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Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients

Overview of attention for article published in Journal of Pharmaceutical Policy and Practice, February 2017
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2 tweeters

Citations

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2 Dimensions

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21 Mendeley
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Title
Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients
Published in
Journal of Pharmaceutical Policy and Practice, February 2017
DOI 10.1186/s40545-017-0099-5
Pubmed ID
Authors

Tsitsi G. Monera-Penduka, Charles C. Maponga, Gene D. Morse, Charles F. B. Nhachi

Abstract

Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved herbal trial in Zimbabwe are described in this report. The national drug regulatory authority and ethics committee were engaged for pre-submission discussions. Six applications were submitted. Application procedures and communications with the various regulatory and ethics review boards were reviewed. Key issues raised and timelines for communications were summarized. There was no special framework for the approval of herbal trials. One local institutional review committee granted an exemption. Key issues raised for revision were around pre-clinical efficacy and safety data, standardization and quality assurance of the intervention as well as consenting procedures. Approval timelines ranged between eight and 72 weeks. In the absence of a defined framework for review of herbal trials, approval processes can be delayed. Dialogue between researchers and regulators is important for successful and efficient protocol approval for herbal trials in developing countries. The study was registered prospectively on August 3, 2011 with clinicaltrials.gov (NCT01410058).

Twitter Demographics

The data shown below were collected from the profiles of 2 tweeters who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 21 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 21 100%

Demographic breakdown

Readers by professional status Count As %
Unspecified 5 24%
Student > Master 4 19%
Student > Ph. D. Student 3 14%
Other 2 10%
Student > Bachelor 2 10%
Other 5 24%
Readers by discipline Count As %
Unspecified 7 33%
Pharmacology, Toxicology and Pharmaceutical Science 3 14%
Nursing and Health Professions 3 14%
Medicine and Dentistry 2 10%
Agricultural and Biological Sciences 2 10%
Other 4 19%

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 26 March 2017.
All research outputs
#5,485,595
of 9,722,866 outputs
Outputs from Journal of Pharmaceutical Policy and Practice
#116
of 137 outputs
Outputs of similar age
#149,953
of 257,577 outputs
Outputs of similar age from Journal of Pharmaceutical Policy and Practice
#7
of 7 outputs
Altmetric has tracked 9,722,866 research outputs across all sources so far. This one is in the 26th percentile – i.e., 26% of other outputs scored the same or lower than it.
So far Altmetric has tracked 137 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 5.6. This one is in the 4th percentile – i.e., 4% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 257,577 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 32nd percentile – i.e., 32% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 7 others from the same source and published within six weeks on either side of this one.