Kent Thoelke
Kent Thoelke
Executive Vice President, Scientific and Medical Affairs

While technology will never fully replace a traditional visit to the doctor, it is quickly and significantly changing how we interface with the healthcare system. The intersection of information technology and healthcare decision making is empowering patients and evolving to meet their specific needs. There is hope that by leveraging technology, we can make healthcare more convenient, efficient, and cost effective.

For more than a decade, PRA Health Sciences has been harnessing the power of technology and data assets to redefine what can be done for patients in an effort to reimagine the future of clinical development. Kent Thoelke, Executive Vice President, Scientific and Medical Affairs shares his insights about that future.

We know that people often use smart devices to monitor heart rate, steps walked, etc. How do you think the clinical development industry can better utilize mobile apps and smart devices?

The ability to collect patient specific data in real time has been advancing at breakneck speed over the last few years. While most consumers are familiar with activity tracking devices such as Fitbits, Garmin, Apple Watches, etc. – the ability to collect patient data using smart devices is far more comprehensive today and includes a broad range of Bluetooth enabled devices that collect health related data in real time.

In the traditional clinical trial model, data such as vital signs (heart rate, blood pressure, pulse oximetry, temperature, etc.) were collected during patient visits to the clinic site. Today, smart devices and Bluetooth enabled technology allow patients to conveniently collect their data from the comfort of their own home and transmit to the clinic site without requiring an on-site visit. Beyond vital signs, there are a range of Bluetooth devices that are validated and approved that can collect specific measurements such as blood glucose, nebulizer data, drug dosing, and electrocardiogram information.

How do you think mobile based medical research can improve participation and retention in clinical studies?

Participation in clinical trials continues to be one of the greatest barriers to getting new drugs to market and to patients. Many patients have busy lives outside of their disease, jobs, children—and the burden to participate is high. Due to the increasing complexity of clinical trials and data collection needs, many patient visits may be required for basic vitals data. Bluetooth technology and smart/mobile devices give us the ability to collect this data at home making clinical participation much easier.

This is especially true for many rare disease patients who may not live near a clinical trial site. Historically, because of geographic limitations, patient participation in trials has been low. Using mobile data collection technology and telemedicine, access to clinical trials for rare patients is possible even when they might be hundreds or thousands of miles away from a clinic site. The deployment of mobile based technologies may be our only hope in enrolling rare and ultra-rare indications successfully.

We know that getting patients to participate in trials is only half the challenge. Keeping patients in trials and collecting long term follow up data is equally difficult but critically important both for efficacy and long term safety. Once again, the use of mobile technology helps by allowing us to engage and interact with patients via text, voice and video over the long term follow up period of a study. Patients are already using their mobile devices in their daily lives to interact routinely with friends, family, and businesses colleagues, why not their healthcare providers. By staying connected with patients we can ensure greater long term follow up compliance and retention in clinical trials.

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What existing examples/data do we have that this works?

We have seen numerous examples to date of increased clinical trial enrollment and participation utilizing mobile technology. The demographics of the potential patient population for inclusion in trials is evolving. Published healthcare behaviors data indicate that the millennial generation patient is more inclined to have their healthcare delivered by an ambulatory clinic or on-demand service such as Teladoc, Urgent Care clinics etc. as opposed to the traditional General Practitioner or Family Practice physician. The majority of the healthcare interactions for this population are mobile – with patient visit scheduling, virtual visits, lab draws, lab results, prescriptions all being done electronically via mobile devices. In order to attract this population to clinical trials, the systems and processes in the trial must match how their healthcare is currently delivered.

Why has the industry been slow to adopt?

There is always concern when adopting new technologies, regardless of industry. However, healthcare and drug development has been particularly slow to use these novel technologies compared to other industries. Much of the hesitance has been related to concerns regarding patient privacy, data security, and validation of devices and the collection methodology. However, these same technologies are deployed successfully, daily, and worldwide in other industries such as banking and financial investing, where consumer data protection, privacy, and compliance are equally paramount.

How do we overcome concerns around data privacy, especially in light of recent cyberattacks on health systems around the world?

Patient data privacy is essential – regardless of how it is collected. Whatever technology is deployed, it is critical that data encryption practices are used to ensure the protection of HIPAA related data. We do this by only deploying smart devices and data collection tools that have been appropriately validated and that have security encryption in place to protect and de-identify all patient related data. Similar to those same privacy policies put in place by financial institutions – the technology already exists and has been tried and tested worldwide to ensure compliance. The clinical trials and drug development industry need to look to other industries and apply best practices when adopting these technologies to assuage the concerns that have been voiced.

How is PRA Health Sciences embracing these technologies?

PRA is a pioneer in the use of data and technology for clinical trials and has built a strategy around the use of data to better inform and deliver clinical trials for over a decade. PRA continues to invest in leading edge mobile technology solutions for clinical trials – most recently via the acquisition of the leading mobile patient based platform company, Parallel6. This company and their mobile, end to end patient engagement solution, Clinical6, now allows PRA to fully deploy mobile based clinical trials. In addition to acquiring this technology, PRA has also recently signed an exclusive partnership with a division of Intel, Care Innovations, for their Bluetooth enabled and wearable devices solutions for clinical trials. The ability to integrate these devices into our new Parallel6 technology provides PRA with the leading mobile technology solution for clinical trials.

How might artificial intelligence help drug development?

Artificial Intelligence is a broad term, but it essentially is using computers to help evaluate data and make decisions and suggestions. AI is particularly useful in its ability to mine significant volumes of data quickly to make connections and observations. Good examples of this technology is its ability to mine all available, published healthcare data to identify safety signals in approved and marketed drugs. This same strategy can be deployed to evaluate all potential treatment options for a patient, inclusive of potential clinical trials for patients. The amount of data being generated today regarding potential treatment options for patients is simply too expansive for clinicians to keep up with regularly. The ability to utilize AI is essential to ensure that all potential data is being evaluated as an option for patient care.

In addition to Parallel6, we’ve also brought Symphony Health Solutions on board, a best-in-class provider of data, analytics and consulting solutions to the life sciences market.