clinical research trials
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2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A834-A835
Author(s):  
Cheow Peng Ooi ◽  
Abdul Hanif Yusof Khan ◽  
Rosliza Abdul Manaf ◽  
Hebatullah M Adulazeem ◽  
Norlela Sukor ◽  
...  

Abstract Background: Relatively little is known on the aspects of research that matter most to patients with thyroid dysfunction (TD). We aimed to explore the patients’ experience when they were diagnosed and treated for TD, as well as what they needed to improve their care: Methods: Qualitative data were obtained online using the Malay language version of the semi-structured qualitative survey in Malaysia, part of the larger research: A CORE OUTCOME SET FOR THYROID DYSFUNCTION. The questionnaires were developed from interactive discussions with patients who have thyroid dysfunction. The responses were analyzed using Braun and Clark’s thematic analysis framework guided by the question: What are the perceptions and experiences of thyroid care that matter most to patients with TD? Results: Responses from 38 participants, in the 18-60 age range, with TD, were analyzed. Most patients across the spectrum of thyroid dysfunctions experienced emotional disturbances. These negative emotions were related to the whole spectrum of disease state, the associated treatments, pre-treatment, post-treatment care, and personal aspects of daily life. Uncertainties in medical outcomes were associated with the personal need for further information. Functional psychosocial impairments and socioeconomic disruptions have a strong ability to arouse the anxiety of outcome uncertainties further. Getting treatment and independence in routine daily activities were prioritized while acknowledging treatments may differ in modality and risk of complications. Physician-patient interactions were valued in alleviating concerns and fear. Four salient themes emerged suggesting emotional security, functional ability, self-care (including psychosocial and socioeconomic well-being), and quality of physician-patient relationships were what matters to these participants. Conclusion: This insight into the problems of patients with TD underlined the need for quality patient-centered thyroid care and may be enhanced, personalized, and improved through outcomes that mattered most to patients in clinical research/trials, routine clinical practice, and the health system.


2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Kirsten M. Christensen ◽  
Margaret Hojlo ◽  
Anna Milliken ◽  
Nicole T. Baumer

2021 ◽  
Vol 4 (3) ◽  
Author(s):  
Gia Mukherjee

Western scholars, pharmaceutical companies, and academic institutions are and have been conducting research in developing countries for many years. These locations boast substantial cost savings, expedited timelines, and little to no regulatory oversight, making them attractive to developed-world researchers. Residents of these communities are impoverished, often illiterate, unemployed, and with untreated health conditions. Because established ethical protocols for international research are often compromised or misconstrued by researchers and/or their sponsors, these individuals are left vulnerable to exploitation and abuse. In this paper, I explore how current utilization of ethical guidelines is enabling exploitation. I identify ethical questions regarding subject recruitment, informed consent, standard of care, and the post-trial obligations of researchers. I then examine specific situations in which exploitation occurred because of drug, vaccine, or clinical trials. I conclude by offering recommendations to create a more streamlined approach to international research that takes into account the experiences and needs of vulnerable populations. This approach helps ensure that participants are fully involved in the ethical approval process; able to choose whether or not to participate without any undue influence or pressure; treated with the standard of care best suited to their context and surroundings; and reasonably given access to any interventions proven effective during the course of the trial.. A respect for beneficence, justice, and self-autonomy should guide researchers’ interactions with subjects before, during, and after the trial.


2020 ◽  
Vol 7 ◽  
Author(s):  
Hasan Hashem ◽  
Mohammad Abufaraj ◽  
Abdelghani Tbakhi ◽  
Iyad Sultan

The response to the COVID-19 pandemic from the research and science community has been vigorous, with information being released faster than that of any other event in human history. Articles related to the virus were being rapidly published by January 2020. A small fraction of these publications comprised reports of prospective clinical trials (0.25%), and many of these trials have imparted conflicting conclusions, leading to confusion among the public and the scientific community. Additionally, the pandemic has raised many serious scientific and ethical concerns related to clinical research. In this review, we divided the conduct of clinical research trials into three steps and critically reviewed each step, along with the challenges and obstacles arising amid the ongoing crisis. The clinical research steps we reviewed include (1) clinical trial design factors such as social and scientific value, feasibility, single vs. multicenter trials, randomization, control groups, endpoints, off-label and compassionate use of medications, data analysis, and verifying the integrity of data; (2) ethical issues such as committee approvals, efficiency, virtual visits and remote monitoring, informed consent, shipping investigational products, and external monitoring and audits; and (3) publication and sharing of preprints, press releases, social media, and misinformation. The COVID-19 pandemic is adversely affecting existing clinical trials for other ailments and diseases, including cancer, with most trials being delayed or deferred. Although urgency is needed to communicate effective treatment and prevention strategies for COVID-19, research efforts should maintain the same high-quality core ethical principles that governed human subject research before the pandemic. Despite the catastrophic devastation caused by the pandemic, the adoption of more flexible, cost-effective methods of conducting clinical trials (without compromising ethical conduct, safety, or data integrity, while maintaining research efficiency) represents a potential silver lining. Streamlining clinical research will help to congruently address other important health issues, despite the ongoing COVID-19 crisis.


2020 ◽  
Vol 11 (4) ◽  
pp. 30
Author(s):  
Sarah J. Mendez ◽  
Brian Raimondo ◽  
Patricia Hughes

Working in Manhattan, the center of the nations’ outbreak of the novel coronavirus-19 virus truly demonstrated how adaptable nurses are. During this time, multiple clinical research trials began at our academic medical center, NYU Langone Health, as researchers attempted to learn what medical interventions worked best to treat critically-ill COVID-19 patients. In designing and implementing these trials, the researchers had little familiarity with the workings of inpatient hospital units. They did not understand how nursing staff provided care to patients on these units. Likewise, many bedside nurses had never assisted researchers in conducting clinical research on their patients. Therefore, a nursing operations team (NOT) was needed to assist both the research teams and the inpatient nurses. NOT met with the researchers to review proposed clinical research trials and determine how nursing staff would be utilized to complete the required research tasks such as specimen and data collection, study intervention administration, and patient monitoring. Toward that end, NOT developed education and training materials on all of the research trials that were implemented at NYU Langone Health for our bedside nurses. This education included tip sheets, safety huddle rounds with the involved units, and “just in time” education to any nurse whose patient was urgently enrolled in a trial. In this way, NOT helped bedside nurses quickly adapt to their role in assisting the research team conduct their studies on our COVID positive inpatients.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 567-567
Author(s):  
Angel Duncan

Abstract This session identifies common misconceptions about identity for persons living with Alzheimer’s disease and related dementias (ADRD). Going beyond diagnostic brain imaging and neurocognitive testing, case studies and research in creativity from around the United States highlights consciousness of persons living with ADRD. Reviewing and discussing artworks is aimed to set dialogue in the question of where memory deposits emerge when engaged in creativity. Through art therapy techniques, this type of self-expression may provide new avenues in treatment for dementia care. Exploring the arts from those with Mild Cognitive Impairment to late stage Alzheimer’s and other forms of dementia, such as frontotemporal dementia, consciousness seems to remain intact despite neural death. This session aims to discourage poor spending allocations and establishing meaningful care. From clinical research trials to creativity of self-expression, the importance of why the arts and sciences matter are demonstrated as effective modalities that enhance quality of life.


2020 ◽  
Vol 33 (03) ◽  
pp. 171-179
Author(s):  
Sanjay Kumar Dey ◽  
Joy Kumar Dey ◽  
Hitaishi Sihag

AbstractSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus strain that has not been ever found in humans before December 2019. Both the coronavirus disease 2019 (COVID-19) case fatality rate and deaths per million population in the top 10 affected countries are increasing a lot due to ever-increasing number of new cases among countries facilitated by increased affinity of SARS-CoV-2 to bind human angiotensin-converting enzyme 2 (ACE2) receptors. While human-to-human transmission of SARS-CoV-2 happens through close contact with an infected individual who spreads respiratory droplets through air or other means, its diagnosis relies mainly on detection of nucleic acid. Repurposing drugs such as dexamethasone, remdesivir, favipiravir and TMPRSS2 (trans membrane protease, serine 2) protease inhibitors have been shown to be effective for the treatment of COVID-19 with albeit requirement of further studies to conclude their complete effectiveness. Personal protective measures should be followed to prevent SARS-CoV-2 infection. Additionally, hundreds of clinical trials of vaccines against SARS-CoV-2 are undergoing, while plasma therapy from the COVID-19 survivors is also being tried to treat the severely affected patients. In addition to these aforementioned modern medicines and therapeutic approaches, homoeopathy also holds promising anti-viral effect as evident from its success against flu and other epidemics, historically. Therefore, present article provides a glimpse of advancements made in the area of homoeopathic ways of treating COVID-19 by summarising the recent homoeopathic clinical, research trials and future scopes of homoeopathy to combat the pandemic. After critical review of most of the ongoing or recently completed homoeopathic treatment efforts against SARS-CoV-2, it was identified that Bryonia alba, Arsenicum album and Gelsemium sempervirens are working best among homoeopathic medicines till now. These studies are also suggesting an increased application of these remedies to treat the current pandemic worldwide; therefore, more such studies are warranted. Those further research will pave the way to understand the mechanism of each of these homoeopathic drugs to cure COVID-19 facilitated by optimising their doses, effects and find the best among these multiple options in homoeopathic medicines for plausible mono- or combination therapies.


2020 ◽  
Vol 131 (6) ◽  
pp. 1657-1662
Author(s):  
Urooj Siddiqui ◽  
Laura Hawryluck ◽  
Muhammad Muneeb Ahmed ◽  
Richard Brull

Diabetologia ◽  
2020 ◽  
Vol 63 (8) ◽  
pp. 1516-1520
Author(s):  
Jack A. Sargeant ◽  
Emer M. Brady ◽  
Francesco Zaccardi ◽  
Frances Tippins ◽  
David R. Webb ◽  
...  

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