Differences in Participation in Experimental Drug Trials Among Persons With AIDS

Diaz, Theresa; Chu, Susan Y.; Sorvillo, Frank; Mokotoff, Eve D.; Davidson, Arthur J.; Samuel, Michael C.; Herr, Mary; Doyle, Brian; Frederick, Margaret; Fann, Alan S.; Conti, Lisa; Hermann, Pat; Checko, Patricia J.

doi:10.1097/00042560-199512050-00010

Cited by 13 publications

(18 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…For example, surveys in the US found that 10-23% of patients interviewed reported experimental antiretroviral use [10,12,14,23]. These figures are generally higher than what is reported in our study.…”

Section: Discussioncontrasting

confidence: 83%

Determinants of access to experimental antiretroviral drugs in an Italian cohort of patients with HIV: a multilevel analysis

Girardi

Scognamiglio

Angeletti

et al. 2012

BMC Health Serv Res

View full text Add to dashboard Cite

BackgroundIdentification of the determinants of access to investigational drugs is important to promote equity and scientific validity in clinical research. We aimed to analyze factors associated with the use of experimental antiretrovirals in Italy.MethodsWe studied participants in the Italian Cohort of Antiretroviral-Naive Patients (ICoNA). All patients 18 years or older who had started cART (≥ 3 drugs including at least two NRTI) after their enrolment and during 1997-2007 were included in this analysis. We performed a random effect logistic regression analysis to take into account clustering observations within clinical units. The outcome variable was the use of an experimental antiretroviral, defined as an antiretroviral started before commercial availability, in any episode of therapy initiation/change. Use of an experimental antiretroviral obtained through a clinical trial or an expanded access program (EAP) was also analyzed separately.ResultsA total of 9,441 episodes of therapy initiation/change were analyzed in 3,752 patients. 392 episodes (360 patients) involved an experimental antiretroviral. In multivariable analysis, factors associated with the overall use of experimental antiretrovirals were: number of experienced drugs (≥ 8 drugs versus "naive": adjusted odds ratio [AOR] = 3.71) or failed antiretrovirals(3-4 drugs and ≥ 5 drugs versus 0-2 drugs: AOR = 1.42 and 2.38 respectively); calendar year (AOR = 0.80 per year) and plasma HIV-RNA copies/ml at therapy change (≥ 4 log versus < 2 log: AOR = 1.55). The probability of taking an experimental antiretroviral through a trial was significantly lower for patients suffering from liver co-morbidity(AOR = 0.65) and for those who experienced 3-4 drugs (vs naive) (AOR = 0.55), while it increased for multi-treated patients(AOR = 2.60). The probability to start an experimental antiretroviral trough an EAP progressively increased with the increasing number of experienced and of failed drugs and also increased for patients with liver co-morbidity (AOR = 1.44; p = 0.053). and for male homosexuals (vs heterosexuals: AOR = 1.67). Variability of the random effect associated to clinical units was statistically significant (p < 0.001) although no association was found with specific characteristics of clinical unit examined.ConclusionsAmong patients with HIV infection in Italy, access to experimental antiretrovirals seems to be influenced mainly by exhaustion of treatment options and not by socio-demographic factors.

show abstract

Section: Discussioncontrasting

confidence: 83%

Determinants of access to experimental antiretroviral drugs in an Italian cohort of patients with HIV: a multilevel analysis

Girardi

Scognamiglio

Angeletti

et al. 2012

BMC Health Serv Res

View full text Add to dashboard Cite

show abstract

“…[12][13][14][15][16][17] Our results are consistent with these findings, indicating that subjects who were nonwhite, of lower educational level, and of younger age were less likely to accept research risk, even in a mock study format. The lower participation rates observed for these populations may in part reflect a general lack of trust in biomedical research.…”

Section: Discussionsupporting

confidence: 83%

Evaluating Acceptance and Understanding of Risk in the Emergency Department:Are All Risk Statements Created Equally?

Feldman

Risbano

Mitchell

et al. 2002

Academic Emergency Medicine

View full text Add to dashboard Cite

Abstract. Objective: To determine whether mathematically equivalent but conceptually different presentations of risk from radioactive isotope exposure might affect the rate of agreement to participate in a hypothetical research study. Methods: This was a prospective study of consenting English-speaking subjects more than 18 years of age who were asked whether they would agree to participate in a mock study when presented with six mathematically equivalent statements of research-related risk. Participants were classified as recognizing the equivalence of the risk statements if they accepted all or refused all of the risk statements. Results: Three hundred forty-six subjects were enrolled. There were 55 subjects (16%; 95% CI = 12% to 20%) who refused all of the six risk statements, and 23 participants (6.7%; 95% CI = 4% to 9%) who accepted all of the given risk statements. Most of the participants (77%; 95% CI = 73% to 82%) did not recognize that the six risk statements were equivalent and agreed to some, or did not understand some of the risk statements. In stepwise multivariate logistic regression, being white, being of older age, and having higher education were associated with a higher likelihood of accepting or rejecting all six of the risk statements. Conclusions: Ethnicity, age, and education affected whether patients recognized the equivalence of six risk statements for a hypothetical study of low-dose radiation. Risk acceptance may be more likely when familiar concepts are used to express research risks. Researchers must focus on strategies that enhance the understanding of research risks and address the reasons for nonparticipation by subjects who are younger, of different ethnic or cultural background, or of lower education.

show abstract

“…Although vaccine trials have been largely conducted in urban areas, our results indicate a greater WTP among urban residents. These results are in consonance with other HIV related studies which suggest that the poor and ethnic minorities show a less willingness to participate in clinical trials [27][28][29][30].…”

Section: Socio-demographic Attributes and Willingness To Participate supporting

confidence: 91%

Willingness to Participate (WTP) in HIV Vaccine Trials among Itinerant Female Hairdressers in Ibadan, Nigeria

Olanrewaju¹

2014

J AIDS Clin Res

View full text Add to dashboard Cite

Differences in Participation in Experimental Drug Trials Among Persons With AIDS

Cited by 13 publications

References 0 publications

Determinants of access to experimental antiretroviral drugs in an Italian cohort of patients with HIV: a multilevel analysis

Determinants of access to experimental antiretroviral drugs in an Italian cohort of patients with HIV: a multilevel analysis

Evaluating Acceptance and Understanding of Risk in the Emergency Department:Are All Risk Statements Created Equally?

Willingness to Participate (WTP) in HIV Vaccine Trials among Itinerant Female Hairdressers in Ibadan, Nigeria

Contact Info

Product

Resources

About