Clinical Researcher—December 2022 (Volume 36, Issue 6)
OVER THE TRANSOM
Edited by Gary W. Cramer (gcramer@acrpnet.org), Managing Editor for ACRP
The arrival of December each year has a way of trying to make me think big thoughts while stuck at home waiting for kayaking weather to return. Certainly, 2022 (no less than the previous few years) has given us all a lot of large—and sometimes seemingly intractable—challenges to ponder upon and then take our best cracks at overcoming. More and more, it seems to this old school editor that while it’s the digital-, data-, and technology-driven “solutions” to what ails different wings of the clinical research enterprise that are gaining the most attention these days, there is still much to be said for the virtues of more practical methods for tackling certain kinds of troubles. I suppose that my big thought, if I really have one worth sharing here and am not just mumbling into my own beard, is that one must have the wisdom to know the difference between a scenario that calls for one approach versus the other.
Here are some examples of how folks in the real world are thinking about and confronting some big challenges in clinical research with a little bit of help from column A and a little bit from column B (no endorsements implied). It is my hope that whichever approach we have to making our way down the stream toward our solutions, in the words of a certain spiritual viewpoint, we will all meet together in the end.
What’s Next in 2023 Health Trends
Syneos Health® has released its 2023 Health Trends: Personally, Purposely Building What’s Next, and cautions that with artificial intelligence (AI) and machine learning producing an era of rapid new pathways, plus an industry-wide push for equitable representation in clinical trials, 2023 will be a catalytic year for biopharma clinical development and commercialization.
The report predicts that technological evolution will likely lead to profound changes in how organizations think about and learn from data. Syneos Health expects AI and machine learning will help drive strategic decisions to accelerate the commercialization of new therapies to patients. Simultaneously, as the healthcare environment grows in complexity—with increasing regulatory scrutiny and new technologies—the urgent need to bridge the gaps between data, medical information exchange, and strategy will drive demand for Medical Affairs innovation.
According to Leigh Householder, executive vice president and managing director of Technology and Data Solutions, Syneos Health, “[W]e expect 2023 to be the year AI moves from promise to performance, helping organizations realize the value and impact of our understanding of population health, improving global data, refining clinical trials, and helping with the development of new vaccines and cures.”
The report highlights 12 trends set to catalyze the year ahead align around the themes of Technology Evolution, Human Engagement, and Healthcare Advancement.
Improving Self-Administration of Injectable Drugs in Clinical Trials
The future of clinical trials is becoming more reliant on connected medical devices for collecting data at the point of care, reducing the need for costly patient visits and cumbersome manual data acquisition. Therefore, Haselmeier, a medmix Brand, and AARDEX Group have joined forces to tackle the challenge of managing patient adherence during clinical trials.
Haselmeier has developed a wireless connected drug delivery solution that can be integrated into AARDEX Group’s adherence software. They say that the combination of the two systems allows researchers to understand and manage patient adherence in clinical trials testing self-injection therapies. The D-Flex injection pen is at the heart of this connected solution. It allows for simplified adaption of specific injection dose volumes by changing only one component. This saves time and cost during clinical testing, especially with dose-ranging studies, because the same pen can be used for both clinical testing and product launch, eliminating the need for additional equivalence and human factor studies and reducing time to market.
The overall D-Flex Logbook consists of the disposable D-Flex injection pen and a connected cap, which replaces the standard cap of the pen. This set-up does not impact patient behavior and results in no additional training. The connected cap tracks injection dose, temperature, and time of up to 1,000 injection events. It can securely transfer data in real-time to AARDEX’s MEMS Connect or any other pre-existing data management system via Bluetooth Low Energy.
Educating Dermatologists and Nephrologists on Racial Disparities in Lupus Trials
The American College of Rheumatology (ACR) has released Continuing Medical Education (CME) for dermatologists and nephrologists to help them learn more about clinical trials for lupus patients in their respective treatment areas and the importance of getting more of their African American/Black patients enrolled. The new CME is part of the ACR’s “Materials to Increase Minority Involvement in Clinical Trials” initiative to provide nephrologists and dermatologists with specific information on racial disparities in lupus clinical trials, why it’s important to increase minority participation in them, and the barriers providers face when encouraging patients to participate.
“Skin and kidney symptoms are common in lupus patients and there are clinical trials specifically targeting these two organ systems. The CME training addresses barriers like patient mistrust, lack of familiarity with trials, and an intimidating consent process,” said Rosalind Ramsey-Goldman, MD, DrPH, chair of the ACR’s Collaborative Initiatives Committee. “It also addresses facilitators like culturally sensitive communication and social support by emphasizing skills that provide support for both the provider and the patient.”
More information about the ACR’s work on lupus awareness and educational programs can be found at www.thelupusinitiative.org.
How Do You Measure Success in Autism Clinical Trials?
How do you know if a treatment for autism is effective? That’s a question that has no easy answer—due in large part to the heterogeneous nature of autism spectrum disorder.
“There’s so much variability in how these children present, what their needs are, what treatments might work, and how they change over time,” says Shafali Spurling Jeste, MD, chief of neurology and co-director of the Neurological Institute and Las Madrinas Chair at Children’s Hospital Los Angeles. “So how do you know if a drug or treatment is working? It’s not straightforward. We need more objective measures.”
Finding and validating those measures is the goal of the Autism Biomarkers Consortium for Clinical Trials (ABC-CT), one of the largest autism research projects in the country. Jeste is the principal investigator for the study at Children’s Hospital Los Angeles, one of five centers participating in the National Institutes of Health–funded study, which is based at Yale University and includes Boston Children’s Hospital, Seattle Children’s Hospital, and Duke University.
According to Jeste, the challenge is that researchers may have a good therapeutic, but they can’t measure its success without the right biomarker or patient selection tool, or they may be measuring the wrong endpoints. Researchers need to develop a better infrastructure for clinical trial readiness, and that’s what ABC-CT is trying to create by gathering large-scale data from across the country to validate measures for use in future clinical trials.
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