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.

A Review of Prolonged Post-COVID-19 Symptoms and Their Implications on Dental Management.

The available data regarding the short and long-term consequences of COVID-19 is still insufficient. This narrative review aims to provide information on the prolonged COVID-19 symptoms in recovered patients and their implications during dental management. Additionally, this manuscript highlights the oral manifestations of COVID-19 and its management. A systematic search was conducted in PubMed, Embase, Cochrane Library and Web of Science databases, WHO and CDC websites, and grey literature was searched through Google Scholar. Clinical articles (clinical trials, case-reports, cohort, and cross-sectional studies) were included, reporting prolonged post-COVID-19 symptoms. Although COVID-19 is an infectious disease primarily affecting the lungs, its multi-organ involvement is responsible for several prolonged symptoms, including oral implications. In recovered patients with prolonged COVID-19 symptoms, considerations for providing dental treatment has to be made as they can present with assortment of symptoms. These prolonged post-COVID-19 symptoms can affect the delivery of the required dental treatment. Hence, the recommendations proposed in this narrative review can be a useful starting point to aid dental teams providing adequate care for such recovered patients.

Psychological Distress during COVID-19 Lockdown among Dental Students and Practitioners in India: A Cross-Sectional Survey.

OBJECTIVE: In response to the coronavirus disease 2019 (COVID-19) pandemic, the Indian Government imposed a countrywide lockdown of 21 days from March 25 to April 14, 2020, which was further extended to 60 days. The sudden draconian measures changed the delivery of dental education and practice throughout the country. The study aimed to screen for depression during the COVID-19 lockdown and the factors associated with it among dental students and practitioners in highly COVID-19 infected states of India. MATERIALS AND METHODS: The current study is an online cross-sectional survey performed in Delhi NCR, Maharashtra, and Tamil Nadu during May 2020. The participants were recruited by convenience sampling. The main outcome measure was the screening of depression using the Patient Health Questionnaire (PHQ-9), which was categorized as mild, moderate, and severe depression. The data analysis was performed with IBM SPSS Version 23.0. A multivariable logistic regression model was fitted to identify the independent predictors of depression. RESULTS: In total, 335 dental students and practitioners participated in the survey. Among this, a significant number of the dental students (54%) and practitioners (44%) scored moderate to severe depression in terms of depression severity according to the PHQ-9 scores. Those who were screened depressed were likely to be males and younger than 30 years old. The results of correlation analysis indicated that worry about the professional growth, concerns regarding setbacks in clinical and research experiences, previous history of mental health issues, and fear of contracting COVID-19 from patients were positively related to higher depression scores in students. Moreover, for practitioners, fear of contracting COVID-19 from the patients scored higher levels of depression. The practitioners who reported less concern about their practice/job post COVID-19 lockdown and those who were able to meet their financial expenses during the lockdown were the least likely to be depressed. CONCLUSION: The results of this study indicate a high level of depression among a significant number of dental students and practitioners. It is important to monitor and address the mental health needs of dental students and practitioners during and after the lockdown.