A number of trends may explain the enthusiasm toward precision medicine in healthcare today.
Approaches to clinical trials and doctor-patient relationships are becoming increasingly user-centric. Advances in medical science have shown how to divide populations into treatment subgroups based on certain characteristics. These characteristics are often genetic in nature; precision medicine usually means identifying patient groups based on predispositions to certain diseases, and tailoring treatments accordingly.
But personalized treatment can go beyond this paradigm. Matters of lifestyle, such as dietary and exercise habits, can also play a role(1). And many of the innovations applied to healthcare in recent years, such as wearables and other mobile devices, have served to collect precisely this kind of information. How far does a given patient walk every day? How much sleep does she get every night? Devices that answer questions like these are expanding the concept of precision medicine to include more than just genetic data.
What kind of devices can aid in precision medicine?
In a clinical trial, data gathered from devices like Fitbit and Apple Watch can help measure the efficacy of a treatment, or even serve as the intervention in a study. They can also facilitate the collection of patient reported outcomes (PRO), a major component of the trend toward precision medicine; some of the apps integrated with Apple’s recently-released CareKit enable users to keep a record of adverse events or any other changes in their condition. In this way and others, doctors can use such tools to monitor their patients’ response to a prescribed treatment and, if need be, modify it. Devices like smart fridges and smart weights, for example, can alert medical professionals if a patient's dietary and exercise routines call for an adjustment in medication(2). Conversely, doctors can also aim to tailor a patient’s lifestyle to the treatment: a device that can detect blood-alcohol content, for example, could notify a doctor if a patient is in danger of experiencing a harmful interaction between alcohol and an antibiotic - the doctor can then remind the patient to eliminate alcohol use until the treatment is up.
Several products designed for personalized care are in production or have been FDA approved(2). They are forming a class of devices that bring the patient-engaged mindset of clinical research today to precision medicine. By equipping patients’ household and mobile devices with data-gathering technology, these devices make it possible to monitor and tailor treatments in a way that is convenient for, and physically close to, the patients that use them.
New tech for Phase I precision
In clinical trials, data gathered from mobile apps has already demonstrated utility in illuminating patient response to a treatment. Those responses can offer insight into the safety or efficacy of a compound and are thus beneficial to all phases of in-human clinical research.
Some devices, though, offer benefits that are particular to certain phases. An essential part of the primary objective in Phase I trials - determining whether a drug is safe in human subjects - is establishing proper dosage. This is by no means a one-size-fits-all quantity; from person to person, proper dosage can vary significantly based on body weight, age, and other factors. The FDA approval of 3D-printed pills has been lauded for enabling medical professionals to customize dosage to a previously unfeasible level of specificity.
The market for patient-centric healthcare technology may be able to contribute to precision medicine with devices that affect the collection and analysis of dosing data. The safety and efficacy of a dose often depends on how much, and how recently, a patient has eaten; could a smart refrigerator quantify a patient’s typical daily caloric intake in a way that could guide dosing levels for that particular person? Similarly, could it offer useful data on what times of day that person typically eats? Someone who tends to eat a small lunch early in the afternoon may be prescribed a different dosage level and medication schedule than someone who usually eats a large lunch a bit later.
If this data is gathered before dosing begins in a Phase I trial, it could equip researchers to start their trials with more informed estimates of the proper dosage for each patient or group of patients. This could abbreviate the dose escalation process, leading to savings in their trial. It could also lead to further dosage adjustments in later phases, when patients spend most of their time off-site and can use mobile or in-home devices to track how an investigational treatment is affecting them.
Genetic analysis can determine inborn traits that allow for more personalized treatments. But user-centric technology can provide lifestyle information that contributes to decisions about what type of medication, as well as what dosage, is ideal for a given patient. And it can do so in a way that is convenient for patients and doctors alike. This is an encouraging sign of just how precise precision medicine can get.