Study goal: This study was carried out to answer the following research question: which motivation do healthy volunteers have to participate in phase I clinical trials? - Methods: A literature search was done through Google Scholar and Academic Search Premier, followed by three interviews with volunteers who had recently concluded their participation in a (non-commercial) phase I trial. - Results: Our literature search revealed mainly commercial motives for volunteers to participate in phase I clinical trials. The interviews (with volunteers in a non-commercial trial) showed that other factors may also play a decisive role, such as: (1) wish to support the investigator (2) wish to contribute to science, (3) access to more/better health care (4) sociability: possibility to relax and to communicate with other participants (5) general curiosity. Precondition is that risks and burden are deemed acceptable. - Conclusions: financial remuneration appears to be the predominant motive to participate voluntarily in a clinical trial. Other reasons were also mentioned however, such as general curiosity, the drive to contribute to science and the willingness to help the investigator. In addition, social reasons were given such as possibility to relax and to meet other people. Potential subjects state that they adequately assess the (safety) risks of participating in a trial as part of their decision process.
From the article: Abstract Sub-chronic toxicity studies of 163 non-genotoxic chemicals were evaluated in order to predict the tumour outcome of 24-month rat carcinogenicity studies obtained from the EFSA and ToxRef databases. Hundred eleven of the 148 chemicals that did not induce putative preneoplastic lesions in the sub-chronic study also did not induce tumours in the carcinogenicity study (True Negatives). Cellular hypertrophy appeared to be an unreliable predictor of carcinogenicity. The negative predictivity, the measure of the compounds evaluated that did not show any putative preneoplastic lesion in de sub-chronic studies and were negative in the carcinogenicity studies, was 75%, whereas the sensitivity, a measure of the sub-chronic study to predict a positive carcinogenicity outcome was only 5%. The specificity, the accuracy of the sub-chronic study to correctly identify non-carcinogens was 90%. When the chemicals which induced tumours generally considered not relevant for humans (33 out of 37 False Negatives) are classified as True Negatives, the negative predictivity amounts to 97%. Overall, the results of this retrospective study support the concept that chemicals showing no histopathological risk factors for neoplasia in a sub-chronic study in rats may be considered non-carcinogenic and do not require further testing in a carcinogenicity study.
PurposeThis study investigates patients’ experiences of interaction with their healthcare professionals (HCPs) during cancer treatment and identifies elements that HCPs can utilize to improve cancer care provision.MethodsPubMed, CINAHL, PsycINFO, SCOPUS, and Embase were systematically searched for relevant studies published from January 2010 until February 2022. Qualitative studies investigating adult patients’ perspectives on their interaction with HCPs during cancer treatment were included. Studies conducted during the diagnosis or end-of-life treatment phase were excluded. Duplicate removal, screening, and quality appraisal were independently performed by four reviewers using Covidence.org. We performed a thematic meta-synthesis of qualitative data extracted from studies meeting the quality criteria in three stages: excerpts coding, codes categorization, and theme identification by merging similar categories.ResultsEighty-eight studies were included for quality appraisal, of which 50 papers met the quality inclusion criteria. Three themes were identified as essential to positively perceived patient-HCP interaction: “Support, respect and agency”, “Quantity, timing, and clarity of information”, and “Confidence, honesty, and expertise”. Overall, patients experienced positive interaction with HCPs when the approach was person-centered and when HCPs possessed strong interpersonal skills. However, patients expressed negative experiences when their preferences regarding communication and the type of personal support needed were ignored.ConclusionsThis meta-synthesis emphasizes the importance for HCPs to recognize all patients’ needs, including communication and personal support preferences, to provide high-quality care. Consequently, healthcare professionals should continuously train their verbal and non-verbal communication, empathy, active listening, and collaboration skills during their undergraduate and continuing education.
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