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The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.

ABSTRACT: AIMS:The parallel regulatory-health technology assessment scientific advice (PSA) procedure allows manufacturers to receive simultaneous feedback from both EU regulators and health technology assessment (HTA) bodies on development plans for new medicines. The primary objective of the present study is to investigate whether PSA is integrated in the clinical development programmes for which advice was sought. METHODS:Contents of PSA provided by regulators and HTA bodies for each procedure between 2010 and 2015 were analysed. The development of all clinical studies for which PSA had been sought was tracked using three different databases. The rate of uptake of the advice provided by regulators and HTA bodies was assessed on two key variables: comparator/s and primary endpoint. RESULTS:In terms of uptake of comparator recommendations at the time of PSA in the actual development, our analysis showed that manufacturers implemented comparators to address both the needs of regulators and of at least one HTA body in 12 of 21 studies. For primary endpoints, in all included studies manufacturers addressed both the needs of the regulators and at least one HTA body. CONCLUSIONS:One of the key findings of this analysis is that manufacturers tend to implement changes to the development programme based on both regulatory and HTA advice with regards to the choice of primary endpoint and comparator. It also confirms the challenging choice of the study comparator, for which manufacturers seem to be more inclined to satisfy the regulatory advice. Continuous research efforts in this area are of paramount importance from a public health perspective.

SUBMITTER: Tafuri G

PROVIDER: S-EPMC5903262 | biostudies-other | 2018 May

REPOSITORIES: biostudies-other

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The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.

Tafuri Giovanni G Lucas Inês I Estevão Steve S Moseley Jane J d'Andon Anne A Bruehl Hannah H Gajraj Elangovan E Garcia Sonia S Hedberg Niklas N Massari Marco M Molina Andrea A Obach Mercè M Osipenko Leeza L Petavy Frank F Petschulies Marco M Pontes Caridad C Russo Pierluigi P Schiel Anja A Van de Casteele Marc M Zebedin-Brandl Eva-Maria EM Rasi Guido G Vamvakas Spiros S

British journal of clinical pharmacology 20180305 5

<h4>Aims</h4>The parallel regulatory-health technology assessment scientific advice (PSA) procedure allows manufacturers to receive simultaneous feedback from both EU regulators and health technology assessment (HTA) bodies on development plans for new medicines. The primary objective of the present study is to investigate whether PSA is integrated in the clinical development programmes for which advice was sought.<h4>Methods</h4>Contents of PSA provided by regulators and HTA bodies for each pro ...[more]

PMID: 29370449

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Project description:BackgroundFollowing approximately 10 years from the beginning of Iran's national Health Technology Assessment (HTA) programme, the present study aims to evaluate its success by examining the impact of HTA and identifying the determinant factors leading to the implementation of HTA report results.MethodsThe triangulation method was employed herein. HTA reports were initially identified and their impact and determinant factors were then examined from the perspectives of both researchers (by preparing a questionnaire according to the Payback model and sending it to HTA principle investigators) and stakeholders (semi-structured interviews held with each HTA stakeholder). Simultaneously, the quality of the HTA reports was examined with relevant critical appraisal checklists.ResultsThe impact of 19 equipment technologies and four pharmaceutical technologies were assessed in this study. Twenty researchers replied (response rate, 86.96%) to the questionnaire on the impact of HTA reports from the researcher's perspective. To assess the impact of HTA reports from the stakeholder's perspective, seven policy-makers were chosen and interviewed as the main target audience. The most common step taken to disseminate the results of the HTA projects was publication. Conducting the HTA had taught researchers and their colleagues' new skills and had facilitated the securing of research grants from other organisations. Most reports had used the systematic review method but the relevant details had been scarcely presented regarding outcomes, costs and analysis. The greatest impact of HTA reports on decision-making had been on policy-makers providing and allocating finances. Barriers in stewardship, identification and prioritisation of topics, performance and dissemination of HTA results were the main barriers of implementing HTAs.ConclusionsIn most aspects, the status of HTA impact reports need improvement. Thus far, the barriers and facilitators of the HTA programme in Iran have been investigated in other studies. These findings should be pooled to reach a solution that can be actively applied to the health system to improve the status quo of HTA in Iran.

Project description:BackgroundThe Government of Indonesia implemented health technology assessment (HTA) to ensure quality and cost control in the National Health Insurance Program (Jaminan Kesehatan Nasional/JKN). The current aim of the study was to improve the usefulness of future economic evaluation for resource allocation by appraising current methodology, reporting, and source of evidence quality of studies.MethodsThe inclusion and exclusion criteria were applied to search for relevant studies using a systematic review. The methodology and reporting adherence were appraised according to Indonesia's HTA Guideline issued in 2017. The differences in adherence before and after the guideline dissemination were compared using Chi-square and Fisher's exact tests for methodology adherence wherever appropriate, and the Mann-Whitney test for reporting adherence. The source of evidence quality was assessed using evidence hierarchy. Two scenarios of the study start date and the guideline dissemination period were tested using sensitivity analyses.FindingsEighty-four studies were obtained from PubMed, Embase, Ovid, and two local journals. Only two articles cited the guideline. No statistically significant difference (P > 0.05) was found between the pre-dissemination and post-dissemination period with respect to methodology adherence, except for outcome choice. Studies during the post-dissemination period showed a higher score for reporting which was statistically significant (P = 0.01). However, the sensitivity analyses revealed no statistically significant difference (P > 0.05) in methodology (except for modelling type, P = 0.03) and reporting adherence between the two periods.InterpretationThe guideline did not impact the methodology and reporting standard used in the included studies. Recommendations were provided to improve the usefulness of economic evaluations for Indonesia.FundingThe Access and Delivery Partnership (ADP) hosted by the United Nations Development Programme (UNDP) and the Health Systems Research Institute (HSRI).

Dataset Information

The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.

Publications

The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.

Similar Datasets

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