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Merrilyn Datta, Ph.D., President and General Manager, Definiens. Source: DefiniensApple recently released news about its new ResearchKit, a medical platform that intends to turn the iPhone and HealthKit into diagnostic tools. The technology, which enables researchers to create apps that gather new types of health data from users who opt-in, has gotten quite a bit of attention throughout the healthcare and technology communities.

ResearchKit is being touted as having immense implications for the future of clinical trials. Identifying participants for trials can be very difficult, even for top universities and clinics, and Apple’s partners are hoping to use the technology to make recruiting from diverse populations easier as well as improve the level of data being gathered to inform trial research. Beyond the initial excitement, however, what impact will consumer-based technologies like ResearchKit actually have on clinical trials, and how might they change the face of drug discovery and development?

Challenges with Clinical Trial Enrollment

While a clinical trial might actually be the best option for a patient’s treatment plan, if he or she doesn’t know about the trial, he can’t join it. And from a patient perspective, finding out about clinical trials is a very challenging and complicated process, resulting in significant barriers to trial enrollment.

The primary way patients learn about trials is through their doctors, which means they are dependent on their doctors knowing about which trials are right for them; physicians work hard to stay up to date on open clinical trials, but they are typically bombarded with information on a regular basis and it’s not always possible for them to know about every trial taking place. The second way patients learn about trials is through web research – in fact, approximately 80 percent of people go online to conduct research. However, sifting through thousands of trials on ClinicalTrials.gov, reading all the fine print and trying to determine if they are eligible to participate in a particular trial can be daunting.

From a pharmaceutical standpoint, issues with clinical trial enrollment represent significant cost and drug development challenges. According to a report by Inventiv Health, nearly a third of the time dedicated to clinical trials is spent on patient recruitment and enrollment, and the original timeline for Phase 2 to 4 studies usually ends up doubling to meet desired enrollment levels. This signifies a huge cost investment for pharma companies; each day that a drug development program is delayed costs over $30K in operational costs and anywhere from $600K to $8M in lost opportunity costs since that drug is not on the market. Additionally, 37 percent of all sites in a given trial fail to meet their enrollment targets, and more than 10 percent never enroll a single patient, meaning that trial – and potentially a helpful drug – is stalled. 

Simply put, pharmaceutical companies are not meeting their recruitment targets. Finding the patients they need and enrolling them in trials is becoming a significant issue.

Opportunities with Consumer Technologies

With the introduction of wearable technologies, consumers have become more engaged with and activists for their own health by tracking their steps, sleep patterns and eating habits, and even monitoring their glucose levels in real time. Soon consumers will take the next step and start tracking key health metrics for preventative wellness as well. The digital revolution that started with fitness wearables and the “WebMD phenomenon,” where patients take the initiative to understand their symptoms and illnesses via online research, is evolving. Today’s patients feel empowered to gather their own information and answers, and that mentality is converging with consumer technology to not only give patients more data but also enable them to interact with their physicians in a new and different way.

Consumer technologies are also now poised to make an impact on clinical trials by reaching patients directly through a device they almost always have on hand: their cell phones. There are several key areas where these technologies, and ResearchKit in particular, have the potential to make inroads in clinical trials and patient health:

Recruitment

While the technology is still in early stages, the possibilities for trial recruitment are endless. Over two billion people own smartphones, so there will be tremendous awareness around clinical trials right off the bat. Looking forward, it’s easy to imagine a sort of iTunes library for clinical trials, where patients can easily scroll and find a study that’s right for them. At some point, there may also be an interface that asks the patient a few simple questions and then automatically directs them to the handful of trials that are relevant to their needs. This kind of technology could also eventually support pharmaceutical companies in reaching smaller populations of patients who are harder to target. 

Ultimately, this technology has the power to not only raise awareness of clinical trials, but also serve as a channel for patients to find and enroll in them, removing some of the current burden from both patients and pharmaceutical companies.

Better Data and Personalized Medicine 

ResearchKit also has the potential to help collect higher volume of data to reach the industry’s goals of not only personalized drugs, but personalized care.

The ResearchKit mPower app, as one example, enables patients with Parkinson’s disease to better track their coordination. For instance, the app’s gyroscope will look at the patient’s gait and track their finger dexterity at various times throughout the day. Similarly the Share the Journey study is aiming to follow breast cancer patients’ post-treatment journey by enabling them to share information about their cognitive abilities, mood and energy levels, with the hopes of understanding how environmental factors influence their recovery.

This kind of tracking data will enable doctors to identify trends such as a Parkinson’s patient’s dexterity being worse at night, a cardiac patient’s heart rate being better on the weekend, or a breast cancer patient’s recovery being faster after engaging in certain activities.  Instead of relying on measurements taken at one point in time at the doctor’s office – which may or may not reflect the patient’s overall health – physicians can have access to continuous, longitudinal data to help them make better treatment decisions. Moreover, rather than looking purely at whether symptoms improved, they can look at a range of factors in a patient’s life to help them optimize their treatment and recovery plans. 

Consumer technology will help collect better patient data and enable doctors to treat patients more effectively and in a more personalized way. Ultimately this data could also be fed back into the R&D loop to support drug development and treatment guidelines.

Potential Roadblocks 

Given the desire of patients to become more involved with their healthcare and their current challenges identifying clinical trials, coupled with the need for pharmaceutical companies to drastically improve trial enrollment rates, there will no doubt be a burst of activity around ResearchKit in the near term. Technology early adopters will jump on board and lead the way for others to follow suit, with the highest level of engagement likely occurring around life threatening diseases where patients are highly motivated to find a new option. Once the technology becomes mainstream, both patients and the industry stand to benefit tremendously.

There are several challenges to consider, however.

Patient Privacy

Patient privacy is always a concern when consumer technologies come into play. Users might worry about privacy controls and who has access to information about them or which trials they’re looking at. In the absence of having patients sign traditional paper HIPAA forms, it’ll be important for app developers and pharmaceutical companies to pay close attention to federal privacy regulations if using the technology for trial enrollment or patient data gathering to ensure they stay compliant.

Data Integrity 

When clinical trials are conducted typically physicians are intimately involved in collecting data and passing that onto the pharmaceutical company. In this new era where a patient might be solely engaged with their phone in terms of data collection, the credibility of that data could be compromised. There needs to be clear study design around how to use this patient-collected data, as well as protocols in place to ensure continued physical involvement and engagement between patients and doctors.

Big Data

Big data is of course critical to the future of clinical trials and personalized medicine. Technologies like ResearchKit have the potential to provide the industry with much more data to create more knowledge. Unfortunately, however, as the industry currently stands there is a shortage in the number of experts with experience in crunching and analyzing this level of big data. As all this new data becomes available, the industry will need a way to handle it effectively; in other words, more experts with big data capabilities are needed in the field. Only then will we be able to capitalize on the wealth of information sure to be gathered.

About the Author

Merrilyn Datta is President and General Manager of Definiens, the Tissue Phenomics company, and has more than 15 years of commercialization experience within the life sciences and biotechnology industry. Dr. Datta joined Definiens from Life Technologies where she held a variety of roles in marketing leadership, strategy, and mergers/acquisitions. Her specialty is commercialization of technology and integrated cross-channel marketing.

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