The FDA holds virtual biotech companies accountable for the clinical trials they sponsor. If a…
Back in March 2015, Apple debuted ResearchKit. It’s a medical platform aimed at connecting clinical trials with a more diverse population and transforms an iPhone into a diagnostic tool. More than a year later, GlaxoSmithKline (GSK) announced that it will be utilizing ResearchKit to conduct a rheumatoid arthritis medical study.
GSK created its own app, but built it using ResearchKit’s framework. The iPhone’s sensors will track symptoms of the disease, including joint pain, fatigue, and mood changes. Participants will be asked to answer health-related questions and complete guided wrist exercises. GSK is looking to measure the impact disease on day-to-day life.
Using an app like ResearchKit is theorized to be a way for companies to reduce the cost of clinical research. Since the data recorded can be kept in a centralized place, patients don’t have to travel to be part of the study. It takes out the factor of having to use a middle-man, such as a physician or a nurse as well. GSK will use this as a baseline to determine whether or not to use Apple’s software in the future and to rethink how it conducts research in a changing technological landscape.
Apple is hoping the study will legitimize its health care technology ambitions. The Apple Watch tracks users’ heart rate and movement, the Health app is a hub for medical data, and there are a plethora of apps aimed at helping users get in shape. There are many ethical and regulatory questions, though.
If Apple wants the iPhone, Apple Watch, or whatever new tech they come up with to be medical devices, that requires studies in itself and approval from the FDA. Medical device software must meet certain specifications and be validated. Others note that there are concerns about data security, that participants are knowledgeable about risks, and that participants are of age to make informed consent.
Technology and innovation are continuing to improve, so it’s not inconceivable that pharma and medicine can one day be managed from our phones or watches.
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