Clinical trial allocation in multinational pharmaceutical companies – a qualitative study on influential factors

Abstract

Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were (1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site‐related qualities companies value most when selecting trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site‐related qualities. The results suggest that headquarters and regional departments are key decision makers during country selection, whereas subsidiaries decide on site selection. Study participants argued that headquarters primarily value timely patient recruitment and quality of data when assessing subsidiaries. The site‐related qualities most commonly emphasized during interviews were study population availability, timely patient recruitment, resources at the site, and site personnel's interest and commitment. Costs of running the trials were described as less important. Site personnel experience in conducting trials was described as valuable but not imperative. In conclusion, multinational pharmaceutical companies consider recruitment‐related factors as crucial when allocating clinical trials. Quality of data and site personnel's interest and commitment are also essential, whereas costs seem less important. While valued, site personnel experience in conducting clinical trials is not imperative.

Criteria for site selection in industry-sponsored clinical trials: a survey among decision-makers in biopharmaceutical companies and clinical research organizations

“…Knowledge of what the pharmaceutical industry emphasizes when selecting European trial sites is sparse; to our knowledge, only two publicly available studies have investigated this [2, 3]. They indicate that recruitment-related factors are pivotal whereas costs are less important.…”

“…The aim of this study was to investigate which site-related qualities multinational biopharmaceutical companies and CROs find most important during site selection and while running clinical trials in the Nordic countries. In continuation of the findings by Gehring et al [3] and findings we made in an interview study conducted in 2016 [2], we particularly focused on recruitment-related factors, costs, and experience in conducting clinical trials. Three main assumptions generated from this previous research were explored: Biopharmaceutical companies and CROs find that recruitment-related factors (i.e.…”

Cross-Border Access to Clinical Trials in the EU: Exploratory Study on Needs and Reality

“…For the same period, phase III clinical trials (all indications) were distributed relatively equally, which is in line with previously reported trends about the increasing clinical trial activity of pharmaceutical companies in Western and Eastern Europe (5,6). Numerous regulatory and legal barriers make the conduct of pan-European clinical trials challenging for sponsors (7,8) and many different criteria inform decision-making for site selection (9)(10)(11). In recent years, new molecularly driven trial designs impose hurdles linked to the prevalence of biomarkers and potentially severe limitations in the availability of a specific study population (12).…”

Inovação e interação: as redes de ensaios clínicos e o Brasil

“…No entanto, para os estudos nos quais os pesquisadores obtiveram aprovação regulamentar, o Brasil apresentou destacado desempenho em relação à alta capacidade dos centros de pesquisa clínica no Brasil para o recrutamento de sujeitos de pesquisa (Russo et al, 2016 (Dombernowsky et al, 2017).…”

“…No entanto, é sabido que o tamanho do país não explicaria completamente o fenômeno da alocação desses estudos, a julgar pelo destaque da participação de países pequenos e a baixa atuação de grandes países. A capacidade de julgamento sobre os critérios de recrutamento e exclusão também tem sido apontada como uma questão de grande relevância(Dombernowsky et al, 2017).Todos os entrevistados ocupam alguma posição de coordenação ou direção em relação às pesquisas clínicas conduzidas nas respectivas organizações. O tempo de atuação profissional deles é de pelo menos dois anos.Seis entrevistas foram conduzidas face a face, enquanto as outras duas foram realizadas por telefone, por conveniência dos próprios entrevistados.…”