IntroductionThe COVID-19 pandemic led to a significant surge in clinical research activities in the search for effective and safe treatments. Attempting to disseminate early findings from clinical trials in a bid to accelerate patient access to promising treatments, a rise in the use of preprint repositories was observed. In the UK, NIHR Innovation Observatory (NIHRIO) provided primary horizon-scanning intelligence on global trials to a multi-agency initiative on COVID-19 therapeutics. This intelligence included signals from preliminary results to support the selection, prioritisation and access to promising medicines.MethodsA semi-automated text mining tool in Python3 used trial IDs (identifiers) of ongoing and completed studies selected from major clinical trial registries according to pre-determined criteria. Two sources, BioRxiv and MedRxiv are searched using the IDs as search criteria. Weekly, the tool automatically searches, de-duplicates, excludes reviews, and extracts title, authors, publication date, URL and DOI. The output produced is verified by two reviewers that manually screen and exclude studies that do not report results.ResultsA total of 36,771 publications were uploaded to BioRxiv and MedRxiv between March 3 and November 9 2020. Approximately 20–30 COVID-19 preprints per week were pre-selected by the tool. After manual screening and selection, a total of 123 preprints reporting clinical trial preliminary results were included. Additionally, 50 preprints that presented results of other study types on new vaccines and repurposed medicines for COVID-19 were also reported.ConclusionsUsing text mining for identification of clinical trial preliminary results proved an efficient approach to deal with the great volume of information. Semi-automation of searching increased efficiency allowing the reviewers to focus on relevant papers. More consistency in reporting of trial IDs would support automation. A comparison of accuracy of the tool on screening titles/abstract or full papers may help to support further refinement and increase efficiency gains.This project is funded by the NIHR [(HSRIC-2016-10009)/Innovation Observatory]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

IntroductionThe National Institute for Health and Care Research Innovation Observatory (IO) is a horizon scanning centre based at Newcastle University, United Kingdom. The IO provides horizon scanning intelligence on new and innovative medicinal products to the National Institute for Health and Care Excellence (NICE) as technology briefing notifications (TBNs). We present an analysis of how TBNs produced between April 2017 and October 2021 feed into the NICE HTA process and used to inform their Technology Appraisal (TA) programme.MethodsTBNs were mapped to relevant published NICE TA guidance and time from horizon scanning identification to NICE recommendation was studied. For mapping technologies undergoing appraisal, provisional guidance-in-development (GID) identification numbers (IDs) were used. For technologies that had not reached the NICE scoping stage yet, the NICE Topic Selection decision and ID was used.ResultsSix hundred and ninety-three TBNs were submitted to NICE between April 2017 and October 2021; 653 were prioritised for TA. Of those, eleven percent mapped to a published NICE TA guidance; forty-three percent to a GID, twenty-two percent were undergoing consultation, and three percent were not traced. Further twenty-one percent mapped to a suspended or terminated TA. Reasons for this included HTA timeliness, regulatory issues or companies unwilling to submit evidence to NICE. Time from technology identification to TA guidance publication ranged from twenty-two to 115 months. The average time from TBN submission to NICE recommendation was thirty months.ConclusionsTimely notification is key in achieving TA recommendation aligned with market authorization but not the only influencing factor. After issuing a TBN, the NICE appraisal process might be terminated, suspended or withdrawn due to unforeseen factors. Horizon scanning plays a key role triggering the NICE TA process; understanding factors that influence the successful TA completion would streamline processes and find efficiencies.

IntroductionThe National Institute for Health Research (NIHR) Innovation Observatory (NIHRIO) is the national Horizon Scanning (HS) organization in England, and the National Institute for Health and Care Excellence (NICE) is its key health technology assessment (HTA) stakeholder. NIHRIO has a remit to notify NICE of innovative technologies with a time horizon of three years prior to regulatory approval in the European Union (EU)/United Kingdom (UK). The notification process produces an initial ‘filtration form’ followed by a ‘technology briefing’ produced 17–20 months prior to licence for those technologies that NICE will consider for appraisal. Since April 2017, NIHRIO has produced ~400 technology briefings. We present an analysis of how this has fed into the NICE HTA process so far.MethodsThe analysis mapped NIHRIO's technology briefings (April 2017 – June 2020) with relevant NICE technology appraisal/highly specialized technologies (TA/HST) guidance during the time period. The analysis followed the timeline of technologies from identification during the horizon scanning process to filtration to briefing submission to NICE and entering the TA/HST process to outcome/recommendation given by NICE.ResultsUntil June 2020, 496 technology briefings entered the NICE TA/HST scoping process. Forty per cent are in progress, four per cent have had a TA/HST recommendation and three per cent that entered the NICE TA/HST scoping process did not complete it. On average it took less time from briefing submission to NICE recommendation for cancer indications. The time from discovery to NICE recommendation ranged from 115 months to 22 months.ConclusionsHS for TA/HST is a lengthy process from identification to final recommendation and there is considerable variation in time duration from identification to briefing submission to NICE recommendation. Average time taken from briefing submission to NICE recommendation is shorter for cancer indications and repurposed medicines. A full TA/HST may not be recommended for all technology briefings, rather they may update existing guidance or find different routes of evaluation. Technologies that enter the TA/HST scoping process might be terminated, suspended or discontinued for several reasons which may include lack of company engagement, change in development or regulatory plans by the company. Timely notification is key in achieving TA/HST recommendation at the time of market authorization but not the only influencing factor.