debate break down
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all raw data
clinical data: anonymous
the patient comprises the data
should not be considered as not "raw": minimum standard for anonymising (or de-identifying) data for the purposes of publication in a peer reviewed biomedical journal or sharing with other researchers, either directly, where appropriate, or via a third party.
if it is about a lot of money spent to acquire the data, e.g., figure labeling: you have already used it, and the publication is the output. This will even help your paper get more exposure, people who use it will have to cite your stuff
ownership of the data: the institute and the funding agency, researchers don't, and if the funding agency disagree, they could choose not to publish
raw data that is relevant
Dr Prasad pointed to the phrase "underpinning the results and analysis" published, and said that wording obligates researchers only to hand over the data that support the conclusion they found, not the data that could lead to other findings.
wary of the "parasite"
who mis understand the original parameter setting, and grab fro their own interests: who ever based on your research data that want to conduct a meta analysis: if their interest is to conduct good research, when they find they cannot replicate, will go to you, if they do bad research, side effect. But the thing is, ppl who do meta analysis have usually very different interest, and you are not necessary competing
at the time of publishing
would harm your first-ness: timeliness has 90% goes to you: analogy as in private detector or information agency: the agent have their sources, their connections, and information from them are the raw data, if the the PD's interest is to promote the truth, as the case in science in general, he or she needs to provide all evidence that allow them to make the claim. make publish your data does not mean giving away the source. you don't wait 6 month to tell ppl
can easily address potential issues and correction
deidentified individual patient data (IPD) underlying their results no later than 6 months after publication as a condition of their study submission.
IPD databases and protocols takes time to prepare: but this is not impossible
condition for publication
from the journal point of view: yes bc they want their publications to be sound and their journal to have more views and downloads
from the author point of view: yes bc when I publish, either 1) scientific discovery 2) novel invention, in the first case, science is based on evidence, to be recognized and agreed by people, I would welcome more people to look at my stuff, and if novel invention, care about how it works. With the raw data, people who wants to use it can see clearly how it works with zero doubts
clinical trial data is a different thing?
If the clinical trial community continues to fail with respect to data sharing, we will only strengthen the public perception that we do clinical trials to benefit ourselves, not our patients.
any scientific study should be based on raw data
data storage space should no longer be a challenge
Raw data or primary data are collected directly related to their object of study (statistical units). When people are the subject of an investigation, we may choose the form of a survey, an observation or an experiment.
does not have to be the complete data that you set out to acquire
the patient need not to be identified
A 2007 federal law requires that the results of most trials of drugs and medical devices be posted on the site ClinicalTrials.gov within one year of completion. Some types of study, such as phase I safety trials, are excluded from this mandate. The law came fully into effect in January 2017.
If we were to share databases, what would be the primary intent? Is it to: (a) replicate the top-line analyses from randomized clinical trials of novel therapeutics? If that is the case, then the US Food and Drug Administration (FDA) at this point has open access to the database if [the investigational drug] goes for approval. So, the top-line results are already being validated, and the FDA is looking at the data every which way.
Dr Harrington: Frequently, when your group or our group leads a clinical trial, it's already being replicated by multiple parties: a sponsor (government or private), an academic research organization, and perhaps a second one.
The question, then, is why so many scientists are so stingy with their information. Because scientific progress relies so heavily on the process of validating and building upon prior material, it might seem counterproductive to withhold information from other researchers. But even science, a discipline grounded in reason, isn’t immune to the influence of ego and emotion. The culture of innovation breeds fierce competition, and those on the brink of making a groundbreaking discovery want to be the first to publish their results and receive credit for their ideas. There’s more at stake than just the acknowledgement of being first and a metaphorical blue ribbon; being first to publish can mean invitations to national meetings, academic promotions, industry appointments, and research awards, including the Nobel Prize.