Adverse ReactionNCT04301219
Knowledge and Practices of ADR Reporting in LMICs
An observational study of Adverse Reaction, run by Getz Pharma at 1 site in Pakistan.
Trial summary
The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries. This survey may help us to identify the common gaps in knowledge and practices about pharmacovigilance so that we can devise the strategy on the basis of outcome. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Adverse Reaction
- How many people
- 1,500 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A self-administered questionnaire was distributed to 1500 HCPs in 11 countries (Afghanistan, Cambodia, Kazakhstan, Kenya, Laos, Myanmar, Nigeria, Pakistan, Philippines, Sri Lanka, and Sudan). The participants were approached at various scientific events and academic interactions during the period and were requested to participate in the survey on a voluntary basis.
Who may be able to join
- Participants who would like to voluntarily fill the survey form
Who cannot join
- Students
- Other than Health care professionals (including but not limited to Physicians, Doctors, Nurses and/or pharmacist)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knowledge and Practices of Adverse Drug Reaction Reporting Among Healthcare Professionals in Low and Middle-income Countries: a Cross-sectional Survey.
The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries. This survey may help us to identify the common gaps in knowledge and practices about pharmacovigilance so that we can devise the strategy on the basis of outcome.
Read the detailed description
Safety evaluation of a product in a market is like a moving ball which need re-evaluation as the data gather in its life cycle.(1) As per the definition of International society of harmonization and World Health Organization, adverse reaction is Adverse drug reaction (ADR) is defined as "A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function." (2) Adverse reaction and adverse event are interchangeable use in pharmacovigilance sector by knowing the difference is that ADR term used when drug is causing the effect (1). The frequency of ADR is getting higher due to the increasing prevalence of chronic disease with the growing trend of combination drugs (3). The non-profitable organization of pharmacovigilance is playing tremendous role in disseminating the awareness of proper usage of drug globally.(3) According to Uppsala database statistics, approximately 3 million reports were listed as suspected ADRs. (4) Nearly 6.7% of hospitalizations were due to serious ADRs (5)
- Conditions
- Adverse Reaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Country-wise Analysis on knowledge of HCPs
Number of HCPs had knowledge about AR in their own country
Measured: 2 years
Country-wise Analysis on practices of HCPs
Number of HCPs practicing AR reporting in their own country
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Apr 2017
- Primary completion1 Mar 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Getz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahwish Raza, Pharm-D, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301219
- Sponsor's protocol ID
- GTZ-PV-001
- Status last verified
- Mar 2020
- First submitted
- 26 Nov 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Practices of Adverse Drug Reaction Reporting Among Healthcare Professionals in Low and Middle-income Countries: a Cross-sectional Survey.
- ClinicalTrials.gov ID
- NCT04301219
- Acronym / sponsor ID
- GTZ-PV-001
- Conditions
- Adverse Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Getz PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries. This survey may help us to identify the common gaps in knowledge and practices about pharmacovigilance so that we can devise the strategy on the basis of outcome.
Detailed description
Safety evaluation of a product in a market is like a moving ball which need re-evaluation as the data gather in its life cycle.(1) As per the definition of International society of harmonization and World Health Organization, adverse reaction is Adverse drug reaction (ADR) is defined as "A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function." (2) Adverse reaction and adverse event are interchangeable use in pharmacovigilance sector by knowing the difference is that ADR term used when drug is causing the effect (1). The frequency of ADR is getting higher due to the increasing prevalence of chronic disease with the growing trend of combination drugs (3). The non-profitable organization of pharmacovigilance is playing tremendous role in disseminating the awareness of proper usage of drug globally.(3) According to Uppsala database statistics, approximately 3 million reports were listed as suspected ADRs. (4) Nearly 6.7% of hospitalizations were due to serious ADRs (5)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A self-administered questionnaire was distributed to 1500 HCPs in 11 countries (Afghanistan, Cambodia, Kazakhstan, Kenya, Laos, Myanmar, Nigeria, Pakistan, Philippines, Sri Lanka, and Sudan). The participants were approached at various scientific events and academic interactions during the period and were requested to participate in the survey on a voluntary basis.
Key inclusion criteria (1 listed)
- Participants who would like to voluntarily fill the survey form
Key exclusion criteria (2 listed)
- Students
- Other than Health care professionals (including but not limited to Physicians, Doctors, Nurses and/or pharmacist)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Country-wise Analysis on knowledge of HCPs
Time frame: 2 years
Number of HCPs had knowledge about AR in their own country
Country-wise Analysis on practices of HCPs
Time frame: 2 years
Number of HCPs practicing AR reporting in their own country
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahwish Raza, Pharm-D principal investigator
Shaheed Zulfiqar Ali Bhutto Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Reaction, run by Getz Pharma at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Country-wise Analysis on knowledge of HCPs (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.