Can new medical publication guidelines help fix diversity in clinical trials?

Over the last 8 months, JAMA have been working on a new set of guidelines for research papers looking to publish with them, which is summarised in their latest editorial release, “The Reporting of Race and Ethnicity in Medical and Science Journals”. Substantial changes have been made in the race/ethnicity data section. But what does this mean?

Essentially, it means that the way that ethnicity data is being published is changing. If authors and editors wish to publish their clinical trial data with JAMA, they need to adhere to the writing style guide, this means that their papers must include demographic information on race and ethnicity. Game changer.

What does the revision actually say?

If you have a spare 10 minutes, then the full article is definitely worth reading. But, just in case you don’t have the time, here’s a short summary of the changes.

1. First up – definitions. The revisions come as a result of shifts in sociocultural factors, and this section of the article clarifies that as sociocultural factors change, so will their definitions of both race and ethnicity.

2. Next – concerns, sensitivities, and controversies. This part outlines how ethnicity and race can be related to other factors, such as socioeconomic status, structural, institutional, demographics, and more. This means that JAMA acknowledges that trends in health outcomes can appear to be related to ethnicity and race, when they are actually a more complicated mix of a few factors.

However, this is also where the article shows the significance of reporting ethnic and racial data. JAMA highlights the benefits of reporting race and ethnicity in clinical research, explaining that clinical research can only be accurately applied to the wider population if the study populations are representative.

3. This is the exciting part – updates to the guidance for reporting ethnicity/race data in research articles. Here’s a summary of the new expectations for reporting this data.

Now, any clinical research articles submitted to JAMA must:

  • Report age, sex, socioeconomic factors, and race/ethnicity data in both the methods and results sections.

  • If one factor is missing, the clinical papers must give reasons as to why that is.

4. The article then goes on to report guidance on using racial/ethnic terms, and rules about writing styles for these terms.

So, what does the reporting of race and ethnicity data mean?

The above guidance, particularly point 3, means that racial/ethnic data either has to be collected and reported, or the research must state why it’s not included. This is really similar to when the Nation Institute of Health (NIH) released a policy called ‘sex as a biological variable’, in an attempt to rectify the underrepresentation of women and female animals in clinical research. The effects of this guidance have been shown in this five-year progress report released last year, alongside other policies and ongoing efforts by the NIH. Now, nearly three decades on from the first requirement for inclusion of women in clinical studies in the U.S. (the 1993 NIH Revitalisation Act), we are seeing how effective such policies can be. So, it’s definitely positive so see the introduction of similar policies to increase representation of ethnic minorities in clinical trials.

What can you do?

The new guidance from JAMA is inviting people to make further comments about the new guidance. If you are reading this - please do make sure you review - comment and make your voice heard.

So, if you’ve made it to the end of this blog, then it’d be a great help to provide JAMA with comments and feedback about the new updates to the guidance and how this could be improved. Alternatively, you could share the article to help spread awareness to other journals, writers, and editors. Here’s the link to the editorial!