Analysis of the Market, Regulatory Landscape, and Current State of Clinical Trials Pertaining to Digital Health

Health care has had to adapt rapidly to COVID-19, and this in turn has highlighted a pressing need for tools to facilitate remote visits and monitoring. Digital health technology, including body-worn devices, offers a solution using digital outcomes to measure and monitor disease status and provide outcomes meaningful to both patients and health care professionals. Remote monitoring of physical mobility is a prime example, because mobility is among the most advanced modalities that can be assessed digitally and remotely. Loss of mobility is also an important feature of many health conditions, providing a read-out of health as well as a target for intervention. Real-world, continuous digital measures of mobility (digital mobility outcomes or DMOs) provide an opportunity for novel insights into health care conditions complementing existing mobility measures. Accepted and approved DMOs are not yet widely available. The need for large collaborative efforts to tackle the critical steps to adoption is widely recognised. Mobilise-D is an example. It is a multidisciplinary consortium of 34 institutions from academia and industry funded through the European Innovative Medicines Initiative 2 Joint Undertaking. Members of Mobilise-D are collaborating to address the critical steps for DMOs to be adopted in clinical trials and ultimately health care. To achieve this, the consortium has developed a roadmap to inform the development, validation and approval of DMOs in Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease and recovery from proximal femoral fracture. Here we aim to describe the proposed approach and provide a high-level view of the ongoing and planned work of the Mobilise-D consortium. Ultimately, Mobilise-D aims to stimulate widespread adoption of DMOs through the provision of device agnostic software, standards and robust validation in order to bring digital outcomes from concept to use in clinical trials and health care.

Download Full-text

Conceptual Framework to Support Clinical Trial Optimization and End-to-End Enrollment Workflow

JCO Clinical Cancer Informatics ◽

10.1200/cci.19.00033 ◽

2019 ◽

pp. 1-10 ◽

Cited By ~ 3

Author(s):

Neha M. Jain ◽

Alison Culley ◽

Teresa Knoop ◽

Christine Micheel ◽

Travis Osterman ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Knowledge Representation ◽

Conceptual Framework ◽

Trial Design ◽

Clinical Trial Design ◽

Prospective Clinical Trial ◽

Future Trends ◽

Current State ◽

Evaluation Strategies

In this work, we present a conceptual framework to support clinical trial optimization and enrollment workflows and review the current state, limitations, and future trends in this space. This framework includes knowledge representation of clinical trials, clinical trial optimization, clinical trial design, enrollment workflows for prospective clinical trial matching, waitlist management, and, finally, evaluation strategies for assessing improvement.

Download Full-text

The United States’ Regulatory Environment Is Evolving to Accommodate a Coming Boom in Gene Therapy Research

Applied Biosafety ◽

10.1177/1535676019854866 ◽

2019 ◽

Vol 24 (3) ◽

pp. 147-152 ◽

Cited By ~ 2

Author(s):

Daniel Eisenman

Keyword(s):

United States ◽

Gene Therapy ◽

Clinical Trials ◽

The United States ◽

Regulatory Environment ◽

Evidence Based ◽

Regulatory Structure ◽

Regulatory Changes ◽

Current State ◽

Therapy Field

Introduction: A dramatic increase in the number of clinical trials involving gene-modified cell therapy and gene therapy is taking place. The field is on the verge of a boom, and the regulatory environment is evolving to accommodate the growth. Discussion: This commentary summarizes the current state of the field, including an overview of the growth. The United States (US) regulatory structure for gene therapy will be summarized, and the evolution of the oversight structure will be explained. Conclusion: The gene therapy field has recently produced its first FDA-approved therapeutics and has a pipeline of other investigational products in the final stages of clinical trials before they can be evaluated by the FDA as safe and effective therapeutics. As research continues to evolve, so must the oversight structure. Biosafety professionals and IBCs have always played key roles in contributing to the safe, evidence-based advancement of gene therapy research. With the recent regulatory changes and current surge in gene therapy research, the importance of those roles has increased dramatically.

Download Full-text

Status Quo and Trends of Intra-Arterial Therapy for Brain Tumors: A Bibliometric and Clinical Trials Analysis

Pharmaceutics ◽

10.3390/pharmaceutics13111885 ◽

2021 ◽

Vol 13 (11) ◽

pp. 1885

Author(s):

Julian S. Rechberger ◽

Frederic Thiele ◽

David J. Daniels

Keyword(s):

Drug Delivery ◽

Clinical Trials ◽

Brain Tumors ◽

Phase 1 ◽

Citation Count ◽

Tumor Therapy ◽

The United States ◽

Blood Brain Barrier Disruption ◽

Current State ◽

Brain Barrier Disruption

Intra-arterial drug delivery circumvents the first-pass effect and is believed to increase both efficacy and tolerability of primary and metastatic brain tumor therapy. The aim of this update is to report on pertinent articles and clinical trials to better understand the research landscape to date and future directions. Elsevier’s Scopus and ClinicalTrials.gov databases were reviewed in August 2021 for all possible articles and clinical trials of intra-arterial drug injection as a treatment strategy for brain tumors. Entries were screened against predefined selection criteria and various parameters were summarized. Twenty clinical trials and 271 articles satisfied all inclusion criteria. In terms of articles, 201 (74%) were primarily clinical and 70 (26%) were basic science, published in a total of 120 different journals. Median values were: publication year, 1986 (range, 1962–2021); citation count, 15 (range, 0–607); number of authors, 5 (range, 1–18). Pertaining to clinical trials, 9 (45%) were phase 1 trials, with median expected start and completion years in 2011 (range, 1998–2019) and 2022 (range, 2008–2025), respectively. Only one (5%) trial has reported results to date. Glioma was the most common tumor indication reported in both articles (68%) and trials (75%). There were 215 (79%) articles investigating chemotherapy, while 13 (65%) trials evaluated targeted therapy. Transient blood–brain barrier disruption was the commonest strategy for articles (27%) and trials (60%) to optimize intra-arterial therapy. Articles and trials predominately originated in the United States (50% and 90%, respectively). In this bibliometric and clinical trials analysis, we discuss the current state and trends of intra-arterial therapy for brain tumors. Most articles were clinical, and traditional anti-cancer agents and drug delivery strategies were commonly studied. This was reflected in clinical trials, of which only a single study had reported outcomes. We anticipate future efforts to involve novel therapeutic and procedural strategies based on recent advances in the field.

Download Full-text

Analysis of Legal and Regulatory Frameworks in Digital Health: A Comparison of Guidelines and Approaches in the European Union and United States

Journal of the International Society for Telemedicine and eHealth ◽

10.29086/jisfteh.8.e11 ◽

2020 ◽

Vol 8 ◽

Author(s):

Fara Aninha Fernandes ◽

Georgi V Chaltikyan

Keyword(s):

United States ◽

European Union ◽

Digital Health ◽

Clinical Decision Support Systems ◽

Clinical Decision ◽

The European Union ◽

Regulatory Pathways ◽

Regulatory Frameworks ◽

The Impact ◽

Regulatory Landscape

The advent of digital technology in healthcare presents opportunities for the improvement of healthcare systems around the world and the move towards value-based treatment. However, this move must be accompanied by strong legal and regulatory frameworks that will not only facilitate but encourage the good use of technology. The goal of the study was to assess the amenability and furtherance of regulatory frameworks in digital health by evaluating and comparing the processes, effectiveness and outcomes of these frameworks in the European Union and United States. Methods: This study incorporated two research methodologies. The first was a research of current legal and regulatory frameworks in digital health in the European Union and United States. A comprehensive online search for publications was carried out which included laws, regulations, policies, green papers, guidelines and recommendations. This research was complemented with interviews of five purposively sampled key informants in the legal and regulatory landscape. Results: Mind-maps revealed key features and challenges of the digital health field in the topics of the current state of regulation of digital health in the EU, Germany and US, regulatory pathways for digital health devices, protection and privacy of health data, mobile health validation, risk-based classification of medical devices, regulation of clinical decision support systems, telemedicine, artificial intelligence and emerging technologies, reimbursement for digital health services and liability for digital health products. The experts expressed and explained key points where current regulation is deficient. The review of the legal frameworks revealed deficiencies which provide opportunities and recommendations to further develop and strengthen the regulatory landscape. Conclusions: A key element to a robust regulatory framework is the ability to ensure trust and confidence in using digital health technology. Technology must measure the impact on quality of life and burden of disease and not merely involve the collection of data.

Download Full-text

Clinical trials participation is directly influenced by the information received by cancer patients (pts) and caregivers: Real-world evidence with the use of a specialized digital health platform.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e18779 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e18779-e18779

Author(s):

Keren Greenfeld-Barsky ◽

Lior Hasid ◽

Daniel A. Vorobiof ◽

Eliran Malki

Keyword(s):

Clinical Trials ◽

Cancer Patients ◽

Treatment Option ◽

Medical Staff ◽

Digital Health ◽

Participation Rate ◽

Current Data ◽

Common Reason ◽

Sources Of Information ◽

Common Diagnosis

e18779 Background: Clinical trials (CT) participation is both crucial for medical advancement and an important treatment option, at times the only one, for oncological pts. However, only an estimate of ̃3% of cancer pts worldwide enrolls into such trials. Different factors have been implicated in underlying this low participation rate, with little current data on patients’ own perspective. In this study, pts & caregivers’ perception, knowledge and experience with CT were assessed via a unique digital health platform. Methods: 290 American and Israeli members of Belong.life cancer application (app) anonymously & voluntarily replied to a 10 questions survey detailing their demographics, diagnosis, and experience with CT as a treatment option. Results: 234 participants were pts (81%) and 56 (19%) caregivers. 73% of participants were US based. 35 participants (12%) were < 50 years of age (yoa), 94 (32%) were 50-59 yoa, 117 (40%) were 60-69 and 44 (15%) were > 70 yoa. There were 79 males and 211 females.The most common diagnosis was breast cancer in 74 (26%), hematologic in 36 (12%), lung in 35 (12%), colorectal in 26 (9%) and ovarian in 26 (9%). Stages were 4 in 117 (40%) and 3 in 52 (18%), early (1&2) in 73 (25%). 134 (46%) have not heard about CT participation as a treatment option. Among 125 participants of the 134 who were not familiar with CT as a treatment option, 115 (92%) stated they would like to learn more about it. Among the 156 participants who were acquainted with this option, 52 (33%) heard about it from medical staff, 41(26%) from multiple online resources, and 39 (25%) only through the Belong.life app. Only 23 participants (8%) previously participated in a CT. The most common reason for not participating was not being offered this treatment option (55, 49%) followed by lack of suitable trials for their condition (26, 23%). The most common reason for considering it was to receive an innovative treatment (60, 44%). Conclusions: Almost half of the pts and caregivers were not aware of CT participation as a valid treatment option. Among them, nearly all have expressed an interest to be better informed. This significant dissonance was also evident among those aware but who were not offered to participate, while expressing a favorable perception regarding participation. While the medical staff is a key source for CT awareness, and whilst patients are exposed to multiple online sources of information, this survey confirmed that 25% of Belong.life members received information about CT availability and participation singly from the app and 8% of them actively participated in a clinical trial. In sum, emphasis should be placed on providing personally tailored CT information to all cancer patients and caregivers. Digital health platforms are an important source for patients CT awareness.

Download Full-text

On the possibilities of digitalization of the design of specialized food products

10.33920/igt-01-2108-08 ◽

2021 ◽

pp. 599-602

Author(s):

V.P. Karagodin

Keyword(s):

Clinical Trials ◽

Food Products ◽

Foreseeable Future ◽

Russian Market ◽

New Approaches ◽

Current State ◽

Individual Consumption

The main problem of the Russian market of specialized food products (SFP) is the lack of reliably confirmed data on their efficacy. Most likely, due to the duration and high cost of clinical trials, this situation will continue in the foreseeable future. However, it seems that the current state of science makes it possible to propose new approaches to confirming the SFP effectiveness, including at the level of individual consumption.

Download Full-text

Cell technologies in the treatment of hip osteoarthritis

MedAlliance ◽

10.36422/23076348-2021-9-2-29-33 ◽

2021 ◽

Vol 9 (2) ◽

pp. 29-33

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Hip Osteoarthritis ◽

Current State ◽

International Registry ◽

Cell Technologies ◽

The Subject ◽

Common Clinical Practice ◽

Clinical Experiment

SummaryThe article is dedicated to the current state and prospects of cell technologies in the treatment of hip osteoarthritis. The material is based on the analysis of clinical trials on this topic submitted to international registry СlinicalTrials.gov. It has been founded 5 clinical trials relevant to the theme. Only one of these trials was completed with the results pub-lished. It has been stated that the use of cell technologies for the treatment of hip osteoarthritis is still in the stage of a pilot clinical experiment. Thus, it can not yet be the subject of any translation into common clinical practice. At the same time, there is a reason to expect in the upcoming years a serious progress in this direction. This is indicated by the fact that, as of March 1, 2020, the СlinicalTrials.govregistry lists 4 active clinical trials in which the usage of cell technologies in the treatment of hip osteoarthritis is tested. Some of these trials have been already recruiting patients or are ready to begin the recruitment.

Download Full-text