Progress Towards a Modernized ClinicalTrials.gov – NLM Musings from the Mezzanine

“In 2019, NLM introduced a multi-year effort to modernize ClinicalTrials.gov, the world’s largest publicly accessible database of privately and publicly funded clinical trials. This effort was launched with a commitment to engage with and serve the millions of users who rely on this essential resource — with a focus on delivering an improved user experience on an updated platform that will accommodate growth and enhance efficiency.

In keeping with that promise, NLM has embarked on several stakeholder activities as part of the roadmap for modernization that we want to highlight in this post. We will also continue to share opportunities for involvement and invite you to join us for an upcoming webinar on February 18, 2021 at 3 pm ET to learn more about our modernization efforts….”

Evaluation of Data Sharing After Implementation of the International Committee of Medical Journal Editors Data Sharing Statement Requirement | Medical Journals and Publishing | JAMA Network Open | JAMA Network

“Question  What are the rates of declared and actual sharing of clinical trial data after the medical journals’ implementation of the International Committee of Medical Journal Editors data sharing statement requirement?

Findings  In this cross-sectional study of 487 clinical trials published in JAMA, Lancet, and New England Journal of Medicine, 334 articles (68.6%) declared data sharing. Only 2 (0.6%) individual-participant data sets were actually deidentified and publicly available on a journal website, and among the 89 articles declaring that individual-participant data would be stored in secure repositories, data from only 17 articles were found in the respective repositories as of April 10, 2020.

Meaning  These findings suggest that there is a wide gap between declared and actual sharing of clinical trial data.”

Open Science to Address COVID-19: Sharing Data to Make Our Research Investment Go Further | SpringerLink

“Over 1000 randomized clinical trials (RCTs) for the treatment and prevention of COVID-19 have been initiated. With access to the data from RCTs, researchers can integrate and summarize findings, evaluate new hypotheses, design future trials, and prioritize the next research questions to be addressed. This ensures that the value from the investment in the RCTs goes beyond the original intent of the trial protocols. None of this is possible without first having easy and responsible systems to allow access to data: the primary tenets of the open science FAIR principles dictate a proactive intent to share results and patient data from clinical trials [Wilkinson]. While much has been written and progress has been made, there is more to be done in this journey to true openness [Rockhold]. Reasons for this include (1) the well-known complexities of data access (patient privacy, content of the trial’s informed consent and the primary data holder’s decision rights as to sharing), (2) concerns about mis-interpretation of data in the context of secondary research (beyond the original intent of the trial), and (3) the use of platform trials where multiple intervention arms are studied relative to a single control arm.

The International COVID-19 Data Alliance (ICODA) is one of the groups initiating concerted data sharing as a powerful mechanism to address COVID-19. We focus our attention to RCTs recognizing that the Alliance will encompass many other data types….”

Transparency in Clinical Trials: adding value to Paediatric Dental Research – Cenci – – International Journal of Paediatric Dentistry – Wiley Online Library

Abstract:  Background

Even though considered as studies with high methodological power, many RCTs in paediatric dentistry do not have essential quality items in their design, development and report, making results’ reliability questionable, replication challenging to conduct, wasting time, money and efforts, and even exposing the participants to research for no benefit.

Aim

We addressed the main topics related to transparency in clinical research, with an emphasis in paediatric dentistry.

Design

We searched for all controlled clinical trials published from January 2019 up to July 2020 in the three paediatric dentistry journals with high journal Impact Factor, indexed on Medline. These papers were assessed for transparency according to Open Science practices and regarding reporting accuracy using some items required by CONSORT.

Results

53.6% of the studies declared registration, 75% had sample size calculation, 98.2% reported randomisation, and from those, 65.4% explained the randomisation method. Besides that, no study shared their data, and 6.8% were published in open access format.

Conclusions

Unfortunately, a large proportion of RCTs in paediatric dental research show a lack of transparency and reproducibility.

Data could hold the key to stopping Alzheimer’s | Bill Gates

“Unfortunately, this siloed approach to research data hasn’t yielded great results. We have only made incremental progress in therapeutics since the late 1990s. There’s a lot that we still don’t know about Alzheimer’s, including what part of the brain breaks down first and how or when you should intervene. But I’m hopeful that will change soon thanks in part to the Alzheimer’s Disease Data Initiative, or ADDI….

I worked with a coalition of partners to create ADDI, because we believe that more data sharing will accelerate progress towards an Alzheimer’s breakthrough. To make this happen, ADDI created the Alzheimer’s Disease workbench.

 

This workbench hosts an open, global, and easy-to-use set of tools and resources. The goal is to simplify how researchers and data scientists around the world work together and share data, code, and knowledge in order to make advances in the field…..”

Ten principles for data sharing and commercialization | Journal of the American Medical Informatics Association | Oxford Academic

Abstract:  Digital medical records have enabled us to employ clinical data in many new and innovative ways. However, these advances have brought with them a complex set of demands for healthcare institutions regarding data sharing with topics such as data ownership, the loss of privacy, and the protection of the intellectual property. The lack of clear guidance from government entities often creates conflicting messages about data policy, leaving institutions to develop guidelines themselves. Through discussions with multiple stakeholders at various institutions, we have generated a set of guidelines with 10 key principles to guide the responsible and appropriate use and sharing of clinical data for the purposes of care and discovery. Industry, universities, and healthcare institutions can build upon these guidelines toward creating a responsible, ethical, and practical response to data sharing.

 

Why is uploading clinical trial results onto trial registries so important?

“Some university researchers still believe that if their clinical trial publishes its outcomes in a peer-reviewed journal, they do not also have to upload its summary results onto trial registries.

 

That is wrong. Here are the facts:

 

Both EU regulations and US law require the results of many (though not all) clinical trial results to be uploaded onto trial registries within 12 months of trial completion.

Best practices set out by the World Health Organization (WHO) require the results of all clinical trials to be uploaded onto a trial registry within that timeframe.

Posting results onto registries accelerates medical progress because the 12-month timeline permits far more rapid results sharing than the slow academic publication process allows.

Posting results onto registries minimises the risk of a trial never reporting its results and becoming research waste, which can happen when a principal investigator dies or leaves their post during the prolonged process of submitting an academic paper to a succession of medical journals.

Results posted on registries are easier to locate and are open access.

Research shows that trial results posted on registries typically give a more comprehensive and accurate picture of patient-relevant trial outcomes than corresponding journal articles do.

Registry reporting facilitates comparison of trial outcomes with a trial’s originally stated aims, and thus discourages harmful research malpractices such as the ‘silent’ suppression, addition, or switching of selected outcomes, HARKing, and p-hacking.

Results on trial registries enable the more rapid and reliable identification of potential safety risks posed by medicines already on the market. …”

Why is uploading clinical trial results onto trial registries so important?

“Some university researchers still believe that if their clinical trial publishes its outcomes in a peer-reviewed journal, they do not also have to upload its summary results onto trial registries.

 

That is wrong. Here are the facts:

 

Both EU regulations and US law require the results of many (though not all) clinical trial results to be uploaded onto trial registries within 12 months of trial completion.

Best practices set out by the World Health Organization (WHO) require the results of all clinical trials to be uploaded onto a trial registry within that timeframe.

Posting results onto registries accelerates medical progress because the 12-month timeline permits far more rapid results sharing than the slow academic publication process allows.

Posting results onto registries minimises the risk of a trial never reporting its results and becoming research waste, which can happen when a principal investigator dies or leaves their post during the prolonged process of submitting an academic paper to a succession of medical journals.

Results posted on registries are easier to locate and are open access.

Research shows that trial results posted on registries typically give a more comprehensive and accurate picture of patient-relevant trial outcomes than corresponding journal articles do.

Registry reporting facilitates comparison of trial outcomes with a trial’s originally stated aims, and thus discourages harmful research malpractices such as the ‘silent’ suppression, addition, or switching of selected outcomes, HARKing, and p-hacking.

Results on trial registries enable the more rapid and reliable identification of potential safety risks posed by medicines already on the market. …”