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6 Digital Health Technologies for Enhancing Real-World Evidence Collection, Patient Centricity, and Post-Market Studies
Pages 75-86

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From page 75...
... (Crouthamel) • Collecting real-world longitudinal digital health data can em power participants throughout the drug development process, including the post-market phase, by illuminating lived experi ences and amplifying the voices of patients.
From page 76...
... She discussed strategies for maximizing the impact of patient-generated health data and for applying patient-centered principles in study design. Edmondo Robinson, chief digital innovation officer at the Moffitt Cancer Center, explored how DHTs for post-marketing surveillance can help address clinician concerns about the effectiveness, tolerability, and adherence to drugs.
From page 77...
... Investigators were able to collect electronic consent forms, disease insights, and sensor data directly from the participants' smartphones. Through this effort, the investigators were also able to develop a novel digital measure of functionality called wrist range of motion, which enabled them to capture information about participants' pain at a more granular level (Crouthamel et al., 2018)
From page 78...
... The balance of protecting study integrity and providing data feedback at appropriate times is a critical consideration of study design, which must avoid compromising resulting statistical analyses. Integrating Digital Health Technologies into Post-Market Study Design Integrating DHTs into post-marketing study design can enable surveillance and the monitoring of product safety among different subtypes of the study population, Crouthamel said.
From page 79...
... USE OF DIGITAL HEALTH TECHNOLOGIES TO EMPOWER PATIENT PARTICIPATION Sally Okun, Director of Policy and Ethics, UnitedHealth Group Research & Development Okun began by underscoring the importance of patient participation in the drug development process from start to finish. Empowering patient
From page 80...
... To make progress toward empowering patient participation, she suggested considering information that can be gleaned from patients and consumers to inform the principles that will help guide tool design, data protection, and privacy. For instance, new social contracts with patients may need to be put in place in order to develop a better understanding of what factors drive them to want to participate in research efforts.
From page 81...
... The study demonstrated that gaining a better understanding of the reasons for non-adherence can help inform possible digital solutions as well as improve understanding of the digital competencies that particular populations may need to take advantage of these digital tools. In collecting information during the postmarketing period, digital tools have value in helping to identify factors that may put a patient at risk of not using the medication as prescribed or otherwise compromising his or her health and safety.
From page 82...
... Using Digital Health Technologies to Inform Patient-Focused Drug Development DHTs have the potential to exponentially amplify the voice of patients and bring patient-focused product development full circle, Okun said.
From page 83...
... By learning from patients and sharing that information broadly across systems, clinicians and researchers collecting this information could also benefit stakeholders who are not directly engaging with digital tools but would benefit from the insights gained from those who are. Okun said that efforts to capture real-time data from people using digital tools during the post-market surveillance period benefit from considering the types of patients who would typically be using the tool for its intended purposes, how they will use the tools, and how mechanisms within the tool will address the specific needs of certain subpopulations of patients, such as those who speak a different language or those with digital literacy issues.
From page 84...
... Maximizing the use of DHTs can help clinicians answer questions related to new drugs that their patients may be taking as well as support their efforts to increase innovation in care delivery. Digital Health Technologies to Understand Drug Effectiveness in Real-World Settings When clinicians consider a drug's effectiveness in the post-market context, Robinson said, a primary concern is whether the drug will work for their own patient population, which may include individuals who are older, sicker, more diverse, and affected by more comorbidities than the population that participated in clinical research.
From page 85...
... Opportunities for DHTs to help answer these types of questions about tolerability include digital survey modalities to evaluate side effects and quality of life, while DHTs for activity tracking, physiological measurements, and remote monitoring can be used to look at side effect endpoints. The increasing use of oncological immunotherapies has created a need to monitor the significant neurological side effects associated with immunotherapy, such as delirium.
From page 86...
... For example, digitally enabled medication dispensers and the use of "digital pills" that can track medication ingestion could be used in place of directly observed therapy to track the number of times that a patient dispenses a medication, Robinson suggested. This type of application could be helpful for supporting adherence for high-risk medications that patients need to take consistently (e.g., anti-tuberculosis medication)


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