Drug Development at the Cusp of Revolutionary Change
Last year alone, we saw nearly 50 new drugs targeted at a variety of diseases receive regulatory approval. These included novel treatment modalities such as gene editing chimeric antigen receptor (CAR) T cell therapy for leukemia and lymphoma, biosimilars, and immunomodulators for cancer therapy. During the same period, the US Food and Drug Administration (FDA) approved a certain digital pill for schizophrenia patients. This pill has an embedded ingestible sensor, which can record if the medication has been taken by the patient – sending messages back to a wearable patch.
Needless to say, we are already pushing the boundaries of medical science and as far as patient compliance is concerned, we may be at the cusp of a breakthrough.
The Patient Challenge
Some studies also require periodic follow-ups and hospital visits over the course of an entire year or more. For patients, this means more investigations, paperwork, and complex medication dosage regimes to adhere to. Studies, which have even longer duration, will experience a large number of patients dropping out. Besides, there is always the risk of patients taking an incorrect drug, a wrong dosage, or even double dosing that could have serious health implications.
Precedence of Adherence
Over the course of a trial, patients have to adhere to the defined dosing schedule, while study sponsors have to follow regulatory guidelines for monitoring patient compliance. Patient adherence declines from 100% to a range of 70%-80%, and by day 300, adherence drops to a range of 60%-70%. If patients participating in clinical trials do not adhere to the dosing schedule, following is the impact:
- Poor outcome of drug effectiveness especially for Phase II studies where potential benefits of a new drug are scrutinized before clinical trial conduct on larger patient population
- Adverse drug effects, increased hospitalization events due to incorrect dosages
- Decreased effectiveness of drugs especially antibiotics
- Patient dropouts and eventually increased cost burden for the study
There are many reasons for a low patient adherence to dosage. These include not filling prescription, taking incorrect dose, taking medication at wrong times, increasing/decreasing frequency of doses, stopping treatment too soon, failure to follow doctors instructions, delay in seeking follow-up, interruptions in periods for long duration studies, and white coat compliance (increase in compliance close to doctor follow-up visits). A good understating of these reasons can help implement effective solutions for tackling non-compliance.
Electronic Adherence and the Digital Pill Solution
Pharma companies have been using different methods for tracking patient compliance to drug dosage regimes:
- Patient self-reporting through follow-up visits, interviews, or by filling up e-diaries
- Pill count, a commonly used method, where the site staff reviews compliance by comparing the number of pills dispensed to the number consumed
- Checking of clinical indicators such as blood pressure, glucose, and drug levels
- Electronic methods such as smart blisters and bottles
Smart blisters with electronic circuits can immediately start registering a patient’s intake once the pill cavity is broken. These devices can then communicate this patient data to a digital platform through the patient’s smartphone using near-field communication (NFC) or Bluetooth technology. Such a digitally enabled adherence method enables registration and verification of individual medication intake via sensor enabled medication packages (smart packages) to eliminate guesswork for medication intake ensuring that the right pill is taken at the right time. This makes it hassle-free for the patient and also improves accuracy and integrity of adherence data. With smartphones and smart devices, additional features can be incorporated such as capture of patient surveys, sharing of patient information through multimedia content, electronic labels, electronic consent, electronic patient recorded outcomes (ePRO) / clinical outcome assessment (eCOA), and capture of data from wearable devices. The electronic adherence methods also allow the site to monitor adherence patterns of patients and take proactive data-driven decisions. For instance, a dipping adherence may lead to dropouts that the site staff can proactively evaluate and start engaging the patient and implementing mitigation actions.
For keeping patient at the center of the drug development life cycle, there is a reasonable impetus for the biopharmaceutical companies to join forces with patients in the discovery, development, advancement, and access of newer treatment options. Technology can play a vital role and can be a key enabler for driving a patient-centric approach.
Smart devices can become the gold standard for adherence measurement due to their precision and can eliminate cumbersome processes to make it easier for patient to adhere to complex study procedures.
TCS will be discussing this and more at Mobile Clinical Trials Europe on May 15 – 16, 2018 London UK.