Running an international paediatric non-commercial clinical trial

Osborne, J. P.; O'Callaghan, Finbar

doi:10.1136/adc.2008.148494

Cited by 3 publications

(4 citation statements)

References 6 publications

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“…Osuntokun described this increasing regulatory burden over time, and discussed the difficulty for academic structures to apply the pediatrics regulations [ 5 ]. Indeed, these regulations are specifically targeted at pharmaceutical companies, and slow down academic research [ 24 , 38 ]. The upcoming European Clinical Trial Regulation should be a major determinant regarding this issue, particularly via the risk-proportionate approach.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, it has been shown that drugs frequently used in pediatric patients were underrepresented among drugs qualifying for pediatric exclusivity [ 17 , 21 – 23 ]. Therefore, in addition to industry-driven research, hospital-based investigation of pediatric drug therapy is needed [ 23 , 24 ].…”

Section: Introductionmentioning

confidence: 99%

“…However, previous studies identified the heavy regulatory burden [ 5 , 25 – 28 ], the pharmaceutical issues and difficulties in establishing contracts with pharmaceutical companies [ 25 , 26 , 29 – 32 ], the inadequate training of investigators, difficulty functioning as both clinician and investigator [ 5 , 25 , 27 , 33 – 37 ], as well as suboptimal communication across disciplines involved [ 25 ], as the main obstacles in conducting academic pediatric studies. Further obstacles relate to the complexity of the 2001 European directive and variability in its interpretation across European Union countries which have resulted in further delays in conducting trials, and has contributed to the loss of European competitiveness in academic research over the past decade [ 24 , 38 ]. Delays affect the competitiveness and attractiveness of European clinical research, and may also be deleterious for the patients, which dissuades some medical doctors from participation in clinical trials [ 5 , 25 , 26 , 33 ].…”

Section: Introductionmentioning

confidence: 99%

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Academic pediatric clinical research: factors associated with study implementation duration

Meier-Girard

Tibi

Abdoul

et al. 2016

BMC Med Res Methodol

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BackgroundThe ethical, methodological, and technical aspects of pediatric research, often results in complications and delays in implementation. Our objective was to identify factors associated with the implementation duration of hospital-based pediatric studies.MethodsAll hospital-based pediatric studies sponsored by AP-HP between 2002 and 2008 were retrospectively identified. Association of the funding mechanism and methodological factors with the implementation duration was assessed using a multivariable mixed linear model. Pharmaceutical factors were explored as part of a subgroup analysis restricted to the studies involving drug therapy. Given that we took an exploratory approach, factors associated with implementation duration with p < 0.10 were kept in the final models.ResultsA total of 139 studies were evaluated. The median implementation duration was 17.1 months (range: 0.9-55.3 months), and tended to increase over time (from 14.9 [25th percentile-75th percentile: 11.5-19.9] months in 2002 to 23.7 [15.2-31.0] months in 2008, p = 0.01). External (coefficient [95 % confidence interval]: -7.7 [-11.9;-3.5] months, p < 0.001) and internal funding (-5.3 95 % CI [-9.8;-0.8], p = 0.02) compared to governmental funding and number of centers (-0.1 95 % CI[-0.2;0.02] months for 1 center increase, p = 0.07) were associated with reduced duration, whereas interventional study (either involving drug therapy (6.0 95 % CI[0.7;11.3] months, p = 0.03 or not (3.5 95 % CI[-0.3;7.3] months, p = 0.06) was associated with increased duration compared to observational study. Regarding the 35 studies involving drug therapy, external funding decreased duration (-6.7 95 % CI[-13.2;-0.2] months, p = 0.05), whereas studies involving solely a pediatric population (7.8 95 % CI[1.1;14.5] months, p = 0.01) (compared to mixed adult-pediatric population), a placebo-controlled design (6.6 95 % CI[0.9;12.3] months, p = 0.01), and inappropriate drug formulation for at least one drug used in the study (6.9 95 % CI[-0.2;14.0] months, p = 0.06) were associated with increased duration.ConclusionImplementation of hospital-based pediatric studies primarily faced delays when they were interventional and, in particular, when they involved drug therapy. Regarding the latter, difficulties that resulted in delayed studies arose with respect to the supply of drugs and placebo in age-appropriate dosages and route of administration. Therefore, difficulties related to the use of pharmaceuticals need to be anticipated earlier in order to avoid implementation delays.Electronic supplementary materialThe online version of this article (doi:10.1186/s12874-016-0138-y) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Academic pediatric clinical research: factors associated with study implementation duration

Meier-Girard

Tibi

Abdoul

et al. 2016

BMC Med Res Methodol

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“…Over the past few years, there have been several reports indicating that the EU Directive has had an adverse effect on the implementation of noncommercial clinical trials conducted in the EU [2][3][4][5][6][7][8][9][10][11][12][13]. Some of the problems arise from specific requirements of the Directive including the need for a single trial sponsor for noncommercial trials, for insurance and indemnification, and for processes for adverse event reporting.…”

Section: Introductionmentioning

confidence: 99%

Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health

et al. 2010

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Background A number of reports have highlighted problems of conducting publicly funded trials in Europe as a consequence of the European Union (EU) Clinical Trials Directive. The impact of the EU Directive on multi-national trials, which include sites in Europe that are funded by the US National Institutes of Health (NIH) have not been described. Methods Four problems in the conduct of two international HIV treatment trials funded by NIH in the EU are described: (1) conflicting regulations on the continuing review of protocols by Institutional Review Boards/Research Ethics Committees; (2) US regulations requiring Federalwide Assurances for sites which are only partially funded by NIH; (3) EU guidance on the designation of studies as a trial of an investigational medicinal product; and (4) EU guidance on trial sponsorship and the requirements for insurance and indemnification. Following the description of the problems, recommendations for improving global collaborations are made to the US Office of Human Research Protections, to NIH, and to the EU and its Member States. Results A lack of harmonization of regulations at multiple levels caused enrollment in one study to be interrupted for several months and delayed for one year the initiation of another study aimed at obtaining definitive evidence to guide the timing of the initiation of antiretroviral therapy for individuals infected with HIV. The delays and the purchase of insurance resulted in substantial increases in trial costs and caused substantial disruption at clinical sites among staff and study participants. Limitations The problems cited and recommendations made pertain to trials funded by NIH and conducted by sites in the EU. There are many other challenges in the conduct of international research, public and private, that global harmonization would alleviate. Conclusions Disharmony, at multiple levels, in international regulations and guidelines is stifling publicly funded global research. International scientific organizations and government groups should make the documentation and solution of these problems a priority.

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The paediatric cancer clinical research landscape in Spain: a 13-year multicentre experience of the new agents group of the Spanish Society of Paediatric Haematology and Oncology (SEHOP)

et al. 2021

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Running an international paediatric non-commercial clinical trial

Cited by 3 publications

References 6 publications

Academic pediatric clinical research: factors associated with study implementation duration

Academic pediatric clinical research: factors associated with study implementation duration

Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health

The paediatric cancer clinical research landscape in Spain: a 13-year multicentre experience of the new agents group of the Spanish Society of Paediatric Haematology and Oncology (SEHOP)

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