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. …”

DECLARATION TO IMPROVE BIOMEDICAL & HEALTH RESEARCH

“We are an international group of researchers and patients who believe that:

it is ethically untenable to remain complicit in the crises that undermine science,

there are simple measures which can improve the quality and openness, and

the public and patients have a right to full access of the research they fund….”

Transparency too little, too late? Why and how Health Canada should make clinical data and regulatory decision-making open to scrutiny in the face of COVID-19

Abstract:  Canada has become a global leader in publicly releasing clinical data behind therapeutic products since 2019. Disclosure of clinical data is, however, limited to the point of product approval. The COVID-19 pandemic has underscored the limitations of such a point-in-time approach to transparency. As interventions are rapidly authorized for clinical trials or clinical use through emergency mechanisms despite weak evidence of safety and effectiveness, we argue that the current level of transparency must be expanded in order to mitigate potential harms to trial participants and patients, improve the reliability of clinical trials, and ultimately preserve trust in regulatory decision-making. Using existing legal powers, we explain how the Canadian regulator can and should seek to expand data transparency by making pre-clinical studies, clinical trial protocols, informed consent forms, interim analyses, and other information transparent upstream in the research process and throughout the product’s lifecycle.

Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop | The National Academies Press

“On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, titled Sharing Clinical Trial Data: Challenges and a Way Forward. The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, and was designed to examine the current state of clinical trial data sharing and reuse and to consider ways in which policy, technology, incentives, and governance could be leveraged to further encourage and enhance data sharing. This publication summarizes the presentations and discussions from the workshop.”

Clinical trial registry searches are under-utilized in systematic reviews from critical care journals: A bibliometric analysis – ScienceDirect

“Highlights

 

• Performing clinical trial registry searches for grey literature can decrease publication bias imputed into systematic reviews.
• 88.7% of critical care systematic reviews did not conduct clinical trial registry searches.
• 56% of systematic reviews that did not perform a trial registry search had at least 1 potentially relevant trial that was not included in their analysis….”

 

Characteristics of academic publications, preprints, and registered clinical trials on the COVID-19 pandemic

Abstract:  The COVID-19 pandemic has unleashed a deluge of publications. For this cross-sectional study we compared the amount and reporting characteristics of COVID-19-related academic articles and preprints and the number of ongoing clinical trials and systematic reviews. To do this, we searched the PubMed database of citations and abstracts for published life science journals by using appropriate combinations of medical subject headings (MeSH terms), and the COVID-19 section of the MedRxiv and BioRxiv archives up to 20 May 2020 (21 weeks). In addition, we searched Clinicaltrial.gov, Chinese Clinical Trial Registry, EU Clinical Trials Register, and 15 other trial registers, as well as PROSPERO, the international prospective register of systematic reviews. The characteristics of each publication were extracted. Regression analyses and Z tests were used to detect publication trends and their relative proportions. A total of 3635 academic publications and 3805 preprints were retrieved. Only 8.6% (n = 329) of the preprints were already published in indexed journals. The number of academic and preprint publications increased significantly over time (p<0.001). Case reports (6% academic vs 0.9% preprints; p<0.001) and letters (17.4% academic vs 0.5% preprints; p<0.001) accounted for a greater share of academic compared to preprint publications. Differently, randomized controlled trials (0.22% vs 0.63%; p<0.001) and systematic reviews (0.08% vs 5%) made up a greater share of the preprints. The relative proportion of clinical studies registered at Clinicaltrials.gov, Chinese Clinical Trial Registry, and EU Clinical Trials Register was 57.9%, 49.5%, and 98.9%, respectively, most of which were still “recruiting”. PROSPERO listed 962 systematic review protocols. Preprints were slightly more prevalent than academic articles but both were increasing in number. The void left by the lack of primary studies was filled by an outpour of immediate opinions (i.e., letters to the editor) published in PubMed-indexed journals. Summarizing, preprints have gained traction as a publishing response to the demand for prompt access to empirical, albeit not peer-reviewed, findings during the present pandemic.