Barriers in phase I cancer clinical trials referrals and enrollment: five-year experience at the Princess Margaret Hospital

BACKGROUND: There is a paucity of literature on the referral outcome of patients seen in phase I trial clinics in academic oncology centres. This study aims to provide information on the accrual rate and to identify obstacles in the recruitment process. METHODS: A retrospective chart review was performed for all new patients referred and seen in the phase I clinic at the Princess Margaret Hospital between January 2000 and June 2005. Data on their demographics, medical history, and details of trial participation or non-entry were recorded. RESULTS: A total of 667 new phase I referrals were seen during the stated period. Of these patients, 197 (29.5%) patients were enrolled into a phase I trial, and 64.5% of them started trial within 1 month of the initial visit. About a quarter (165 of 667) of the patients referred were deemed ineligible at their first visit, with the most frequent reasons for ineligibility being poor performance status, unacceptable bloodwork, too many prior treatments and rapid disease progression. The remaining 305 patients (45.7%) were potentially eligible at their initial visit, but never entered a phase I trial. The main reasons for their non-entry were patient refusal, other treatment recommended first, and lack of available trials or trial spots. CONCLUSION: This study provides information on the clinical realities underlying a referral to a phase I clinic and eventual trial enrollment. Better selection of patients, appropriate education of referring physicians, and opening phase I trials with fewer restrictions on some criteria such as prior therapy may enhance their recruitment rates

Perfil de sujeitos de pesquisa clínica em um centro ambulatorial independente Profile of clinical research subjects in an independent outpatient center

Este artigo tem como objetivos avaliar a qualidade de atendimento de um centro de pesquisa clínica e o entendimento do termo de consentimento informado (TCLE); determinar os motivos da participação e detalhar níveis socioeconômicos. Foi feito um estudo transversal em centro de pesquisa ambulatorial, através de questionário auto-explicativo. Dos cem questionários avaliados, todos os sujeitos de pesquisa consideraram o centro como ótimo (86%) ou bom (9%). A quase totalidade foi bem informada do conteúdo do TCLE e o conhecimento do direito "confidencialidade", comum a todos os TCLEs, foi seis vezes maior que " acesso aos dados", que não faz parte. Os principais motivos para participarem foram para "saber mais sobre a sua saúde" (59%) e para "beneficiar outras pessoas no futuro" (47%). A principal faixa de renda salarial dos participantes foi entre dois e cinco salários mínimos (48%) e a maioria (66%) concluiu pelo menos até a 4º série do ensino fundamental. A população possui o mesmo perfil econômico do Rio de Janeiro, nível de escolaridade suficiente para assinar e compreender o que está assinando, conhecendo não só a existência do TCLE, mas demonstrando conhecer seu conteúdo. O motivo principal para participação é para autobenefício e por atitude altruísta.<br>This paper assesses the quality of assistance in a clinical trial outpatient center as well as the patients´understanding of the informed consent (IC); determine the reasons why they participate and detail socio-economic levels. A cross-sectional study was adopted in a clinical trial outpatient center using a self-explanatory questionnaire. All 100 respondents considered the assistance at the center excellent (86%) or good (9%). Almost all of them were well informed about the content of the IC. Their knowledge about the right to "confidentiality", present in all ICs, was 6 times higher than their knowledge about their right to "access the results", generally not included in the IC. The main reasons for participating were "to know more about ones health" (59%) and to "to benefit other people in the future" (47%). The participants´ income varied from 3 to 5 minimum wages (48%) and most (66%) concluded at least the 4th grade of basic education in Brazil. The subjects showed the economical characteristics of the average population of Rio de Janeiro. Their level of education allowed them to sign and to understand what they were signing. They were aware of the existence of the IC and its content. The main reason for participating was for one´s own benefit and for the benefit of others