Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)

Abstract

Background Healthcare 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. Methods We 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. Results For 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. Conclusion An 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.

Quality assessment and its influencing factors of lung cancer clinical research registration: a cross-sectional analysis

“…Secondly, researchers with retrospective registrations may not register to avoid publishing negative results or to enable them to change the primary outcomes, and hence, could deliberately avoid registration until a journal requires it (51). This study also found that government-sponsored studies were more likely to have high registration quality than industry-sponsored studies, which was consistent with previous studies (52,53). Government-sponsored studies were often required to be published in journals as part of the funding conditions (54), and researchers would need to follow registration requirements (52).…”

“…This study also found that government-sponsored studies were more likely to have high registration quality than industry-sponsored studies, which was consistent with previous studies (52,53). Government-sponsored studies were often required to be published in journals as part of the funding conditions (54), and researchers would need to follow registration requirements (52). Furthermore, due to "trade secrets", commercially-funded researchers were more resistant to register (53).…”

Methodological Quality and Risk of Bias Assessment of Cardiovascular Disease Research: Analysis of Randomized Controlled Trials Published in 2017

“…The source of funding may have an important impact on trial planning, conduct, and reporting ( 23 – 25 ). In our study, we investigated the role of funding sources on RoB by comparing trials both funded or not by the industry.…”

Panoramic quality assessment tool for investigator initiated trials

“…Our study found that almost half (117/257) of the research protocol adjusted during the implementation process may be associated with poor design. It is important that all research findings, including negative and inconclusive results are reported transparently and made publicly available in order to avoid unnecessary duplication of research or biases in the clinical knowledge base ( 8 ). While our study found that 80% of the project research protocols have not been published in public journals or websites, which was consistent with the literature ( 29 ).…”

“…Over the past decade, more and more studies emphasized on the importance of methodology and the quality of research report, both in IITs and ISTs ( 8 , 9 ). Several publications highlighted that risk-adapted monitoring was important for quality control and sufficient to identify critical questions in the conduct of clinical trials ( 10 , 11 ).…”