Adoption of Decentralization: Are Our Perceptions Holding Us Back?

Incorporating decentralized approaches into clinical trials is a critical innovation with potential implications for improved accessibility and diversity, as well as lower burden for participants and caregivers. As we move forward in a collective effort to modernize clinical trials, we consistently hear of hurdles that interfere with the adoption of decentralized approaches. But are these hurdles really the impediments we think they are? In this commentary, we offer three perceptions that are commonly heard as impediments to the adoption of digital and decentralized clinical trials. Leveraging the Clinical Trial Transformation Initiative's Digital Health Trial hub of work, interactions with members and regulators, and observations related to adoption, we address those perceptions and note some resources that exist to overcome them. In working through these barriers, we can instill confidence in sponsors and designers to leverage all the clinical trial design tools available to them to advance the use of decentralized approaches.

A placebo-controlled randomized trial of warfarin in idiopathic pulmonary fibrosis.

RATIONALE: Animal and human studies support the importance of the coagulation cascade in pulmonary fibrosis. OBJECTIVES: In a cohort of subjects with progressive idiopathic pulmonary fibrosis (IPF), we tested the hypothesis that treatment with warfarin at recognized therapeutic doses would reduce rates of mortality, hospitalization, and declines in FVC. METHODS: This was a double-blind, randomized, placebo-controlled trial of warfarin targeting an international normalized ratio of 2.0 to 3.0 in patients with IPF. Subjects were randomized in a 1:1 ratio to warfarin or matching placebo for a planned treatment period of 48 weeks. International normalized ratios were monitored using encrypted home point-of-care devices that allowed blinding of study therapy. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was the composite outcome of time to death, hospitalization (nonbleeding, nonelective), or a 10% or greater absolute decline in FVC. Due to a low probability of benefit and an increase in mortality observed in the subjects randomized to warfarin (14 warfarin versus 3 placebo deaths; P = 0.005) an independent Data and Safety Monitoring Board recommended stopping the study after 145 of the planned 256 subjects were enrolled (72 warfarin, 73 placebo). The mean follow-up was 28 weeks. CONCLUSIONS: This study did not show a benefit for warfarin in the treatment of patients with progressive IPF. Treatment with warfarin was associated with an increased risk of mortality in an IPF population who lacked other indications for anticoagulation.

Patient-focused intervention to improve long-term adherence to evidence-based medications: a randomized trial.

BACKGROUND: Nonadherence to cardiovascular medications is a significant public health problem. This randomized study evaluated the effect on medication adherence of linking hospital and community pharmacists. METHODS: Hospitalized patients with coronary artery disease discharged on aspirin, ß-blocker, and statin who used a participating pharmacy were randomized to usual care or intervention. The usual care group received discharge counseling and a letter to the community physician; the intervention group received enhanced in-hospital counseling, attention to adherence barriers, communication of discharge medications to community pharmacists and physicians, and ongoing assessment of adherence by community pharmacists. The primary end point was self-reported use of aspirin, ß-blocker, and statin at 6 months postdischarge; the secondary end point was a ≥ 75% proportion of days covered (PDC) for ß-blocker and statin through 6 months postdischarge. RESULTS: Of 143 enrolled patients, 108 (76%) completed 6-month follow-up, and 115 (80%) had 6-month refill records. There was no difference between intervention and control groups in self-reported adherence (91% vs 94%, respectively, P = .50). Using the PDC to determine adherence to ß-blockers and statins, there was better adherence in the intervention versus control arm, but the difference was not statistically significant (53% vs 38%, respectively, P = .11). Adherence to ß-blockers was statistically significantly better in intervention versus control (71% vs 49%, respectively, P = .03). Of 85 patients who self-reported adherence and had refill records, only 42 (49%) were also adherent by PDC. CONCLUSIONS: The trend toward better adherence by refill records with the intervention should encourage further investigation of engaging pharmacists to improve continuity of care.