IN PARTNERSHIP


are being treated for chronic illness fully adhere to their prescribed therapy2


. Unfortunately, even today, researchers may


lack access to evidence-based adherence measures. Without such evidence, researchers may assume that patients are taking their study products exactly as prescribed; and patients tend not to tell their providers, clinicians, or consultants otherwise. In the clinical trial setting, other consequences can arise. Here, non- adherence can threaten the integrity of study data, jeopardising important and expensive research, as well as potentially triggering regulatory and public health problems after a drug has been approved and is on the market.


Proven and scalable: SMART digital adherence technology (DAT) When patients are made aware of their adherence patterns through engagement and counselling, they are empowered to change their behaviour and improve their medication adherence. While a variety of currently available electronic monitoring systems can provide data on patient medication adherence in clinical trials and in daily use, the most effective options have minimal impact on the patient, and require little or no effort. Medication packaging that


integrates electronic monitoring features is a proven, easy-to-use solution that holds great promise for improving medication adherence. In various packaging formats, electronic sensors can detect when a package has been opened, or when a dose has been withdrawn, and collect timing and dose-taking information. Data is seamlessly captured, downloaded, and compiled into a dosing history, which investigators and/or providers can use for “adherence” informed and impactful one-on- one counselling with patients.


Evidence-based adherence feedback enables digital therapeutics and patient empowerment With compiled individual adherence data in hand, researchers and providers can identify patients who are non-adherent and arrange to meet with those individuals to discuss their medication-taking patterns. These informed counselling events have been proven to have  medication adherence3


. Numerous studies have shown that SMART


 medication adherence compared with traditional approaches. Studies represented


Outsourcing in Clinical Trials Handbook | 83


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100