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Pregled bibliografske jedinice broj: 1050510

Characteristics of clinical trials on drug-drug interaction registered in the ClinicalTrials.gov from 2005 to 2015


Jurić, Diana; Pranić, Shelly; Pavličević, Ivančica; Marušić, Ana
Characteristics of clinical trials on drug-drug interaction registered in the ClinicalTrials.gov from 2005 to 2015 // Global Evidence Summit 2017
Cape Town, South Africa, 2017. 1047, 2 (poster, međunarodna recenzija, sažetak, znanstveni)


CROSBI ID: 1050510 Za ispravke kontaktirajte CROSBI podršku putem web obrasca

Naslov
Characteristics of clinical trials on drug-drug interaction registered in the ClinicalTrials.gov from 2005 to 2015

Autori
Jurić, Diana ; Pranić, Shelly ; Pavličević, Ivančica ; Marušić, Ana

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Skup
Global Evidence Summit 2017

Mjesto i datum
Cape Town, South Africa, 13.-16.09.2017

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
Drug-drug interactions ; Clinical Trials ; Registration

Sažetak
Background: Drug-drug interactions (DDIs) underlie 15-20% of adverse-drug reactions requiring hospitalisation and have caused several market withdrawals due to related adverse events (AEs). More prevalent polypharmacy in ageing populations and increasing numbers of chemical entities emphasise the need for clinical studies of DDIs. Objectives: To review the characteristics of clinical trials on DDIs and assess their registered and published safety data in a publicly available trial register. Methods: We performed an observational study of clinical trials retrieved from ClinicalTrials.gov by using the search term 'drug-drug interaction' (search performed on 16 October 2015). Trials were included if they were: 1) investigating the DDIs ; 2) had a ClinicalTrials.gov registration number ; 3) closed and completed in October 2015 ; 4) registered between 23 June 2005 and 16 October 2015. Publications were identified through CT.gov, PubMed and SCOPUS. Data on 8 items from the World Health Organization minimum dataset on AEs were abstracted by one author and verified by another. Results: Among the 2059 retrieved clinical trials, 762 were excluded because of the incorrect classification as related to DDIs. Most were industry-sponsored (65%), started before registration (57%), and were primarily interventional studies (96%) in phase I (72%). Only a few studies had registered results (13%), among which 23% registered occurrence of serious and other AEs. 71 trials (5%) had both registered and published data (Table 1). Reported SAE and OAE description, frequencies and/or absolute numbers were identical to registered data for only 17 trials (24%). Conclusions: We found a remarkably low rate of reporting of study results and AEs, as well as high discrepancy between registered and published AEs. Immediate efforts of all stakeholders to improve transparency are needed, as well as more stringent regulatory requirements for trial registration and drug marketing authorisation for DDIs.

Izvorni jezik
Engleski



POVEZANOST RADA


Ustanove:
Medicinski fakultet, Split

Citiraj ovu publikaciju

Jurić, Diana; Pranić, Shelly; Pavličević, Ivančica; Marušić, Ana
Characteristics of clinical trials on drug-drug interaction registered in the ClinicalTrials.gov from 2005 to 2015 // Global Evidence Summit 2017
Cape Town, South Africa, 2017. 1047, 2 (poster, međunarodna recenzija, sažetak, znanstveni)
Jurić, D., Pranić, S., Pavličević, I. & Marušić, A. (2017) Characteristics of clinical trials on drug-drug interaction registered in the ClinicalTrials.gov from 2005 to 2015. U: Global Evidence Summit 2017.
@article{article, year = {2017}, pages = {2}, chapter = {1047}, keywords = {Drug-drug interactions, Clinical Trials, Registration}, title = {Characteristics of clinical trials on drug-drug interaction registered in the ClinicalTrials.gov from 2005 to 2015}, keyword = {Drug-drug interactions, Clinical Trials, Registration}, publisherplace = {Cape Town, South Africa}, chapternumber = {1047} }
@article{article, year = {2017}, pages = {2}, chapter = {1047}, keywords = {Drug-drug interactions, Clinical Trials, Registration}, title = {Characteristics of clinical trials on drug-drug interaction registered in the ClinicalTrials.gov from 2005 to 2015}, keyword = {Drug-drug interactions, Clinical Trials, Registration}, publisherplace = {Cape Town, South Africa}, chapternumber = {1047} }




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