A little over 40 years ago, I received a call from a study coordinator who asked if I was willing to participate in a trial regarding the use of anesthetics during dental surgery. Caught up in projects and obligations of my own, my immediate, internal reaction was “no,” but after thinking about it for a few seconds, I accepted. I realized how inappropriate a refusal would have been, especially coming from a scientist. I’d like to think my participation helped the study and advanced the care of patients. I have not since refused any invitation to participate in an eligible clinical trial.
I share this anecdote because I’ve been thinking about the crucial role that clinical trials play in health care. They have contributed to countless medical breakthroughs and scientific advances. They are the primary means by which we can determine whether a new form of treatment is safe and effective for patients.
Yet, there is growing awareness that clinical trials often fall short when it comes to one important consideration: representation. People can experience the same disease or disorder differently, but too many clinical trials fail to truly reflect the general population at risk of the disease or condition that is under investigation. This is a significant concern due to the increasing diversity of patients in our country and throughout the world.
ASH is determined to change that narrative. The Society is moving forward with an ambitious initiative that seeks to bolster diversity within and improve access to hematology clinical trials, as well as promote greater transparency when it comes to demographic data in the trials.
On the latter point, ASH is amplifying its request that demographic information regarding sex, gender, race, ethnicity, age, disability, or other relevant factors of enrolled subjects be included when clinical trial data are shared as part of ASH events, including relevant annual meeting invited program sessions, submitted abstracts, and oral and poster presentations. If some or all demographic information is not available, the investigators submitting the study for consideration should disclose the data limitations clearly within the abstract. Furthermore, ASH is encouraging all presenters to share this information explicitly during oral presentations.
ASH’s reinvigorated push for greater transparency in hematology clinical trials was preceded by the development and release (this past December at the 65th ASH Annual Meeting and Exposition), of the ASH DEI Toolkit for Clinical Trial Sponsors. A groundbreaking resource, the toolkit lays out actionable steps to incorporate diversity, equity, and inclusion (DEI) in the clinical trial process, staring with the formulation of the research question, continuing with trial design and budget, reviews, data collection, and culminating with the analysis of data and the reporting of the results. Such action is essential to ensure the applicability of the clinical findings data to a vast majority of patients, not merely a select group of willing patients participating in trials.
I extend my heartfelt thanks to participants (whether by focus groups or surveys) in the Society’s Roadmap to Improve DEI in Hematology Clinical Trials and members of ASH’s Subcommittee on Clinical Trials and Health Equity Task Force whose expertise and guidance were invaluable in developing the toolkit.
The clinical trials initiative stems from the Society’s broad and unwavering commitment to both DEI and sound science. There is more activity unfolding with this initiative, significantly more than I can share in a single column. I encourage you to stay tuned for further updates from ASH, including new guidelines for abstract submissions.
In closing, please allow me to make four (I hope) modest requests:
Download, use, and share the ASH DEI Toolkit for Clinical Trial Sponsor available on the ASH website at hematology.org/diversity-equity-and-inclusion/toolkits.
Talk to your colleagues and your patients (especially those from underrepresented populations) about the importance of representation in clinical trials. Winning the confidence of underrepresented minorities to participate in clinical trials is vital. And generating greater awareness will be a key component of long-term and impactful success.
Practice transparency with demographic data in your hematology clinical trials.
Please share with me any thoughts you have on how we can continue to strengthen diversity and inclusion in clinical trials. You can reach me at TheHematologist@hematology.org.
The solution to this challenge does not rest with any one person, not even any one organization. But ASH, with its toolkit and renewed call for greater transparency, has taken a huge step forward in bolstering DEI in hematology clinical trials. As we continue, our collective efforts will be an example for other fields and disciplines in health care. I strongly believe this issue is of critical importance to ensure that all of our patients, not only a select few, get the very best care possible.
