Search

Objectives: The term Postlaunch Evidence Generation (PLEG) refers to evidence generated after the launch or licensing of a health technology. The aim of this paper is to provide an overview of the implementation of these practices in the European Union in order to explore cross-border cooperation opportunities. Methods: In December 2019, a survey composed of nine closed-ended questions with multiple choice answers about the PLEG practices in each country was sent to all twenty-five dedicated work package (WP5B) partners of the European Network of Health Technology Assessment (EUnetHTA) Joint Action 3. In addition to the survey, the national practices were discussed during a face-to-face meeting with WP5B partners. Results: Twelve Health TechnologyAssessment (HTA) bodies completed the survey. Of these, eleven reported procedures in place for official requests for PLEGs in their remit. In the large majority of cases, the requests are made at the time of the assessment/appraisal. Several agencies participate in the definition of the scope of the PLEG or review of its protocol. Data collection and analysis mainly lie with companies for pharmaceuticals, whereas it is more the responsibility of the HTA bodies for medical devices. Only one agency owns the data and is able to exchange them without asking permission. Conclusions: Most agencies recommend European collaboration on PLEG commence once the evidence gaps have been defined or during the production of the HTA report in the case of European joint assessment. [ABSTRACT FROM AUTHOR]

Background: The treatment of choice for acute ischaemic stroke is the intravenous administration of recombinant tissue plasminogen activator within 3-4.5 h of symptom onset. However, the use of a thrombolytic would be limited by its narrow therapeutic window and contraindications. As a result, in recent years, techniques such as mechanical thrombectomy have emerged, which employ thrombus retrieval devices, such as stent retrievers (Solitaire™, Trevo® or Revive™), whose safety and efficacy in the endovascular treatment of acute ischaemic stroke is analysed in this article., Methods: A systematic literature search was undertaken until March 2015. The quality of evidence was assessed according to the GRADE methodology. A meta-analysis of the results of randomised controlled trials (RCTs) was performed, and the weighted average for the case series' sample size was calculated (Review Manager v5.2 and SPSS v19)., Results: Seventeen primary studies (2 RCTs, Solitaire™ and Trevo® vs. Merci®, and 15 case series) were selected. The RCT results show that stent retrievers have a safety profile similar to the Merci® device. However, both Solitaire™ and Trevo® achieved a higher recanalisation success rate (OR, 4.56; 95% CI, 2.63-7.90; p < 0.00001) and appropriate clinical outcome at 90 days (OR, 2.54; 95% CI, 1.52-4.25; p < 0.0004), although the 90-day mortality rate was similar in both groups (OR, 0.75; 95% CI, 0.17-3.37; p = 0.70)., Conclusions: Stent retrievers appear to be safe and effective devices, achieving high recanalisation rates and good clinical outcomes in the endovascular treatment of patients with acute ischaemic stroke due to the occlusion of intracranial arteries in comparison with the clot retriever Merci®.