Impact of therapeutic investigator initiated trials on medical practice
Public Health, Healthcare Research, Social and Occupational Medicine
Final Report Abstract
A major part of this project was to create balanced comparison sub-cohorts, to refine the search strategy for primary and secondary research articles and to further develop the projects methods. Of the 691 trials, 576 (83%) were published as a method article or a result article in a medical journal and/or the trial results were made available in study registries; results were available for 555 (80%) of the trials. More than half (52%) of the trials were cited in a systematic review and about a quarter (26%) reached an impact in a clinical guideline. Drug trials and larger trials are 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 journal article, results of ISTs more often in study registries. International ISTs gain less often impact by inclusion in systematic reviews than publicly sponsored trials or guidelines. An encouraging proportion of clinical trials investigated was published and gained an impact on clinical practice, depending on specific study characteristic. Study registries have become an important alternative or complement to journal articles for publishing study results. Nevertheless, there still were a certain proportion of trials that were not published and/or had no impact, which needs to be decreased to increase the efficiency and to reduce waste in medical research. As a first step, special attention could be given to smaller trials and non-drug trials, which were significantly less often published or cited by systematic reviews or clinical guidelines than larger trials and non-drug trials. For statistical reasons, larger trials had a higher probability to generate statistically significant results. Nevertheless, trials with a smaller number of participants, e.g. as is the case in early phase studies or in case of limited scientific resources, are also justified and should be available for inclusion in the total body of evidence. Further research is needed to identify the reasons and risk factors for non-publication or delayed publication of registered trials and for non-citation in reviews and guidelines. A standardized reporting system, implemented in the lifecycle of studies, that requests the reasons in these cases could be an approach to reach that goal. Such a system could also reveal, why published results of commercial trials appear less often in reviews and guidelines than academic trials. Further efforts are needed to ensure that the results of all trials conducted are published. Publication of all results of all trials should become mandatory, e.g. by legal regulation and by the requirement of funding organizations. The proportion of published results of commercial trials is comparable to those of academic trials, but they appear less often in reviews and guidelines. Further research is needed to investigate the reasons for this phenomenon. In this project, the only criterion for measuring impact of trials on medical practice was inclusion or exclusion of their results. A more detailed quantitative analysis of the “value” of their contribution to the overall body of evidence and on medical practice would be helpful to identify “valuable” trials. Considering their study characteristics in the planning of future trials, could increase the impact of clinical research. Specifically for Germany, IITs funded by governmental bodies reached an impact comparable to international IITs and ISTs that is respectable. Thus, funding of high-quality IITs by governmental bodies is worth the effort, should be continued and further encouraged.
Publications
- Transparency and completeness of reporting in study registries – a comparative study. Abstracts of the 25th Cochrane Colloquium, Edinburgh, UK. Cochrane Database of Systematic Reviews 2018;(9 Suppl 1)
Anette Blümle, Ralph Möhler, Katharina Kunzweiler
(See online at https://doi.org/10.1002/14651858.CD201801) - Impact of investigator initiated trials and industry sponsored trials on medical practice (IMPACT). REWARD | EQUATOR Conference, 2020 – Abstracts – Berlin, 20–22 February 2020
Wollmann K, Bischoff K, Nury E, Lohner S, Nitschke K, Blümle A
- Impact of investigator initiated trials and industry sponsored trials on medical practice (IMPACT): rationale and study design. BMC Med Res Methodol. 2020 Oct 2; 20(1):246
Nury E, Bischoff K, Wollmann K, Nitschke K, Lohner S, Schumacher M, Rücker G, Blümle A
(See online at https://doi.org/10.1186/s12874-020-01125-5) - Impact of investigator initiated trials and industry sponsored trials on therapeutic medical practice (IMPACT): Results of a cohort study. BMC Med Res Methodol.
Blümle A, Wollmann K, Bischoff K, Lohner S, Nury E, Nitschke K, Rücker G, Schumacher M
(See online at https://doi.org/10.21203/rs.3.rs-106925/v1)
