Enrollment of female participants in United States drug and device phase 1–3 clinical trials between 2016 and 2019

Sosinsky, Alexandra Z.; Rich‐Edwards, Janet W.; Wiley, Aleta; Wright, Kalifa; Spagnolo, Primavera A.; Joffe, Hadine

doi:10.1016/j.cct.2022.106718

Cited by 46 publications

(24 citation statements)

References 15 publications

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“…With MTBs serving as an important referring system especially for early clinical trials, efforts to ensure a more balanced distribution of sex are critical. It has been reported multiple times that female patients are under-represented in clinical studies, especially phase I trials [ 20 – 23 ]. Standardized local regulations as to which patients should receive CGP can be helpful to minimize a potential selection bias by the treating physician.…”

Section: Discussionmentioning

confidence: 99%

Precision Oncology in Pancreatic Cancer: Experiences and Challenges of the CCCMunichLMU Molecular Tumor Board

et al. 2023

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Background In pancreatic cancer, systemic treatment options in addition to chemotherapy remain scarce, and so far only a small proportion of patients benefit from targeted therapies. Objective The patients with pancreatic cancer discussed in the CCCMunich LMU Molecular Tumor Board were reviewed to gain a better real-world understanding of the challenges and chances of precision oncology in this hard-to-treat cancer. Methods Patients with pancreatic cancer who received comprehensive genomic profiling and were discussed in the interdisciplinary Molecular Tumor Board between May 2017 and July 2022 were included. These patients’ medical charts, comprehensive genomic profiling results, and Molecular Tumor Board recommendations were analyzed in this retrospective cohort study. Results Molecular profiles of 165 patients with pancreatic cancer were discussed in the Molecular Tumor Board. In the 149 cases where comprehensive genomic profiling was successful, KRAS mutations were detected in 87.9%, TP53 in 53.0%, and CDKN2A in 14.1%. 33.3% of KRAS wild-type patients harbored targetable mutations, while these were only found in 19.1% of patients with the KRAS mutation; however, this difference was not statistically significant. 63.8% of patients with successful testing received a targeted treatment recommendation by the Molecular Tumor Board; however, only 3.2% of these were put into practice. Compared to a historic cohort of patients with pancreatic cancer with synchronous metastatic disease diagnosed between 2010 and 2017, the patients from the pancreatic cancer cohort with synchronous metastatic disease had a longer survival. Conclusions This single-center experience emphasizes the challenges of targeted treatment in pancreatic cancer. Very few patients ultimately received the recommended therapies, highlighting the need for more and better targeted treatment options in pancreatic cancer, early comprehensive genomic profiling to allow sufficient time to put Molecular Tumor Board recommendations into practice, and close cooperation with clinical trial units to give patients access to otherwise not available targeted treatments.

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Section: Discussionmentioning

confidence: 99%

Precision Oncology in Pancreatic Cancer: Experiences and Challenges of the CCCMunichLMU Molecular Tumor Board

et al. 2023

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“…Strategies to not only increase the inclusion of women in trials, but also to collect female sexspecific factors have been outlined elsewhere (39,40). Fortunately the representation of women in kidney transplant trials appears to be better than for other fields in medicine (4,(6)(7)(8). Whether transplant researchers are intentionally more inclusive with recruitment, or women living with a kidney transplant are more willing to participate in trials remains to be seen.…”

Section: Discussionmentioning

confidence: 99%

“…A recent study published in 2021 examined the PPR for women and minority populations in 172 abdominal transplant trials in the United States from 2000 to 2018. Compared to non-transplant studies where women have been historically and often woefully under included (4,(6)(7)(8), in abdominal transplant trials, women were surprisingly well represented (PPR 0.87) (9). Importantly however, this study did not examine trial characteristics that may have influenced female recruitment.…”

Section: Introductionmentioning

confidence: 87%

Representation of Women in Contemporary Kidney Transplant Trials

Vinson

Ahmed

2023

Transpl Int

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Women are often underrepresented in clinical trials. It is unclear if this applies to trials in kidney transplant (KT) and whether the intervention or trial focus influences this. In this study, the weighted participation-to-prevalence ratio (PPR) for women enrollees in KT trials was determined for leading medical transplant or kidney journals between 2018 and 2023 using meta-regression overall and in three sensitivity analyses by: 1) Whether the intervention involved immunosuppression; 2) Area of trial focus; rejection, cardiometabolic, infection, lifestyle, surgical; 3) Whether the intervention was medical/surgical or social/behavioral. Overall, 33.7% of participants in 24 trials were women. The overall pooled PPR for the included trials was 0.80, 95% CI 0.76–0.85, with significant heterogeneity between trials (I2 56.6%, p-value < 0.001). Women had a lower PPR when the trial involved immunosuppression (PPR 0.77, 95% CI 0.72–0.82) than when it did not (PPR 0.86, 95% CI 0.80–0.94) and were less likely to participate in trials with a medical/surgical versus behavioral intervention; the lowest PPR for women was in studies examining rejection risk (PPR 0.75, 95% CI 0.70–0.81). There is better representation of women in KT trials compared to other medical disciplines, however women remain underrepresented in transplant trials examining immunosuppression and rejection.

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“…A recent study investigating the exclusion of females in clinical trials found that females were underrepresented compared with their proportion of disease population in cardiovascular trials (41.9% vs. 49%), psychiatry clinical trials (60% vs. 42%), and cancer trials (51% vs. 41%). 1 Without female inclusion in clinical trials, toxicity‐ and treatment‐related sex‐based differences remain a mystery. For instance, it has been demonstrated that women are more susceptible to toxicity from various chemotherapy regimens.…”

mentioning

confidence: 99%

EDI and open access: How JACMP is the future of ethical publishing—A tale in two parts

Hedrick

Richardson

2022

J Applied Clin Med Phys

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Enrollment of female participants in United States drug and device phase 1–3 clinical trials between 2016 and 2019

Cited by 46 publications

References 15 publications

Precision Oncology in Pancreatic Cancer: Experiences and Challenges of the CCCMunichLMU Molecular Tumor Board

Precision Oncology in Pancreatic Cancer: Experiences and Challenges of the CCCMunichLMU Molecular Tumor Board

Representation of Women in Contemporary Kidney Transplant Trials

EDI and open access: How JACMP is the future of ethical publishing—A tale in two parts

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