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Introduction: Recruitment is an important aspect of clinical research, as poor recruitment could undermine the scientific value of a trial or delay the development process of new treatments. The development of electronic medical records provides a new way to identify potential participants for trials by matching the eligibility criteria with patients’ data within electronic medical records. Methods: A literature search was performed to examine the effectiveness and efficiency of the electronic medical record recruitment method using MEDLINE, PubMed, PubMed Central, CINAHL Plus with Full Text, ScienceDirect and Cochrane Library databases. These searches generated 11 articles that met the eligibility criteria, and handsearching reference lists generated two additional articles bringing the total number of articles to 13. These articles were subjected to critical appraisal utilising the Effective Public Health Practice Project tool. Results: Out of the 13 included articles, 11 provided quantitative data on recruitment effectiveness while seven articles provided quantitative data on recruitment efficiency. The automation in screening and patient identification by using alerts, a notification system, to notify research staff of a potential participant, was observed to contribute to higher recruitment yield and reduced workload due to its specificity on participant screening. The use of electronic medical record alerts was found to be associated with better recruitment outcomes when they were sent to dedicated research staff rather than physicians. Using electronic medical records for recruitment was found to be effective due to its capability for patient identification outside working hours and fast processing time, which was particularly useful for clinical trials in acute conditions. Several challenges may hinder the impact of the electronic medical record recruitment method, including the lack of conformity of clinical trial eligibility criteria and electronic medical record data structure and missing data. ‘Alert fatigue’ could also impact on the effectiveness of this method in the long term. Conclusion: The results from this review supports electronic medical record being an effective and efficient method for clinical trial recruitment. Recommendations were made in order to maximise the potential of the electronic medical record recruitment method and also for future research in order to improve the quality of evidence to support this strategy for recruitment.

In 2012, USA Food and Drug Administration (FDA) approved 39 new drugs, however, there are only two botanical drugs (one topical and one oral) approved by FDA since the publication of the FDA's industry guidelines for the botanical drug product in June 2004. The approval shows the Western guideline can be used for herbal medicines, authors investigate current regulation on herbal medicine clinical research, identify challenges conducting clinical trials, and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area. Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials. Authors critically explore case study of the 1st FDA approved botanical drugs, Veregen (sinecatechins), green tea leaves extract, a topical cream for perianal and genital condyloma. In consideration of current regulation environment in USA, based on the findings and analysis through the literature review and Veregen case study, authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considering in a herbal medicine clinical trial.

This systematic review describes tools which could be considered for use for holistic needs assessment (HNA) in brain cancer. MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and PsycINFO were searched. Studies were included which met the following criteria; primary research published in English which reported the development, psychometric testing or clinical utility testing of patient‐reported outcome measures (PROMs) for the assessment of adult brain cancer patients’ needs, problems or concerns or generic cancer needs assessment tools developed specifically on a brain cancer or brain tumour population. Nine articles describing four tools were identified. The tools were first assessed using the COSMIN protocol for systematic reviews of measurement properties and then assessed for their quality and usefulness as a holistic needs assessment tool. None of the four tools had strong psychometric properties; however, the two symptom questionnaires had better psychometric properties but would need adapted to holistically assess the multiple domains of need. The two HNA tools had only minimal psychometric testing. The lack of a tool, which adequately meets all requirements for HNA, supports the need to further development of tools to optimise this intervention.

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