Impact of investigator initiated trials and industry sponsored trials on medical practice (IMPACT): rationale and study design.
Access to information
Clinical decision making
Clinical guidelines
Evidence-based medicine
Industry sponsored trials
Investigator initiated trials
Knowledge translation
Randomized controlled trial
Study registry
Systematic reviews
Journal
BMC medical research methodology
ISSN: 1471-2288
Titre abrégé: BMC Med Res Methodol
Pays: England
ID NLM: 100968545
Informations de publication
Date de publication:
02 10 2020
02 10 2020
Historique:
received:
08
06
2020
accepted:
18
09
2020
entrez:
3
10
2020
pubmed:
4
10
2020
medline:
25
6
2021
Statut:
epublish
Résumé
The German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) initiated large research programs to foster high quality clinical research in the academic area. These investigator initiated trials (IITs) cover important areas of medical research and often go beyond the scope of industry sponsored trials (ISTs). The purpose of this project was to understand to what extent results of randomized controlled IITs and ISTs have an impact on medical practice, measured by their availability for decisions in healthcare and their implementation in clinical practice. We aimed to determine study characteristics influencing a trial's impact such as type of sponsor and place of conduct. In this article, we describe the rationale and design of this project and present the characteristics of the trials included in our study cohort. The research impact of the following sub-cohorts was compared: German IITs (funded by DFG and BMBF or by other German non-commercial organizations), international IITs (without German contribution), German ISTs, and international ISTs. Trials included were drawn from the DFG-/BMBF-Websites, the German Clinical Trials Register, and from ClinicalTrials.gov . Research impact was measured as follows: 1) proportion of published trials, 2) time to publication, 3) proportion of publications appropriately indexed in biomedical databases, 4) proportion of openly accessible publications, 5) broadness of publication's target group, 6) citation of publications by systematic reviews or meta-analyses, and 7) appearance of publications or citing systematic reviews or meta-analyses in clinical practice guidelines. We also aimed to identify study characteristics associated with the impact of trials. We included 691 trials: 120 German IITs, 200 International IITs, 171 German ISTs and 200 International ISTs. The median number of participants was 150, 30% were international trials and 70% national trials, 48% drug-trials and 52% non-drug trials. Overall, 72% of the trials had one pre-defined primary endpoint, 28% two or more (max. 36). The results of this project deepen our understanding of the impact of biomedical research on clinical practice and healthcare policy, add important insights for the efficient allocation of scarce research resources and may facilitate providing accountability to the different stakeholders involved.
Sections du résumé
BACKGROUND
The German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) initiated large research programs to foster high quality clinical research in the academic area. These investigator initiated trials (IITs) cover important areas of medical research and often go beyond the scope of industry sponsored trials (ISTs). The purpose of this project was to understand to what extent results of randomized controlled IITs and ISTs have an impact on medical practice, measured by their availability for decisions in healthcare and their implementation in clinical practice. We aimed to determine study characteristics influencing a trial's impact such as type of sponsor and place of conduct. In this article, we describe the rationale and design of this project and present the characteristics of the trials included in our study cohort.
METHODS
The research impact of the following sub-cohorts was compared: German IITs (funded by DFG and BMBF or by other German non-commercial organizations), international IITs (without German contribution), German ISTs, and international ISTs. Trials included were drawn from the DFG-/BMBF-Websites, the German Clinical Trials Register, and from ClinicalTrials.gov . Research impact was measured as follows: 1) proportion of published trials, 2) time to publication, 3) proportion of publications appropriately indexed in biomedical databases, 4) proportion of openly accessible publications, 5) broadness of publication's target group, 6) citation of publications by systematic reviews or meta-analyses, and 7) appearance of publications or citing systematic reviews or meta-analyses in clinical practice guidelines. We also aimed to identify study characteristics associated with the impact of trials.
RESULTS
We included 691 trials: 120 German IITs, 200 International IITs, 171 German ISTs and 200 International ISTs. The median number of participants was 150, 30% were international trials and 70% national trials, 48% drug-trials and 52% non-drug trials. Overall, 72% of the trials had one pre-defined primary endpoint, 28% two or more (max. 36).
CONCLUSIONS
The results of this project deepen our understanding of the impact of biomedical research on clinical practice and healthcare policy, add important insights for the efficient allocation of scarce research resources and may facilitate providing accountability to the different stakeholders involved.
Identifiants
pubmed: 33008297
doi: 10.1186/s12874-020-01125-5
pii: 10.1186/s12874-020-01125-5
pmc: PMC7532587
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
246Subventions
Organisme : German Research Foundation (DFG)
ID : BL 1395/2-1
Pays : International
Références
Trials. 2010 Apr 13;11:37
pubmed: 20388211
Lancet. 2014 Jan 18;383(9913):257-66
pubmed: 24411650
Lancet. 2014 Jan 11;383(9912):166-75
pubmed: 24411645
Soc Sci Med. 2008 May;66(9):1909-14
pubmed: 18299169
ANZ J Surg. 2020 Jan;90(1-2):21-26
pubmed: 31480098
BMJ. 2003 May 31;326(7400):1167-70
pubmed: 12775614
Contemp Clin Trials. 2008 Mar;29(2):109-13
pubmed: 17919992
BMJ. 1997 Sep 13;315(7109):640-5
pubmed: 9310565
Lancet. 2004 Dec 4-10;364(9450):2021-9
pubmed: 15582059
BMJ. 2006 Oct 14;333(7572):782
pubmed: 17028106
PLoS Med. 2017 Aug 9;14(8):e1002370
pubmed: 28792957
CMAJ. 2004 Feb 17;170(4):477-80
pubmed: 14970094
PLoS One. 2014 Dec 23;9(12):e114023
pubmed: 25536072
J Clin Epidemiol. 2010 Feb;63(2):117-25
pubmed: 19880289
Cochrane Database Syst Rev. 2014 Apr 10;(4):CD008965
pubmed: 24718923
Stat Med. 2010 Mar 30;29(7-8):760-9
pubmed: 20213703
Lancet. 2014 Jan 18;383(9913):267-76
pubmed: 24411647
Am J Epidemiol. 2008 May 1;167(9):1120-9
pubmed: 18334500
Aust New Zealand Health Policy. 2007 Jun 28;4:14
pubmed: 17597545
Methods Inf Med. 2014;53(6):459-63
pubmed: 25270884
Ann Transl Med. 2019 Jul;7(14):310
pubmed: 31475180
BMJ. 2013 Nov 11;347:f6409
pubmed: 24217206
BMJ. 1996 Jan 13;312(7023):71-2
pubmed: 8555924
Lancet. 2014 Jan 11;383(9912):156-65
pubmed: 24411644
BMJ. 2002 Aug 3;325(7358):249
pubmed: 12153921
N Engl J Med. 2007 Jun 28;356(26):2734-6
pubmed: 17548427
J Med Libr Assoc. 2010 Jan;98(1):17-23
pubmed: 20098647
J R Soc Med. 2011 Dec;104(12):532-8
pubmed: 22179297
JAMA. 2003 Jan 22-29;289(4):454-65
pubmed: 12533125
Oncologist. 2013;18(2):232-8
pubmed: 23363807
PLoS One. 2013;8(1):e54583
pubmed: 23382919
N Engl J Med. 2009 Feb 19;360(8):824-30
pubmed: 19228628
JAMA. 2003 Aug 20;290(7):921-8
pubmed: 12928469
Spine J. 2014 Feb 1;14(2):308-14
pubmed: 24231776
BMJ Open. 2012 Mar 30;2(2):e000897
pubmed: 22466037
Isr Med Assoc J. 2006 Jul;8(7):451-4
pubmed: 16889157
BMJ. 2010 Oct 12;341:c4737
pubmed: 20940209
Ann Oncol. 2018 Apr 1;29(4):1063-1065
pubmed: 29253146
JAMA. 1998 Jan 28;279(4):281-6
pubmed: 9450711
Lancet. 2014 Jan 11;383(9912):176-85
pubmed: 24411646
Lancet. 2014 Jan 11;383(9912):101-4
pubmed: 24411643
Lancet. 1991 Apr 13;337(8746):867-72
pubmed: 1672966
Int J Surg. 2020 Mar;75:130-138
pubmed: 31991242
J Clin Epidemiol. 2015 Jul;68(7):803-10
pubmed: 25797837
J Laryngol Otol. 2019 Oct 31;:1-7
pubmed: 31668151
ESMO Open. 2018 Jan 6;3(1):e000258
pubmed: 29344408
Health Technol Assess. 2010 Feb;14(8):iii, ix-xi, 1-193
pubmed: 20181324