Publicação
Investigator-initiated clinical trials (IICTs) in Portugal: clinical investigator needs and support from clinical research infrastructure networks
| Resumo: | Although the number of clinical trials is growing positively, both in Portugal and in other European countries, the number of investigator-initiated clinical trials (IICTs) remains very low. Nevertheless, IICTs are essential due the use of a patient-oriented approach, not aiming at the protection of a commercial institution's interests. In this type of studies, the ownership of the data and the intellectual property rights arise from the trial lies with the person or group of persons who conceives of and conducts the study. Despite its importance, these studies go through several challenges due to limited resources, financial constraints, lack of local supportive infrastructures, inadequate research training and complex and strict regulation. The involvement of local and distributed (i.e., spanning across different countries) infrastructures to support investigators throughout the entire process of a clinical study seems crucial to fulfil the requirements and achieve the objectives in IICTs. As such, the involvement of European Clinical Research Infrastructures Network (ECRIN) a non-profit organisation and a distributed network, and a Portuguese Clinical Research Infrastructure Network (PtCRIN), a national network encompassing multiple Portuguese partners, is a step in the right direction to increase the number of IICTs in Portugal, although still insufficient. In order to increase the number of clinical trials in Portugal, given its relevance both to raising the quality of life of individuals and to the wellbeing of society in general, it would be important to identify the problems and needs of clinical investigators and respective research centres to carry out further IICTs. Thus, the main goal of this work is to identify the type of support needed of clinical investigators and respective clinical research centre (CRCs) in Portugal to become more competitive in conducting IICTs. As secondary objective we intent to characterize the IICTs registered in Portugal from 2004 to 2018. This work will be under the framework of PtCRIN and will ultimately contribute to align the strategy of this national network of research infrastructures, with the needs of its members. To achieve this goal, a systematic search of trial registrations from 1 October 2004 to 30 September 2018 – using four clinical trials registries – was carried out to characterize the IICTs registered in Portugal. The Portuguese institutions (CRCs and investigators) conducting higher number of IICTs were identified and a survey on Google Forms was built and launched to the principal investigators of IICTs in order to characterize the investigator, identify their previous experience in commercial trials and IICTs, the support infrastructures and the needs that the investigator consider necessary for conducting IICTs. Three hundred and thirty-nine IICTs were identified in Portugal. Of these, 41.9% (n=142) were trials with medicinal products and 26.8% (n=91) behavioural trials, mostly sponsored by universities and funded by public organizations. The CRC that participates, as a recruiting center, in more IICTs in Portugal is the Hospital Centre of Lisboa Norte followed by the Portuguese Institute of Oncology Francisco Gentil of Lisbon (IPO-L) and Hospital Centre of São João. For the survey, 132 Portuguese investigators were identified. The survey was received by 94 investigators but only 18 (19.1%) answered it. The lack of specific funding for clinical research, the missing support infrastructures, such as CTUs, the statistical support and bureaucracy were the limitations more frequently pointed by these investigators. A wellstructured CTU can help investigators overcome most of these limitations. The needs that investigator identified in the survey are totally aligned with PtCRIN objectives and mission. PtCRIN started with two CTUs and in the last five years the number the CTU has increased to five. PtCRIN will continue to develop CTUs, provide support to national investigators seeking to internationalise clinical trials and also involve their country in clinical trials initiated by investigators in other European countries, develop specific forward-looking initiatives to show the importance of specific clinical research funding and how this might have impact on the national performance in IICTs. |
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| Autores principais: | Matias, Daniela Maria Sequeira |
| Assunto: | Investigator-initiated clinical trial Clinical research centre Clinical trial unit PtCRIN Teses de mestrado - 2019 |
| Ano: | 2019 |
| País: | Portugal |
| Tipo de documento: | dissertação de mestrado |
| Tipo de acesso: | acesso aberto |
| Instituição associada: | Universidade de Lisboa |
| Idioma: | inglês |
| Origem: | Repositório da Universidade de Lisboa |
| Resumo: | Although the number of clinical trials is growing positively, both in Portugal and in other European countries, the number of investigator-initiated clinical trials (IICTs) remains very low. Nevertheless, IICTs are essential due the use of a patient-oriented approach, not aiming at the protection of a commercial institution's interests. In this type of studies, the ownership of the data and the intellectual property rights arise from the trial lies with the person or group of persons who conceives of and conducts the study. Despite its importance, these studies go through several challenges due to limited resources, financial constraints, lack of local supportive infrastructures, inadequate research training and complex and strict regulation. The involvement of local and distributed (i.e., spanning across different countries) infrastructures to support investigators throughout the entire process of a clinical study seems crucial to fulfil the requirements and achieve the objectives in IICTs. As such, the involvement of European Clinical Research Infrastructures Network (ECRIN) a non-profit organisation and a distributed network, and a Portuguese Clinical Research Infrastructure Network (PtCRIN), a national network encompassing multiple Portuguese partners, is a step in the right direction to increase the number of IICTs in Portugal, although still insufficient. In order to increase the number of clinical trials in Portugal, given its relevance both to raising the quality of life of individuals and to the wellbeing of society in general, it would be important to identify the problems and needs of clinical investigators and respective research centres to carry out further IICTs. Thus, the main goal of this work is to identify the type of support needed of clinical investigators and respective clinical research centre (CRCs) in Portugal to become more competitive in conducting IICTs. As secondary objective we intent to characterize the IICTs registered in Portugal from 2004 to 2018. This work will be under the framework of PtCRIN and will ultimately contribute to align the strategy of this national network of research infrastructures, with the needs of its members. To achieve this goal, a systematic search of trial registrations from 1 October 2004 to 30 September 2018 – using four clinical trials registries – was carried out to characterize the IICTs registered in Portugal. The Portuguese institutions (CRCs and investigators) conducting higher number of IICTs were identified and a survey on Google Forms was built and launched to the principal investigators of IICTs in order to characterize the investigator, identify their previous experience in commercial trials and IICTs, the support infrastructures and the needs that the investigator consider necessary for conducting IICTs. Three hundred and thirty-nine IICTs were identified in Portugal. Of these, 41.9% (n=142) were trials with medicinal products and 26.8% (n=91) behavioural trials, mostly sponsored by universities and funded by public organizations. The CRC that participates, as a recruiting center, in more IICTs in Portugal is the Hospital Centre of Lisboa Norte followed by the Portuguese Institute of Oncology Francisco Gentil of Lisbon (IPO-L) and Hospital Centre of São João. For the survey, 132 Portuguese investigators were identified. The survey was received by 94 investigators but only 18 (19.1%) answered it. The lack of specific funding for clinical research, the missing support infrastructures, such as CTUs, the statistical support and bureaucracy were the limitations more frequently pointed by these investigators. A wellstructured CTU can help investigators overcome most of these limitations. The needs that investigator identified in the survey are totally aligned with PtCRIN objectives and mission. PtCRIN started with two CTUs and in the last five years the number the CTU has increased to five. PtCRIN will continue to develop CTUs, provide support to national investigators seeking to internationalise clinical trials and also involve their country in clinical trials initiated by investigators in other European countries, develop specific forward-looking initiatives to show the importance of specific clinical research funding and how this might have impact on the national performance in IICTs. |
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