scholarly journals Perceived Implications of Current Conflict of Interest Policy in Individuals Accepted or Rejected for Participation in Food and Drug Administration Advisory Committee

2020 ◽  
Author(s):  
Yuichi J. Shimada ◽  
Kyle Hair ◽  
Adrienne Faerber ◽  
Christian G. Zimmerman ◽  
Timothy Houchin ◽  
...  
Keyword(s):  
Drug Administration ◽  
Online Survey ◽  
Conflicts Of Interest ◽  
Present Report ◽  
Food And Drug Administration ◽  
Cross Sectional Study ◽  
Advisory Committees ◽  
Cross Sectional ◽  
Interest Policy

ABSTRACTBackground and ObjectiveThe Food and Drug Administration (FDA) relies on advice from scientific and medical experts to make approval decisions about new prescription medications and medical devices. Therefore, it is crucial that FDA Advisory Committees (ACs) include the most knowledgeable scientists and clinicians in the decision-making process. However, to ensure that the advice is free from biases, current FDA policy often excludes those most qualified from participating in ACs due to perceived conflicts of interest (COI). The objective of the present study is to elicit opinion among subject matter experts regarding current FDA COI rules and regulations.MethodsWe conducted a cross-sectional study using formal, self-administered online survey consisting of 14 questions, 3 of which addressed perceived implications of current FDA COI policy. We send a formal online survey to study subjects via Qualtrics. Study subjects were 1) individuals who participated in FDA ACs and 2) those who were interested in participating in ACs and had completed FDA COI paperwork but rejected by the FDA due to COI. The outcome measure is response to the 3 questions about the perceived implications of current FDA COI policy. Responses were scored on a 5-point Likert-type scale.ResultsAmong 403 study subjects (200 AC members and 203 individuals who were rejected due to COI), 145 (36%) responded to the survey including 90 AC members and 55 rejected individuals. Respondents included 41 (28%) females. 97% were holding MD or PhD degrees. 88% were age 46 and over, and 66% had more than 25 years in practice. The primary findings were that 49% of respondents agreed that the current FDA regulations lead to a lower quality of experts on ACs, 72% agreed that current policies exclude qualified experts from serving on ACs, and 48% agreed that FDA policy lowers the overall quality of AC input, to at least a “moderate” extent (19%-37% to a “high” or “very high” extent).ConclusionsThe prevailing opinion among respondents to the formal survey is that current FDA COI policy has the potential effects to lowering quality of experts, excluding qualified experts, and lowering overall quality of AC input. The present report elucidates a potential need for the FDA to discuss the benefit and risk of the current AC COI policies.

scholarly journals Diabetes knowledge, risk perception, and quality of life among South Asian caregivers in young adulthood

2020 ◽  
Vol 8 (2) ◽  
pp. e001268
Author(s):  
Angela Koipuram ◽  
Sandra Carroll ◽  
Zubin Punthakee ◽  
Diana Sherifali
Keyword(s):  
Quality Of Life ◽  
Risk Perception ◽  
South Asian ◽  
Online Survey ◽  
Educational Interventions ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Significant Difference ◽  
Design And Methods

IntroductionPersons of South Asian descent have a higher prevalence of type 2 diabetes mellitus (T2DM). The management of T2DM in the South Asian community has required the support of adult children, potentially impacting the quality of life, diabetes-related knowledge, and risk perception among these caregivers.Research design and methodsTo investigate diabetes-related knowledge, quality of life, risk perception, and actual risk of developing diabetes among South Asian young adults whose parents are living with T2DM. A cross-sectional study was conducted (n=150). An online survey was administered. Data were analyzed with descriptive and inferential statistics.ResultsThere was a statistically significant difference in diabetes-related knowledge between males and females (p<0.001). Males (in comparison to females) had a lower risk perception of developing diabetes (p=0.06). Further, risk perception and diabetes-related knowledge were positively associated with caregiver’s physical health (p=0.002).ConclusionFindings highlight the importance of providing gender-specific and culturally tailored diabetes educational interventions.

Conflicts of Interest Among Patient and Consumer Representatives to U.S. Food and Drug Administration Drug Advisory Committees

2016 ◽  
Vol 165 (8) ◽  
pp. 606 ◽  
Author(s):  
S. Scott Graham ◽  
Daniel J. Card ◽  
Seokhoon Ahn ◽  
Sang-Yeon Kim ◽  
Molly M. Kessler ◽  
...  
Keyword(s):  
Drug Administration ◽  
Conflicts Of Interest ◽  
Food And Drug Administration ◽  
Advisory Committees

scholarly journals Urinary Incontinence in Competitive Women Powerlifters: A Cross-Sectional Survey

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Lolita Wikander ◽  
Marilynne N. Kirshbaum ◽  
Nasreena Waheed ◽  
Daniel E. Gahreman
Keyword(s):  
Urinary Incontinence ◽  
Pelvic Floor ◽  
Online Survey ◽  
Severity Index ◽  
Cross Sectional Study ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Pelvic Floor Exercises ◽  
Body Mass Index Score

Abstract Background Urinary incontinence (UI) can negatively affect a woman’s quality of life, participation in sport and athletic performance. The objectives of this study were to determine the prevalence of UI in competitive women powerlifters; identify possible risk factors and activities likely to provoke UI; and establish self-care practices. Methods This international cross-sectional study was conducted using an online survey completed by 480 competitive women powerlifters aged between 20 and 71 years. The Incontinence Severity Index (ISI) was used to determine the severity of UI. Results We found that 43.9% of women had experienced UI within the three months prior to this study. The deadlift was the most likely, and the bench-press the least likely exercise to provoke UI. ISI scores were positively correlated with parity (τ = 0.227, p < 0.001), age (τ = 0.179, p < 0.001), competition total (τ = 0.105, p = 0.002) and body mass index score (τ = 0.089, p = 0.009). There was no significant correlation between ISI and years strength training (τ = − 0.052, p = 0.147) or years powerlifting (τ = 0.041, p = 0.275). There was a negative correlation between ISI score with having a pelvic floor assessment (η = 0.197), and the ability to correctly perform pelvic floor exercises (η = 0.172). Conclusion The prevalence of UI in this cohort was at the upper limit experienced by women in the general population. Women who had undergone a pelvic floor examination or were confident in correctly performing pelvic floor exercises experienced less severe UI.

scholarly journals Do drug package inserts meet the rules and regulations of Iran’s Food and Drug Administration in terms of informing patients?

2019 ◽  
Vol 9 (3) ◽  
pp. 214-222
Author(s):  
Tahereh Eteraf-Oskouei ◽  
Saeid Abdollahpour ◽  
Moslem Najafi ◽  
Vahideh Zarea Gavgani
Keyword(s):  
Drug Administration ◽  
Mobile Apps ◽  
Food And Drug Administration ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Microsoft Excel ◽  
Cross Sectional ◽  
Reference Category ◽  
Package Inserts ◽  
Source Of Information

Background: Drug package inserts (PIs) are the most accessible source of information for users and are designed to aid the safe use of medicines and avert adverse events. This study measured the conformity of PIs with the health communications standards of Iran’s Food and Drug Administration (FDA). Methods: This descriptive cross-sectional study evaluated 92 PIs related to 22 best-selling neurological and psychiatric drugs in Iran based on criteria approved by Iran’s FDA. Six categories of criteria were considered in evaluating the extent of conformity: I) writing and formatting, II) references, III) drug description, IV) warnings and precautions, V) interactions, and VI) side effects. Each PI was scored based on observation of standards; data was analyzed using Microsoft Excel pivot tables. Results: In total, 2929 items from 92 PIs were evaluated, of which 37 (40.2%) were related to antidepressants, 31 (33.7%) to sedatives and hypnotics, and 24 (26%) to anticonvulsant drugs. The PI content was insufficient in various aspects of conformity with standards in each category. Among the six categories, the best match was found in warnings and precautions with 667 items (72.5%), followed by writing and formatting with 663 (69.1%). The lowest conformity was found in the reference category with 194 (26.4%) items. Conclusion: The PIs of Iranian neurological drugs do not fully meet Iran’s FDA standards. It is strongly recommended that smart PIs be developed using mobile apps to overcome this problem.

scholarly journals Relationship between Quality of Nursing Work Life and Uniformed Nurses’ Attitudes and Practices Related to COVID-19 in the Philippines: A Cross-Sectional Study

2021 ◽  
Vol 18 (19) ◽  
pp. 9953
Author(s):  
Juneffer Villamen Navales ◽  
Amadou Wurry Jallow ◽  
Chien Yu Lai ◽  
Chieh Yu Liu ◽  
Shu Wen Chen
Keyword(s):  
Online Survey ◽  
Pearson Correlation ◽  
Critical Role ◽  
Cross Sectional Study ◽  
The Philippines ◽  
Work Life ◽  
Cross Sectional ◽  
Attitudes And Practices ◽  
Quality Of Nursing

(1) Background: Coronavirus disease 2019 (COVID-19) has spread rapidly worldwide. Uniformed nurses have played a critical role during the COVID-19 pandemic in the Philippines; however, uptake of literature is limited. This study assessed the relationship between quality of nursing work life (QNWL) and nurses’ attitudes and practices during the COVID-19 pandemic. (2) Methods: A descriptive cross-sectional design was used. Participants were recruited from four government hospitals in the Manila metropolitan area of the Philippines. Participants completed three questionnaires in an online survey: a demographic questionnaire, a QNWL questionnaire, and the attitude and practices toward COVID-19 questionnaire. Descriptive statistics, an independent t-test, a one-way analysis of variance, the Pearson correlation coefficient, and hierarchical linear regression were applied for data analysis. (3) Results: The mean age of the participants was 29 years. Most of the participants were single women who were not certified in their specialties. A total of QNWL scores were high, indicating that the participants displayed favorable attitudes and practices in relation to COVID-19. A statistically significant relationship was observed between QNWL, specialty certification, and practices related to COVID-19. Practices related to COVID-19 were a significant predictor of QNWL and one of its subscales, work design. (4) Conclusion: Young adult uniformed nurses in the Philippines have assumed numerous responsibilities during the COVID-19 pandemic. Providing these frontline nurses with comprehensive specialized education and training is crucial.

Impact of the Approval of Eculizumab by the Food and Drug Administration on the Frequency of Patients Screened for Paroxysmal Nocturnal Hemoglobinuria

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4377-4377
Author(s):  
Javier Munoz ◽  
Mohamad A. Younes ◽  
Karen Olarte-Merida ◽  
Philip Kuriakose
Keyword(s):  
Drug Administration ◽  
Paroxysmal Nocturnal Hemoglobinuria ◽  
Conflicts Of Interest ◽  
Food And Drug Administration ◽  
Thrombotic Event ◽  
Fda Approval ◽  
Number Of Patients ◽  
Study Population ◽  
Terminal Complement

Abstract Abstract 4377 Background: Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired complement-mediated hemolytic disorder. Eculizumab, a monoclonal antibody designed to inhibit terminal complement activation, reduces intravascular hemolysis while leading to improvements in anemia, fatigue, and quality of life as well as reductions in blood transfusions and thrombosis. This medication was approved by the Food and Drug Administration (FDA) in March 16, 2007. The intent of our study was to assess if the number of patients screened for PNH has increased after the approval of eculizumab by the FDA. Methods: Retrospective single institution chart review over a period of 6 years from January 2004 to June 2010. Our study population comprised 174 patients screened for PNH by flow cytometry. Results: Between January 2004 and March 16, 2007 (39 months), a total of 68 cases were screened for PNH. On the other hand, between March 17, 2007 (date of FDA approval) and June 2010 (39 months), a total of 106 cases were screened for PNH with an increase in the frequency of testing by 55.8% (Figure 1). 1 out of 68 cases (1.5%) screened before March 16, 2007 were positive for PNH. 6 out of 106 cases (5.6%) screened after March 16, 2007 were positive for PNH (Table 1). 74 patients were male (42.5%) and 100 were female (57.5%). Average age at screening for PNH was 53.3 years. Screening was most commonly requested by Hematology (151 cases; 86.7%) followed by Internal medicine (5 cases), Hepatology (3 cases), Neurology (1 case) and Pulmonary (1 case). We found no information available in 13 cases regarding the location of the patient or the service that requested PNH screening. The clinical indications to screen for PNH were cytopenias (110 cases; 63.2%), thrombotic events (39 cases; 22.4%), or a combination of cytopenia plus a thrombotic event (9 cases; 5.2%). No indication for PNH screening was documented in 16 cases. Conclusion: Our hypothesis is that an approval of a new medication can increase both, the awareness of a disease among physicians, and the frequency of ordering its diagnostic tests. The number of patients screened for PNH sharply increased after the approval of eculizumab by the FDA, confirming our hypothesis. Disclosures: No relevant conflicts of interest to declare.

scholarly journals The impact of the COVID-19 pandemic on resident physicians: A cross-sectional study

Work ◽  
2021 ◽  
pp. 1-8
Author(s):  
Anja Barac ◽  
Paola Krnjaic ◽  
Nikola Vujnovic ◽  
Nino Matas ◽  
Edita Runjic ◽  
...  
Keyword(s):  
Online Survey ◽  
Negative Impact ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Personal Lives ◽  
Resident Physicians ◽  
Negative Effect ◽  
Stress At Work ◽  
The Impact

BACKGROUND: COVID-19 presents a threat to the mental health of the medical staff working with COVID-19 patients. OBJECTIVE: To investigate the impact of working during the COVID-19 pandemic on resident physicians. METHODS: The study was conducted via anonymous online survey and included resident physicians. The survey contained questions about sociodemographic information, general job satisfaction during the COVID-19 pandemic, and the impact of the COVID-19 pandemic on their personal lives. RESULTS: This study included a response from 728 resident physicians. The majority of residents rated that the COVID-19 pandemic had a mostly negative impact on their satisfaction with professional life (59.9%) and quality of work (62.8%), their personal lives (44.7%) and quality of life (57.1%). Half of all residents indicated that they did not have enough personal protective equipment (PPE). About one-third of residents indicated that the level of stress at work during the COVID-19 pandemic was higher. CONCLUSIONS: Working as resident physicians during COVID-19 pandemic had a negative effect on participants’ professional and personal lives. Residents did not have all the necessary PPE nor felt safe working with patients with suspected or proven COVID-19. Further action is needed to provide support for physician residents working during the COVID-19 pandemic.

scholarly journals US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018

2021 ◽  
pp. 174077452110050
Author(s):  
Joshua J Skydel ◽  
Audrey D Zhang ◽  
Sanket S Dhruva ◽  
Joseph S Ross ◽  
Joshua D Wallach
Keyword(s):  
Drug Administration ◽  
Clinical Studies ◽  
Clinical Evidence ◽  
Food And Drug Administration ◽  
Median Number ◽  
Cross Sectional Study ◽  
Interquartile Range ◽  
New Drugs ◽  
Cross Sectional ◽  
The Us

Background/Aims The US Food and Drug Administration outlines clinical studies as postmarketing requirements and commitments to be fulfilled following approval of new drugs and biologics (“therapeutics”). Regulators have increasingly emphasized lifecycle evaluation of approved therapeutics, and postmarketing studies are intended to advance our understanding of therapeutic safety and efficacy. However, little is known about the indications that clinical studies outlined in postmarketing requirements and commitments investigate, including whether they are intended to generate evidence for approved or other clinical indications. Therefore, we characterized US Food and Drug Administration postmarketing requirements and commitments for new therapeutics approved from 2009 to 2018. Methods We conducted a cross-sectional study of all novel therapeutics, including small-molecule drugs and biologics, receiving original US Food and Drug Administration approval from 2009 to 2018, using approval letters accessed through the Drug@FDA database. Outcomes included the number and characteristics of US Food and Drug Administration postmarketing requirements and commitments for new therapeutics at original approval, including the types of studies outlined, the indications to be investigated, and the clinical evidence to be generated. Results From 2009 to 2018, the US Food and Drug Administration approved 343 new therapeutics with 1978 postmarketing requirements and commitments. Overall, 750 (37.9%) postmarketing requirements and commitments outlined clinical studies. For 71 of 343 (20.7%) therapeutics, no postmarketing requirements or commitments for clinical studies were outlined, while at least 1 was outlined for 272 (79.3%; median 2 (interquartile range: 1–4)). Among these 272 therapeutics, the number of postmarketing requirements and commitments for clinical studies per therapeutic did not change from 2009 (median: 2 (interquartile range: 1–4)) to 2018 (median: 2 (interquartile range: 1–3)). Among the 750 postmarketing requirements and commitments for clinical studies, 448 (59.7%) outlined new prospective cohort studies, registries, or clinical trials, while the remainder outlined retrospective studies, secondary analyses, or completion of ongoing studies. Although 455 (60.7%) clinical studies investigated only original approved therapeutic indications, 123 (16.4%) enrolled from an expansion of the approved disease population and 61 (8.1%) investigated diseases unrelated to approved indications. Conclusions The US Food and Drug Administration approves most new therapeutics with at least 1 postmarketing requirement or commitment for a clinical study, and outlines investigations of safety or efficacy for both approved and unapproved indications. The median number of 2 clinical studies outlined has remained relatively constant over the last decade. Given increasing emphasis by the US Food and Drug Administration on faster approval and lifecycle evaluation of therapeutics, these findings suggest that more postmarketing requirements and commitments may be necessary to address gaps in the clinical evidence available for therapeutics at approval.

scholarly journals Inequality in accessing learning during pandemic crises in developing countries: Reflections from COVID-19-induced online learning at a Kenyan pharmacy school

2021 ◽  
pp. 713-722
Author(s):  
Kihugi Veronica Njambi ◽  
Godfrey Wabwile Mayoka
Keyword(s):  
Developing Countries ◽  
Online Learning ◽  
Student Satisfaction ◽  
Online Survey ◽  
Cross Sectional Study ◽  
First Year ◽  
Cross Sectional ◽  
Perceptions Of Students ◽  
Learning Platforms

Background: Virtual learning platforms gained unprecedented prominence after the coronavirus disease 2019 (COVID-19) outbreak. Assuring the quality of education and student satisfaction are critical, especially in developing countries often plagued with infrastructural limitations, including information technology. Objectives: This study was conducted to assess the perceptions of students at a Kenyan Pharmacy School of online learning with regards to affordability and overall effectiveness. Methods: A cross-sectional study was conducted using an online survey containing pre-determined questions aligned to achieve the research objectives. Results: Students in senior classes (Fifth year) viewed online learning more favourably and had fewer challenges with accessibility than students in the lower classes (First year to third year). Conclusion: The study identified areas of strength, such as convenience, time-efficiency, and self-initiative, as well as weaknesses, including inequitable access, internet connectivity challenges, and unsatisfactory lecturer digital competency, with relation to online learning.

scholarly journals Participation in physical activity decreased more in people with rheumatoid arthritis than the general population during the COVID-19 lockdown: a cross-sectional study

2021 ◽  
Author(s):  
Christopher Balchin ◽  
Ai Lyn Tan ◽  
Oliver J. Wilson ◽  
Jim McKenna ◽  
Antonios Stavropoulos-Kalinoglou
Keyword(s):  
Rheumatoid Arthritis ◽  
Physical Activity ◽  
Body Weight ◽  
Online Survey ◽  
Cross Sectional Study ◽  
Mental Wellbeing ◽  
Cross Sectional ◽  
The Impact ◽  
Exercise Equipment

AbstractThe COVID-19 pandemic and social distancing restrictions have significantly reduced population-wide physical activity (PA) levels. However, the impact of the pandemic and relevant restrictions on PA participation, and any potential barriers to it, in people with rheumatoid arthritis (RA) are not clear. Furthermore, we are unsure if any such PA changes have affected their body weight, mental wellbeing, and/or quality of life (QoL). Thus, the aim of this study was to examine the impact of the lockdown on PA participation in people with RA, versus people without RA. Participants (n = 128; RA = 27, non-RA = 101) completed a self-administered online survey, which included questions on PA, body weight, mental wellbeing and QoL. PA participation during lockdown was significantly lower among RA versus non-RA participants (p < 0.001). Additionally, a similar profile of results was found where more RA participants vs non-RA participants reported reduced habitual PA (59% vs 33%) and increased body weight (59% vs 35%). Mental wellbeing scores were similarly low in both groups during lockdown (RA: 20.8 ± 4.2; non-RA: 22.2 ± 3.4, p = 0.080). Matched group comparisons identified similar trends to full sample analyses. In the first months of the lockdown, more people with RA reported decreased PA participation and increased body weight than their non-RA counterparts. Access to exercise equipment and facilities appears to be the main cause for these results. Looking beyond COVID-19, specific PA promotion for people with RA will be required to prevent a pandemic of inactivity.

Sign in / Sign up

Export Citation Format

Share Document