Meeting our ethical obligations to register and report clinical trials

Dr. Kelly Cobey, Investigator and Publications Officer, Centre for Journalology, Ottawa Hospital Research Institute

How would you feel if I told you that many health research studies, including clinical trials, never have their results made public in any way?  Or, that, among studies that do publish their findings, many are not reported clearly, making them of questionable trustworthiness and hard to use. There is evidence that the results of studies with positive findings (i.e., those that show the intervention was effective) are more likely to be shared than those with negative findings (i.e., those that show the intervention was not effective). This is called publication bias. It means that at any given time only the results of specific clinical trials on a particular topic are available to the community. This can mean that what we see and use is a biased representation and not accurate when considering all the evidence potentially available. It also means that the critical importance of participants in trials is not fully realized.

We owe it to participants who give their time and volunteer to participate in clinical trials, despite potential risks to their health, to ensure that the knowledge that researchers obtain from their study is disseminated responsibly, widely and openly. In order to address this ethical issue, the Declaration of Helsinki created a requirement that required all clinical trials must be registered in a publicly available database before they begin. This is called study registration. Patients and the public have been, and continue to be, a major driving force behind the policy and culture change to ensure study registration. A campaign called AllTrials has raised much needed awareness about this issue.

The impact of this advocacy is that researchers now must describe aspects of their study, such as the intervention they are evaluating and their analysis plan, before they start recruiting participants to take part. Then, when the study is complete, researchers ought to report their results in the registry too. Registries therefore can provide a complete account of what was planned, what was done, and what the results are. This allows for scrutiny and audit. In the absence of this process there is no way to monitor and prevent publication bias.

In Canada, the Canadian Institutes of Health Research require study registration and results reporting in a registry too. There has been some incredibly positive progress since these types of mandates were introduced. The proportion of researchers that register their trial is now much higher than it once was. One driver for this has been that many academic journals will not publish clinical trials that were not registered. However, many researchers unfortunately still fail to subsequently report the results of their studies in the trial registry, or otherwise.

So, why do researchers fall short when it comes to reporting clinical trial results? One issue is that some researchers believe that if they publish their trials results in an academic journal that they have effectively shared their findings. This isn’t the case – many academic journals require subscriptions to access which creates a barrier for patients and even other researchers. Journals are historically quite poor at ensuring researchers report all of the outcomes they registered regarding their trial too, this means publications often do not contain results of the full study. Study registries not only provide clinical trial results in a publicly available way, they do so in standardized formats, that ensure essential information is clearly reported, enhancing trust. Another possible explanation is that researchers are not often formally trained on the processes involved with conducting and reporting research studies. Many of these skills are learned on the job creating the potential for gaps in understanding or of processes.

Ensuring the clinical trials are registered and having their results reported is a shared responsibility of several stakeholders. Continuing education about the imperative to register and report clinical trials will be critical to help change researchers’ behaviour and ensure compliance. Further, we need proactive audits of registration and results reporting to measure how we are doing over time. This type of audit is notably absent within the Canadian clinical trials landscape but starting to happen elsewhere. A series of open access digital tools to track compliance automatically present an effective way to integrate audit processes moving forward. These have proven effective in other jurisdictions. Patients in Canada and beyond would benefit enormously from these measures to increase much needed clinical trial reporting and transparency.


#TalkClinicalTrials is a campaign led by CTO with the a goal of building awareness around clinical trials. Why? Because clinical trials matter to all of us. They help to generate better treatments and technologies and ultimately help shape the future of medicine. Explore more stories from the series and join the conversation on social media using #TalkClinicalTrials.