Digital Tools for Clinical Trials
There is progress being made in the clinical trials arena!
The Apple Research Kit was introduced several months ago and is making headway in the world of clinical trials, facilitating clinical trial enrollment, navigation and process for patients.
The Apple Research Kit is an open-source software framework for collecting clinical trial data. Researchers and developers of clinical trials are encouraged to use the kit to develop apps for patients who will use their iPhone to contribute data and participate in clinical research.
Patient Recruitment Made Easy
Several major institutions have developed apps using the kit for clinical studies on asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease. Other providers and developers are sure to jump on the band-wagon as recruiting patients by iPhone is much easier and user-friendly than posting fliers or sending out applications by mail. The major institutions that developed the first apps say that instead of the national year-long effort to recruit patients, they got thousands of volunteers within a day of launch.
Besides helping to recruit patients, ResearchKit could also help solve other problems in clinical research.
Objective Data Gathering
iPhone, with the user’s consent, can gather objective data with advanced sensors like an accelerometer, barometer and gyroscope. Apple is introducing other quantifiable metrics, like an app that requires patients in a Parkinson’s trial to regularly complete touchscreen exercises that would measure tremor incidence. And in the future, other sensors or apps will become available that could track all sorts of metrics useful for clinical research. And what a boon for patients! They can use metrics and the iPhone to track data automatically and easily, certainly reducing visits to a provider and helping patients in more remote areas by making participation in a trial much more accessible.
Frequent Data Gathering
Most iPhone users keep their iPhone close to them at all times, ensuring that data is gathered consistently, rather than at scheduled hospital visits. The data can be gathered instantly and sent automatically as long as the user consents.
Concerns About Privacy, Ethics, and Compliance
Some have questions about information privacy or the ethics involved in recruiting patients remotely. Can Apple and others keep the information gathered private?
And who is to say that all participants are over the age of consent when there is no one checking IDs at the door?
The ResearchKit is presently available only to those with an iPhone. These people tend to be more wealthy individuals – is this a problem? Are these the patients that clinical trial researchers want to recruit?
And currently, there is no easy way for participants to pose questions.
These concerns and others are certainly problems that Apple is aware of and is working on.
All in All, A Step Ahead for Clinical Research
With all the iPhones in use by countless patients all over the world, there is a trove of excellent data that certainly can be useful for clinical research. Apple and the clinical researchers and developers working with the ResearchKit are trying to help patients by gathering and analyzing this data. And with sensors and trackers available at their fingertips, patients can participate in research more easily than before.
Fabio Gratton, CEO of CureClick, a crowdsourced clinical trial recruitment platform, believes ResearchKit is a promising tool to help the cause of clinical trials:
“66% of trials today fail to meet recruiting goals, and 80% fail to finish on time due to both recruiting and operational challenges. That is why we created CureClick, which is the first clinical trial recruiting platform to use crowdsourcing through social media to identify patient volunteers. We believe that ResearchKit is another innovation that can help streamline the trial process, both in identifying patients and gathering data from participants in an efficient and real-time basis”.
“ResearchKit is a high-potential platform,” says Mikey Wills, CureClick’s lead designer, “But it still needs strong front-end development to make it a viable tool for clinical trial sponsors.”
Last month CureClick was tapped by Thread Research, another southern-California digital health firm that has been working closely with Apple to develop ResearchKit-powered apps, to assist in the development of the PRIDE Study app in partnership with UCSF, helping to create the largest database yet of the physical, mental and social issues that uniquely affect gay and transgender men and women. To date the app has helped recruit over 15,000 study participants.
The goal, through this partnership, is to address the general challenges the industry faces in getting patients to participate in the clinical trial process.
Consider Clinical Trials!
And perhaps #mHealth will lead the way to more awareness about clinical trials. More and more data is being collected via mobile phone. Many are used to using phones with fitness apps, nutrition apps, using their phones to track how they exercise and how they eat. If phones can help patients enroll, navigate and take part in clinical trials – so much the better! The more patients that consider clinical trials, the more research will progress and the more patient outcomes will improve.