Evidence map›Paper›PMID 24551586›Full record

ArticlePerspectives in clinical research2014

Best practices sharing: Setting up a professional clinical research unit in India.

Uma Divate, Soma Das, Neelambari Bhosale, Pathik Divate

Open access · diamondAbstract read
In one paragraph

Article in Perspectives in clinical research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Paperless clinical trials: Myth or reality?Indian journal of pharmacology
    Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Uma DivateJehangir Clinical Development Centre, Jehangir Hospital Premises, Pune, Maharashtra, India.
Soma DasJehangir Clinical Development Centre, Jehangir Hospital Premises, Pune, Maharashtra, India.
Neelambari BhosaleJehangir Clinical Development Centre, Jehangir Hospital Premises, Pune, Maharashtra, India.
Pathik DivateJehangir Clinical Development Centre, Jehangir Hospital Premises, Pune, Maharashtra, India.
Jehangir Clinical development Centre · INJehangir Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Drug Controller General of India has recently come up with very stringent laws to tighten the regulatory framework around clinical trials. One-way of improving the credibility of India and its researchers in the eyes of the regulators, sponsors and the general public is through professional site management team or setting up clinical research unit (CRU). The CRU acts as a bridge between the sponsor and the investigator. The CRU model has been better explained with the help of a good example of a clinical research institute. Since, a successful clinical trial needs high quality data, timeliness and clear communication between all parties, a professional CRU with a team of dedicated and trained professionals and infrastructure with written procedures and policies may be a solution to the pain and agony of poor site performance and investigator insufficiency and pressure.

Indexed as

Clinical research unitclinical trialinvestigator

Identifiers

PMID24551586
PMCPMC3915368
OpenAlexW2014900856

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.