Improving Risk Assessment in Clinical Trials: Toward a Systematic Risk-Based Monitoring Approach

Regulatory authorities have encouraged the usage of a monitoring (RBM) system in clinical trials before trial initiation for detection of potential risks and inclusion of a mitigation plan in the monitoring strategy. Several RBM tools were developed after the International Council for Harmonization gave sponsors the flexibility to initiate an approach to enhance quality management in a clinical trial. However, various studies have demonstrated the need for improvement of the available RBM tools as each does not provide a comprehensive overview of the characteristics, focus, and application. This research lays out a rationale for a risk methodology assessment (RMA) within the RBM system. The core purpose of RMA is to deliver a scientifically based evaluation and decision of any potential risk in a clinical trial. Thereby, a monitoring plan can be developed to elude prior identified risk outcome. To demonstrate RMA's theoretical approach in practice, a Shiny web application (R Foundation for Statistical Computing) was designed to describe the assessment process of risk analysis and visualization tools that eventually aid in focusing monitoring activities. RMA focuses on the identification of an individual risk and visualizes its weight on the trial. The scoring algorithm of the presented approach computes the assessment of the individual risk in a radar plot and computes the overall score of the trial. Moreover, RMA's novelty lies in its ability to decrease biased decision making during risk assessment by categorizing risk influence and detectability; a characteristic pivotal to serve RBM in assessing risks, and in contributing to a better understanding in the monitoring technique necessary for developing a functional monitoring plan. Future research should focus on validating the power of RMAs to demonstrate its efficiency. This would facilitate the process of characterizing the strengths and weaknesses of RMA in practice. © 2021 The Author(s

Patient Benefit of Clinical Research in Diversely Advanced African Developing Countries

Background: The globalization of clinical research should also benefit the population in developing markets. In this context, the approval of tested medicines and the associated expansion of medical care beyond clinical studies would be desirable as a possible long-term benefit. Objectives: This study was designed to compare the development of the number of clinical trials with the number of marketing authorizations of medicines on the African continent. To contrast these 2 parameters, the data were analyzed using the model of an ecological study. Methods: To reflect the broad spectrum of African developing countries with diverse levels of development, the data collection was based on 2 geographically selected sample countries each from Central, North, East, West, and Southern Africa. Based on the ClinicalTrials.gov registry, the first step was to collect trends data on the development of the clinical trials in the 10 selected countries of the country list of the African Region published by the World Health Organization for the period 2015 to 2018. Subsequently, data on the current number of marketing authorizations of medicines in the selected sample countries were identified using the online registries of the national authorities. The data were utilized in comparative analyses. Results: Eight out of 10 model countries showed an increase in the number of clinical trials, with the exceptions of Cameroon and Libya, which showed an overall decline in research activity over the entire time. In direct comparison with drug registrations, the numbers indicate a similar development. The only exception here is Nigeria, a country with a solid performance in clinical research and yet a decrease in medicine registrations since 2015. Conclusions: The expected increase in the development of clinical research as result of the globalization trend can basically be observed in most of the model countries. However, this increase does not guarantee an improvement in the number of medicine registrations. Although this is evident in some of the selected model countries, it cannot be projected to the entire African region. This may be linked to the diverse development of the individual countries due to the different political situations and the varying degrees of clinical research infrastructure. (Curr Ther Res Clin Exp. 2022; 82:XXX–XXX) © 2021 The Author(s

Mothers’ perception of recovery and satisfaction with patent medicine dealers’ treatment of childhood febrile conditions in rural communities

Background Infant mortality in rural areas of Nigeria can be minimized if childhood febrile conditions are treated by trained health personnel, deployed to primary healthcare centres (PHCs) rather than the observed preference of mothers for patent medicine dealers (PMDs). However, health service utilization/patronage is driven by consumer satisfaction and perception of services/product value. The objective of this study was to determine ‘mothers’ perception of recovery’ and ‘mothers’ satisfaction’ after PMD treatment of childhood febrile conditions, as likely drivers of mothers’ health-seeking behaviour, which must be targeted to reverse the trend. Methods Ugwuogo-Nike, in Enugu, Nigeria, has many PMDs/PHCs, and was selected based on high prevalence of childhood febrile conditions. In total, 385 consenting mothers (aged 15–45 years) were consecutively recruited at PMD shops, after purchasing drugs for childhood febrile conditions, in a cross-sectional observational study using a pre-tested instrument; 33 of them (aged 21–47 years) participated in focus group discussions (FGDs). Qualitative data were thematically analysed while a quantitative study was analysed with Z score and Chi square statistics, at p < 0.05. Results Most participants in FGDs perceived that their child had delayed recovery, but were satisfied with PMDs’ treatment of childhood febrile conditions, for reasons that included politeness, caring attitude, drug availability, easy accessibility, flexibility in pricing, shorter waiting time, their God-fearing nature, and disposition as good listeners. Mothers’ satisfaction with PMDs’ treatment is significantly (p < 0.05) associated with mothers’ perception of recovery of their child (χ2 = 192.94, df = 4; p < 0.0001; Cramer’s V = 0.7079). However, predicting mothers’ satisfaction with PMDs’ treatment from a knowledge of mothers’ perception of recovery shows a high accord (lambda[A from B] = 0.8727), unlike when predicting mothers’ perception of recovery based on knowledge of mothers’ satisfaction with PMDs’ treatment (lambda[A from B] = 0.4727). Conclusions Mothers’ satisfaction could be the key ‘driver’ of mothers’ health-seeking behaviour and is less likely to be influenced by mothers’ perception of recovery of their child. Therefore, mothers’ negative perception of their child’s recovery may not induce proportionate decline in mothers’ health-seeking behaviour (patronage of PMDs), which might be influenced mainly by mothers’ satisfaction with the positive attributes of PMDs’ personality/practice and sets an important agenda for PHC reforms

Knowledge, attitude and practices of antibiotic usage among university students from Karachi, Pakistan

Background: Antimicrobial resistance has become a serious global problem. A potential post-antibiotic era is threatening present and future medical advances. In Pakistan, the usage of antibiotic is unnecessarily high and due to over exposure to these drugs, bacteria are developing resistance against these drugs. It is necessary to improve public awareness about the rational use of antibiotics in order to bring a change in consumer’s behaviour. Therefore, present study was undertaken to assess the existing knowledge, attitude and practices related to antibiotic usage among university students.Methods: A cross-sectional study was carried out among university students from Karachi, Pakistan during May-June 2018. 200 students were approached to participate in the study of which 159 agreed to participate (males: 70, females: 89). Pretested questionnaire was distributed to the study subjects and the collected data was analyzed using IBM SPSS version 23.Results: Substantial number of (33% and 50%) participants were unaware about the differences in antibiotic: anti-inflammatory drugs and antibiotic: antipyretics respectively. 29% of the participants thought it is right to stop antibiotics only based on symptomatic improvement. Thirty nine percent and eighty three percent participants believed that antibiotics should always be prescribed to treat flu like symptoms and pneumonia respectively.Conclusions: Participants demonstrated average knowledge about antibiotics. Similarly, their attitude and practice toward antibiotic use was associated with misconceptions. An educational intervention is necessary to make them aware about rational use of antibiotics

Oral cancer awareness among university students from Karachi, Pakistan

Background: Oral cancers (OC) are malignant lesions occurring in the oral cavity that include squamous cell carcinomas (SCC), salivary gland and odontogenic neoplasms. Even though it is the eighth most common malignancy globally but in Pakistan it is the second commonest type of cancer. Lack of awareness about ill-effects of preventable risk factors of oral cancer increases the burden of disease due to the associated high cost of treatment, permanent impairment and high mortality. Hence, awareness can be very helpful in prevention, control and early diagnosis of oral cancer.Methods: A cross-sectional study was carried out among university students from Karachi, Pakistan during April to May 2018. Three hundred students were approached to participate in the study of which 277 agreed to participate. Pretested questionnaire was distributed and collected data was analysed using IBM SPSS version 23.Results: There were 125 (45%) males and 152 (55%) females in the study and response rate was 94%. Sixty one percent (154/250) respondents correctly identified smoking, and tobacco chewing as possible causes of oral cancer. Almost one third (74%; 184/250) respondents correctly responded that oral cancer does not spread from person to person through touch or speaking. Sixty six percent (164/250) respondents believed that oral cancer is curable. Mean score of knowledge was higher in females (61%) than males (53%). Significantly higher number of females compared to male participants answered correctly to questions regarding cause of oral cancer, spread of disease and occurrence of oral cancer in AIDS patients.Conclusions: Participants showed poor knowledge about oral cancer. Female participants showed better knowledge compared to male counterparts. Details about oral cancer should be incorporated in the university curriculum and periodic awareness programs should be organized for students

Knowledge, attitude and practices of antibiotic usage among students from Mumbai University

Background: Discovery of antibiotics have helped to manage the devastating diseases. Presently, the antibiotic era is threatened by the emergence of high level of antibiotic resistance of important pathogens. Misuse of antibiotics poses a serious risk to infectious disease control. It is necessary to improve public awareness to bring a change in the behavior of consumers. Therefore, present study was undertaken to assess the existing knowledge, attitude and practices related to antibiotic usage among university students.Methods: A cross-sectional study was carried out among students from Mumbai University, India during May-June 2017. 300 students were approached to participate in the study of which 250 agreed to participate (males: 117; females: 133). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.Results: Substantial number (33% and 40%) participants were unaware about the differences in antibiotic-anti-inflammatory drugs and antibiotic-antipyretics respectively. 28% of the participants thought it is right to stop antibiotics only based on symptoms improvement. Sixty eight percent and seventy nine percent participants believed that antibiotics should always be prescribed to treat flu like symptoms and pneumonia respectively.Conclusions: Participants demonstrated poor knowledge about antibiotics. Similarly, their attitude and practice toward antibiotic use was associated with misconceptions. An educational intervention can be introduced to make them aware about rational antibiotic practices

A study to determine the knowledge of pharmacovigilance among pharmacy students from Mumbai university

Background: Pharmacovigilance (PV); also known as drug safety surveillance, is the science of enhancing patient care and patient safety regarding the use of medicines by collecting, monitoring, assessing, and evaluating information from healthcare providers and patients. Pharmacists are pivotal players in adverse drug event (ADE) monitoring and reporting. However, most pharmacists are unaware or not knowledgeable about the guidelines used by their respective countries’ drug regulatory bodies. It is the need of the hour to train pharmacy students on the concept of pharmacovigilance.Methods: A cross-sectional study was carried out among pharmacy students from Mumbai University, India during May-June 2017. On the basis of the eligibility criterion 352 students were selected for the present study. Four hundred students were approached to participate in the study of which 201 agreed to participate (males: 179; females: 173). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.Results: Overall pharmacovigilance knowledge (44%) and perception (58%) was low among the participants of the present study. Seventy four percent of the participants felt that adverse drug reaction (ADR) reporting should be made compulsory for healthcare professionals. And only 21% agreed that the topic of Pharmacovigilance is well covered in pharmacy curriculum.Conclusions: Pharmacy council of India, pharmacy teacher’s association and respective pharmacy college should take necessary steps to increase the knowledge and create awareness regarding pharmacovigilance and adverse drug reaction reporting among pharmacy students.

A study to assess knowledge and attitude towards HIV among students from Mumbai university

Background: India has the third largest HIV epidemic in the world. The Indian epidemic is characterized by low levels in the general population and elevated concentrations among high-risk groups. The present study was planned to determine the awareness of HIV among students from Mumbai University.Methods: A cross-sectional study was carried out among students from Mumbai University, India during May–June 2017. Two hundred and fifty students were approached to participate in the study of which 199 agreed to participate (males: 132; females: 67). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.Results: Study participants had high knowledge (86%) and attitude score (87%). There was no significant difference between males and female participants for attitude and knowledge, except for one question regarding knowledge about HIV transmission via breastfeeding to child.Conclusions: Present study showed that there are no misconceptions or negative attitudes regarding HIV among students. A longitudinal study with a larger sample size across India is recommended for further investigation

Knowledge, attitude and practices of antibiotic usage among students from Mumbai University

Background: Discovery of antibiotics have helped to manage the devastating diseases. Presently, the antibiotic era is threatened by the emergence of high level of antibiotic resistance of important pathogens. Misuse of antibiotics poses a serious risk to infectious disease control. It is necessary to improve public awareness to bring a change in the behavior of consumers. Therefore, present study was undertaken to assess the existing knowledge, attitude and practices related to antibiotic usage among university students. Methods: A cross-sectional study was carried out among students from Mumbai University, India during May-June 2017. 300 students were approached to participate in the study of which 250 agreed to participate (males: 117; females: 133). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23. Results: Substantial number (33% and 40%) participants were unaware about the differences in antibiotic-anti-inflammatory drugs and antibiotic-antipyretics respectively. 28% of the participants thought it is right to stop antibiotics only based on symptoms improvement. Sixty eight percent and seventy nine percent participants believed that antibiotics should always be prescribed to treat flu like symptoms and pneumonia respectively. Conclusions: Participants demonstrated poor knowledge about antibiotics. Similarly, their attitude and practice toward antibiotic use was associated with misconceptions. An educational intervention can be introduced to make them aware about rational antibiotic practices

Perception of university students about doctors and quality of health care provision at clinics: a multi-national study in India, Pakistan, Spain and United States of America

Background: Patient satisfaction is considered as an indicator of the healthcare quality. Information on patient satisfaction based on medical expertise of the physician, interpersonal skills, physician-patient interaction time, perception and needs of the patient allow policymakers to identify areas for improvement. Primary care services and healthcare structure differ between the countries. The present study was done to determine and analyze the determinants associated with patient satisfaction in India, Pakistan, Spain and USA.Methods: This descriptive study was performed in January to August 2019 among students from Mumbai University, India, Dow University of Health Sciences, Karachi, Pakistan, University CEU Cardenal Herrera, Valencia, Spain, Texas State University, Texas, USA. On the basis of the eligibility criterion (those who gave a written informed consent and were registered students of respective university) 890 (India: 369, Pakistan: 128, Spain: 195, USA: 99) students were selected for the present study.Results: India had almost similar male (49%) to female (51%) ratio of participants. For other 3 countries (PK, ES, US), female participant percentage was nearly 20% or even more as compared to male participants. Overall participant’s satisfaction score about medial expertise of the doctor were highest in India (71%) and were lowest in Spain (43%). Overall satisfaction score about time spent with doctor were highest for India (64%) and were lowest for Spain (41%). Overall satisfaction score about communication with doctor were highest for US (60%) and were lowest for PK (53%). Overall satisfaction score for medical care given by the doctor was lowest in PK (43%) and was highest in US (64%). Overall satisfaction about doctor, highest number of US (83%) and lowest number of PK (32%) participants were satisfied about medical interaction with doctors.Conclusions: These multi-country findings can provide information for health policy making in India, Pakistan, Spain and USA. Although the average satisfaction per country, except Pakistan is more than 60%, the results suggest that there is ample room for improvement