Do trialists endorse clinical trial registration? Survey of a Pubmed sample

Sanitas Research Institute, Fundación Universitaria Sánitas, Bogotá, Colombia.
Trials (Impact Factor: 1.73). 02/2007; 8(1):30. DOI: 10.1186/1745-6215-8-30
Source: PubMed

ABSTRACT Despite intense interest in trial registration, there is a wide gap between theoretical postulates on trial registration and its implementation worldwide.
We aimed to evaluate trialists views about current international guidelines on trial registration, including the World Health Organization's (WHO) International Clinical Trials Registry Platform (ICTRP) policies and the Ottawa Statement, as well as their intention to register any future clinical trials they conduct.
We identified all 40,158 PUBMED-indexed clinical trials published from May 2005 to May 2006 using an advanced search strategy. From a random sample of 500 confirmed clinical trials, corresponding authors with e-mail contact addresses were surveyed.
A total of 275 (60%) questionnaires from 45 countries were completed. 31% of the respondents had received only nonindustry funding during the past ten years, while 5% and 61% had received only industry or mixed funding respectively. Approximately two third of participants supported registration of all 20 WHO Data Set items, and endorsed the Ottawa Statement part 1 and part 2. Delayed public disclosure of some essential data in instances where they may be considered sensitive for competitive commercial reasons was supported by 30% of the participants, whereas immediate disclosure was supported by 53%. Only 21% of participants had registered all of their ongoing trials since 2005, while 47% stated that they would provide the 20 WHO Data Set items to a publicly accessible register for all their future clinical trials; a significantly higher proportion of participants who received only nonindustry funding (62%) was found among those who would always provide the 20 WHO items for future trials, compared to 42% of participants who received mixed or only industry funding. Among those who were undecided about endorsing registration. One third of participants expressed a lack of sufficient knowledge as the primary reason.
Although disagreement was apparent on certain issues, our findings illustrate that trial registration is gradually becoming part of the current research paradigm internationally. Our results also suggest that researchers require more knowledge to inform their decision to comply with the International standards at this early stage of voluntary trial registration.

Download full-text


Available from: Ludovic Reveiz, Sep 26, 2015
18 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: Seit vielen Jahren zeigen Untersuchungen, dass die Ergebnisse klinischer Studien häufig selektiv publiziert werden mit einer statistisch signifikanten und im klinischen Ausmaß sehr bedeutenden Übervorteilung positiver Studienergebnisse. Diese selektive Publikation führt zu einer systematischen Fehlleitung verschiedener medizinischer Entscheidungen bzw. der diesen Entscheidungen zu Grunde liegenden Nutzen-Schaden-Abwägungen. Man muss davon ausgehen, dass solche Fehlleitungen die Patientenversorgung, die Patientenaufklärung, den Probandenschutz und die medizinische Lehre verschlechtern und somit in vielerlei Hinsicht ethisch unakzeptable Konsequenzen haben. Studienregister stellen die international bevorzugte Strategie dar, um der selektiven Publikation entgegenzutreten. Wann und in welchem Umfang für in Deutschland durchgeführte klinische Studien eine Verpflichtung zur Studienregistrierung faktisch etabliert wird ist weiterhin offen. Der vorliegende Artikel führt unter Verweis auf zentrale internationale Literatur in die theoretischen und empirischen Hintergründe zum selektiven Publizieren und zur Studienregistrierung ein. Die ethischen Probleme des selektiven Publizierens werden systematisch dargestellt. Hierauf aufbauend wird für die Notwendigkeit einer restriktiven Regulierung der Studienregistrierung seitens der deutschen Gesundheitspolitik und der medizinischen Selbstverwaltung zur deutlichen Reduktion des selektiven Publizierens argumentiert. Abschließend diskutiert der Beitrag, inwieweit den deutschen Institutionen der medizinischen und forschenden Selbstverwaltung eine prospektive und retrospektive Verantwortung für eine effektive Regulierung der Studienregistrierung (bzw. für das Fehlen eben dieser) zugeschrieben werden kann. Background For many years now, studies have shown that the results of clinical trials are often published selectively, with a statistically significant bias towards positive results, which becomes very significant at the clinical level. This publication bias produces a systematic misdirection of various medical decisions and the harm-benefit analyses underlying these decisions. It has to be assumed that such misdirection negatively affects the quality of patient care, patients’ right to informed choice, the protection of research participants, and medical education and, thus, has diverse ethically unacceptable consequences. Registries of trials are the internationally favored strategy to compensate for this publication bias. However, it is an open question when and to what extent the registration of trials will become an established and regulated obligation for clinical trials conducted in Germany. Analysis This article describes the theoretical and empirical background of both selective publication and study registries with reference to the central international literature. The ethical problems of selective publishing are presented systematically. Building on this, the article argues for the necessity of a restrictive regulation of trials registration on the part of the self-governing bodies of the German health and research system as well as of the Federal Ministry of Health in order to significantly reduce selective publication. Conclusion The article demonstrates the extent to which German self-governing bodies and politics in medicine and research can be ascribed a prospective and retrospective responsibility for the effective regulation of study registries (or for the lack thereof). SchlüsselwörterForschungsethik–Studienregister–Publikationsbias–Selektive Publikation–Fürsorgeverantwortung KeywordsResearch ethics–Trial registration–Publication bias–Selective publication–Accountability
    Ethik in der Medizin 01/2011; 23(3):177-189. DOI:10.1007/s00481-010-0071-2 · 0.33 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Isometric contraction forces were registered in sheep rectus femoris muscles at two different types of simulation through the femoral nerve. Conventional single-channel nerve stimulation (two electrodes) on one leg was compared with multichannel stimulation (four electrodes with rotating activity) on the contralateral leg. Fatigue indices were evaluated according to R.E. Burke et al. (1973), with stimulation parameters modified for the larger dimensions in sheep. Fatigue indices were calculated after 2, 4, 10, 20, 40, and 60 min. After 2 min, submaximal multichannel stimulation resulted in at least 14% less muscle fatigue compared to single-channel stimulation. Accordingly, after prolonged stimulation up to 60 min, higher contraction forces were recorded at multichannel stimulation. The fatigue indices were 0.43 for single-channel and 0.66 for multichannel stimulation. The data clearly indicate that multichannel stimulation results in 23% less muscle fatigue. The experimental results demonstrate the advantages of multichannel stimulation in patients
    Engineering in Medicine and Biology Society, 1989. Images of the Twenty-First Century., Proceedings of the Annual International Conference of the IEEE Engineering in; 12/1989
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Randomized trials are an excellent research design with major advantages. However, randomized trials are not immune to biases, and inferences from them may be sometimes flawed or irrelevant. The present review addresses, in brief, some of the major threats to the credibility and relevance of the results of clinical trials: power problems, biases affecting internal validity (poor design, conduct, and analysis), biases affecting the total randomized evidence on a specific topic (publication bias and selective outcome and analysis reporting bias), lack of relevance, poor generalizability, and biases in the interpretation of the results.
    Bulletin of the NYU hospital for joint diseases 02/2008; 66(2):135-9.
Show more