Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India

The current public health crisis has highlighted the need to accelerate healthcare innovation. Despite unwavering levels of cooperation among academia, industry, and policy makers, it can still take years to bring a life-saving product to market. There are some obvious limitations, including lack of blinding or masking and small sample size, which render the results less applicable to the real world. Traditional randomized controlled trials (RCTs) are lengthy, expensive, and have a low success rate. There is a growing acknowledgement that the current process no longer fully meets the growing healthcare needs. Advances in technology coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for a new paradigm. Virtual randomized controlled trials (vRCTs) have the potential to drastically shorten the clinical trial cycle while maximizing patient-centricity, compliance, and recruitment. This new approach can inform clinical trials in real time and with a holistic view of a patient’s health. This paper provides an overview of virtual clinical trials, addressing critical issues, including regulatory compliance, data security, privacy, and ownership.

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Clinical trial registries as Scientometric data: A novel solution for linking and deduplicating clinical trials from multiple registries

Scientometrics ◽

10.1007/s11192-021-04111-w ◽

2021 ◽

Author(s):

Christian Thiele ◽

Gerrit Hirschfeld ◽

Ruth von Brachel

Keyword(s):

Clinical Trials ◽

Random Forest ◽

Random Forest Model ◽

Scientometric Analysis ◽

Data Set ◽

The Public ◽

Forest Model ◽

Clinical Trial Registries ◽

Multiple Primary ◽

Clinical Trials Registry

AbstractRegistries of clinical trials are a potential source for scientometric analysis of medical research and serve important functions for the research community and the public at large. Clinical trials that recruit patients in Germany are usually registered in the German Clinical Trials Register (DRKS) or in international registries such as ClinicalTrials.gov. Furthermore, the International Clinical Trials Registry Platform (ICTRP) aggregates trials from multiple primary registries. We queried the DRKS, ClinicalTrials.gov, and the ICTRP for trials with a recruiting location in Germany. Trials that were registered in multiple registries were linked using the primary and secondary identifiers and a Random Forest model based on various similarity metrics. We identified 35,912 trials that were conducted in Germany. The majority of the trials was registered in multiple databases. 32,106 trials were linked using primary IDs, 26 were linked using a Random Forest model, and 10,537 internal duplicates on ICTRP were identified using the Random Forest model after finding pairs with matching primary or secondary IDs. In cross-validation, the Random Forest increased the F1-score from 96.4% to 97.1% compared to a linkage based solely on secondary IDs on a manually labelled data set. 28% of all trials were registered in the German DRKS. 54% of the trials on ClinicalTrials.gov, 43% of the trials on the DRKS and 56% of the trials on the ICTRP were pre-registered. The ratio of pre-registered studies and the ratio of studies that are registered in the DRKS increased over time.

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Oc021—Clinical Trials Registry And Good Clinical Practice: In Indian Scenario

Clinical Therapeutics ◽

10.1016/j.clinthera.2013.07.020 ◽

2013 ◽

Vol 35 (8) ◽

pp. e9

Author(s):

A. Prakash ◽

B. Medhi ◽

S. Kaur ◽

S. Kumari ◽

P. Sarotra

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Good Clinical Practice ◽

Clinical Trials Registry ◽

Indian Scenario

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Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory

Military Medicine ◽

10.1093/milmed/usab458 ◽

2021 ◽

Author(s):

Joseph Ali ◽

Margaret Antonelli ◽

Lori Bastian ◽

William Becker ◽

Cynthia A Brandt ◽

...

Keyword(s):

Clinical Trials ◽

Pain Management ◽

Pragmatic Trial ◽

Dissemination And Implementation ◽

Large Network ◽

Military Health ◽

Healthcare Needs ◽

Unmet Healthcare Needs ◽

Pragmatic Clinical Trials ◽

The Impact

ABSTRACT Pragmatic clinical trials (PCTs) are well-suited to address unmet healthcare needs, such as those arising from the dual public health crises of chronic pain and opioid misuse, recently exacerbated by the COVID-19 pandemic. These overlapping epidemics have complex, multifactorial etiologies, and PCTs can be used to investigate the effectiveness of integrated therapies that are currently available but underused. Yet individual pragmatic studies can be limited in their reach because of existing structural and cultural barriers to dissemination and implementation. The National Institutes of Health, Department of Defense, and Department of Veterans Affairs formed an interagency research partnership, the Pain Management Collaboratory. The partnership combines pragmatic trial design with collaborative tools and relationship building within a large network to advance the science and impact of nonpharmacological approaches and integrated models of care for the management of pain and common co-occurring conditions. The Pain Management Collaboratory team supports 11 large-scale, multisite PCTs in veteran and military health systems with a focus on team science with the shared aim that the “whole is greater than the sum of the parts.” Herein, we describe this integrated approach and lessons learned, including incentivizing all parties; proactively offering frequent opportunities for problem-solving; engaging stakeholders during all stages of research; and navigating competing research priorities. We also articulate several specific strategies and their practical implications for advancing pain management in active clinical, “real-world,” settings.

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Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)

Quality of Life Research ◽

10.1007/s11136-018-2080-4 ◽

2018 ◽

Vol 28 (4) ◽

pp. 955-962 ◽

Cited By ~ 1

Author(s):

Rebecca Mercieca-Bebber ◽

◽

Douglas Williams ◽

Margaret-Ann Tait ◽

Claudia Rutherford ◽

...

Keyword(s):

Clinical Trials ◽

New Zealand ◽

Clinical Trials Registry

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FDA given new powers over data reporting to national clinical trials registry

BMJ ◽

10.1136/bmj.e6629 ◽

2012 ◽

Vol 345 (oct02 2) ◽

pp. e6629-e6629 ◽

Cited By ~ 1

Author(s):

B. Roehr

Keyword(s):

Clinical Trials ◽

Data Reporting ◽

Clinical Trials Registry

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Creating an NIH Clinical Trials Registry: A User-friendly Approach to Health Care

JAMA ◽

10.1001/jama.1994.03510460021008 ◽

1994 ◽

Vol 271 (22) ◽

pp. 1729 ◽

Cited By ~ 4

Author(s):

William R. Harlan

Keyword(s):

Health Care ◽

Clinical Trials ◽

Clinical Trials Registry ◽

User Friendly

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Attribution of non-ClinicalTrials.gov registries among WHO International Clinical Trials Registry Platform-registered trials from 2014 to 2018: A protocol for a meta-epidemiological study

10.7287/peerj.preprints.27298v1 ◽

2018 ◽

Author(s):

Masahiro Banno ◽

Yasushi Tsujimoto ◽

Yuki Kataoka

Keyword(s):

Clinical Trials ◽

Epidemiological Study ◽

Medical Information ◽

University Hospital ◽

World Health ◽

Study Phase ◽

Target Sample Size ◽

Registration Number ◽

Health Organization ◽

Clinical Trials Registry

Background. The attribution of non-ClinicalTrials.gov registries among registered trials of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) had increased until 2013. However, the attribution after 2013 is unknown. Moreover, no study has investigated the usage of non-ClinicalTrials.gov registries after 2015 or compared the characteristics of trials under non-ClinicalTrials.gov and ClinicalTrials.gov registries. Methods. This will be a meta-epidemiological study. It will include all trials registered on the ICTRP from January 1, 2014, to December 31, 2018. First, we will describe the total attribution of non-ClinicalTrials.gov registries among the ICTRP-registered trials for each year and each registry worldwide. Second, we will compare the recruitment status, target sample size, study type, study design, countries, prospective registration, funding, and study phase of the trials on ClinicalTrials.gov and other registries from 2014 to 2018. Third, we will report on the distribution of primary registries of trials from the top five countries in order of the quantity of registered trials on the ICTRP. Ethics & Dissemination. Ethics approval is not required for this study. This protocol has been registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The findings will be published in a peer-reviewed journal and may be presented at conferences. Trial Registration Number. UMIN000034401

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Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy

International Journal of Stroke ◽

10.1177/1747493018790055 ◽

2018 ◽

Vol 13 (8) ◽

pp. 863-880 ◽

Cited By ~ 1

Author(s):

Erin Godecke ◽

Tapan Rai ◽

Dominique A Cadilhac ◽

Elizabeth Armstrong ◽

Sandy Middleton ◽

...

Keyword(s):

Clinical Trials ◽

Statistical Analysis ◽

Statistical Analysis Plan ◽

Steering Committee ◽

Aphasia Therapy ◽

Detailed Statistical Analysis ◽

Registration Number ◽

Clinical Trials Registry ◽

Potential Trial ◽

Stroke Trial

Background Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care. Objective To publish the detailed statistical analysis plan for the VERSE trial prior to unblinding. This statistical analysis plan was based on the published and registered VERSE trial protocol and was developed by the blinded steering committee and management team, led by the trial statistician. This plan was developed using outcome measures and trial data collection forms. Results The VERSE statistical analysis plan is consistent with reporting standards for clinical trials and provides for clear and open reporting. Conclusions Publication of a statistical analysis plan serves to reduce potential trial reporting bias and outlines transparent pre-specified analyses. Australian New Zealand Clinical Trials Registry (ANZCTR) Registration number: ACTRN12613000776707; Universal Trial Number (UTN) is U1111-1145-4130.

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