scholarly journals L’etica della sperimentazione sull’uomo dal processo di Norimberga ai comitati di etica

2010 ◽  
Vol 59 (6) ◽  
Author(s):  
Roberta Minacori ◽  
Dario Sacchini ◽  
Marina Cicerone ◽  
Nunziata Comoretto ◽  
Antonio G. Spagnolo
Keyword(s):  
Clinical Trials ◽  
Ethics Committees ◽  
Bioethical Issue ◽  
Linee Guida ◽  
The Public ◽  
Vulnerable People ◽  
Risk Acceptability ◽  
Ethical Significance ◽  
Theoretical Reflection ◽  
Large Diffusion

L’articolo analizza come la rivista “Medicina e Morale” ha affrontato nella sua storia il tema dell’etica nella sperimentazione clinica, che rappresenta una parte molto ampia e complessa della bioetica ma anche della deontologia medica. Gli aspetti che questa tematica comprende sono ormai numerosissimi e la letteratura prodotta ingentissima. L’etica della sperimentazione ha ricevuto particolare vigore e attenzione in seguito a diverse sperimentazioni non etiche che hanno profondamente turbato l’opinione pubblica e reso necessario un forte ripensamento nell’ambito della ricerca clinica. In generale, dagli anni ’60 agli anni ’80 del XX secolo, ha prevalso nella letteratura un intenso impegno e interesse nella elaborazione dei principi di riferimento e nella riflessione teorica relativa a varie questioni (quali il consenso informato, il significato etico della ricerca clinica, la tutela dei soggetti vulnerabili, l’accettabilità del rischio). Dagli anni ’90 in poi si è invece intensificata – probabilmente per le esigenze nate in seno ai Comitati di etica che proprio in quel periodo hanno iniziato a diffondersi massicciamente – la elaborazione di codici, regolamenti, linee-guida che ha orientato lo sviluppo della disciplina più in senso procedurale e con un approccio etico-deontologico. In particolare, Medicina e Morale è stata sempre presente su queste tematiche, fin dagli inizi della sua storia, costituendo una voce originale nel dibattito, oltre che uno strumento di diffusione (in particolare nell’era pre-internet) di documenti nazionali e soprattutto internazionali. La Rivista ha rappresentato, soprattutto nell’ultimo trentennio, un vero punto di riferimento a livello nazionale ed in alcuni casi anche internazionale, proponendo a volte orientamenti originali, che sono stai poi accolti nell’ambito di linee-guida e di normative. ---------- The article deals with how the journal “Medicina e Morale” has faced ethics in clinical trials, which represents a very large and complex bioethical issue, but also deontological one. This area comprises many questions and the literature is huge. It has risen after unethical clinical trials that have shocked the public and have produced a big rethinking about it. In general, from the ’60s to the ’80s of the XXth century, an intense commitment and interest have prevailed on the elaboration of the reference principles and on theoretical reflection on various issues, such as informed consent, the ethical significance of clinical research, the protection of vulnerable people, the risk acceptability). Since the ’90s onwards the development of codes, regulations, guidelines – that have guided the development of the discipline in a procedural and also deontological sense – has increased, probably due to the large diffusion of ethics committees. Particularly, the journal “Medicine and Morale” has always been present on these issues, since the beginning of its history, creating an original voice in the debate, as well as a dissemination tool (especially in the pre-internet era) of national and especially international documentation. The journal has been, especially in the last thirty years, a real national, and sometimes international, benchmark, offering original suggestions which are then accepted in guidelines and regulations.

scholarly journals Patient and public involvement prior to trial initiation: lessons learnt for rapid partnership in the COVID-19 era

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Zahra Jamal ◽  
◽  
Alexander Perkins ◽  
Christopher Allen ◽  
Richard Evans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
Public Involvement ◽  
Ethics Committees ◽  
Patient And Public Involvement ◽  
Research Ethics Committees ◽  
The Public ◽  
Clinical Trials Unit ◽  
The Uk

Plain English summary Patient and Public Involvement (PPI) describes the active involvement of patients and the public in the research process. Through PPI, patients and members of the public are increasingly involved in the design and conduct of clinical trials. PPI has been shown to improve the quality and relevance of research. During the COVID-19 pandemic, clinical trials have been playing a vital role in helping us find ways to prevent and treat the infection and improve our understanding of the virus. It is important that patients and the public are actively involved in deciding how COVID-19 research is carried out. Unfortunately, Research Ethics Committees in the UK have seen far less PPI for COVID-19 research studies compared with research before the pandemic. A key reason for this is that research is being designed much faster than normal and researchers may feel they do not have time to properly involve patients and the public. In this paper, we share our experiences of PPI for a COVID-19 clinical trial. We show that it is possible to rapidly involve patients and the public in COVID-19 clinical trials. We also explain how the design of the clinical trial was changed in response to feedback from public contributors. Lastly, we discuss the wider learning from this process which might be useful for researchers planning PPI activities for COVID-19 clinical trials in the future. Abstract Background: Clinical trials are playing a critical role in the global public health response to the COVID-19 pandemic. Despite the increasing recognition of the value of PPI in clinical trials, just 22% of the COVID-19 research proposals reviewed by Research Ethics Committees in the UK at the start of the pandemic reported PPI. There is a perception that PPI might result in delays in delivering research and therefore delays in obtaining important results. In this paper, we report our experience of rapid PPI for a COVID-19 clinical trial. Methods: RAPID-19 is a COVID-19 clinical trial which was planned to be submitted for fast-track ethics review in the United Kingdom. During the development of the trial protocol, the PPI Panel at the London School of Hygiene & Tropical Medicine Clinical Trials Unit was involved in the design of the study. The meeting with the PPI Panel lasted just over 1 h and was conducted by teleconference. Results: Although we only had a short period of time to explore the study with the PPI Panel, we were able to gain valuable insight into how the trial would be perceived by potential trial participants. Substantive changes were made to the trial to improve the acceptability of the research without compromising the study timelines. Having access to public contributors with relevant lived experience is an important resource for a Clinical Trials Unit and is critical for rapid PPI. The move to remote working due to lockdown required virtual discussions which helped to overcome some of the barriers to organising face-to-face meetings at short notice. Conclusions: PPI for clinical trials can be conducted in a time-efficient manner within the pressured environment of a pandemic. Involving PPI contributors at an early stage in protocol development maximised the opportunity to shape and influence the trial as well as limited potential delays which could occur if changes to the protocol had to be made at a later stage.

Using social media to recruit study participants for a randomised trial for hypertension (Preprint)

2020 ◽  
Author(s):  
Lida Feyz ◽  
Yale Wang ◽  
Atul Pathak ◽  
Manish Saxena ◽  
Felix Mahfoud ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Social Media ◽  
Clinical Trials ◽  
Statistical Analysis ◽  
Ethics Committees ◽  
Patient Recruitment ◽  
Recruitment Strategies ◽  
Hypertensive Patients ◽  
Total Cost ◽  
Recruitment Period

BACKGROUND Great and costly efforts are required to recruit potential participants into clinical trials. Using social media may make the recruitment process more efficient. Merely 20% of clinical trials are completed on time, a finding mostly linked to challenges in patient recruitment [1]. Recruitment through social media is increasingly being recognized as a tool to efficiently identify eligible subjects at lower costs [2, 3]. One of the key reasons for its success is the strong adherence of users to specific social media platforms. Facebook for instance has over 2.38 billion active monthly users of which about 75% access the network on a daily basis [4]. As such, the platform and other like it offer great potential to quickly and affordably enroll patients into clinical trials and surveys [3, 5-7]. At present, little evidence is available on the efficacy of using social media to recruit patients into cardiovascular and hypertension trials [8]. The aim of the present study was to evaluate the efficacy of social media as an approach to recruit hypertensive patients into the RADIANCE-HTN SOLO trial. OBJECTIVE The aim of the present study was to evaluate the efficacy of social media as an approach to recruit hypertensive patients into the RADIANCE-HTN SOLO trial. METHODS The RADIANCE-HTN SOLO (NCT02649426) is a multicenter, randomised study that was designed to demonstrate the efficacy and safety of endovascular ultrasound renal denervation (RDN) to reduce ambulatory blood pressure at 2 months in patients with combined systolic–diastolic hypertension in the absence of medications. Between March 28, 2016, and Dec 28, 2017, 803 patients were screened for eligibility and 146 were randomised to undergo RDN (n=74) or a sham procedure (n=72) [9]. Key entry criteria included: age 18-75 years with essential hypertension using 0-2 antihypertensive drugs. Patients were recruited from 21 hospitals in the USA and 18 hospitals in Europe. The study was approved by local ethics committees or institutional review boards and was performed in accordance with the declaration of Helsinki. All participants provided written informed consent. All recruitment materials including social media campaigns was approved by local ethics committees of the involved sites. Recruitment strategies included social media (Facebook), conventional advertisements (ads) (magazine, brochure/poster, radio, newspaper), web search (the clinical website, craigslist and web-browsing), and physician referral. Both newspaper ads and posters contained brief information about study entry criteria. Newspapers were distributed at public transport places and posters were displayed in outpatient cardiology and hypertension clinics. Radio ads were run for 30 or 60 seconds providing a short summary of the study, entry criteria and contact information. Ads were run in major metropolitan areas on radio stations with large adult listener bases during popular days and times. Facebook ads were targeted towards subjects >45 years old within a certain distance from a recruitment site (range 20-50 miles). Criteria were modified over time in order to increase response rates [i.e. distance was increased or decreased, age was increased to >55 year]. Facebook ads referred to a dedicated study website translated into country specific languages. If interested, subjects could complete an anonymous online screening questionnaire which provided direct automatic feedback on study eligibility. Eligible subjects were asked to provide contact details (name and telephone number) to receive additional information, a process coordinated via a secure online portal (Galen Gateway Patient Recruitment Portal, Galen Patient Recruitment, Inc., Cumberland, RI). Study site were only able to contact potential candidates within their area. The study sponsor was not able to access any personal data. Trained local site personnel or contracted secondary screeners contacted candidates by phone to verify eligibility and answer potential questions. A subsequent outpatient clinic visit was scheduled during which the study was explained in greater detail and the informed consent form could be signed. Statistical analysis Categorical variables were expressed as percentages and counts. Continuous variables were described as mean  standard deviation (SD) when normally distributed, data was compared using an Independent-Samples or Paired-Samples T test to analyze the difference between recruitment methods. In case of non-normal distribution, median data was presented with the interquartile range [IQR]. All statistical tests are 2-tailed. A P-value <0.05 was considered statistically significant. Statistical analysis was performed using SPSS statistical analysis (version 24.0).   RESULTS Results Facebook ads were active during a 115-day recruitment period between August and November 2017. A total of 285 potential candidates were recruited by different recruitment strategies in this specific time period, of which 184 (65%) were consented through Facebook (Table 1). The average age of the subjects consented through Facebook was 59 ± 8 years and 51% were male (Table 2). Facebook reached 5.3 million people in 168 separate campaigns run in proximity to 19 sites in the US and 14 sites in Europe. The number of candidates per site was variable with a median of 23 [17 – 26] candidates per site that passed the questionnaire (Figure 1). A total of 27/184 subjects were eventually randomised. Total cost for the Facebook ads was $152,412; costing $907/campaign and $0.83/click. This resulted in a total cost of $828/consent. During the same recruitment period, 7-day radio spots were launched with a total cost of $2,870; resulting in 9 inquiries with eventually 5 potential candidates and 2 consents ($1,435/consent).   CONCLUSIONS Conclusion Targeted social media was a successful and efficient strategy to find potential candidates for a multicenter blood pressure clinical trial. Whether this approach can be replicated across other disease states or demographics remains to be studied.

scholarly journals Behavioral and Attitudinal Correlates of Trusted Sources of COVID-19 Vaccine Information in the US

2021 ◽  
Vol 11 (4) ◽  
pp. 56
Author(s):  
Carl A. Latkin ◽  
Lauren Dayton ◽  
Jacob R. Miller ◽  
Grace Yi ◽  
Afareen Jaleel ◽  
...  
Keyword(s):  
Regression Models ◽  
Logistic Regression Models ◽  
The Public ◽  
Public Health Systems ◽  
Online Study ◽  
News Sources ◽  
The Us ◽  
Vulnerable People ◽  
Two Factors ◽  
Vaccine Information

There is a critical need for the public to have trusted sources of vaccine information. A longitudinal online study assessed trust in COVID-19 vaccine information from 10 sources. A factor analysis for data reduction revealed two factors. The first factor contained politically conservative sources (PCS) of information. The second factor included eight news sources representing mainstream sources (MS). Multivariable logistic regression models were used. Trust in Dr. Fauci was also examined. High trust in MS was associated with intention to encourage family members to get COVID-19 vaccines, altruistic beliefs that more vulnerable people should have vaccine priority, and belief that racial minorities with higher rates of COVID-19 deaths should have priority. High trust in PCS was associated with intention to discourage friends from getting vaccinated. Higher trust in PCS was also associated with participants more likely to disagree that minorities with higher rates of COVID-19 deaths should have priority for a vaccine. High trust in Dr. Fauci as a source of COVID-19 vaccine information was associated with factors similar to high trust in MS. Fair, equitable, and transparent access and distribution are essential to ensure trust in public health systems’ abilities to serve the population.

scholarly journals Clinical trial registries as Scientometric data: A novel solution for linking and deduplicating clinical trials from multiple registries

2021 ◽  
Author(s):  
Christian Thiele ◽  
Gerrit Hirschfeld ◽  
Ruth von Brachel
Keyword(s):  
Clinical Trials ◽  
Random Forest ◽  
Random Forest Model ◽  
Scientometric Analysis ◽  
Data Set ◽  
The Public ◽  
Forest Model ◽  
Clinical Trial Registries ◽  
Multiple Primary ◽  
Clinical Trials Registry

AbstractRegistries of clinical trials are a potential source for scientometric analysis of medical research and serve important functions for the research community and the public at large. Clinical trials that recruit patients in Germany are usually registered in the German Clinical Trials Register (DRKS) or in international registries such as ClinicalTrials.gov. Furthermore, the International Clinical Trials Registry Platform (ICTRP) aggregates trials from multiple primary registries. We queried the DRKS, ClinicalTrials.gov, and the ICTRP for trials with a recruiting location in Germany. Trials that were registered in multiple registries were linked using the primary and secondary identifiers and a Random Forest model based on various similarity metrics. We identified 35,912 trials that were conducted in Germany. The majority of the trials was registered in multiple databases. 32,106 trials were linked using primary IDs, 26 were linked using a Random Forest model, and 10,537 internal duplicates on ICTRP were identified using the Random Forest model after finding pairs with matching primary or secondary IDs. In cross-validation, the Random Forest increased the F1-score from 96.4% to 97.1% compared to a linkage based solely on secondary IDs on a manually labelled data set. 28% of all trials were registered in the German DRKS. 54% of the trials on ClinicalTrials.gov, 43% of the trials on the DRKS and 56% of the trials on the ICTRP were pre-registered. The ratio of pre-registered studies and the ratio of studies that are registered in the DRKS increased over time.

scholarly journals The Disclosure Decision of Foreign Clinical Trials in China: Moderating Effects of Firms’ Contingencies

SAGE Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 215824402110163
Author(s):  
Tariq H. Malik ◽  
Chunhui Huo
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Risk Taking ◽  
Academic Community ◽  
Moderating Effects ◽  
The Public ◽  
Industrial Enterprises ◽  
Unit Increase ◽  
Clinical Trial Results ◽  
Clinical Trial Activity

Result disclosure of clinical trial posts a conflicting logic between private secrecy and public interest. Despite ethical and legal requirements for disclosing clinical trial results, clinical trials’ sponsors tend to withhold the results. We explored the location, timing, and rationale behind the withheld clinical trial results. Based on the entrepreneurial orientation (EO) perspective, we propose that organizational EO contingencies moderate the disclosure decision. We used the completed clinical trial projects in China by foreign and domestic sponsors. First, we found that a unit increase in the sponsor’s experience can increase the disclosure about 1.01 times. Second, we found that industrial enterprises disclose results about 3.7 times more than universities do. Third, we found that foreign clinical trial projects in China tend to disclose 3.9 times more than domestic projects. We link these findings to two types of audience. First, we inform the academic community on the theory and empirics regarding risk-taking behavior in the biopharmaceutical industry’s clinical trial activity. Second, we address the general audiences concerned about the ethical and socioeconomic wellbeing of the public.

scholarly journals Fair and equitable subject selection in concurrent COVID-19 clinical trials

2020 ◽  
Vol 47 (1) ◽  
pp. 7-11
Author(s):  
Maud O. Jansen ◽  
Peter Angelos ◽  
Stephen J. Schrantz ◽  
Jessica S. Donington ◽  
Maria Lucia L. Madariaga ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Research Design ◽  
Ethics Committees ◽  
Scientific Uncertainty ◽  
Moral Concern ◽  
Structural Barriers ◽  
Ethical Guidelines ◽  
Academic Medical Centre ◽  
Subject Selection ◽  
Study Results

Clinical trials emerged in rapid succession as the COVID-19 pandemic created an unprecedented need for life-saving therapies. Fair and equitable subject selection in clinical trials offering investigational therapies ought to be an urgent moral concern. Subject selection determines the distribution of risks and benefits, and impacts the applicability of the study results for the larger population. While Research Ethics Committees monitor fair subject selection within each trial, no standard oversight exists for subject selection across multiple trials for the same disease. Drawing on the experience of multiple clinical trials at a single academic medical centre in the USA, we posit that concurrent COVID-19 trials are liable to unfair and inequitable subject selection on account of scientific uncertainty, lack of transparency, scarcity and, lastly, structural barriers to equity compounded by implicit bias. To address the critical gap in the current literature and international regulation, we propose new ethical guidelines for research design and conduct that bolsters fair and equitable subject selection. Although the proposed guidelines are tailored to the research design and protocol of concurrent trials in the COVID-19 pandemic, they may have broader relevance to single COVID-19 trials.

The Relational Public

2021 ◽  
pp. 073527512110046
Author(s):  
Paul Starr
Keyword(s):  
Body Politic ◽  
The Body ◽  
Social Categories ◽  
The Public ◽  
Shared Stories ◽  
Theoretical Reflection

This article sets out three ways of conceiving publics: (1) an organic conception, the public as the body politic; (2) an individualized conception, the public as an aggregate of individuals, grouped by social categories; and (3) a relational conception, in which publics are defined as open-ended networks of actors linked through flows of communication, shared stories, and civic or other collective concerns. These conceptions have emerged not only through theoretical reflection but also as the result of historical and institutional developments. Building on work from Tarde and Habermas down to recent theorists, I seek to advance the relational conception, suggest its implications for research, and highlight its connection to contemporary developments in both theory and society.

scholarly journals Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Daria Kim ◽  
Joerg Hasford
Keyword(s):  
Clinical Trials ◽  
Health Risks ◽  
Ethics Committees ◽  
Medical Community ◽  
Significant Extent ◽  
Regulatory Requirements ◽  
Trial Participants ◽  
Clinical Trials Regulation ◽  
Clinical Trial Regulation ◽  
The Eu

Abstract The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

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