Will Registered Reports be clinical trial’s new hero?

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It is estimated that 33 to 60% of clinical trials never report results. And throughout the course of trial history, there has been numerous strikingly scandalous cases in which data were faked, fabricated or distorted. This is because of the natural yet unhealthy trend to favor positive and groundbreaking results in the scientific community.

To be more specific, studies proving that a new treatment is superior to the old ones face no obstacles in finding their ways to respected journals. A positive outcome makes everyone happy: sponsors, scientific journals, news agencies, the community, and of course the authors. Having their papers published in various prestigious journals means a boost in career to researchers, which is why many of them choose to play some tricks on the dataset.

This win-win scenario lures scientists into the utopia that clinical trials are supposed to produce positive results, while in fact, it is the opposite. A so-called negative conclusion, which says that the drug is not better, or even worse than the ones in use, also contributes to our understanding of medicines. In answer to this pressing problem, Registered Report made its debut in the clinical trial industry this August.

Why Registered Report?

Launched in 2013, the concept is gaining more support in the scientific community. Different from the traditional report, researchers who wish to conduct a Registered Report have to propose the study protocol to the journal for peer review at Stage 1 before actually carrying out the research. If the study meets high-quality standards and has its methods approved, then the journal commits to publishing the paper no matter what the results will be.

The procedure of Registered Reports. (c) Open Science Framework

This is no doubt good news to authors. By having their papers pre-approved for publication, they completely get rid of the fear that their work will be good-for-nothings. In this system, groundbreaking results are just as good as null outcomes, because both will be published anyway. Plus, researchers can withdraw their manuscripts if there are sights of favorable results so that they can choose to submit them to other well-respected journals.

Editors and journals themselves benefit from the Registered Report movement too. According to Chris Chambers, one of the founders of the concepts, while editors are able to contribute and follow studies from their infancy stages of study design to their conclusions, journals can build a stock of high-quality papers in terms of ideas and methods, and at the same time strengthen as well as promote the integrity and non-bias in science.

The last beneficiary of Registered Reports is the whole scientific community, or in the case of reports in clinical trials, the pharmaceutical community. By embracing reports regardless of their results, the system clears out the incentives to commit frauds and misconducts among trial conductors. Cleaner data and more honest reports mean more trust and more support is placed in clinical trials, which hopefully will make it easier to conduct them.

Clinical Trial Registration vs. Registered Reports

The 2013 Declaration of Helsinki regulates that every trial that includes human participants must be registered in a public database before enrolling any subject. Other authoritative entities have also put forward similar regulations concerning clinical trial registration. Thus, there are arguments that Registered Report is, in fact, a copy of the pre-existing trial registry.

ClinicalTrials.gov – one clinical trial registry platform

Two points need to be made clear here. First, Registered Reports allow researchers continuous peer reviews from Stage 1 on the study design and protocols to Stage 2 on the comparison between the manuscript and the initial plan. Whereas in clinical trial registration, only one-third of peer reviewers actually do the comparison. What’s more, most registration platforms don’t offer peer reviews on the protocol. This, in turn, means that researchers can slip through the gap and manifest the database.

Second, clinical trial registration doesn’t guarantee paper publication. This is the selling point of Registered Reports. In fact, only 13% of registered studies published their outcomes on ClinicalTrials.gov, according to a study by The BMJ. Registered Reports deal with this low rate and guarantee that once the study protocols are approved and researchers follow suit, the paper is set to be published.

To sum up

Of course, Registered Report is not a perfect one-size-fits-all solution. If there happens to be any major change in the process, researchers will have to run back and forth between the journal and the Institutional Review Board (IRB)/ Institutional Ethics Committee (IEC) to resolve the issue. This process can be burdensome and time-consuming.

However, taking into consideration all the benefits that Registered Reports can bring to clinical trials, we have the right to expect that this movement will spark a radical revolution in the industry. The vision of fraud-free and highly trustworthy trials is not so far away.   

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