Data from the Indian drug regulator and from Clinical Trials Registry-India does not always match

IntroductionIn India, regulatory trials, which require the drug regulator’s permission, must be registered with the Clinical Trials Registry-India (CTRI) as of 19 March 2019. In this study, for about 300 trials, we aimed to identify the CTRI record that matched the trial for which the regulator had given permission. After identifying ‘true pairs’, our goal was to determine whether the sites and Principal Investigators mentioned in the permission letter were the same as those mentioned in the CTRI record.MethodsWe developed a methodology to compare the regulator’s permission letters with CTRI records. We manually validated 151 true pairs by comparing the titles, the drug interventions, and the indications. We then examined discrepancies in their trial sites and Principal Investigators.ResultsOur findings revealed substantial variations in the number and identity of sites and Principal Investigators between the permission letters and the CTRI records.DiscussionThese discrepancies raise concerns about the accuracy and transparency of regulatory trials in India. We recommend easier data extraction from regulatory documents, cross-referencing regulatory documents and CTRI records, making public the changes to approval letters, and enforcing oversight by Institutional Ethics Committees for site additions or deletions. These steps will increase transparency around regulatory trials running in India

Improving cold chain technologies through the use of phase change material

Gemstone Team FRESHVaccine-preventable diseases are responsible for about 25% of the 10 million deaths occurring annually for children under five years of age. The World Health Organization's Expanded Programmes on Immunization succeed in providing standardized guidelines for vaccine storage and distribution, but often fail to accommodate the unique infrastructure between and within countries. In order to better regulate the temperature of vaccines as they travel through countries, we have selected and characterized an appropriate phase change material (PCM) that will resist temperature fluctuations outside of a range of 2-8 °C, based on appropriate thermophysical properties. Additionally, we have integrated the selected PCM within a geometrically and thermally optimized cold box, maintaining long-term stabilization of temperatures within a range of 2-8 °C. In meeting these objectives, we have demonstrated the feasibility of a technological solution that may be readily implemented in the existing vaccine distribution supply chain, or that holds potential to be the centerpiece for new, more efficient vaccine distribution strategies

Zero-Shot Multi-View Indoor Localization via Graph Location Networks

Indoor localization is a fundamental problem in location-based applications. Current approaches to this problem typically rely on Radio Frequency technology, which requires not only supporting infrastructures but human efforts to measure and calibrate the signal. Moreover, data collection for all locations is indispensable in existing methods, which in turn hinders their large-scale deployment. In this paper, we propose a novel neural network based architecture Graph Location Networks (GLN) to perform infrastructure-free, multi-view image based indoor localization. GLN makes location predictions based on robust location representations extracted from images through message-passing networks. Furthermore, we introduce a novel zero-shot indoor localization setting and tackle it by extending the proposed GLN to a dedicated zero-shot version, which exploits a novel mechanism Map2Vec to train location-aware embeddings and make predictions on novel unseen locations. Our extensive experiments show that the proposed approach outperforms state-of-the-art methods in the standard setting, and achieves promising accuracy even in the zero-shot setting where data for half of the locations are not available. The source code and datasets are publicly available at https://github.com/coldmanck/zero-shot-indoor-localization-release.Comment: Accepted at ACM MM 2020. 10 pages, 7 figures. Code and datasets available at https://github.com/coldmanck/zero-shot-indoor-localization-releas

Knowledge and awareness of informed consent among orthodontists and patients: A pilot study

Aim: Despite fixed professional opinion of what might constitute optimal treatment, patients must be informed of the various treatment options available in orthodontics to manage their clinical problem. The purpose of this study was to compare and evaluate the knowledge and awareness among practicing orthodontists and patients with regard to informed consent in clinical practice and research. Materials and Methods: Twenty-five orthodontists and 25 patients were enrolled in a questionnaire study which was descriptive and cross-sectional in the nature. The questionnaire focused on the following aspects; contents of informed consent, at what age and who can give consent. Results: The study showed a majority of orthodontists (79.14%) were aware of knowledge regarding informed consent when compared to patients(35.14%). Conclusion: The overall result showed the huge gap that exists between orthodontists and patients and thus making it categorical for patients to be more involved in the decision-making process

Representation from India in multinational, interventional, phase 2 or 3 trials registered in Clinical Trials Registry-India: A cross-sectional study.

In multinational trials that have run in India, we wished to determine whether there was too much (60% or higher) recruitment from India. We downloaded all trial records from Clinical Trials Registry-India, CTRI, and stored them in a local SQLite database. We queried records registered in a recent 8-year period, ie 2013-2020 and evaluated the fraction of local participants in interventional Phase 2 or Phase 3 studies. 62 trials were completed, with completion dates available. Five trials (8%) had 60% or more planned recruitment from India. Four of the five (7% of 62) had a foreign sponsor, and therefore there was an unfair burden-benefit ratio on the Indian population. Seven trials (11%), of which six (10% of 62) had foreign sponsors, had 60% or more (of the total) actual recruitment from India, and for two trials (both with foreign sponsors), the data were meaningless. There were 362 studies that were listed as not completed, although, given their start date and estimated duration, some of them ought to have been. Twenty five cases (7% of 362) had 60% or more planned recruitment from India. Of these, 18 (5% of 362) had foreign sponsors and were potentially problematic. Even allowing for some delays in completion, 128 (35% of 362) studies ought to have been completed by the time of our study. As such, we identified several problematic trials for which the planned recruitment from India in multinational studies was 60% or more. We also identified trials in which the actual recruitment was significantly higher than the planned recruitment. Further, the records of several studies that were probably completed were not updated in CTRI in a timely manner. The Indian drug regulator needs to be particularly alert to the planned, or actual, over-recruitment of participants from India. Further, CTRI, alone or in collaboration with the regulator, needs to ensure that multinational trial records for the enrollment fields in particular are updated, in a timely manner