Influences on recruitment to randomised controlled trials in mental health settings in England: a national cross-sectional survey of researchers working for the Mental Health Research Network

Background: Recruitment to trials is complex and often protracted; selection bias may compromise generalisability. In the mental health field (as elsewhere), diverse factors have been described as hindering researcher access to potential participants and various strategies have been proposed to overcome barriers. However, the extent to which various influences identified in the literature are operational across mental health settings in England has not been systematically examined. Methods: A cross-sectional, online survey of clinical studies officers employed by the Mental Health Research Network in England to recruit to trials from National Health Service mental health services. The bespoke questionnaire invited participants to report exposure to specified influences on recruitment, the perceived impact of these on access to potential participants, and to describe additional positive or negative influences on recruitment. Analysis employed descriptive statistics, the framework approach and triangulation of data. Results: Questionnaires were returned by 98 (58%) of 170 clinical studies officers who reported diverse experience. Data demonstrated a disjunction between policy and practice. While the particulars of trial design and various marketing and dommunication strategies could influence recruitment, consensus was that the culture of NHS mental health services is not donducive to research. Since financial rewards for recruitment paid to Trusts and feedback about studies seldom reaching frontline services, clinicians were described as distanced from research. Facing continual service change and demanding clinical workloads, clinicians generally did not prioritise recruitment activities. Incentives to trial participants had variable impact on access but recruitment could be enhanced by engagement of senior investigators and integrating referral with routine practice. Comprehensive, robust feasibility studies and reciprocity between researchers and clinicians were considered crucial to successful recruitment. Conclusions: In the mental health context, researcher access to potential trial participants is multiply influenced. Gatekeeping clinicians are faced with competing priorities and resources constrain research activity. It seems that environmental adjustment predicated on equitable resource allocation is needed if clinicians in NHS mental health services are to fully support the conduct of randomised controlled trials. Whilst cultural transformation, requiring changes in assumptions and values, is complex, our findings suggest that attention to practical matters can support this and highlight issues requiring careful consideration

Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency

Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG). A phase I study showed good local tolerability of IgPro20, a new 20% liquid SCIG stabilized with L-proline. A prospective, open-label, multicenter, single-arm, phase III study evaluated the efficacy and safety of IgPro20 in patients with PID over 15 months. Forty-nine patients (5–72 years) previously treated with IVIG received weekly subcutaneous infusions of IgPro20. The mean serum IgG level was 12.5 g/L. No serious bacterial infections were reported. There were 96 nonserious infections (rate 2.76/patient per year). The rate of days missed from work/school was 2.06/patient per year, and the rate of hospitalization was 0.2/patient per year. Ninety-nine percent of AEs were mild or moderate. No serious, IgPro20-related AEs were reported. IgPro20 effectively protected patients with PID against infections and maintained serum IgG levels without causing unexpected AEs

So Different, yet So Similar: Meta-Analysis and Policy Modeling of Willingness to Participate in Clinical Trials among Brazilians and Indians

BACKGROUND: With the global expansion of clinical trials and the expectations of the rise of the emerging economies known as BRICs (Brazil, Russia, India and China), the understanding of factors that affect the willingness to participate in clinical trials of patients from those countries assumes a central role in the future of health research. METHODS: We conducted a systematic review and meta-analysis (SRMA) of willingness to participate in clinical trials among Brazilian patients and then we compared it with Indian patients (with results of another SRMA previously conducted by our group) through a system dynamics model. RESULTS: Five studies were included in the SRMA of Brazilian patients. Our main findings are 1) the major motivation for Brazilian patients to participate in clinical trials is altruism, 2) monetary reimbursement is the least important factor motivating Brazilian patients, 3) the major barrier for Brazilian patients to not participate in clinical trials is the fear of side effects, and 4) Brazilian patients are more likely willing to participate in clinical trials than Indians. CONCLUSION: Our study provides important insights for investigators and sponsors for planning trials in Brazil (and India) in the future. Ignoring these results may lead to unnecessary fund/time spending. More studies are needed to validate our results and for better understanding of this poorly studied theme

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