for the trial. Perhaps if some more conventional recruiting methods had been used they could have enrolled quicker and once enrolled used the technology devices.
- Compliance: Patient compliance for taking medications is notoriously low – why do we assume it will be better in a clinical trial where not only are they responsible for taking the medication, but also all of the documentation via a technology source (smart phone, tablet, etc.). Medication that is only required to be taken once a day will have better compliance than one that has to be taken two or more times a day.
- Cost: Cost would be another consideration – smart phone, iPads, etc. are not cheap. What if the trial consists of hundreds or thousands?
- Structure: Humans like structure. A virtual trial may not have enough structure for some participants. The fact that they must go to the doctor’s office and look someone in the eye and attest that they took the drug may be what they need to actually take it.
- Adverse events: Will the adverse events be captured as they should be? Will the patient associate the headache they have today as something that needs to be “written” in the smart phone? Or does he/she think the headache was due to her noisy grandchildren and doesn’t even consider the study drug?
- Clean data: The data that is entered is the data you have to analyze. The data that is entered is the source data. Does it need to be monitored? How would you “clean” it? When would you receive it?
Overall, we definitely need to keep pushing that envelope and utilize technology where it makes the trial better. But if there is no added value, then why do it? Would love to hear your thoughts and reactions. Please share a comment below.
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