Investigational medicinal products, related costs and hospital pharmacy services for investigator-initiated trials: a mixed-methods study

BACKGROUND: Conducting high quality investigator-initiated trials (IITs) is challenging and costly. The costs of investigational medicinal products (IMPs) in IITs and the role of hospital pharmacies in the planning of IITs are unclear. We conducted a mixed-methods study to compare planned and actual costs of IMPs in Swiss IITs, to examine potential reasons for differences, and to gather stakeholder views about hospital services for IITs. METHODS: We included all IITs with IMP services from the Basel hospital pharmacy invoiced between January 2014 and June 2020 (n = 24). We documented trial and IMP characteristics including planned and actual IMP costs. Our working definition for a substantial cost difference was that the actual IMP costs were more than 10% higher than the planned IMP costs in a trial. We conducted semi-structured interviews with investigators, clinical trials unit and hospital pharmacy staff, and qualitatively analyzed transcribed interviews. RESULTS: For 13 IITs we observed no differences between planned and actual costs of IMPs (median, 11'000 US$; interquartile range [IQR], 8'882-16'302 US$), but for 11 IITs we found cost increases from a median of 11'000 US$(IQR, 8'922-36'166 US$) to a median over 28'000 US$(IQR, 13'004-49'777 US$). All multicenter trials and 10 of 11 IITs with patients experienced substantial cost differences. From the interviews we identified four main themes: 1) Patient recruitment and organizational problems were identified as main reasons for cost differences, 2) higher actual IMP costs were bearable for most investigators, 3) IMP services for IITs were not a priority for the hospital pharmacy, and 4) closer collaboration between clinical trial unit and hospital pharmacy staff, and sufficient staff for IITs at the hospital pharmacy could improve IMP services. CONCLUSIONS: Multicenter IITs enrolling patients are particularly at risk for higher IMP costs than planned. These trials are more difficult to plan and logistically challenging, which leads to delays and expiring IMP shelf-lives. IMP services of hospital pharmacies are important for IITs in Switzerland, but need to be further developed

Peningkatan Kemampuan Memnulis Cerpen Berdasarkan Pengalaman Ppribadi dengan Menggunkan Model Pembelajaran Think-talk-write

Penelitian ini ditujukan untuk mendeskripsikan penggunaan model pembelajaran think-talk-write dalam meningkatkan kemampuan menulis cerpen bagi siswa kelas IX SMP Negeri 04 Satu Atap Pinoh Selatan Tahun Pelajaran 2018/2019; Mendeskripsikan aktivitas menulis cerpen siswa menggunakan model pembelajaran think-talk-write siswa kelas IX SMP Negeri 04 Satu Atap Pinoh Selatan Tahun pelajaran 2018/2019; Mendeskripsikan peningkatan kemampuan menulis cerpen menggunakan model pembelajaran think-talk-write siswa kelas IX SMP Negeri 04 Satu Atap Pinoh Selatan Tahun Pelajaran 2018/2019. Metode penelitian adalah kualitatif dan bentuk penelitian adalah Penelitian Tindakan Kelas (PTK). Alat pengumpul data dalam penelitian ini adalah lembar observasi, tes, lembar wawancara. Subyek penelitian siswa kelas IX SMP Negeri 04 Satu Atap Pinoh Selatan yang berjumlah 27 orang. Hasil penelitian ditemukan bahwa penggunaan model pembelajaran think-talk-write di kelas IX SMP Negeri 04 Satu Atap Pinoh Selatan dapat meningkatkan aktivitas belajar siswa. peningkatan kemampuan menulis cerpen menggunakan model pembelajaran think-talk-write pada siswa kelas IX SMP Negeri 04 Satu Atap Pinoh Selatan dikategorikan sangat baik yaitu pada hasil siklus I ketuntasan belajar siswa adalah 74,07% dan pada siklus II mengalami peningkatan menjadi 92,59% sehingga terjadi peningkatan dari siklus I ke siklus II sebesar 18,52%., hal ini menunjukkan bahwa model pembelajaran think-talk-write mampu menjadi sebuah sarana yang menghantar pada pengembangan kemampuan berpikir (kognitif), bertindak (afektif), dan terampil menulis cerpen (psikomotorik). Penelitian ini disarankan bagi guru, siswa, sekolah dan penelitian selanjutnya dalam penggunaan model pembelajaran think-talk-write pada proses belajar mengajar khususnya pada mata pelajaran Bahasa Indonesia

The Anxiety of Lung-TB Patients Consuming Medicine more than 6 Months

Introductions: Treatment for pulmonary TB requires a long period of time, at least six months of taking medication. The impact of this long process results in saturation of pulmonary TB patients to complete their treatment program. This condition increases the patient's anxiety about the timeliness of taking medication regularly. This study aims to describe the level of anxiety of pulmonary TB patients while taking TB drugs for a period of more than 6 months in the working area of the Bakunase Health Center. Methods: This is a descriptive study with a cross sectional design approach. The sampling technique was total sampling with a total of 53 pulmonary TB patients. The research instrument used was the Zung Self-Ratining Anxiety Scale (SAS/SRAS) questionnaire. Descriptive statistical test analysis. Result: The results showed that the characteristics of pulmonary TB patients at the Bakunase Health Center were mostly 26-35 years old as many as 13 people, 28 women, 41 people with 6-12 months of treatment, housewives/not working and self-employed as many as 13 people, and 19 people have high school/high school education. The level of anxiety that occurs in pulmonary TB patients while taking TB drugs for a period of more than 6 months in the work area of the Bakunase Health Center has an average value of 46.83 with the highest value of 69 and the lowest being 27, pulmonary TB patients experience a mild level of anxiety. Conclusion: Characteristics of respondents based on age, gender, length of treatment, education, and occupation of pulmonary TB patients are factors that influence the level of anxiety. keywords: Kecemasan; pengobatan tuberkulosis; tingkat kecemasan; tuberkulosi

A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials

OBJECTIVES: To systematically assess the kind of placebos used in investigator-initiated randomized controlled trials (RCTs), where they are obtained, and what hurdles exist in obtaining them. STUDY DESIGN AND SETTING: PubMed was searched for recently published non-commercial, placebo-controlled randomized drug trials. Corresponding authors were invited to participate in an online survey. RESULTS: From 423 eligible articles, 109 (26%) corresponding authors (partially) participated. Twenty-one of 102 (21%) authors reported that the placebos used were not matching (correctly labelled in only 1 publication). The main sources in obtaining placebos were hospital pharmacies (32 of 107; 30%) and the manufacturer of the study drug (28 of 107; 26%). RCTs with a hypothesis in the interest of the manufacturer of the study drug were more likely to have obtained placebos from the drug manufacturer (18 of 49; 37% vs. 5 of 29; 17%). Median costs for placebos and packaging was 58,286 US$(IQR 2,428-160,770 US$; n=24) accounting for a median of 10.3% of the overall trial budget. CONCLUSION: Although using matching placebos is widely accepted as a basic practice in RCTs, there seems to be no standard source to acquire them. Obtaining placebos requires substantial resources and using non-matching placebos is common