Janssen Tests Ideas, Apps, in Bid for Clinical Trials Innovation

As the cost and complexity of drug development has skyrocketed in recent decades, Big Pharma has focused increasingly on improving the way clinical trials are conducted.

In 2007, the FDA and Duke University Medical Center established a public-private collaboration called the Clinical Trials Transformation Initiative (CTTI). The idea was to streamline the process so clinical trials could be done more quickly and efficiently while maintaining patient safety and ensuring data reliability and integrity. In 2012, ten pharmaceutical giants followed suit by forming a nonprofit, Transcelerate BioPharma, with the goal of accelerating drug development while eliminating the inefficiencies that drive up R&D costs.

Johnson & Johnson, a central player at the beginning of both CTTI and Transcelerate, also established a team focused on clinical trial innovation that through its Janssen Healthcare Innovation and Janssen Research and Development units. The San Diego-based group is led by Andreas Koester, a Janssen executive who says his latest efforts are focused in particular on making the process easier for two key groups of constituents—patients and principal investigators.

The underlying premise, Koester says, is “to share information readily with others, so everyone doesn’t have to reinvent the wheel” for each clinical trial. In other words, to apply advances in information technology that have transformed other industries over the past two decades to reduce costs, improve data collection, and quality, and to expedite the time required to stage clinical trials.

To help principal investigators, Koester worked with Merck and Eli Lilly to help create a shared resource known simply as the “Investigator Databank.” As Koester told me in 2012, the databank is intended to alleviate the red tape that Big Pharmas impose on principal investigators. Instead of requiring the academic scientists who oversee clinical trials to file the same regulatory documents and certifications again and again for each clinical trial, they can now upload such documents to the databank, which is hosted by DrugDev and is now shared by Janssen, Lilly, Merck, Pfizer (other pharmaceuticals are expected to join in the collaboration).

Since it was created, the Investigator Databank has grown to contain data from over 120,000 principal investigators and more than 25,000 clinical trial sites, with full details on more than 4,000 clinical studies. More recently, the website InvestigatorDatabank.org has been added to 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?”

Andreas_Koester_Janssen-IMG_8023One 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.

Bruce V. Bigelow was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Follow @bvbigelow

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