key: cord-1033594-6zm597j8 authors: Rabow, Maya; Wang, Christine; Zhang, Sylvia; Tahir, Peggy Mary; Small, Eric J.; Borno, Hala T. title: Examining reporting and representation of patients with cancer in COVID‐19 clinical trials date: 2021-02-23 journal: Cancer Rep (Hoboken) DOI: 10.1002/cnr2.1355 sha: 87f558213fb7de7a83157a03782039c87df8f19b doc_id: 1033594 cord_uid: 6zm597j8 BACKGROUND: Patients with cancer are particularly vulnerable in the current COVID‐19 pandemic. Emerging evidence suggests that patients with a cancer diagnosis are three times more likely to die from COVID‐19 compared to non‐cancer patients. Due to these observed risks, it is critical that emerging COVID‐19 therapies demonstrate safety and efficacy among patients with cancer. AIM: This study sought to examine reporting and representation of patients with cancer among published COVID‐19 treatment‐related research studies. METHODS AND RESULTS: All published COVID‐19 treatment‐related clinical research studies published from March 1 to August 20, 2020 recruiting from North America and Europe were identified. The date published, study design, therapeutics studied, and study population were evaluated. Of the 343 studies identified through initial search and researcher knowledge, 55 (16%) reported on COVID‐19 treatments. Twenty‐one COVID‐19 therapeutic studies (n = 15, prospective; n = 6, retrospective) that recruited from the United States and Europe were identified. Among these studies, eight (38%) reported on the number of trial participants with a cancer diagnosis in the publication and two (10%) specified tumor type. Four of the studies (19%) did not collect cancer history. Among studies where cancer history was available, patients with a cancer diagnosis participated at a proportion higher than overall cancer prevalence and greater than the known proportion of COVID‐19 patients with cancer. CONCLUSION: This study observed that cancer history was not uniformly collected or reported among published COVID‐19 therapeutic studies. Among reported publications, we observed that patients with a cancer diagnosis were generally overrepresented. However, patients with a cancer diagnosis were notably underrepresented in outpatient COVID‐19 therapeutic studies. A large number of clinical trials testing a broad variety of interventions to treat SARS-CoV-2 infected patients have been reported since the onset of the global COVID-19 pandemic. In studies reported from the United States, the characteristics of study participants in COVID-19 treatment trials often do not reflect the distribution of the COVID-19 disease burden among the general population. In particular, racial and ethnic minorities face higher infection and mortality rates from COVID- 19 1 yet are underrepresented in COVID-19 therapeutic clinical research. 2 It is not known if other vulnerable populations, such as patients with a cancer diagnosis, are also underrepresented in these trials. The inclusion of cancer patients in COVID-19 therapeutic trials is of importance, as cancer patients may develop cancer-or treatment-related symptoms that may influence a clinician's ability to diagnose COVID- 19. 3 Furthermore, cancer treatments may also increase the risk of severe respiratory symptoms that can be seen with SARS-CoV-2 infection. 4 Due to the potential additional risks associated with SARS-CoV-2 infection among patients with a cancer diagnosis, inclusion of patients with a cancer diagnosis in clinical trials testing COVID-19 therapeutic interventions is essential. This study sought to examine the extent to which COVID-19 therapeutic clinical trials have reported on the comorbidity of cancer diagnosis and, when available, achieved representation among participants. March 1 to August 20, 2020 were identified by searching "COVID-19 drug therapy" on PubMed and searching "COVID-19" using the Clinical Query filter. As shown in Figure 1 Figure 2B illustrates that patients with cancer were overrepresented in both prospective (5.4%) and retrospective (8.73%) studies based on the overall percentage of COVID-19 patients with cancer (3.82%). While patients with cancer were overrepresented in inpatient studies (7.24%), as shown in Figure 2C , they were significantly underrepresented in outpatient studies (0.25%). The potential impact of a cancer diagnosis on COVID- 19 The authors have stated explicitly that there are no conflicts of interest in connection with this article. All study procedures received institutional ethical approval. 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