Is ClinicalTrials.gov a database?
The law also requires the submission of results for certain trials. This led to the development of the ClinicalTrials.gov results database, which contains summary information on study participants and study outcomes, including adverse events.
ClinicalTrials.gov is a registry and results database of publicly and privately supported research studies conducted in the United States and around the world. Sponsors or investigators of certain clinical trials are required by U.S. law to register their trials on and submit summary results to ClinicalTrials.gov.
Find Studies With Results Posted on ClinicalTrials.gov
To search for studies with results posted on ClinicalTrials.gov, go to Advanced Search and select Studies With Results from the Study Results field dropdown list. You can also enter additional search terms in the other fields.
The WHO also has requirements for publishing clinical trial data: results must be published open access within 12 months in a peer-reviewed journal or made publicly available within 24 months, and they must be posted on a clinical trial registry within 12 months.
ClinicalTrials.gov is a US government web-based resource maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH) where clinical studies can be registered, information updated, and if required, results and documents posted.
for most clinical trials, retaining research data for 15 years or more may be necessary • for areas such as gene therapy, research data must be retained permanently (e.g. data in the form of patient records) • if the work has community, cultural or historical value, research data should be kept permanently, preferably ...
According to a special report published in the journal Radiology, clinical data should be treated as a public good when it is used for secondary purposes, such as research or the development of AI algorithms.
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.
"Researchers have a duty to make publicly available the results of their research on human subjects... Negative and inconclusive as well as positive results should be published or otherwise made publicly available" (para.
ClinicalTrials.gov is a registry and results database of privately and publicly funded clinical studies conducted around the world. The resource is provided by the U.S. National Library of Medicine. Each study record includes a summary of the study protocol.
Who owns clinical trial data?
At the present time, clinical trial data reside with the sponsor of the trial, which is usually a company or an academic institution. A great deal has been written about the failure of the clinical trial system as it currently operates (2–4).
Around the Nation and Worldwide
To search for other diseases and conditions, you can visit ClinicalTrials.gov. This is a searchable registry and results database of federally and privately supported clinical trials conducted in the United States and around the world.
Although there have been rare cases of patient deaths involving clinical trials, experts say the vast majority of clinical trials have impeccable safety records. In clinical trials, statisticians periodically review data on cure rates and side effects.
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 ...
Peer review is a process by which a study is checked by experts in the discipline to assess the study's scientific validity. This process involves the researcher writing up their study methods and results, and sending this to a journal. The manuscript is then usually sent to two to three experts for peer review.
ClinicalTrials.gov allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to: Any applicable human subject or ethics review regulations (or equivalent) Any applicable regulations of the national or regional health authority (or equivalent)
- The trial has one or more sites in the United States.
- The trial is conducted under an FDA investigational new drug application or investigational device exemption.
Enter a word or phrase into one or more of the search fields: Use Condition or disease for terms such as asthma or breast cancer. This tells the search function to find all studies with the disease, disorder, syndrome, illness, or injury that was entered. You can choose one of the suggested terms or type in your own.
Generally, requestors must submit a research proposal for review before being granted access to data. All sponsors have limitations on data release that are generally enforced by requiring requestors to sign a Data Use Agreement (DUA) prior to data access.