Clinical trials in medical congresses: a study on conflicts of interest

Nascimento, Milton Luiz; Lorenzo, Cláudio; Sanchez, Mauro Niskier

doi:10.1590/1983-80422022302528PT

Brasil

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Research • Rev. Bioét. 30 (2) • Apr-Jun 2022 • https://doi.org/10.1590/1983-80422022302528EN linkcopy

Clinical trials in medical congresses: a study on conflicts of interest

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

This article seeks to investigate conflicts of interest involving the presentation of clinical trials in Brazilian congresses of five medical specialties between 2004 and 2018. A total of 407 abstracts in 22 annals were studied. After applying selection criteria, we reached a corpus of 77 essays. A higher frequency of conflicts of interest was found involving essays with drugs for which no generic/similar option was available (p=0.000), and 48% of those with a conflict of interest declared nothing. Favorable results to the test drug occurred in 90.9% of the total of essays, but 48.6% of them lacked the p-value. The most tested therapeutic categories were immunosuppressors and immunomodulators, antidiabetic, and antineoplastic, which, together, amounted to 68.9% of the total of the involved drugs. The results pointed to hidden conflicts of interest, overvaluing of positive results of test drugs, not always with sufficient evidence, and focus of production on high-cost drugs.

Clinical trial; Drug industry; Conflict of interest; Research, ethics; Clinical conference

Drugs involved in the trials and year of registration with ANVISA		Number of trials per year of publications in the proceedings	Number of published drug trials in relation to the year of registration		Number of drug trials with outcomes favorable to the test drug		Number of drug trials with outcomes unfavorable to the test drug	Number of trials with one or more authors in conflicts of interest	Presence of conflict declaration in the publication
			≤5 years	≥5 years	With p- value	No p- value			Presence of conflict declaration in the publication
Abciximab 2001		1 (2015)	0	1	1	0	1	0	_
Baricitinib 2018		2 (2015)	2	0	2	2	0	2	2
		2 (2016)	2	0	2	0	0	2	2
		1 (2017)	1	0	0	1	0	1	1
Basiliximab 1998		2 (2012)	0	2	0	0	1	0	_
Cinacalcet 2010		4 (2012)	4	0	2	2	0	0	_
Daclizumab 1999		1 (2004)	1	0	0	1	0	0	_
Dapagliflozin 2017		1 (2018)	1	0	1	0	0	0	_
Dulaglutide 2015		1 (2018)	1	0	0	1	0	1	1
Dulaglutide 2015		1 (2014)	1	0	1	0	0	1	1
Etanercept 2009		2 (2014)	2	0	0	2	0	1	1
Fluvastatin 1997		2 (2004)	0	4	2	0	0	0	_
FTY720 2011		4 (2004)	4	0	1	2	1	0	_
Fondaparinux 2017		3 (2014)	3	0	3	0	0	3	1
GQ-16 No registration		1 (2012)	1	0	0	1	0	0	_
HD203 No registration		1 (2014)	1	0	0	0	1	0	_
HTK No registration		1 (2004)	1	0	1	0	0	0	_
Immunoglobulin 2006		1 (2008)	1	0	1	0	0	0	_
Ivabradine 2007		1 (2013)	0	1	1	0	0	0	_
		1 (2015)	0	1	1	0	0	0	_
		2 (2016)	0	2	2	0	0	2	_
Liraglutide 2016		13 (2016)	13	0	8	5	0	10	_
Lixisenatide 2017		5 (2014)	5	0	4	0	1	5	_
Paliperidona 2011		1 (2016)	1	0	0	1	0	1	_
Palivizumab 1999		1 (2016)	0	1	0	1	0	1	_
Rituximab 1998		1 (2014)	0	1	0	1	0	1	_
Rituximab 1998		3 (2016)	0	3	1	2	0	2	_
Secukinumab 2015		4 (2015)	4	0	3	0	1	4	_
Semaglutide 2018		1 (2016)	1	0	0	1	0	1	_
Sirolimus 2000		4 (2004)	4	0	2	2	0	3	_
Sirolimus 2000		4 (2008)	0	4	2	2	1	1	_
Tirofiban 1999		1(2013)	0	1	0	0	1	0	_
Tocilizumab 2009		3 (2017)	0	3	1	2	0	3	_
Tofacitinib 2014		1 (2015)	1	0	0	1	0	1	_
Triamcinolone 1988		1 (2014)	1	0	1	0	0	1	_
Total	28 drugs	77 trials	55 <5a	22 >5a	43	34	8	47	_

Analyzed variables	Proportion in trials involving drugs without generics	Proportion in trials involving drugs with generics	Difference between proportions	95%CI for the difference between proportions	p -value
Favorable outcomes	90.9% (50/55)	90.9% (20/22)	0	-14.2-14.2%	1.000
Favorable outcomes with p- value	80.6% (29/36)	19.4% (07/36)	61.2%	42.8-79.4%	0.000
Favorable outcomes with no p- value	61.8% (21/34)	38.2% (13/34)	23.6%	0.04-4.7%	0.052
Placebo control	85% (17/20)	15% (3/20)	70%	47.9-92.1%	0.000
Sponsorship of the interested industry	76.9% (10/13)	23.1% (3/13)	53.8%	21.5-86.2%	0.006
Trials with an author in conflict	85.7% (36/42)	14.3% (6/42)	71.4%	56.5-86.4%	0.000
Declaration of conflict, if any	66.9% (23/36)	83.3% (5/6)	-19.4%	-53.1-14.2%	0.350

Therapeutic class	Number of trials
Antianginals and vasodilators	3
Platelet antiaggregants, anticoagulants and antithrombotics	5
Antidiabetics	21
Antineoplastics	10
Anti-inflammatory drugs	8
Antiparathyroids	4
Antilipemics	2
Antiviral	1
Immunosuppressants and immunomodulators	22
Neuroleptics	1
Total	77

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