committee-on-elimination-of-racial-discrimination-decides-to-draft-guidance-document-on-states-obligation-to-undertake-measures-feb-20-2009-2pp

2014 ◽  
Vol 70 (3) ◽  
pp. 311
Author(s):  
David Gauvin ◽  
Jill Dalton ◽  
Margaret McComb ◽  
Robert Code ◽  
Michael Eliel ◽  
...  

2021 ◽  
Vol 37 (S1) ◽  
pp. 27-28
Author(s):  
John Scott ◽  
Moira McMurray ◽  
Rickie O'Connell ◽  
Pauline McGuire ◽  
Noreen Downes

IntroductionThe Scottish Medicines Consortium (SMC) conducts early health technology assessment (HTA) of new medicines on behalf of the National Health Service Scotland based on pharmaceutical company submissions. As the appraisals are conducted close to the point of marketing authorization, there is often a lack of direct head-to-head data. In 2019, assessment of relevant comparative efficacy was informed via indirect treatment comparisons (ITC) in 55 percent (36/66) of submissions. While the ITCs are essential to the decision-making process, they are frequently incomplete.MethodsA focus group was conducted with the clinical assessment team (n = 11) to explore problems in the submission process and to identify areas for improvement. It was agreed that providing improved guidance to companies prior to submission may prevent future inconsistencies. A working group (n = 5) was tasked with identifying and implementing potential solutions. The group reviewed the focus group findings, relevant literature, and guidance from other organizations. Draft guidance was developed that was reviewed by two pharmaceutical industry representatives (SMC subcommittee members).ResultsFindings from the focus group highlighted issues broadly related to the incomplete presentation and reporting of ITCs. The improved guidance document outlined specific requirements in a checklist format for reporting and presenting the results of different ITC data. This guidance was published in February 2020. To evaluate the impact of the updated guidance and to identify any further changes required, a follow-up focus group and survey of industry representatives is planned for March 2021.ConclusionsThe aim of the ITC guidance is to provide pharmaceutical companies with direction to improve the quality and transparency of reporting, which will in turn improve the quality of HTAs and thus strengthen the recommendations provided by the SMC. The follow-up focus groups and survey will assess the impact of the guidance. It is acknowledged that the results of this process may be limited by the small sample size and short duration of the assessment.


2021 ◽  
Author(s):  
Joanne Soo Min Kim ◽  
Michelle Pollock ◽  
David Kaunelis ◽  
Laura Weeks

Abstract BackgroundA systematic review (SR) helps us make sense of a body of research while minimizing bias and is routinely conducted to evaluate intervention effects in a health technology assessment (HTA). In addition to the traditional de novo SR, which combines the results of multiple primary studies, there are alternative review types that use systematic methods and leverage existing SRs, namely updates of SRs and overviews of SRs. This paper shares guidance that can be used to select the most appropriate review type to conduct when evaluating intervention effects in an HTA, with a goal to leverage existing SRs and reduce research waste where possible. MethodsWe identified key factors and considerations that can inform the process of deciding to conduct one review type over the others to answer a research question and organized them into guidance comprising a summary and a corresponding flowchart. This work consisted of three steps. First, a guidance document was drafted by methodologists from two Canadian HTA agencies based on their experience. Next, the draft guidance was supplemented with a literature review. Lastly, broader feedback from HTA researchers across Canada was sought and incorporated into the final guidance. ResultsNine key factors and six considerations were identified to help reviewers select the most appropriate review type to conduct. These fell into one of two categories: the evidentiary needs of the planned review (i.e., to understand the scope, objective, and analytic approach required for the review) and the state of the existing literature (i.e., to know the available literature in terms of its relevance, quality, comprehensiveness, currency, and findings). The accompanying flowchart, which can be used as a decision tool, demonstrates the interdependency between many of the key factors and considerations and aims to balance the potential benefits and challenges of leveraging existing SRs instead of primary study reports. ConclusionsSelecting the most appropriate review type to conduct when evaluating intervention effects in an HTA requires a myriad of factors to be considered. We hope this guidance adds clarity to the many competing considerations when deciding which review type to conduct and facilitates that decision-making process.


Author(s):  
Adam Toft ◽  
David Lidbury ◽  
Rossitza Miteva ◽  
Dimitar Vasilev

Risk-Informed In-Service Inspection (RI-ISI) aims to integrate service experience, plant and operating conditions, other deterministic information, and risk insights in developing augmented in-service inspection (ISI) programmes for Nuclear Power Plant (NPP). RI-ISI is a developing methodology which is increasingly being adopted world-wide, and is seen as having the potential to make ISI programmes more effective and efficient in terms of both nuclear safety and the economical operation of nuclear plant. The Nuclear Regulatory Agency (NRA) bears responsibility for regulating nuclear facilities in Bulgaria. In anticipation of a forthcoming application by Kozloduy NPP to adopt an RI-ISI programme for selected systems in WWER-1000 plant, the NRA required a suitable regulatory guidance document to help assess such an application. The UK Department of Trade and Industry-funded Project NSP/04-B23 “Assistance with the Regulatory Aspects of Risk-informed In-Service Inspection (RI-ISI)” has enabled the development of a guidance document, the initial draft of which was produced by Serco Assurance in close consultation with the NRA and other Bulgarian stakeholders. This paper presents a description of how current international best practice has been tailored to Bulgarian NPP, and provides a summary of the draft guidance document produced as the principal output of Project NSP/04-B23.


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