Transparency and accuracy in funding investigator-initiated clinical trials: a systematic search in clinical trials databases

Abstract

ObjectivesThis study aims to identify the sources of funding for investigator-initiated clinical trials (IICTs) in Portugal, and to recommend ways to improve the quality of information collected from clinical trial databases about funding.Design and methodsA systematic search of trial registrations over the last 13 years—using the WHO International Clinical Trials Registry Platform (WHO-ICTRP) and four clinical trials registries (CTRs)—was carried out to identify IICTs in Portugal, used as a case study. Data from the databases were compared with data contained in publications to evaluate the consistency of information on funding sources. The term ‘database’ is used in this study to refer to both the WHO-ICTRP and the CTRs. When mentioned separately, the WHO-ICTRP is referred to as a ‘platform’, while the CTRs are referred to as ‘registries’.OutcomeSuggestions to improve clinical trials databases to clearly identify the funding sources and data ownership in IICTs.ResultsTwo hundred and eighty-two IICTs were identified in Portugal. Twenty per cent of trials were supported by industry with unclear information on the ownership of the results. Inaccuracy was found in the information about sponsors and funders. The information about funding in all resulting publications (77 out of 133 completed studies) was also inconsistent between databases in 35 out of 77 (45%) of the studies. Notably, 23% of the trials funded by non-profit organisations (n=226) received funds from international and/or national funding agencies.ConclusionsIdentification of IICT funding and ownership of results is unclear in the databases used for this study, which may lead to misunderstandings about the independence of the obtained results. Transparency and accuracy are desirable so that public decision makers and strategic partners can accurately evaluate national performance in this particular type of clinical research.

Investigator initiated clinical trials (IICTs): a systematic search in registries comparing Czech Republic and Portugal in terms of funding policies and scientific outcomes

“…In this study we show that the main funders of IICTs in both countries are public or non-pro t organizations ( Figure 2D). However, we cannot provide accurate data on the origin of funding because, as we previously published, CTRs do not provide a clear separation between sponsor and funders 5 . Only a small percentage of the public funding to IICTs in both countries is provided by national funding agencies (25% in Czech Republic and 18% in Portugal - Figure 3).…”

“…The Portuguese Clinical Research Infrastructure Network (PtCRIN) has been developing several national studies where the status of IICTs in Portugal were assessed [4,5]. Despite the relevance of such data to de ne national strategies for this area, the impact of such analysis can be maximised through a comprehensive benchmarking with other European countries, particularly the ones with similar characteristics.…”

European survey on national harmonization in clinical research

“…• Collaboration with different international registries for clinical trials in order to align content and improve comparability (eg, to better identify funding sources and data ownership). 20 • Transnational implementation of the Erasmus + CONSCIOUS project on innovative educational methodology will provide a new tool for many countries to standardize clinical trials and increase their efficiency at EU level and worldwide.…”

The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic

“…According to the screened registries, it is not possible to find out who is ownership of the results. Nowadays, some journals have introduced a requirement of the full disclosure of funders [ 23 ].…”

“…The selection of the databases used for the search was based on previous research undertaken by Madeira et al [ 23 ], namely: ClinicalTrials.gov The European Union Clinical Trials Register (EUCTR) BioMed Central International Standard Randomized Controlled Trial Number Registry (ISCTRN) Australia and New Zealand Clinical Trials Registry (ANZCTR) …”