Setting the IMPACT (IMProve Access to Clinical Trial data) Observatory baseline

Introduction: The aim of the IMPACT (IMProving Access to Clinical Trial data) Observatory is to assess the transformation of clinical trials (CT) related to the evolution of sharing of CT data. The objective of this study is to establish a baseline for monitoring CT data sharing by the Observatory. Materials and methods: In this scoping review we searched for publications that address sharing, dissemination, transparency or reuse of CT data published prior to December 31st 2000. Two authors screened titles and abstracts of 1204 records received by Medline searches and added 47 publications from direct discovery. Four researchers extracted, coded, and analyzed the predefined information from 102 selected papers. Results: We found a growing recognition of the importance of data sharing prior to 2001. However, there were numerous obstacles including the ambiguity of the concept of data sharing, the absence of specific terminology and the lack of an “open” culture. By the end of 2000, data, metadata, and evidence based medicine were defined. Data sharing, registries, databases and re-analyses of individual patient data (IPD) emerged. The use of systematic reviews and IPD meta-analysis in decision making was promoted. Most arguments for broader data sharing came from oncology, paediatrics, rare diseases, AIDS, pregnancy, perinatal medicine, and media reporting related scandals. Conclusions: Our findings indicate that the year 2000 could be used as a baseline for monitoring the evolution of CT data sharing as basic prerequisites were set in place, including greater understanding that CT data sharing is essential for decision making and the advancements of the Internet

Clinical Trial Registration: The Differing Views of Industry, the WHO, and the Ottawa Group

Registration of clinical trials is an essential step in ensuring that data from all trials are reported. However, there are differing opinions on what registration should include

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

<p>Abstract</p> <p>Introduction</p> <p>Despite intense interest in trial registration, there is a wide gap between theoretical postulates on trial registration and its implementation worldwide.</p> <p>Objective</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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.</p

Reporting of Methodologic Information on Trial Registries for Quality Assessment: A Study of Trial Records Retrieved from the WHO Search Portal

Background: Although randomized clinical trials (RCTs) are considered the gold standard of evidence, their reporting is often suboptimal. Trial registries have the potential to contribute important methodologic information for critical appraisal of study results. Methods and Findings: The objective of the study was to evaluate the reporting of key methodologic study characteristics in trial registries. We identified a random sample (n = 265) of actively recruiting RCTs using the World Health Organization International Clinical Trials Registry Platform (ICTRP) search portal in 2008. We assessed the reporting of relevant domains from the Cochrane Collaboration’s ‘Risk of bias’ tool and other key methodological aspects. Our primary outcomes were the proportion of registry records with adequate reporting of random sequence generation, allocation concealment, blinding, and trial outcomes. Two reviewers independently assessed each record. Weighted overall proportions in the ICTRP search portal for adequate reporting of sequence generation, allocation concealment, blinding (including and excluding open label RCT) and primary outcomes were 5.7% (95% CI 3.0–8.4%), 1.4% (0–2.8%), 41% (35–47%), 8.4% (4.1–13%), and 66% (60–72%), respectively. The proportion of adequately reported RCTs was higher for registries that used specific methodological fields for describing methods of randomization and allocation concealment compared to registries that did not. Concerning other key methodological aspects, weighted overall proportions of RCTs with adequately reported items were as follows: eligibility criteria (81%), secondary outcomes (46%), harm (5%) follow-up duration (62%), description of the interventions (53%) and sample size calculation (1%). Conclusions: Trial registries currently contain limited methodologic information about registered RCTs. In order to permit adequate critical appraisal of trial results reported in journals and registries, trial registries should consider requesting details on key RCT methods to complement journal publications. Full protocols remain the most comprehensive source of methodologic information and should be made publicly available