Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review.

BACKGROUND: Although well recognized for its scientific value, data sharing from clinical trials remains limited. Steps toward harmonization and standardization are increasing in various pockets of the global scientific community. This issue has gained salience during the COVID-19 pandemic. Even for agencies willing to share data, data exclusivity practices complicate matters; strict regulations by funders affect this even further. Finally, many low- and middle-income countries (LMICs) have weaker institutional mechanisms. This complex of factors hampers research and rapid response during public health emergencies. This drew our attention to the need for a review of the regulatory landscape governing clinical trial data sharing. OBJECTIVE: This review seeks to identify regulatory frameworks and policies that govern clinical trial data sharing and explore key elements of data-sharing mechanisms as outlined in existing regulatory documents. Following from, and based on, this empirical analysis of gaps in existing policy frameworks, we aimed to suggest focal areas for policy interventions on a systematic basis to facilitate clinical trial data sharing. METHODS: We followed the JBI scoping review approach. Our review covered electronic databases and relevant gray literature through a targeted web search. We included records (all publication types, except for conference abstracts) available in English that describe clinical trial data-sharing policies, guidelines, or standard operating procedures. Data extraction was performed independently by 2 authors, and findings were summarized using a narrative synthesis approach. RESULTS: We identified 4 articles and 13 policy documents; none originated from LMICs. Most (11/17, 65%) of the clinical trial agencies mandated a data-sharing agreement; 47% (8/17) of these policies required informed consent by trial participants; and 71% (12/17) outlined requirements for a data-sharing proposal review committee. Data-sharing policies have, a priori, milestone-based timelines when clinical trial data can be shared. We classify clinical trial agencies as following either controlled- or open-access data-sharing models. Incentives to promote data sharing and distinctions between mandated requirements and supportive requirements for informed consent during the data-sharing process remain gray areas, needing explication. To augment participant privacy and confidentiality, a neutral institutional mechanism to oversee dissemination of information from the appropriate data sets and more policy interventions led by LMICs to facilitate data sharing are strongly recommended. CONCLUSIONS: Our review outlines the immediate need for developing a pragmatic data-sharing mechanism that aims to improve research and innovations as well as facilitate cross-border collaborations. Although a one-policy-fits-all approach would not account for regional and subnational legislation, we suggest that a focus on key elements of data-sharing mechanisms can be used to inform the development of flexible yet comprehensive data-sharing policies so that institutional mechanisms rather than disparate efforts guide data generation, which is the foundation of all scientific endeavor.

Challenges and prospects in india's digital health journey.

India's journey in the digital health arena and its contribution to the landmark resolution on digital health by the World Health Organization has been recognized globally. India has demonstrated its commitment to leverage digital health as a health system strengthening intervention, as outlined in the National Digital Health Blueprint based on which, the National Digital Health Mission (NDHM) is currently being piloted by the National health authority. Further, the Sandbox environment of NDHM is actively encouraging all the ecosystem partners to familiarize with the evolving national digital health infrastructure. The strategy to enhance the India's progress in implementation and scale-up of digital health interventions are drawing attention to workforce capacity building, harnessing health data to facilitate research and development, evidence-informed development of policies, sustaining efficiency and quality of system through appropriate monitoring, and periodic evaluation informed by frameworks specific to digital health or those adapted to evaluate health informatics applications.

The global experience of digital health interventions in COVID-19 management.

Digital health interventions are globally playing a significant role to combat coronavirus disease 2019 (COVID-19), which is an infectious disease caused by Severe Acute Respiratory Syndrome coronavirus 2. Here, we present a very brief overview of the multifaceted digital interventions, globally, and in India, for maintaining health and health-care delivery, in the context of the Covid-19 pandemic.

Challenges in delivering primary care via telemedicine during COVID-19 pandemic in India: A review synthesis using systems approach.

Background: Countries, including India, were quick to adopt telemedicine for delivering primary care in response to the widespread disruptions due to the coronavirus disease 2019 (COVID-19) pandemic. This expeditious adoption was critical and the challenges faced during this exigency could guide the design and delivery of future telemedicine applications toward strengthening primary healthcare services. Methods: To identify the challenges in delivering primary care via telemedicine technology in the Indian context, a scoping review was conducted. Drawing from the systems approach in healthcare delivery, the review findings are summarized at four levels, patient, provider, healthcare organizations, and policy. Results: The initial search yielded 247 articles and 13 met our inclusion criteria. This review highlighted that telemedicine facilitated the continuity of care during COVID-19 but not without challenges. Low levels of education and computer literacy along with the language barriers posed the predominant challenges at the patient level. Providers had concerns related to digital literacy, clinical process flows, legal liabilities, and unethical behavior of the patients. The policy-level challenges include data privacy and security, reimbursement models, unethical behavior by the patient, or provider, and regulating prescriptions of psychotropic drugs. A lack of an integrated telehealthcare model covering diagnostics, prescriptions, and medication supply mirrored the existing fragmentation of care delivery. Conclusion: Telemedicine has the potential to improve primary healthcare delivery even beyond COVID-19. Currently, telemedicine applications in India are only facilitating a remote consultation wherein an integrated person-centered care is lacking. There is a need to acknowledge and factor in the inter-connectedness of health system elements for ensuring an effective and efficient healthcare delivery via telemedicine.

Implementation and Experiences of Telehealth: Balancing Policies With Practice in Countries of South Asia, Kuwait, and the European Union.

This viewpoint summarizes the discussion that occurred during the "Translating Policy to Practice in Telehealth-Lessons from Global Implementation Experiences" panel that was held virtually at Telemedicon2020, December 18-20, 2020. This panel brought together policy and implementation experts from some countries of South Asia, Kuwait, and the European Union to share their experiences in the development and implementation of telehealth standards and of the scale up of telehealth interventions within health systems. Several common themes arose from the discussion, including the significant role of people; encouragement by respective government policymakers; addressing concerns, particularly related to privacy, confidentiality, and security; and capacity building of human resources. These are discussed in turn, along with the future directions identified by the panelists, which emphasized the need for active encouragement toward the adoption and diffusion of digital health in general and of telehealth in particular. All stakeholders, ranging from governmental policymakers to common citizens, need to come together to build trusting partnerships to realize the advantages offered by telehealth.

Basic medical science education must include medical informatics.

Medical Informatics is the science and art of processing medical information. In this age of "Information Explosion" choosing the useful one is rather difficult, and there lies the scope of electronic database management. However, still many outstanding personnel related to the healthcare sector take pride in being "computer illiterate". The onus of the best use lies on the end-user health care providers only. Another term tele-health encompasses all the e-health and telemedicine services. Computer aided or assisted learning (CAL) is a computer based tutorial method that uses the computer to pose questions, provide remedial information and chart a student through a course. Now the emphasis in medical education, is on problem based learning (PBL) and there CAL could be of utmost help if used judiciously. Basic Medical Education and Research lays the foundation for advancing and applying proper healthcare delivery systems. There is no doubt that deep knowledge of anatomy is mandatory for successful surgery. Also, comprehensive knowledge of physiology is essential for grasping the principles of pathology and pharmacology adequately, to avoid incorrect and inadequate practice of medicine. Similarly, medical informatics is not just a subject to be learnt and forgotten after the first professional MBBS examination. The final aim of every student should not only be to become a good user but also an expert for advancing medical knowledge base through medical informatics. In view of the fast changing world of medical informatics, it is of utmost necessity to formulate a flexible syllabus rather than a rigid one.

Public and health professionals' misconceptions about the dynamics of body weight gain/loss.

Human body energy storage operates as a stock-and-flow system with inflow (food intake) and outflow (energy expenditure). In spite of the ubiquity of stock-and-flow structures, evidence suggests that human beings fail to understand stock accumulation and rates of change, a difficulty called the stock-flow failure. This study examines the influence of health care training and cultural background in overcoming stock-flow failure. A standardized protocol assessed lay people's and health care professionals' ability to apply stock-and-flow reasoning to infer the dynamics of weight gain/loss during the holiday season (621 subjects from seven countries). Our results indicate that both types of subjects exhibited systematic errors indicative of use of erroneous heuristics. Stock-flow failure was found across cultures and was not improved by professional health training. The problem of stock-flow failure as a transcultural global issue with education and policy implications is discussed.

A farce called the National Board of Examinations.

The National Board of Examinations is a body formed to enhance the standards of post graduate examinations in modern medicine in India. Unfortunately, the outdated mode of examinations and the arbitrarily set high cut-off marks for passing the examinations defeat the very purpose of its formation and functioning.

The state of medical informatics in India: a roadmap for optimal organization.

In India, the healthcare delivery systems are based on manual record keeping despite a good telecommunication infrastructure. Unfortunately, Indian policy makers are yet to realize the importance of medical informatics (including tele-health, which comprises e-Health and Telemedicine) in delivering healthcare. In the medical curriculum also, nowhere is this treated as a subject or even as a tool for learning. The final aim of most of the medical and paramedical students should be to become good users, and if possible, also experts for advancing medical knowledge base through medical informatics. In view of the fast changing world of medical informatics, it is essential to formulate a flexible syllabus rather than a rigid one for incorporating into the regular curriculum of medical and paramedical education. Only after that one may expect all members of the healthcare delivery systems to adopt and apply medical informatics optimally as a routine tool for their services.