The Heather Vole, Genus Phenacomys, in Alaska

Four specimens of heather vole (genus Phenacomys) collected in the coastal mountains of Southeast Alaska document the first Recent records of this vole in Alaska. Alternative hypotheses on the relationship of these newly-discovered populations to extant and historical populations are outlined, and additional studies proposed

A novel drug management system in the Febuxostat versus Allopurinol Streamlined Trial:A description of a pharmacy system designed to supply medications directly to patients within a prospective multicenter randomised clinical trial

Background: Trials of investigational medicinal products are required to adhere to strict guidelines with regard to the handling and supply of medication. Information technology offers opportunities to approach clinical trial methodology in new ways. This report summarises a novel pharmacy system designed to supply trial medications directly to patients by post in the Febuxostat versus Allopurinol Streamlined Trial.Method: A bespoke web-based software package was designed to facilitate the direct supply of trial medications to Febuxostat versus Allopurinol Streamlined Trial participants from a pharmacy based in the Medicines Monitoring Unit, University of Dundee.Results: To date, 65,467 packs of medication have been dispensed using the system to 3978 patients. Up to 238 packs per day have been dispensed.Conclusion: The Medicines Monitoring Unit Febuxostat versus Allopurinol Streamlined Trial drug management system is an effective method of administering the complex drug supply requirements of a large-scale clinical trial with advantages over existing arrangements. A low rate of loss to follow-up in the Febuxostat versus Allopurinol Streamlined Trial may be attributable to the drug management system.</p

Learning from remote decentralised clinical trial experiences:a qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders

AIMS: The aim of the study was to identify actionable learning points from stakeholders in remote decentralised clinical trials (RDCTs) to inform their future design and conduct. METHODS: Semistructured interviews were carried out with a purposive sample of stakeholders, including senior managers, trial managers, technology experts, principal investigators, clinical investigators, research scientists, research nurses, vendors, patient representatives and project assistants. The interview data were coded using a thematic approach, identifying similarities, differences and clustering to generate descriptive themes. Further refinement of themes was guided by empirical phenomenology, grounding explanation in the meanings that interviewees gave to their experiences. RESULTS: Forty‐eight stakeholders were interviewed. Actionable learning points were generated from the thematic analysis. Patient involvement and participant engagement were seen as critical to the success of RDCTs where in‐person contact is minimal or nonexistent. Involving patients in identifying the research question, creating recruitment materials, apps and websites, and providing ongoing feedback to trial participants were regarded as facilitating recruitment and engagement. Building strong relationships early with trial partners was thought to support RDCT conduct. Multiple modes of capturing information, including patient‐reported outcomes (PROs) and routinely collected data, were felt to contribute to data completeness. However, RDCTs may transfer trial activity burden onto participants and remote‐working research staff, therefore additional support may be needed. CONCLUSION: RDCTs will continue to face challenges in implementing novel technologies. However, maximising patient and partner involvement, reducing participant and staff burden, and simplifying how participants and staff interact with the RDCT may facilitate their implementation

When innovation outpaces regulations:The legal challenges for direct-to-patient supply of investigational medicinal products

AIMS: We profile the lack of specific regulation for direct‐to‐patient postal supply (DTP) of clinical trial medications (investigational medicinal products, IMPs) calling for increased efficiency of patient‐centred multi‐country remote clinical trials. METHODS: Questionnaires emailed to 28 European Economic Area (EEA) Medical Product Licensing Authorities (MPLAs) and Swissmedic MPLA were analysed in 2019/2020. The questionnaire asked whether DTP of IMPs was legal, followed by comparative legal analysis profiling relevant national civil and criminal liability provisions in 30 European jurisdictions (including The Netherlands), finally summarising accessible COVID‐19‐related guidance in searches of 30 official MPLA websites in January 2021. RESULTS: Twenty MPLAs responded. Twelve consented to response publication in 2021. DTP was not widely authorised, though different phrases were used to explain this. Our legal review of national laws in 29 EEA jurisdictions and Switzerland did not identify any specific sanctions for DTP of IMPs; however, we identified potential national civil and criminal liability provisions. Switzerland provides legal clarity where DTP of IMPs is conditionally legal. MPLA webpage searches for COVID‐19 guidance noted conditional acceptance by 19 MPLAs. CONCLUSIONS: Specific national legislation authorising DTP of IMPs, defining IMP categories, and conditions permitting the postage and delivery by courier in an EEA‐wide clinical trial, would support innovative patient‐centred research for multi‐country remote clinical trials. Despite it appearing more acceptable to do this between EU Member States, provided each EU MPLA and ethics board authorises it, temporary Covid‐19 restrictions in national Good Clinical Practice (GCP) guidance discourages innovative research into the safety and effectiveness of clinical trial medications

Home blood pressure monitors owned by participants in a large decentralised clinical trial in hypertension:the Treatment In Morning versus Evening (TIME) study

Various home blood pressure monitors (HBPMs) are available to the public for purchase but only some are validated against standardised protocols. This study aimed to assess whether HBPMs owned by participants taking part in a clinical trial were validated models. The TIME study is a decentralised randomised trial investigating the effect of antihypertensive medication dosing time on cardiovascular outcomes in adults with hypertension. No HBPMs were provided to participants in this trial but patients were asked to report if they already owned one. We identified the model of HBPM reported by participants, then cross-referenced this against lists of validated HBPMs produced by dabl Educational Trust and the British and Irish Hypertension Society (BIHS). Of 21,104 participants, 10,464 (49.6%) reported their model of HBPM. 7464 (71.3%) of these participants owned a monitor that could be identified from the participants’ entry. Of these, 6066 (81.3%) participants owned a monitor listed as validated by either dabl (n = 5903) or BIHS (n = 5491). Some were listed as validated by both. 1398 (18.7%) participants owned an identifiable HBPM that lacked clear evidence of validation. 6963 (93.3%) participants owned an upper arm HBPM and 501 (6.7%) owned a wrist HBPM. Validated HBPMs had a higher median online retail price of £45.00 compared to £20.00 for HBPMs lacking clear evidence of validation. A significant number of participants own HBPMs lacking evidence of validation

Mammal Fleas (Siphonaptera: Ceratophyllidae) New for Alaska and the Southeastern Mainland Collected During Seven Years of a Field Survey of Small Mammals

Ten taxa of mammal fleas were among 124 collection records from 12 host species (one shrew, nine rodents and two carnivores), at 72 localities on the southeastern Alaska mainland in 1989 and during an extensive survey of mammals in 1992-1995 and 1997-1999. Megabothris asio megacolpus (Jordan) ex Microtus pennsylvanicus (Ord), Malaraeus telchinus (Rothschild) ex Peromyscus keeni (Rhoads) and Clethrionomys gapperi (Vigors) are new fleas for Alaska. Orchopeas caedens (Jordan) ex Tamiasciurus hudsonicus (Erxleben) is a new flea for southeastern Alaska. Synaptomys borealis (Richardson) is a new host record for Opisodasys k. keeni (Baker). The other six taxa of fleas collected were Hystrichopsylla dippiei spinata Holland, H. o. occidentalis Holland, Catallagia charlottensis (Baker), Ceratophyllus ciliatus protinus Jordan, Megabothris abantis (Rothschild) and Opisodasys vesperalis (Jordan). Of these, H. o. occidentalis, C. charlottensis and M. abantis have seven new host records for the southeastern Alaska mainland. Distribution patterns of the fleas and their host relationships in North America are discussed