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

ABSTRACT: OBJECTIVES:This 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 METHODS:A 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'. OUTCOME:Suggestions to improve clinical trials databases to clearly identify the funding sources and data ownership in IICTs. RESULTS:Two 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. CONCLUSIONS:Identification 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.

SUBMITTER: Madeira C

PROVIDER: S-EPMC6530385 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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

Madeira Catarina C Santos Francisco F Kubiak Christine C Demotes Jacques J Monteiro Emília Carreira EC

BMJ open 20190514 5

<h4>Objectives</h4>This 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.<h4>Design and methods</h4>A 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 Portu ...[more]

PMID: 31092640

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Project description:ImportanceRandomized clinical trials (RCTs) are an essential method of evaluating health care interventions and a cornerstone for evidence-based health care. However, RCTs have become increasingly complex and costly, which is particularly challenging for independent investigator-initiated clinical trials (IICTs). IICTs have an essential role in clinical research, and it is important that efforts are made to ensure IICTs are adequately funded and are conducted cost-effectively.ObjectiveTo examine the practices and attitudes of Swiss stakeholders regarding IICT funding acquisition and cost management.Design, setting, and participantsFor this qualitative study, interviews were conducted in Switzerland between February and August 2020. The purposive sample comprised 48 stakeholders from 4 different groups: primary investigators (n = 27), funders and sponsors (n = 9), clinical trial support organizations (n = 6), and ethics committee members (n = 6).Main outcomes and measuresPractices and attitudes of stakeholders regarding IICT funding acquisition and cost management were assessed using individual semistructured qualitative interviews. Interviews were analyzed using conventional content analysis.ResultsAfter interviews with 48 IICT stakeholders (75% male presenting), these participants identified a systemic problem of IICTs being underfunded, which can lead to compromises being made regarding the quality and conduct of IICTs. Participants identified 2 overarching and interconnected groups of reasons why IICTs in Switzerland are regularly underfunded. First, it was reported that IICT budget estimations are often inaccurate because of poor planning and preparation, unforeseeable events, investigators intentionally underestimating budgets, and limited budget assessment and oversight. Second, with the exception of a specific IICT funding program by the Swiss National Science Foundation, it was reported that limited funding sources and unrealistic expectation of funders led to underlying challenges in getting IICTs fully funded. A number of measures that could help reduce the underfunding of IICTs were identified, including improving the support of investigators and IICTs, strengthening networking and guidance, harmonizing and simplifying bureaucracy, and increasing public funding of IICTs.Conclusions and relevanceThis study highlights the inadequate expertise of Swiss stakeholders to correctly, systematically, and reproducibly calculate RCT budgets and the need for transparency on trial costs as well as training in budgeting practices. Limited financial resources for academic clinical research and issues regarding the professional planning and conduct of IICTs are persistent issues that many other countries also face.

Project description:BackgroundHealthcare decisions are ideally based on clinical trial results, published in study registries, as journal articles or summarized in secondary research articles. In this research project, we investigated the impact of academically and commercially sponsored clinical trials on medical practice by measuring the proportion of trials published and cited by systematic reviews and clinical guidelines.MethodsWe examined 691 multicenter, randomized controlled trials that started in 2005 or later and were completed by the end of 2016. To determine whether sponsorship/funding and place of conduct influence a trial's impact, we created four sub-cohorts of investigator initiated trials (IITs) and industry sponsored trials (ISTs): 120 IITs and 171 ISTs with German contribution compared to 200 IITs and 200 ISTs without German contribution. We balanced the groups for study phase and place of conduct. German IITs were funded by the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), or by another non-commercial research organization. All other trials were drawn from the German Clinical Trials Register or ClinicalTrials.gov. We investigated, to what extent study characteristics were associated with publication and impact using multivariable logistic regressions.ResultsFor 80% of the 691 trials, results were published as result articles in a medical journal and/or study registry, 52% were cited by a systematic review, and 26% reached impact in a clinical guideline. Drug trials and larger trials were associated with a higher probability to be published and to have an impact than non-drug trials and smaller trials. Results of IITs were more often published as a journal article while results of ISTs were more often published in study registries. International ISTs less often gained impact by inclusion in systematic reviews or guidelines than IITs.ConclusionAn encouraging high proportion of the clinical trials were published, and a considerable proportion gained impact on clinical practice. However, there is still room for improvement. For publishing study results, study registries have become an alternative or complement to journal articles, especially for ISTs. IITs funded by governmental bodies in Germany reached an impact that is comparable to international IITs and ISTs.

Project description:Objective:In children many antiepileptic drugs (AEDs) are prescribed off-label due to a lack of well-designed randomized controlled trials (RCTs). We conducted a multicenter RCT in the Netherlands to compare levetiracetam and valproic acid as monotherapy in children with newly diagnosed epilepsy. After 2 years, we had to stop this investigator-initiated trial prematurely because the inclusion rate was too low. We analyzed the reasons for this failure, assessed the various issues involved in performing RCTs in children, and now give recommendations for future studies. Methods:A questionnaire was completed by all investigators involved in the study. It included questions about the motivation to participate and the perceived reasons for recruitment failure. We also studied literature about financial, logistic, legal, and ethical aspects of RCTs in children. Results:Main reasons for recruitment failure were overestimation of the number of eligible AED-naive children referred by general pediatricians; personal preferences of investigators for specific antiepileptic drugs; and the extensive administrative load due to extra regulations and guidelines for children. Fundraising for investigator-initiated trials is difficult and the majority of RCTs concerning AEDs are sponsored by pharmaceutical companies. Involving children requires balancing between protection and participation; the randomization procedure and obtaining informed consent are complex for both children and parents. Significance:Performing RCTs with AEDs in children is important but complicated by logistic, regulatory, legal, and ethical restrictions. Based on our recent experience, our advice to colleagues who are planning a similar trial would be to perform a feasibility pilot study; to set up intensive collaboration with referring pediatricians; to arrange support of a clinical trials unit and a local research nurse during the complete trial period; and to incorporate the possibility of extending the recruitment period. Major investments, both financially from governmental organizations and in time, are imperative for independent RCTs in children.

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

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

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