enable clinical trial sponsors to search directly for investigators and trial sites. A section of this new website also allows principal investigators to edit their own profile, upload new information, and provide additional comments about their research.
Making the clinical trial process easier for patients represents a more amorphous challenge.
“The patients give us so much of their time and blood and saliva and everything else,” Koester says, and yet the requirements for patient data often dictate taking even more—and without good reason.
For example, he says a clinical study that requires multiple liver biopsies reflects a mindset that doesn’t give much consideration to how volunteer patients might react to repeatedly undergoing a painful invasive procedure. Koester says the result is “too much patient attrition,” resulting in a waste of resources and an inability to conduct follow-up studies. So he’s asking, “How can we make clinical trials easier for patients to participate?”
One solution Janssen’s clinical trial innovation team has developed is an iPad app that serves as an “electronic informed consent form,” and is intended to ensure that patients have a clearer understanding of the clinical trial and what to expect.
“Patients are often not well-informed when they enter a clinical trial,” Koester says. “They typically listen to explanations from their doctors and sign the informed consent forms.”
“We want the patients to understand what they’re signing up for, and to remain committed to staying in the trial,” Koester explains. So the app is written in a simple and easy-to-understand way, and includes animated video explanations and a final quiz “to make sure that patients understand what they’re getting into.”
Koester says a pilot study using the app is underway with patients in three countries, with results anticipated later this year.
In another study currently underway, Janssen is testing the concept of creating an online “patient portal” specifically tailored for the patients participating in each clinical study. Such a portal would include consumer-oriented information about the clinical trial and what to expect, as well as a guide to the medical center where the study is being conducted, including directions and parking.
Koester says, “Other pharmas take a look and say, ‘Yeah, it’s a great idea, but we really don’t have time to initiate this kind of program.”
To Koester, however, the purpose of these types of pilot programs is take a risk, determine if they are feasible, and whether they decrease some burden for the people involved.
He says Janssen has completed another pilot study of “eMeds,” a program that uses smartphones, smart medication packaging, and scanners to assess how well patients are following their dosing instructions. Instead of providing a booklet that explains how to take their medication, Koester asks, “Wouldn’t it be better to have this information on a smartphone? If a pill was not taken, we can send a reminder. You could change the parameters of the prescription based on new data.
“We think we are the only company thus far to have done something like this,” Koester says. Now he’s looking for other pharmaceutical companies that want to collaborate.
