Factores asociados con la participación de pacientes en ensayos clínicos en cáncer

Dueñas, José Alexander Carreño; Zabaleta, Yeinnyer Muleth; Díaz, María Elena; Calderón, Mariuxi Elizabeth Salvatierra; Pedraza, Ricardo Sánchez

doi:10.1016/j.rccan.2017.10.001

Cited by 2 publications

(2 citation statements)

References 18 publications

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“…A local study established that 64% of patients would be willing to participate in a CT and that the most determinant factors in the decision are related to the information received about the risks and benefits, participation rights and informed, independent consent. Other factors such as sociocultural factors and education level [ 23 ] in this study accepted to participate in clinical trials was 45.5%. Many patients when asked to participate in clinical trials express high expectations and concerns that include, among others, the fear of presenting a reduction in their quality of life, the concern about receiving a placebo, the potential side effects, the concern that the drug in research may not be the best option, strictness of participation, aversion to randomization, feeling coerced, and loss of control over your treatment decisions [ 24 – 26 ].…”

Section: Resultsmentioning

confidence: 99%

Comparison of clinical outcomes among cancer patients treated in and out of clinical trials

Duenas,

Sanchez P.,

Bonilla

2023

BMC Cancer

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Background It is unknown if participation in a cancer clinical trial confers clinical benefits to patients. There is not enough scientific evidence in this regard and the available publications are scarce and provide ambiguous and limited information. Objective Compare overall and progression-free survival and response to treatment among those who met the eligibility criteria and accepted to participate and those who refused to participate in cancer clinical trials. Methods An observational cross-sectional study with an analytical component was carried out, which included patients diagnosed with cancer who participated in phase III clinical trials and patients who, being eligible, refused to participate. The patients were cared for at the National Institute of Cancerology in Colombia between 2019 and 2022. Analysis of differences in proportions and means of sociodemographic and clinical variables was included; overall survival and progression-free survival time were described and the survival curves between groups were compared. Variables related to survival were determined using a Cox regression model and Hazard Ratios were calculated. Results 62 women and 50 men were included. In the women group, we found a statistical association between clinical trial participation and non-serious events adverse and progression. The stable disease and complete response were higher in participants than in refusers. The median progression-free survival for refusers was 7,4 m meantime for participants the median was not reached and 74,1% remained without progression at 28 months. In the men group, we also found a statistical association between clinical trial participation and the occurrence of non-serious events adverse meanwhile there were no significant differences in overall response, progression, and death, even though the proportion of progression was minor in participants 20% vs. refusers 26% respectively. The median survival was not reached for any group, even though in the participants group 55,2% were still alive at month 20 and in the refusers group still alive at 56,8% at month 45. Covariables included for the multivariate Cox regression only age had a statistical association with overall survival in the women’s group and the men group any covariables reached statistical association. Conclusion It can be considered that participation in clinical trials could give participants a better response to treatment, without increasing the probability of death and with the probability of decreasing the progression of the disease. Participation in trials could improve the outcomes of clinical response rates, no change in overall survival, and progression-free.

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Section: Resultsmentioning

confidence: 99%

Comparison of clinical outcomes among cancer patients treated in and out of clinical trials

Duenas,

Sanchez P.,

Bonilla

2023

BMC Cancer

View full text Add to dashboard Cite

show abstract

“…A local study established that 64% of patients would be willing to participate in a CT and that the most determinant factors in the decision are related to the information received about the risks and bene ts, participation rights and informed, independent consent. Other factors such as sociocultural factors and education level (23) in this study accepted to participate in clinical trials was 45.5%. Many patients when asked to participate in clinical trials express high expectations and concerns that include, among others, the fear of presenting a reduction in their quality of life, the concern about receiving a placebo, the potential side effects, the concern that the drug in research may not be the best option, strictness of participation, aversion to randomization, feeling coerced, and loss of control over your treatment decisions (24)(25)(26).…”

Section: Survivalmentioning

confidence: 91%

Comparison of clinical outcomes among cancer patients treated in and out of clinical trials

Dueñas

Sánchez

Bonilla

2023

Preprint

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Background. It is unknown if participation in a cancer clinical trial confers clinical benefits to patients. There is not enough scientific evidence in this regard and the available publications are scarce and provide ambiguous and limited information. Objective. Compare overall and progression-free survival and response to treatment among those who met the eligibility criteria and accepted to participate and those who refused to participate in cancer clinical trials. Methods. An observational cross-sectional study with an analytical component was carried out, which included patients diagnosed with cancer who participated in phase III clinical trials and patients who, being eligible, refused to participate. The patients were cared for at the National Institute of Cancerology in Colombia between 2019 and 2022. Analysis of differences in proportions and means of sociodemographic and clinical variables was included; overall survival and progression-free survival time were described and the survival curves between groups were compared. Variables related to survival were determined using a Cox regression model and Hazard Ratios were calculated. Results. 112 patients were included (51 participants and 61 refusers). Median progression-free survival for participants was 18.1 months (95%CI 14.0-22.2) vs 24.0 months (95%CI 16.4-31.5) in refusers p=0.23 and median overall survival for participants was 21.9 months (95CI % 17.6-26.1) vs refusers 33.2 months (CI95% 24.0-42.3), for the participating women it was 21.6 months (14.7-28.5 IC95%) vs refusers 22.7 months (9.3-36.0 IC95%) and for the group of participating men was 16.7 months (14.3-19.1 IC95%) and for refusers 32.4 months (25.5-39.3 IC95%). In the Cox proportional hazards model, only ECOG 1 was a better predictor of survival HR 0.48 (95%CI 0.23-0.97) p=0.042. Conclusion. This investigation found that participation in a clinical trial regarding rejection was associated with improved response rates, with no significant difference in overall or progression-free survival outcomes.

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Factores asociados con la participación de pacientes en ensayos clínicos en cáncer

Cited by 2 publications

References 18 publications

Comparison of clinical outcomes among cancer patients treated in and out of clinical trials

Comparison of clinical outcomes among cancer patients treated in and out of clinical trials

Comparison of clinical outcomes among cancer patients treated in and out of clinical trials

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