Title of Research
Start Date
19-3-2018 10:00 AM
End Date
19-3-2018 11:30 AM
Abstract
Systematic Review: Diversity of Enrollment in Multiple Myeloma Drug Trials Among Different Ethnicities
Kaitlin Adams & Laura Guerrieri
Faculty Sponsor: Dr. Joseph Tariman
Background & Significance: Multiple Myeloma is 2 to 3 times more prevalent in non-Hispanic Blacks (NHBs) when compared to Non-Hispanic Whites (NHWs), and the overall survival is also dissimilar between these two racial groups. Among patients 65 to 74 years of age, the 10-year Relative Survival Rates (RSRs) have been found to be statistically improved for NHWs (13.3% vs. 20.5%; p =p = .06). Since 2003, The FDA has approved 10 new drugs for myeloma treatment and they have been credited for the improvement in the 10-year RSRs.
Objective: The objective of this systematic review is to determine if there are statistically significant differences in clinical drug trial participation rates between NHW and NHB and other racial group such as Hispanics after adjusting for the incidence of myeloma for each of these three racial groups.
Methods: This systematic review analyzed 37 clinical drug trial publications for their reporting on age, ethnicity, and gender enrollment. In these 37 clinical drug trials, eight out of 10 FDA-approved drugs were investigated: bortezomib, carfilzomib, ixazomib, lenalidomide, pomalidomide, elotuzumab, daratumumab and panobinostat. Descriptive and independent samples t test statistics were used to analyze the data.
Results: After the analysis of sociodemographic data across the 37 clinical drug trials for myeloma, the average percent of NHBs’ participation in myeloma drug trial was 5.3% versus 83% (p = .000) of NHWs’ participation in myeloma drug trial. The average number of NHWs enrolled in these clinical drug trials came out to be 394.27 compared to the NHBs’ average enrollment of only 11.73. The average number of female participants was 172.68, while the average number of male participants was 197.87. Detailed information on study results can be found in Table 1.
Conclusion: The statistically significant low enrollment of NHBs in myeloma clinical drug trial brings up many questions. It is not understood why NHBs are not adequately enrolled in these clinical trials, but this study was not investigating that. So more investigation will be needed to find an answer as to why NHBs are not enrolled more in myeloma clinical drug trials. Another aspect that needs to be investiaged is why some studies do not report the ethnicities of their participants. The NHBs population could be enrolled more frequently in these studies than what the literature suggests. However, this is hard to know since the researchers and journal editors do not consistently report the statistical data on the participants’ ethnicities. Interventions to improve NHBs participation in myeloma drug clinical trials should be developed to close this racial gap.
Keywords
multiple myeloma, randomized controlled trial, drug trial, clinical trial, ethnicity, bortezomib, carfilzomib, ixazomib, lenalidomide, pomalidomide, elotuzumab, daratumumab, panobinostat
Included in
Systematic Review: Diversity of Enrollment in Multiple Myeloma Drug Trials Among Different Ethnicities
Systematic Review: Diversity of Enrollment in Multiple Myeloma Drug Trials Among Different Ethnicities
Kaitlin Adams & Laura Guerrieri
Faculty Sponsor: Dr. Joseph Tariman
Background & Significance: Multiple Myeloma is 2 to 3 times more prevalent in non-Hispanic Blacks (NHBs) when compared to Non-Hispanic Whites (NHWs), and the overall survival is also dissimilar between these two racial groups. Among patients 65 to 74 years of age, the 10-year Relative Survival Rates (RSRs) have been found to be statistically improved for NHWs (13.3% vs. 20.5%; p =p = .06). Since 2003, The FDA has approved 10 new drugs for myeloma treatment and they have been credited for the improvement in the 10-year RSRs.
Objective: The objective of this systematic review is to determine if there are statistically significant differences in clinical drug trial participation rates between NHW and NHB and other racial group such as Hispanics after adjusting for the incidence of myeloma for each of these three racial groups.
Methods: This systematic review analyzed 37 clinical drug trial publications for their reporting on age, ethnicity, and gender enrollment. In these 37 clinical drug trials, eight out of 10 FDA-approved drugs were investigated: bortezomib, carfilzomib, ixazomib, lenalidomide, pomalidomide, elotuzumab, daratumumab and panobinostat. Descriptive and independent samples t test statistics were used to analyze the data.
Results: After the analysis of sociodemographic data across the 37 clinical drug trials for myeloma, the average percent of NHBs’ participation in myeloma drug trial was 5.3% versus 83% (p = .000) of NHWs’ participation in myeloma drug trial. The average number of NHWs enrolled in these clinical drug trials came out to be 394.27 compared to the NHBs’ average enrollment of only 11.73. The average number of female participants was 172.68, while the average number of male participants was 197.87. Detailed information on study results can be found in Table 1.
Conclusion: The statistically significant low enrollment of NHBs in myeloma clinical drug trial brings up many questions. It is not understood why NHBs are not adequately enrolled in these clinical trials, but this study was not investigating that. So more investigation will be needed to find an answer as to why NHBs are not enrolled more in myeloma clinical drug trials. Another aspect that needs to be investiaged is why some studies do not report the ethnicities of their participants. The NHBs population could be enrolled more frequently in these studies than what the literature suggests. However, this is hard to know since the researchers and journal editors do not consistently report the statistical data on the participants’ ethnicities. Interventions to improve NHBs participation in myeloma drug clinical trials should be developed to close this racial gap.
Keywords
multiple myeloma, randomized controlled trial, drug trial, clinical trial, ethnicity, bortezomib, carfilzomib, ixazomib, lenalidomide, pomalidomide, elotuzumab, daratumumab, panobinostat