COVID-19 challenges in clinical trials

Clinical research involves working with human subjects to answer questions relevant to their well-being in an ethical manner. The current scenario from the past one year has drastically changed the face of the clinical trials. The present COVID prevalence and simultaneously conducting the research with all the regulations and the precautions has been the difficult task for the contract research organisations (CRO).

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Ethical Regulations of Medical Research Involving Human Subjects: Exploring the Perspective of Trial Participants

Journal for Undergraduate Ethnography ◽

10.15273/jue.v9i1.8883 ◽

2019 ◽

Vol 9 (1) ◽

pp. 34-49

Author(s):

Anna Kravets

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Medical Research ◽

Broad Spectrum ◽

Human Subjects ◽

Well Being ◽

Research Protocols ◽

Ethnographic Data ◽

Protection Of Human Subjects ◽

Trial Participants

In this paper I address the question of whether the existing ethical regulations of clinical research ensure protection and well-being of human subjects. Drawing on ethnographic data gathered in Berlin, Germany, I show that German institutions which are meant to ensure the ethical validity of clinical research cannot address posed issues. It appears that these institutions (Berlin Ethik-Kommission in particular) only evaluate research protocols and do not consider the broad spectrum of processes and interactions involved in clinical research. The experience of professional human subjects, as well as the consideration of the every-day life in a clinic, shows that there is much more to clinical trials. The argument of this paper is that the inability of institutions to address protection of human subjects originates from the bureaucratic logic of their organization. Drawing on Bauman’s (1992) argument that the bureaucratic machine is characterized by separation between morality and purpose, with the example of Berlin Ethik-Kommission, I argue that the bureaucratic machine cannot be sensitive to morality and ethics, even if these are its main purposes.

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Putting Contract Research Organisations on the Radar: An Exploratory Study on Outsourcing of Clinical Trials by Pharmaceutical Companies To Contract Research Organisations in Non-Traditional Trial Regions

SSRN Electronic Journal ◽

10.2139/ssrn.1759265 ◽

2011 ◽

Author(s):

SOMO Submitter ◽

Mariette Van Huijstee ◽

Irene Schipper

Keyword(s):

Clinical Trials ◽

Exploratory Study ◽

Pharmaceutical Companies ◽

Contract Research ◽

Research Organisations ◽

Contract Research Organisations

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Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic

Ethics & Bioethics ◽

10.2478/ebce-2021-0018 ◽

2021 ◽

Vol 11 (3-4) ◽

pp. 181-195

Author(s):

Anetta Jedličková

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Human Subjects ◽

Subject Matter Experts ◽

Ethical Challenges ◽

Wide Audience ◽

Ethical Implications ◽

The Subject ◽

Research Professionals ◽

Trial Participants

Abstract The current coronavirus disease 2019 (COVID-19) pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and study protocol modifications may significantly impact ethically salient fundamentals, such as the risk-benefit profile and safety of clinical trial participants, which raise key ethical challenges the subject-matter experts must face. This article aims to acquaint a wide audience of clinical research professionals, ethicists, as well as the general public interested in this topic with the legal, ethical and practical considerations in the field of clinical trials during the COVID-19 pandemic and to support the clinical researchers and study sponsors to fulfil their responsibilities in conducting clinical trials in a professional way that does not conflict with any legal or ethical obligations.

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Addressing guideline and policy changes during pragmatic clinical trials

Clinical Trials ◽

10.1177/1740774519845682 ◽

2019 ◽

Vol 16 (4) ◽

pp. 431-437 ◽

Cited By ~ 4

Author(s):

Lesley H Curtis ◽

Laura M Dember ◽

Miguel A Vazquez ◽

David Murray ◽

Lynn DeBar ◽

...

Keyword(s):

Public Health ◽

Clinical Trials ◽

Large Scale ◽

Well Being ◽

Clinical Equipoise ◽

Opioid Use ◽

Pragmatic Clinical Trials ◽

The Face ◽

Stage Renal Disease ◽

End Stage

While conducting a set of large-scale multi-site pragmatic clinical trials involving high-impact public health issues such as end-stage renal disease, opioid use, and colorectal cancer, there were substantial changes to both policies and guidelines relevant to the trials. These external changes gave rise to unexpected challenges for the trials, including decisions regarding how to respond to new clinical practice guidelines, increased difficulty in implementing trial interventions, achieving separation between treatment groups, and differential responses across sites. In this article, we describe these challenges and the approaches used to address them. When deliberating appropriate action in the face of external changes during a pragmatic clinical trial, we recommend considering the well-being of the participants, clinical equipoise, and the strength and quality of the evidence associated with the change; involving those charged with data and safety monitoring; and where possible, planning for potential external changes as the trial is being designed. Any solution must balance the primary obligation to protect the well-being of participants with the secondary obligation to protect the integrity of the trial in order to gain meaningful answers to important public health questions.

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A Preliminary Investigation of the Views of People With Parkinson's (With and Without Psychosis) and Caregivers on Participating in Clinical Trials During the Covid-19 Pandemic: An Online Survey

Frontiers in Psychiatry ◽

10.3389/fpsyt.2020.602480 ◽

2020 ◽

Vol 11 ◽

Author(s):

Katie McGoohan ◽

Anneesa Amjad ◽

Natasha Ratcliffe ◽

Sagnik Bhattacharyya ◽

Gillian Granville ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Clinical Trials ◽

Clinical Research ◽

Online Survey ◽

Preliminary Investigation ◽

Well Being ◽

Support Network ◽

Ongoing Research ◽

Related Research

Background: The coronavirus pandemic is having a profound impact on non-COVID-19 related research, including the delivery of clinical trials for patients with Parkinson's disease.Objectives: A preliminary investigation to explore the views of Parkinson's disease (PD) patients, with and without experience of psychosis symptoms, and carers on the resumption of clinical research and adaptations to trials in light of COVID-19.Methods: An anonymous self-administered online survey was completed by 30 PD patients and six family members/carers via the Parkinson's UK Research Support Network to explore current perceptions on taking part in PD research and how a planned clinical trial for psychosis in PD may be adapted so participants feel safe.Results: Ninety-one percent of respondents were enthusiastic about the continuation of non-COVID-19 related research as long as certain safety measures were in place. Ninety-four percent stated that they would be happy to complete assessments virtually. However, they noted that care should be taken to ensure that this does not exclude participants, particularly those with more advanced PD who may require assistance using portable electronic devices. Regular and supportive communication from the research team was also seen as important for maintaining the psychological well-being of participants while taking part in the trial.Conclusions: In the era of COVID-19 pandemic, standard approaches will have to be modified and rapid adoption of virtual assessments will be critical for the continuation of clinical research. It is important that alongside the traditional methods, new tools are developed, and older ones validated for virtual assessments, to allow safe and comprehensive assessments vital for ongoing research in people with Parkinson's.

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Trends in US pediatric mental health clinical trials: An analysis of ClinicalTrials.gov from 2007–2018

PLoS ONE ◽

10.1371/journal.pone.0248898 ◽

2021 ◽

Vol 16 (4) ◽

pp. e0248898

Author(s):

Joshua R. Wortzel ◽

Brandon E. Turner ◽

Brannon T. Weeks ◽

Christopher Fragassi ◽

Virginia Ramos ◽

...

Keyword(s):

Mental Health ◽

Clinical Trials ◽

Clinical Research ◽

Mental Health Research ◽

Funding Source ◽

Annual Growth Rate ◽

Compound Annual Growth Rate ◽

The Past ◽

Us Government ◽

Pediatric Mental Health

Whereas time trends in the epidemiologic burden of US pediatric mental health disorders are well described, little is known about trends in how these disorders are studied through clinical research. We identified how funding source, disorders studied, treatments studied, and trial design changed over the past decade in US pediatric mental health clinical trials. We identified all US pediatric interventional mental health trials submitted to ClinicalTrials.gov between October 1, 2007 and April 30, 2018 (n = 1,019) and manually characterized disorders and treatments studied. We assessed trial growth and design characteristics by funding source, treatments, and disorders. US pediatric mental health trials grew over the past decade (compound annual growth rate [CAGR] 4.1%). The number of studies funded by industry and US government remained unchanged, whereas studies funded by other sources (e.g., academic medical centers) grew (CAGR 11.3%). Neurodevelopmental disorders comprised the largest proportion of disorders studied, and Non-DSM-5 (Diagnostic and Statistical Manual-5) conditions was the only disorder category to grow (14.5% to 24.6%; first half to second half of decade). There was significant growth of trials studying non-psycho/pharmacotherapy treatments (33.8% to 49.0%) and a decline in trials studying pharmacotherapies (31.7% to 20.6%), though these trends differed by funding source. There were also notable differences in funding sources and treatments studied within each disorder category. Trials using double blinding declined (26.2% to 18.0%). Limitations include that ClinicalTrials.gov is not an exhaustive list of US clinical trials, and trends identified may in part reflect changes in trial registration rather than changes in clinical research. Nevertheless, ClinicalTrials.gov is among the largest databases available for evaluating trends and patterns in pediatric mental health research that might otherwise remain unassessable. Understanding these trends can guide researchers and funding bodies when considering the trajectory of the field.

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Bodies and Buildings

The Oxford Handbook of Victorian Medievalism ◽

10.1093/oxfordhb/9780199669509.013.24 ◽

2020 ◽

pp. 393-415

Author(s):

Corinna Wagner

Keyword(s):

Medical Research ◽

Human Subjects ◽

Well Being ◽

Urban Environments ◽

The Body ◽

Victorian Culture ◽

The Past ◽

Research On Human Subjects ◽

The Dead ◽

Health And Well Being

Issues around the body have tended to be seen as the concerns of medical materialists and utilitarians, but rarely medievalists. This perception is reflected in the fact that the body only features occasionally in scholarship on Victorian medievalism. However, this chapter makes the claim that medievalists were deeply invested in issues of health and death, as well as anatomy and other branches of medicine. Moreover, medievalists often evoked the past in support of views about the ethics and care of the body that were surprisingly comparable to that of their supposed sworn enemies, materialists and utilitarians. There is a strain of thought, and an aesthetics, that runs through Victorian culture, which could be called ‘materialist medievalism’. I argue that the view of a bifurcated Victorian society has obscured how often opinions between seemingly incompatible thinkers overlapped on aesthetic, philosophical, and ‘condition of England’ questions that focused on the body. It is my hope that this reconsideration will help us better understand the Victorian foundations of our modern concerns with surveillance, medical research on human subjects, health and well-being in urban environments, and memorialization and care of the dead.

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Spondyloarthritis: state of the art and future perspectives

Annals of the Rheumatic Diseases ◽

10.1136/ard.2009.119529 ◽

2010 ◽

Vol 69 (6) ◽

pp. 949-954 ◽

Cited By ~ 15

Author(s):

Désirée van der Heijde ◽

Walter P Maksymowych

Keyword(s):

Clinical Research ◽

Disease Activity ◽

Effective Treatment ◽

State Of The Art ◽

Well Being ◽

Plain Radiography ◽

Future Perspectives ◽

Comprehensive Understanding ◽

The Past ◽

Physical Modalities

Advances in the understanding of this group of arthritides over the past decade can be considered transformational from the perspective of basic mechanisms as well as clinical research focusing on the development of imaging technologies and a spectrum of standardised clinical outcomes that aim at a more comprehensive understanding of disease activity, functioning and disability, and prognosis. Prior to this decade, treatment was unsatisfactory and limited to physical modalities and non-steroidal anti-inflammatory agents, while diagnostic ascertainment primarily focused on clinical evaluation and plain radiography. Today, patients with spondyloarthritis (SpA) can look forward to earlier diagnosis and more effective treatment but significant challenges remain. This review will summarise the past decade's major accomplishments in the understanding of the basic mechanisms contributing to the development of SpA, outline those advances in clinical and imaging outcomes that have enabled major therapeutic advances and now permit a broader understanding of the early development of disease and its impact on patient well-being, and will describe new approaches to the development of diagnostic criteria that incorporate advances in imaging.

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Rett Syndrome: Coming to Terms with Treatment

Advances in Neuroscience ◽

10.1155/2014/345270 ◽

2014 ◽

Vol 2014 ◽

pp. 1-20 ◽

Cited By ~ 7

Author(s):

Alan Percy

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Rett Syndrome ◽

Basic Science ◽

Basic Research ◽

The Past ◽

Research Consortium ◽

Science Investigations ◽

Remarkable Progress ◽

Important Progress

Rett syndrome (RTT) has experienced remarkable progress over the past three decades since emerging as a disorder of worldwide proportions, particularly with discovery of the linkage of RTT to MECP2 mutations. The advances in clinical research and the increasing pace of basic science investigations have accelerated the pattern of discovery and understanding. Clinical trials are ongoing and others are planned. A review of these events and the prospects for continued success are highlighted below. The girls and women encountered today with RTT are, overall, in better general, neurologic, and behavioral health than those encountered earlier. This represents important progress worldwide from the concerted efforts of a broadly based and diverse clinical and basic research consortium as well as the efforts of parents, family, and friends.

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