From eClinical to Patient-Centered mClinical
In Clinical Trials, Does the Patient Experience Matter?” While an interesting rhetorical question, the more strategic question is: "What role should patients play in clinical development going forward?"
Clinical R&D in its current state is not sustainable. The good news, however, is new technology, as it often does, enables a fundamental rethinking of processes, relationships and priorities. The enabling technology today is mobility and mhealth.
"2014 is the year of mobile in clinical research"
– Craig Lipset, Head of Clinical Innovation, Pfizer
The existing era of eClinical was ushered in by the adoption of electronic data capture (EDC) systems resulting in the automation of existing site-centric clinical trials which had, until then, been a laborious, paper-based undertaking (“Back up the truck!”). The new era of mClinical is now being ushered in by connected patients: patients connected with smartphones, tablets and wearable devices providing a platform for continuous two-way communication, both patient to trial and trial to patient.
Smartphones & Apps: A New Platform for Patient Engagement
Smartphones have changed our lives and penetration has now reached critical mass in many parts of the world: 56 percent of US adults, 62 percent of UK adults and 73 percent of Korean adults use smartphones. In the US, 83 percent of users don’t leave home without them and 63 percent check their smartphones at least once per hour.
Furthermore, the use of mobile applications (apps) has exploded with over 1 TRILLION sessions in 2014 and researches forecast a 25 percent increase in new mhealth apps each year for the foreseeable future.
In short, our smartphones have become indispensable extensions of ourselves, thus providing a pervasive mobile infrastructure for a new era of patient engagement. Smartphones, tablets and apps offer a secure, controlled environment for continuous two-way communication with patients — both during trial execution and post-trial.
Wearables - Final Piece of mClinical Puzzle
“Remote monitoring of patients through sensors and devices represents an immense opportunity”
While we keep smartphones and tablets near us, the next level of engagement comes in the form of wearable devices we keep on us, like smart bracelets (e.g., Fitbit, Jawbone, Nike Fuel), glasses and watches. With these devices and others more purpose-built to capture specific biometrics, patients can “self-quantify” themselves, thereby de-emphasizing the need for site visits.
However, due to compact form factors, wearables have limited user interfaces. As a result, according to research firm Gartner, wearable devices will drive 50 percent of all app interactions by 2017 ⇒ the app will continue to be the focal point of the connected patient experience.
Harnessing the Passion of Patients
Many patients have a personal desire and drive to fight their disease or condition by finding a cure. Harnessing this passion and engaging patients as partners in research presents enormous opportunity, especially as the industry recognizes the need to move from a volume-based model to a value model, a priority shared by regulators. According to a recent McKinsey article, "How big data can revolutionize pharmaceutical R&D":
“Real-world outcomes are becoming more important to pharmaceutical companies as payors increasingly impose value-based pricing.”
Similarly, Deloitte’s 2014 Outlook on Life Sciences describes the need for “a robust comparative effectiveness (CE) strategy and a real-world evidence program.”
The Road Ahead
So where does mClinical take us? For patients, it will provide a robust forum to actively fight disease. For doctors, it enables a return to medical practitioner from data collector. For the life sciences industry, mClinical offers a lens into the real additive value of treatments across many patient segments and indications via rich, unbiased, real world data directly from patients.
So what role do smartphone-equipped patients play in clinical development going forward? How about partner?
The transformation of clinical development will take time but regulators increasingly wanting the “voice of the patient” incorporated into research, and now pervasive mobile infrastructure available to do so, this change may be closer than we think.