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1.
Farm Hosp ; 44(7): 66-70, 2020 06 13.
Artigo em Inglês | MEDLINE | ID: mdl-32533675

RESUMO

The health crisis resulting from the rapid spread of SARS-CoV-2 worlwide, added to the low evidence of currently used treatments has led to the development of a large number of clinical trials (CT) and observational studies. Likewise,  important measures have been adopted in healthcare and research centers  aimed at halting the pandemic as soon as possible. The objective of this study is  to gather the main aspects of the clinical research studies undertaken by the  Departments of Hospital Pharmacy (DHP) of Spain during the COVID-19 crisis. The decision of the Spanish Society of Hospital Pharmacy (SEFH) to sponsor CTs made it possible that 13% of DHP had been led at least one CT.  The Spanish Agency for Medicines and Medical Devices (AEMPS), in coordination  with Institutional Review Boards, has adopted a fast-track review procedure to  accelerate authorizations for CTs related to the treatment or prevention of  COVID-19. There have also been numerous public and private calls for financing  research projects aimed at contributing to the fight against this virus. Despite  the pandemic, actions have been taken to continue ongoing CTs and studies  while the safety and well-being of patients are guaranteed. More specifically, the AEMPS and the European Medicines Agency (EMA) have issued guidelines that  incorporate changes to CT protocols that will have to be applied until the  pandemic is over. In this health emergency, the scientific community has found  itself in a race against time to generate evidence. It is at this moment that  hospital pharmacists emerge as key players in clinical research and are  contributing to a rational, effective and safe healthcare decision-making.


Assuntos
Betacoronavirus , Ensaios Clínicos como Assunto , Infecções por Coronavirus/tratamento farmacológico , Controle de Infecções/organização & administração , Estudos Multicêntricos como Assunto , Estudos Observacionais como Assunto , Pandemias , Serviço de Farmácia Hospitalar/organização & administração , Pneumonia Viral/tratamento farmacológico , Antivirais/uso terapêutico , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/estatística & dados numéricos , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Tomada de Decisões , Drogas em Investigação/uso terapêutico , Previsões , Humanos , Estudos Multicêntricos como Assunto/economia , Estudos Multicêntricos como Assunto/estatística & dados numéricos , Estudos Observacionais como Assunto/economia , Estudos Observacionais como Assunto/estatística & dados numéricos , Pandemias/prevenção & controle , Segurança do Paciente , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Projetos de Pesquisa , Apoio à Pesquisa como Assunto , Papel (figurativo) , Espanha
5.
PLoS One ; 15(1): e0227898, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32005037

RESUMO

Millions of volunteers take part in clinical trials every year. This is unsurprising, given that clinical trials are often much more lucrative than other types of unskilled work. When clinical trials offer very high pay, however, some people consider them repugnant. To understand why, we asked 1,428 respondents to evaluate a hypothetical medical trial for a new Ebola vaccine offering three different payment amounts. Some respondents (27%) used very high pay (£10,000) as a cue to infer the potential risks the clinical trial posed. These respondents were also concerned that offering £10,000 was coercive- simply too profitable to pass up. Both perceived risk and coercion in high-paying clinical trials shape how people evaluate these trials. This result was robust within and between respondents. The link between risk and repugnance may generalize to other markets in which parties are partially remunerated for the risk they take and contributes to a more complete understanding of why some market transactions appear repugnant.


Assuntos
Ensaios Clínicos como Assunto/psicologia , Doença pelo Vírus Ebola/epidemiologia , Voluntários/psicologia , Ensaios Clínicos como Assunto/economia , Vacinas contra Ebola/economia , Vacinas contra Ebola/uso terapêutico , Feminino , Doença pelo Vírus Ebola/prevenção & controle , Doença pelo Vírus Ebola/psicologia , Humanos , Masculino , Medição de Risco , Salários e Benefícios/economia
7.
BMC Public Health ; 20(1): 67, 2020 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-31941478

RESUMO

BACKGROUND: As HIV cure research advances, there is an increasing need for community engagement in health research, especially in low- and middle-income countries with ongoing clinical trials. Crowdsourcing contests provide an innovative bottom-up way to solicit community feedback on clinical trials in order to enhance community engagement. The objective of this study was to identify facilitators and barriers to participating in crowdsourcing contests about HIV cure research in a city with ongoing HIV cure clinical trials. METHODS: We conducted in-depth interviews to evaluate facilitators and barriers to participating in crowdsourcing contests in Guangzhou, China. Contests included the following activities: organizing a call for entries, promoting the call, evaluating entries, celebrating exceptional entries, and sharing entries. We interviewed 31 individuals, including nine HIV cure clinical trial participants, 17 contest participants, and five contest organizers. Our sample included men who have sex with men (20), people living with HIV (14), and people who inject drugs (5). We audio-recorded, transcribed, and thematically analyzed the data using inductive and deductive coding techniques. RESULTS: Facilitators of crowdsourcing contest participation included responsiveness to lived experiences, strong community interest in HIV research, and community trust in medical professionals and related groups. Contests had more participants if they responded to the lived experiences, challenges, and opportunities of living with HIV in China. Strong community interest in HIV research helped to drive the formulation and execution of HIV cure contests, building support and momentum for these activities. Finally, participant trust in medical professionals and related groups (community-based organizations and contest organizers) further strengthened the ties between community members and researchers. Barriers to participating in crowdsourcing contests included persistent HIV stigma and myths about HIV. Stigma associated with discussing HIV made promotion difficult in certain contexts (e.g., city squares and schools). Myths and misperceptions about HIV science confused participants. CONCLUSIONS: Our data identified facilitators and barriers of participation in HIV cure crowdsourcing contests in China. Our findings could complement existing HIV community engagement strategies and help to design HIV contests for community engagement in other settings, particularly in low- and middle-income countries.


Assuntos
Participação da Comunidade/estatística & dados numéricos , Crowdsourcing , Erradicação de Doenças/economia , Infecções por HIV/tratamento farmacológico , Infecções por HIV/prevenção & controle , Ensaios Clínicos como Assunto/economia , Participação da Comunidade/economia , Feminino , Infecções por HIV/economia , Humanos , Masculino , Pesquisa Qualitativa
8.
Am J Ophthalmol ; 211: 132-141, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31730839

RESUMO

PURPOSE: To perform a comprehensive analysis of characteristics of ophthalmology trials registered in ClinicalTrials.gov. DESIGN: Cross-sectional study. METHODS: All 4,203 ophthalmologic clinical trials registered on ClinicalTrials.gov between October 1, 2007, and April 30, 2018, were identified by using medical subject headings (MeSH). Disease condition terms were verified by manual review. Trial characteristics were assessed through frequency calculations. Hazard ratios and 95% confidence intervals were determined for characteristics associated with early discontinuation. RESULTS: The majority of trials were multiarmed (73.6%), single-site (69.4%), randomized (64.8%), and had <100 enrollees (66.3%). A total of 33% used a data-monitoring committee (DMC), and 50.6% incorporated blinding. Other groups (51.6%) were funded by industry, whereas 2.6% were funded by the US National Institutes of Health (NIH). NIH trials were significantly more likely to address oncologic (NIH = 15.5%, Other = 3%, Industry = 1.5%; P < 0.001) or pediatric disease (NIH = 20.9%, Other = 5.9%, Industry = 1.4%; P < 0.001). Industry-sponsored trials (69.6% of phase 3 trials) were significantly more likely to be randomized (Industry = 68.7%, NIH = 58.9%, Other = 60.8%; P < 0.001) and blinded (Industry = 57.2%, NIH = 42.7%, Other = 43.5%; P < 0.001). A total of 359 trials (8.5%) were discontinued early, and 530 trials (12.6%) had unknown status. Trials were less likely to be discontinued if funded by sources other than industry (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.55-0.95; P = 0.021) and/or had a DMC (HR, 0.71; 95% CI, 0.55-0.92; P = 0.010). CONCLUSIONS: Ophthalmology trials in the past decade reveal heterogeneity across study funding sources. NIH trials were more likely to support historically underfunded subspecialties, whereas Industry trials were more likely to face early discontinuation. These trends emphasize the importance of carefully monitored and methodologically sound trials with deliberate funding allocation.


Assuntos
Ensaios Clínicos como Assunto/estatística & dados numéricos , Bases de Dados Factuais/estatística & dados numéricos , Oftalmologia/estatística & dados numéricos , Sistema de Registros/estatística & dados numéricos , Projetos de Pesquisa , Ensaios Clínicos como Assunto/economia , Estudos Transversais , Financiamento Governamental/economia , Organização do Financiamento/economia , Pesquisa sobre Serviços de Saúde , Humanos , National Institutes of Health (U.S.)/estatística & dados numéricos , National Library of Medicine (U.S.)/estatística & dados numéricos , Oftalmologia/economia , Apoio à Pesquisa como Assunto/economia , Estados Unidos
11.
BMC Med Ethics ; 20(1): 96, 2019 12 17.
Artigo em Inglês | MEDLINE | ID: mdl-31847854

RESUMO

BACKGROUND: Much like academic-industry partnerships, industry financial support of patient advocacy organizations (PAOs) has become very common in recent years. While financial conflicts of interest (FCOI) between PAOs and industry have received more attention in recent years, robust efforts to mitigate these conflicts are still limited. MAIN BODY: The authors outline the possible benefits and ethical concerns that can result from financial interactions between biomedical companies and PAOs. They argue that the use of novel strategies, such as the creation of a standing ethics committee, could be helpful in managing FCOIs and ensuring the warranted trust of PAO's constituents. Although ethics committees to address FCOIs are common in the academic context, its use by PAOs is still limited. The authors conclude by describing the process of development and implementation of such an ethics committee at the Crohn's & Colitis Foundation. CONCLUSIONS: While collaborations with industry can result in conflicts of interest, PAOs can develop strategies to address those conflicts. One such strategy is the creation of a standing independent ethics committee to guide PAOs on new and/or existing programs and protocols as they pertain to their industry relationships.


Assuntos
Conflito de Interesses , Comitês de Ética em Pesquisa , Apoio Financeiro/ética , Fundações , Defesa do Paciente , Ensaios Clínicos como Assunto/economia , Conflito de Interesses/economia , Indústria Farmacêutica , Estudos de Casos Organizacionais
12.
Ger Med Sci ; 17: Doc10, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31728135

RESUMO

The objective of clinical trials is to transfer findings gained from basic research to patients and to result in innovative treatment approaches. Along with basic research, results from clinical trials thus represent a core area of medical advances. As a location for clinical trials, Germany is currently well-positioned and internationally competitive. This is evident in its position as No. 2 in Europe and No. 3 worldwide - behind the US and UK - in clinical trials of pharmaceuticals [1]. Maintaining and further improving this favorable positioning as a location for clinical trials is in the mutual interest of all parties involved in the field of clinical research, patients, trial sites and sponsors of clinical trials. For patients, clinical trials offer opportunities to gain early access to innovative therapy options. In addition to the scientific interest from medical faculties, clinical research is thereby an important aspect for university clinics in Germany as they fulfill their medical care mandate. Their involvement in clinical trials gives physicians the ability to gather experience with new treatment approaches at an early stage and to pass this know-how on to their patients. A location's clinical research is thus an important competitive factor in terms of international comparison as well. Industry likewise benefits from the favorable research infrastructure in Germany, which provides rapid patient recruitment and outstanding quality of results obtained and can thus contribute to the early approval of new drugs. From the perspective of the authors, it is therefore essential that Germany continues to remain competitive as a location for conducting clinical trials, precisely because the number of clinical trials is decreasing overall. Companies themselves are in international competition internally and externally, which often creates a certain pressure on trial preparation and thus on the start of a clinical trial. To ensure that a clinical trial can begin early, it is essential that contracts related to the trial are concluded quickly and simply, including remuneration for participants and full, transparent and comprehensible coverage of content for the business relationship. The swift agreement of key contractual and budgetary aspects is therefore in the interest of everyone involved. Against this backdrop, the German Association of Medical Faculties (MFT), the German Association of Academic Medical Centers (VUD), the Coordination Center for Clinical Studies (KKS-Netzwerk) and the German Association of Research-Based Pharmaceutical Companies (vfa) have held joint discussions regarding an important aspect of the contract negotiations - the cost consideration of clinical trials. As a result of these talks, these organizations have developed and published joint "Recommendations for the preparation of a total services calculation for remuneration related to the conduct of a clinical trial in a trial center" [2], [3]. The parties concerned share the conviction that, against the backdrops described, it would be helpful if the potential contract partners had access to recommendations that offer examples of constantly recurring cost positions in order to more precisely determine remuneration related to the conduct of a clinical trial. This article explains how the "Recommendations for the preparation of a total services calculation for remuneration related to the conduct of a clinical trial in a trial center" [2], [3] were developed and provides an overview of their content.


Assuntos
Ensaios Clínicos como Assunto/organização & administração , Contratos , Ensaios Clínicos como Assunto/economia , Contratos/economia , Contratos/normas , Indústria Farmacêutica/economia , Indústria Farmacêutica/organização & administração , Alemanha , Humanos , Remuneração
13.
Health Qual Life Outcomes ; 17(1): 156, 2019 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-31619266

RESUMO

BACKGROUND: Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. METHODS: Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. RESULTS: Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. CONCLUSIONS: PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. TRIAL REGISTRATION: Systematic Review registration PROSPERO CRD42017067799.


Assuntos
Ensaios Clínicos como Assunto/métodos , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/psicologia , Análise Custo-Benefício , Humanos , Projetos de Pesquisa/normas
14.
Rev Invest Clin ; 71(5): 297-305, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31599878

RESUMO

Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects' first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.


Assuntos
Ensaios Clínicos como Assunto/métodos , Indústria Farmacêutica/economia , Comitês de Ética em Pesquisa/organização & administração , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/ética , Humanos , Consentimento Livre e Esclarecido , Apoio à Pesquisa como Assunto/economia
15.
BMJ ; 367: l5766, 2019 10 23.
Artigo em Inglês | MEDLINE | ID: mdl-31645328

RESUMO

OBJECTIVE: To determine the extent to which late stage development of new drugs relies on support from public funding. DESIGN: Cohort study. SETTING: All new drugs containing one or more new molecular entities approved by the US Food and Drug Administration (FDA) between January 2008 and December 2017 via the new drug application pathway. MAIN OUTCOME MEASURES: Patents or drug development histories documenting late stage research contributions by a public sector research institution or a spin-off company, as well as each drug's regulatory approval pathway and first-in-class designation. RESULTS: Over the 10 year study period, the FDA approved 248 drugs containing one or more new molecular entities. Of these drugs, 48 (19%) had origins in publicly supported research and development and 14 (6%) originated in companies spun off from a publicly supported research program. Drugs in these groups were more likely to receive expedited FDA approval (68% v 47%, P=0.005) or be designated first in class (45% v 26%, P=0.007), indicating therapeutic importance. CONCLUSIONS: A review of the patents associated with new drugs approved over the past decade indicates that publicly supported research had a major role in the late stage development of at least one in four new drugs, either through direct funding of late stage research or through spin-off companies created from public sector research institutions. These findings could have implications for policy makers in determining fair prices and revenue flows for these products.


Assuntos
Ensaios Clínicos como Assunto/economia , Aprovação de Drogas/economia , Setor Público/economia , Pesquisa Médica Translacional/economia , Ensaios Clínicos como Assunto/estatística & dados numéricos , Estudos de Coortes , Aprovação de Drogas/legislação & jurisprudência , Aprovação de Drogas/estatística & dados numéricos , Humanos , Patentes como Assunto/estatística & dados numéricos , Setor Público/estatística & dados numéricos , Pesquisa Médica Translacional/estatística & dados numéricos , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudência , United States Food and Drug Administration/estatística & dados numéricos
16.
BMC Med Ethics ; 20(1): 64, 2019 09 18.
Artigo em Inglês | MEDLINE | ID: mdl-31533704

RESUMO

BACKGROUND: Most studies are inclined to report positive rather than negative or inconclusive results. It is currently unknown how clinicians appraise the results of a randomized clinical trial. For example, how does the study funding source influence the appraisal of an RCT, and do positive findings influence perceived credibility and clinical relevance? This study investigates whether psychiatrists' appraisal of a scientific abstract is influenced by industry funding disclosures and a positive outcome. METHODS: Dutch psychiatrists were randomized to evaluate a scientific abstract describing a fictitious RCT for a novel antipsychotic drug. Four different abstracts were created reporting either absence or presence of industry funding disclosure as well as a positive or a negative outcome. Primary outcomes were the perceived credibility and clinical relevance of the study results (10-point Likert scale). Secondary outcomes were the assessment of methodological quality and interest in reading the full article. RESULTS: Three hundred ninety-five psychiatrists completed the survey (completion rate 45%). Industry funding disclosure was found not to influence perceived credibility (Mean Difference MD 0.12; 95% CI - 0.28 to 0.47, p?) nor interpretation of its clinical relevance (MD 0.14; 95% CI - 0.54 to 0.27, p?). A negative outcome was perceived as more credible than a positive outcome (MD 0.81 points; 95% Confidence Interval (CI) 0.43 to 1.18, p?), but did not affect clinical relevance scores (MD -0.14; 95% CI - 0.54 to 0.27). CONCLUSIONS: In this study, industry funding disclosure was not associated with the perceived credibility nor judgement of clinical relevance of a fictional RCT by psychiatrists. Positive study outcomes were found to be less credible compared to negative outcomes, but industry funding had no significant effects. Psychiatrists may underestimate the influence of funding sources on research results. The fact that physicians indicated negative outcomes to be more credible may point to more awareness of existing publication bias in the scientific literature.


Assuntos
Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/ética , Conflito de Interesses , Indústria Farmacêutica/economia , Indústria Farmacêutica/ética , Psiquiatria/economia , Psiquiatria/ética , Apoio à Pesquisa como Assunto/ética , Humanos , Países Baixos
18.
PLoS One ; 14(9): e0222117, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31553736

RESUMO

BACKGROUND: Commercial or industry funding is associated with outcomes that favour the study funder in published studies, across various areas of research. However, it is currently unclear whether there are differences between trials with and without industry involvement at the stage of trial registration. OBJECTIVE: To determine whether industry involvement (industry sponsorship, funding, or collaboration) is associated with trial characteristics at the time of trial registration. METHODS: We conducted a cross-sectional analysis of all interventional studies registered on the Australian New Zealand Clinical Trials Registry in 2017 and classified them by industry involvement. We analysed whether there were differences in study characteristics (including type of control, sample size, study phase, randomisation, registration timing, and purpose of study) by industry involvement. RESULTS: Industry involvement was reported by 21% of the 1,433 included trials. Only 40% of trials with industry involvement used an active control compared to 58% of non-industry trials (OR = 0.49, 95%CI = 0.38 to 0.63, p < .001), and industry trials reported smaller sample sizes (Median(IQR)industry = 45(24-100), Median(IQR)non-industry = 70(35-160), Mean Difference = -153, 95% CI = -233 to -75, p < .001). Industry trials were more likely to be earlier phase trials (Χ2(df) = 71.46(4), p < .001). There was no difference in use of randomisation between industry (70%) and non-industry trials (73%) (OR = 0.88, 95%CI = 0.67-1.20, p = .38). Eighty-three percent of industry trials compared to 70% of non-industry trials were prospectively registered (OR = 2.02, 95%CI = 1.47-2.82, p < .001). Industry trials were more likely to assess treatment (85%), rather than prevention, education or diagnosis compared to non-industry trials (64%) (OR = 3.02, 95%CI = 2.17-4.32, p < .001). CONCLUSION: The current study gives insight into differences in trial characteristics by industry involvement at registration stage. There was a reduced use of active controls in trials with industry involvement which has previously been proposed as a mechanism behind more favourable results. Non-industry funders and sponsors are crucial to ensure research addresses not only treatments, but also prevention, diagnosis and education questions.


Assuntos
Ensaios Clínicos como Assunto/métodos , Indústrias , Pesquisa Biomédica , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/estatística & dados numéricos , Estudos Transversais , Indústria Farmacêutica/economia , Administração Financeira/estatística & dados numéricos , Humanos , Indústrias/economia , Nova Zelândia , Sistema de Registros/estatística & dados numéricos
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