Sage-Tips

Do clinical trial results have to be published?

Publication of Clinical Trial Results Where the main findings are also to be submitted for publication in a journal, this should be done within 12 months of study completion, to be published through an open-access mechanism in a peer-reviewed journal.

Should all clinical trials be published?

Negative and inconclusive as well as positive results must be published or otherwise made publicly available”. There is an ethical imperative to report the results of all clinical trials, including those of unreported trials conducted in the past.

Why clinical trials are not published?

It’s unclear why researchers don’t publish, although a 2014 paper in PLOS One found that the most common excuse scientists gave was a “lack of time or low priority.” The “file drawer problem” — “Oh, those results aren’t interesting enough for a prestigious journal that can help our careers” — is a real one.

How do you publish a research result?

Start with the results of the most important question, then the second most important, and so on. Or organize the section chronologically. Use subheadings to denote each question or section. There should be no interpretation of findings in results.

What is excluded research?

Examples of excluded research include: “collection and analysis of data, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes;” “quality assurance or improvement activities involving the implementation …

Where do clinical trials get published?

The results of clinical trials are usually published in specialist medical journals and online libraries of evidence. Some of the most well-known examples are: The Lancet medical journal. British Medical Journal (BMJ)

WHO publishes clinical research results?

Study results are often published in medical journals. On ClinicalTrials.gov, publication citations are displayed at the bottom of the Study Details tab of the study record, under the More Information heading.

Who owns clinical research data?

study sponsor
For most clinical research studies, data are legally owned by the study sponsor (the organisation(s) that paid for the study to be conducted), which is usually a medicines company or an academic institution like a teaching hospital or school of medicine.

How do you report clinical trials?

How to Report Clinical Trial Results

1. Step 1: Review the Requirements for Reporting Results. Review the Results Data Elements Definitions to understand what information is required.
2. Step 2: Complete the Results Modules.
3. Step 3: Upload Supplemental Documentation.
4. Step 4: Release the Record.
5. Step 5: Address PRS Review Comments.

Why is it important to publish the results of research findings?

Publishing results of research projects in peer-reviewed journals enables the scientific and medical community to evaluate the findings themselves. It also provides instructions so that other researchers can repeat the experiment or build on it to verify and confirm the results.

What published research?

In academic publishing, a paper is an academic work that is usually published in an academic journal. It contains original research results or reviews existing results. A paper may undergo a series of reviews, revisions, and re-submissions before finally being accepted or rejected for publication.

How long do you have to submit clinical trial results?

The ClinicalTrials.gov results database was launched in September 2008 to implement Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (PDF), which requires the submission of “basic results” for certain clinical trials, generally no later than 1 year after their Completion Date (see Primary Completion Date on

When did sponsors start submitting results to ClinicalTrials?

In September 2008, as required by FDAAA 801, ClinicalTrials.gov began allowing sponsors and principal investigators to submit the results of clinical studies. The submission of adverse event information was optional when the results database was released but was required beginning in September 2009.

What is the results database for clinical trials?

What Is the Results Database? The ClinicalTrials.gov results database was launched in September 2008 to implement Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (PDF), which requires the submission of “basic results” for certain clinical trials, generally no later than 1 year after their Completion Date

When did clinical trials become required to be registered?

The first U.S. Federal law to require trial registration was the Food and Drug Administration Modernization Act of 1997 (FDAMA) (PDF). Section 113 of FDAMA (FDAMA 113) required the National Institutes of Health (NIH) to create a public information resource on certain clinical trials regulated by the Food and Drug Administration (FDA).