Quiz: Clinical Trials Day Quiz
- Question 1 of 9
1.
When did the International Committee of Medical Journal Editors (ICMJE) introduce the requirement that all clinical trials must be registered to be considered in their journals?
Yes that’s right. This requirement came into effect in 2005 and was seen as a major milestone in increasing clinical trial transparency. The main purpose for clinical trial registration is to prevent selective publication and selective reporting, as well as increase awareness in the field of what clinical trials are planned or on-going to reduce unnecessary duplication of efforts and resources.
Other key milestones that have had a positive impact on clinical trial registration include updates and legislations from the FDA, EMA, WHO and other bodies, summarised in Figure 1 of this article published in BMJ Open looking at global trends in clinical trial registration.
More information on the ICMJE policy can be found here.
No not quite. This requirement came into effect in 2005 and was seen as a major milestone in increasing clinical trial transparency. The main purpose for clinical trial registration is to prevent selective publication and selective reporting, as well as increase awareness in the field of what clinical trials are planned or on-going to reduce unnecessary duplication of efforts and resources.
Other key milestones that have had a positive impact on clinical trial registration include updates and legislations from the FDA, EMA, WHO and other bodies, summarised in Figure 1 of this article published in BMJ Open looking at global trends in clinical trial registration.
More information on the ICMJE policy can be found here.
- Question 2 of 9
2.
What are the current estimates for the number of clinical trials being registered prospectively compared to retrospectively?
Yes that’s right. Recent estimates from an article published in Trials found only 31% of clinical trials included in their study were prospectively registered. However, over the last 10 years the ISRCTN registry, administered by BioMed Central, has seen large increases in the amount of trials being registered prospectively, with approximately 16% of UK-based studies prospectively registered in 2006 compared to 48% in 2016.
This is a promising trend as we all know that the gold standard for registration is for it to be prospective; for more information about an editors’ dilemma between retrospectively and prospectively registered trials, check out this BioMed Central blog.
No not quite. Recent estimates from an article published in Trials found only 31% of clinical trials included in their study were prospectively registered. However, over the last 10 years the ISRCTN registry, administered by BioMed Central, has seen large increases in the amount of trials being registered prospectively, with approximately 16% of UK-based studies prospectively registered in 2006 compared to 48% in 2016.
This is a promising trend as we all know that the gold standard for registration is for it to be prospective; for more information about an editors’ dilemma between retrospectively and prospectively registered trials, check out this BioMed Central blog.
- Question 3 of 9
3.
What year was the first version of the CONSORT Statement for reporting randomised controlled trials published?
Yes that’s right. The first version of CONSORT, at that time called the Standardized Reporting of Trials (SORT) Statement, was published in 1994 and was the outcome of a meeting in Ottawa, Canada, where medical journal editors, clinical trialists, epidemiologists, and methodologists met to discuss how the quality of reporting of clinical trials could be improved.
In 1996, a revised version was published which for the first time included a checklist for the reporting items and was renamed the Consolidated Standards of Reporting Trials (CONSORT) Statement. CONSORT is continually evolving and further updates were published in 2001 and 2010.
Find out more about the history of CONSORT via the CONSORT Statement website.
No not quite. The first version of CONSORT, at that time called the Standardized Reporting of Trials (SORT) Statement, was published in 1994 and was the outcome of a meeting in Ottawa, Canada, where medical journal editors, clinical trialists, epidemiologists, and methodologists met to discuss how the quality of reporting of clinical trials could be improved.
In 1996, a revised version was published which for the first time included a checklist for the reporting items and was renamed the Consolidated Standards of Reporting Trials (CONSORT) Statement. CONSORT is continually evolving and further updates were published in 2001 and 2010.
Find out more about the history of CONSORT via the CONSORT Statement website.
- Question 4 of 9
4.
What are the recent estimates on how CONSORT has impacted clinical trial reporting?
Yes that’s right. A study published in Systematic Reviews in 2012, which is the largest synthesis of CONSORT impact on reporting to date, found that 69 of 81 meta-analyses looking at CONSORT impact showed a benefit for those journals that endorsed CONSORT.
This analysis also found that between endorsing and non-endorsing journals, 25 CONSORT items were improved with endorsement and five of these were significantly improved. However, overall, there are still improvements needed to the completeness of trial reporting.
No not quite. A study published in Systematic Reviews in 2012, which is the largest synthesis of CONSORT impact on reporting to date, found that 69 of 81 meta-analyses looking at CONSORT impact showed a benefit for those journals that endorsed CONSORT.
This analysis also found that between endorsing and non-endorsing journals, 25 CONSORT items were improved with endorsement and five of these were significantly improved. However, overall, there are still improvements needed to the completeness of trial reporting.
- Question 5 of 9
5.
What are the current estimates for the proportion of biomedical journals that endorse and mandate the use of CONSORT with submissions reporting randomised controlled trials?
Yes that’s right. Most recent estimates come from a study published in Trials that surveyed high impact factor biomedical journals “Instructions to Authors” in 2014 to assess the extent and nature of the journals’ endorsements. They concluded that 63% of journals endorse the use of CONSORT with submissions and 42% mandate it.
No not quite. Most recent estimates come from a study published in Trials that surveyed high impact factor biomedical journals “Instructions to Authors” in 2014 to assess the extent and nature of the journals’ endorsements. They concluded that 63% of journals endorse the use of CONSORT with submissions and 42% mandate it.
- Question 6 of 9
6.
How many extensions to the original CONSORT Statement have been published?
Yes that’s right. According to the CONSORT Statement website , as of May 3rd 2017 there are currently 11 CONSORT extensions which are categorised into designs (cluster trials, non-inferiority and equivalence trials, pragmatic trials, N-of-1 trials and pilot and feasibility trials), interventions (herbal medicinal interventions, non-pharmacologic treatment interventions, and acupuncture interventions) and data (CONSORT-PRO, Harms and Abstracts). More information on each can be found here.
If you want to keep an eye on what extensions might be coming up next, there are at least seven CONSORT extensions listed in the ‘Reporting guidelines under development’ via the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network.
No not quite. According to the CONSORT Statement website , as of May 3rd 2017 there are currently 11 CONSORT extensions which are categorised into designs (cluster trials, non-inferiority and equivalence trials, pragmatic trials, N-of-1 trials and pilot and feasibility trials), interventions (herbal medicinal interventions, non-pharmacologic treatment interventions, and acupuncture interventions) and data (CONSORT-PRO, Harms and Abstracts). More information on each can be found here.
If you want to keep an eye on what extensions might be coming up next, there are at least seven CONSORT extensions listed in the ‘Reporting guidelines under development’ via the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network.
- Question 7 of 9
7.
What year was the first version of the SPIRIT Statement for reporting study protocols of randomised controlled trials published?
Yes that’s right. There has only been one version of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), which was published in 2013. The SPIRIT statement was created to improve the completeness and quality of trial protocol reporting. It was developed by an international group of stakeholders that included trialists, methodologists, journal editors, and ethicists from across academia, industry and funding agencies.
Find out more about the history of SPIRIT via the SPIRIT Statement website.
No not quite. There has only been one version of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), which was published in 2013. The SPIRIT statement was created to improve the completeness and quality of trial protocol reporting. It was developed by an international group of stakeholders that included trialists, methodologists, journal editors, and ethicists from across academia, industry and funding agencies.
Find out more about the history of SPIRIT via the SPIRIT Statement website.
- Question 8 of 9
8.
What year was the first study protocol for a controlled trial published (according to PubMed)?
Yes that’s right. The first study protocol for a controlled trial was published in 1975 in the European Journal of Cancer.
For more information on the importance of writing and publishing trial protocols, Doug Altman (University of Oxford, UK and co-Editor-in-Chief of Trials) previously discussed this crucial step in the clinical trial timeline via our Blogs Network.
PubMed now has over five and a half thousand study protocols for trials indexed.
[PubMed. Accessed 15 May 2017 with search criteria (“protocol”[Title] AND “trial”[Title]) followed by manually checking of titles].
No not quite. The first study protocol for a controlled trial was published in 1975 in the European Journal of Cancer.
For more information on the importance of writing and publishing trial protocols, Doug Altman (University of Oxford, UK and co-Editor-in-Chief of Trials) previously discussed this crucial step in the clinical trial timeline via our Blogs Network.
PubMed now has over five and a half thousand study protocols for trials indexed.
[PubMed. Accessed 15 May 2017 with search criteria (“protocol”[Title] AND “trial”[Title]) followed by manually checking of titles].
- Question 9 of 9
9.
What year was the first statistical analysis plan for a randomised controlled trial published as a standalone article?
Yes that’s right. The first statistical analysis plan (SAP) for a randomised controlled trial was published in Critical Care and Resuscitation in 2012.
Over recent years, we’ve seen increasing numbers of SAPs submitted to Trials (using the Update article type) and predict that as the field progresses these will become a staple part of the clinical trial reporting record.
[PubMed. Accessed 15 May 2017 with search criteria (“statistical plan”[Title] AND “trial”[Title]) followed by manually checking of titles].
No not quite. The first statistical analysis plan (SAP) for a randomised controlled trial was published in Critical Care and Resuscitation in 2012.
Over recent years, we’ve seen increasing numbers of SAPs submitted to Trials (using the Update article type) and predict that as the field progresses these will become a staple part of the clinical trial reporting record.
[PubMed. Accessed 15 May 2017 with search criteria (“statistical plan”[Title] AND “trial”[Title]) followed by manually checking of titles].
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Now that you’ve completed our quiz, read about what’s next for clinical trial reporting, including machine learning, CONSORT integration into peer review, linked reports of clinical trials and data sharing.
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