From The Editor | May 15, 2015

Can Apple's ResearchKit Transform Clinical Trials?

By Ed Miseta, Chief Editor, Clinical Leader

Merrilyn Datta

There is a lot of excitement in the clinical space around Apple’s ResearchKit and its potential to transform data collection, patient lives, and clinical trials. Despite the optimism, there are others in the industry that feel it is nothing more than a tool whose benefit beyond consumer use is yet to be determined. So what can we really expect from it in the future?

Dr. Merrilyn Datta believes ResearchKit will be good for the industry and patient recruitment in particular. She also believes it has the potential to be the gateway to personalized medicine. Datta is chief commercial officer for tissue phenomics company Definiens.  

Although it’s very early on, we are already seeing what ResearchKit is capable of doing. A release on states the Parkinson’s App had over 5,000 participants shortly after launching. According to that same release, when Stanford University conducted a cardiovascular study using ResearchKit, they gathered more than 11,000 participants overnight. The promotion has clearly made people aware of ResearchKit.   

Solving The Enrollment Problem

Those early results have to be exciting to companies performing clinical trials. The recruitment process has always been a bottleneck in process of conducting trials. There are generally two ways that patients find out about a trial. The first is their physician mentions it to them. That would require the doctor to be aware of the trial, be proactive, and take the time to decide if the patient is right for the trial. The other way is for the patient to be proactive and have the initiative to go on to find applicable trials. Datta believes most patients who have used the site would tell you it is difficult to search and navigate to find an appropriate trial.

“One of the first major impacts ResearchKit will make is enabling companies to reach a lot of patients who could be signing up for clinical trials but do not have the knowledge or wherewithal to locate one on their own,” she says. “Close to two billion people now have smart phones, so this is a recruitment tool that most people can hold right in the palm of their hand. But it’s also exciting because we can all see the hype that occurs whenever Apple announces a new product. All of these smart phone users will now have a way to know if there is an easy way for them to sign up for clinical trials. Those who are interested are definitely going to check it out. Based on that alone, I think the signups for clinical trials alone are going to be amazing.”

When you realize that about 30 percent of the cost of doing clinical trial development is in patient recruitment and enrollment. Not only can ResearchKit reach more patients, it will do so faster, more efficiently, and help to bring down the cost of developing new drugs for patients.

Multiple Apps, Study Credibility, And Patient Privacy

Awareness is the key driver to getting patients enrolled in trials. ResearchKit is uniquely positioned to do just that. But once a patient becomes aware of a trial, the logistics involved with getting them enrolled, and calming their fears about privacy, can still result in a significant drop-off rate.

“The apps patients can access may enable them to do the enrollment and screening right on the spot, via their smart phones,” says Datta. “They do not have to show up at a special study center, and there is no paperwork for them to fill out.”

While some apps are already available, the open developer kit will enable many more to hit the market in the future. Datta believes this will have a network effect and drive further adoption. One of the first big apps out of the gate was one for breast cancer. In the future there may be 10 different apps for breast cancer, where patients would be asked questions to determine if they meet certain requirements. They could be screened for acceptance for a study based on their answers. If accepted, the gathering of data could start almost immediately right through their mobile device. Choice is good, and the more that exist, the more patients will become convinced that there is something out there for them. They will also have the motivation to keep going back and looking.

For the effort to be successful, Datta also believes there will need to be a medical credibility piece in place. Ultimately a physician should review enrollment and patients will want to know what hospital is affiliated with a certain medical study, and whether or not the study is credible. She notes it may be too early to know exactly how that will play out, but suspects eventually there will be some type of overview of the study noting the affiliated organization and name and bio of the person overseeing it.

The other key concern here will be patient privacy. When you perform more traditional trial enrollment, everyone signs a HIPPA form and it is generally done in a doctor’s office where everyone knows the proper procedures.  With everything going through someone’s iPhone, this is an entirely different procedural situation, especially pertaining to compliance of data security. Users will want to know that their patient data is safe and private.

Enabling Personalized Medicine

There are two final aspects of ResearchKit that could be interesting if it takes off. The first is there will be a lot more longitudinal data. “We will be looking at people over time, rather than just at a moment in time when someone is completing a survey,” says Datta. “This will now be done on a more regular basis, since patients could be monitored every day over a period of time. The types of data clinics can receive, and the trends in it, will be a lot richer.”

Datta believes this is also the type of big data generation that will, eventually, enable personalized medicine. More participants means the patient data will be more representative of the population. This increases the ability to perform clinical decision support. Patients could be identified who would be most likely to respond to a certain treatment option. “I think it may well be the real gateway to personalized medicine,” adds Datta.