CWWeekly’s occasional company profile feature, Insider Insights, interviews executives of companies and organizations in the clinical trials space. Staff Writer Ronald Rosenberg sat down with Jonathan Commons, vice presi­dent, digital strategy and solutions team at Quintiles.

Q: How will consumer and personal health data play a larger role in clinical research?

A: Different types of research will vary in their data requirements. In outcomes research, we are relying more on patient reported outcomes through digital channels, and collecting that feedback from patients. In the broader sense, we collect personal health data in a very controlled way at the investigative site with a client investigator. The data is collected in a controlled way to allow for filings with the FDA. With wear­ables (fitness devices, etc.), the challenge is the amount of data, the quality of data and how well they fit the requirements for the clinical study endpoints, as some of the data are not very useful.

Where consumer and personal health data help is in framing some of the ques­tions, the thinking and the design of clinical research. While many in the industry are very good at assessing the data needs, it is the hu­man element that tends to be missed: “Am I health literate? Can I answer that question? Do I understand what’s been asked of me? How might I respond?”

Clinical trial design could be better improved with more understanding of the consumer and the patient. Overall, aware­ness of clinical research and clinical trials are pretty low. According to a 2009 survey conducted for Research!America, only 6% of patients said their doctors had ever suggest­ed participating in a clinical research study.

Q: How does your health and engagement communications group augment the search for better data to identify potential clinical trial participants?

A: Right now, we have run more than 400 direct-to-patient studies. Sometimes, those studies are collecting baseline health information from patients directly through a call center or a digital platform.

Those data could be medical history, self-reported health status and/or conditions, typically used to prequalify the appropri­ate patients for additional screening at the investigative site level.

When you start getting into more complex clinical research, and more medi­cally complex patients, having a very high screen-fail rate at a site—maybe 90% of the people who turn up are ineligible—is a huge burden on a site. How do you best qualify a clinical trial participant before he turns up at the site? We try to do that as much as we can through our digital platform and call center to reduce the burden on the site and refer the best qualified participant. More and more, we are seeing greater data collection in advance of site visits, because some sites have lower-quality referrals.

Q: For all the promise of using wearables in clinical trials, what concerns you about misusing or relying on these devices?

A: Concerns and considerations that we have are data and data privacy. When we design applications there is password protec­tion, so the data are encrypted both at rest and in flight. Data security is a big concern for us. We have a chief security officer as part of Quintiles’ lead­ership. There is data overload, with patients, with physicians and in clinical research.

In some physicians’ offices you’ll see a month’s worth of health data coming from fitness devices. What is a physi­cian supposed to do? That situation is similar in clinical research, in which there is a whole raft of data from those devices. But much of it is unusable. We are looking at how some of those devices might be used. With patient diaries, we are looking at how we might automate the diary and other data collection processes.

Apps are a very broad area. We have to be careful to make the distinction between medical devices and apps. Typically, in clini­cal research we are using validated instru­ments and medical devices.

Q: With big data being gathered from wearables and other technologies, the information can begin to provide a greater understanding of the lives of individuals, whether they are healthy, sick or on a specific medication. One result is that it raises privacy issues about personal data. How should the Informed Consent process now be handled?

A: The Informed Consent needs to be very specific to the clinical trial protocol. The type of data you have potentially collected needs to be very thoughtful. What data you want to collect needs to be the most relevant, rather than collecting everything. That raises the question: What are the ethical and medical obligations of everyone in the value chain?

We will remain very focused on identify­ing the requirements of the clinical trial and making sure the Informed Consent is aligned with the clinical study goals and ethical re­quirements. We have to be very clear on what we are doing, what data we are collecting and the exact purposes of those data.

We have made adjustments to the Informed Consent as it relates to the digital settings to make sure we have met the requirements for the IRB and the ethics committees. Those changes are more about delivering an Informed Consent through a digital channel or digital experience and making sure it is clear to the patient.

Q: The ecosystem to understand con­sumer-generated data for meaningful insights is just beginning to develop, includ­ing mobile technology to capture biometric information. How are these data captured and provided to sponsors, which need ap­plications for both trial and care settings that can integrate these data?

A: We are careful about making the distinction between a wearable fitness device versus a medical device. The biomet­ric information technologies that are coming include Google’s contact lens that measures glucose levels for diabetics and sends data to a smartphone. More and more data are being generated. This whole area is explod­ing, with very lightweight biometric sensors akin to a Band-Aid, linked to a mobile device to collect data.

Wearable technology is very much at the beginning and we are careful: Is it a medical device or a wearable? That wearable might inform the right group of patients to com­municate or engage in research. It might inform the right type of segmentation and outreach to potential study participants but, again, there are very specific requirements.

Consumer data research helps with the planning, understanding and development of insights that can inform clinical trial design, participant communication, feasibil­ity, awareness and the language used in participant communications.

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 18, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »