Can case processing (triage, causality, etc.) of published case reports on a particular drug be considered as research project?
Dear Aryendu Kumar
Broad access for number of suspected ADR give you EudraVigilance homepage. Its a link: http://www.adrreports.eu/en/index.html
Literature based or database based research could be of course considered as research project. Using such reports for example from EudraVigilance homepage you can access many numerical data which can be very useful for future analysis comparisons etc.
Best regards
Tomasz
Yes.
Why not?
Plz refer ..... Shang N, Xu H, Rindflesch TC, Cohen T. Identifying plausible adverse drug reactions using knowledge extracted from the literature. J Biomed Inform. 2014;52:293-310.
Screening Scientific Literature for Adverse Drug Reactions: Relevant for Patient Safety or Just a Time-Consuming Regulatory Obligation?
Sukanta Sen
Mam,
I was confused with the fact that if screening scientific literature can be made as THE BASIS for the research project or not at the post graduation level and yes it is relevant for the patient safety.
Firstly, there cannot be a 'literature based' monitoring of Adverse Events (AE)!. AE Monitoring needs to be real time, clinical and patient based. The literature includes reports of already observed AEs. If you base your work on literature, there can be no new finding/observation and in short, no research!
The AE reports published in literature can be either 'reviewed' or subjected to a 'meta analysis'. What needs to be checked is whether such review or meta analysis would be acceptable from the University/Institute point of view.
Alternatively, it can be a combination of review plus a real-life small pharmacoepidemiological study in hospital/clinic setting. This will have more credibility.
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