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‣ Clinical trial design in non-invasive brain stimulation psychiatric research

BRUNONI, Andre Russowsky; FREGNI, Felipe
Fonte: WILEY-BLACKWELL Publicador: WILEY-BLACKWELL
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
67.04104%
Major depressive disorder (MDD) trials - investigating either non-pharmacological or pharmacological interventions - have shown mixed results. Many reasons explain this heterogeneity, but one that stands out is the trial design due to specific challenges in the field. We aimed therefore to review the methodology of non-invasive brain stimulation (NIBS) trials and provide a framework to improve clinical trial design. We performed a systematic review for randomized, controlled MDD trials whose intervention was transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) in MEDLINE and other databases from April 2002 to April 2008. We created an unstructured checklist based on CONSORT guidelines to extract items such as power analysis, sham method, blinding assessment, allocation concealment, operational criteria used for MDD, definition of refractory depression and primary study hypotheses. Thirty-one studies were included. We found that the main methodological issues can be divided in to three groups: (1) issues related to phase II/small trials, (2) issues related to MDD trials and, (3) specific issues of NIBS studies. Taken together, they can threaten study validity and lead to inconclusive results. Feasible solutions include: estimating the sample size a priori; measuring the degree of refractoriness of the subjects; specifying the primary hypothesis and statistical tests; controlling predictor variables through stratification randomization methods or using strict eligibility criteria; adjusting the study design to the target population; using adaptive designs and exploring NIBS efficacy employing biological markers. In conclusion...

‣ A success in Toxinology translational research in Brazil: Bridging the gap

Ferreira, Ana Silvia S. B. S.; Barraviera, Benedito; Barraviera, Silvia Regina C. S.; Abbade, Luciana Patrícia Fernandes; Caramori, Carlos Antonio; Ferreira, Rui Seabra
Fonte: Universidade Estadual Paulista Publicador: Universidade Estadual Paulista
Tipo: Artigo de Revista Científica Formato: 50-54
Português
Relevância na Pesquisa
56.816763%
Basic research is fundamental for discovering potential diagnostic and therapeutic tools, including drugs, vaccines and new diagnostic techniques. On this basis, diagnosis and treatment methods for many diseases have been developed. Presently, discovering new candidate molecules and testing them in animals are relatively easy tasks that require modest resources and responsibility. However, crossing the animal-to-human barrier is still a great challenge that most researchers tend to avoid. Thus, bridging this current gap between clinical and basic research must be encouraged and elucidated in training programmes for health professionals. This project clearly shows the challenges faced by a group of Brazilian researchers who, after discovering a new fibrin sealant through 20 years of painstaking basic work, insisted on having the product applied clinically. The Brazilian government has recently become aware of this challenge and has accordingly defined the product as strategic to the public health of the country. Thus, in addition to financing research and development laboratories, resources were invested in clinical trials and in the development of a virtual platform termed the Virtual System to Support Clinical Research (SAVPC); this platform imparts speed...

‣ Description of research design of articles published in four Brazilian physical therapy journals

Saragiotto,Bruno T.; Costa,Lucíola C. M.; Oliveira,Ronaldo F.; Lopes,Alexandre D.; Moseley,Anne M.; Costa,Leonardo O. P.
Fonte: Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia Publicador: Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/02/2014 Português
Relevância na Pesquisa
67.14282%
Background : While the research design of articles published in medical journals and in some physical therapy journals has already been evaluated, this has not been investigated in Brazilian physical therapy journals. Objective : To describe the research design used in all articles published in Brazilian scientific journals that are freely available, have high Qualis rankings, and are relevant to physical therapy over a 7-year period. Method : We extracted the bibliometric data, research design, research type (human or animal), and clinical area for all articles published. The articles were grouped into their level of evidence, and descriptive analyses were performed. We calculated the frequency, proportions of articles, and 95% confidence interval of these proportions with each research design in each journal. We cross-tabulated the clinical areas with research designs (expressed as number and percentages). Results : A total of 1,458 articles from four Brazilian journals were found: Revista Brasileira de Fisioterapia, Revista Fisioterapia em Movimento, Revista Fisioterapia e Pesquisa, and Revista Acta Fisiátrica. The majority of articles were classified as level II of evidence (60%), followed by level III (29%) and level I (10%). The most prevalent research designs were cross-sectional studies (38%)...

‣ Current clinical research environment: focus on psychiatry

Dainesi,Sonia Mansoldo; Elkis,Helio
Fonte: Associação Brasileira de Psiquiatria - ABP Publicador: Associação Brasileira de Psiquiatria - ABP
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/09/2007 Português
Relevância na Pesquisa
66.886523%
The introduction of international guidelines on Good Clinical Practices (GCP) in 1996, immediately followed by the publication of Resolution CNS 196/96 in Brazil, created a great opportunity for Brazilian research centers to participate in international trials. Such studies must be strictly monitored in order to assure compliance with the regulations, as well as with the standards of patient safety. Clear agreement among the investigator, the sponsor and the institution carrying out the study must be previously defined in order to avoid any conflicts of interest during or after the study. Operational aspects, such as the time needed to gain regulatory approval of the study design, strategies for patient recruitment/retention and appropriate logistics, are also important. In 2005, the Brazilian National Clinical Research Network was established, bringing together a number of research centers in teaching hospitals. The objective was to subsidize public clinical research with state-of-the-art practices and appropriate technical/scientific training programs. The development of research protocols that prioritize public health care needs in Brazil is other fundamental goal of this network. This article addresses general aspects of clinical research...

‣ Innovations in Clinical Research Design and Conduct in Psychiatry: Shifting to Pragmatic Approaches

Marks, David M.; J, Thanaseelan; Pae, Chi-Un
Fonte: Korean Neuropsychiatric Association Publicador: Korean Neuropsychiatric Association
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
57.197783%
The classically structured clinical trial does not offer enough flexibility to make use of continuously emerging knowledge that is generated as the trial progresses. In this regard, there are consistent issues impeding effective psychiatric research, including limitations in efficiency, difficulty demonstrating significant differences between treatment arms, poor external validity, and ethical constraints. For example, research in the field of psychiatry shows that it is growing increasingly more challenging to demonstrate superiority of interventions to placebo in part related to the increasing placebo response rates. Various design innovations and other tricks of the trade have surfaced to improve sensitivity towards detecting drug-placebo differences and reduce sources of bias in psychiatric research. Diverse strategies have been developed to address these obstacles and improve the outcomes of clinical research in psychiatry. The current review highlights many of these innovations and describes examples of their practical use, mainly focusing on the study design and conduct perspectives. In the study design issues, adaptive, equipoise stratified, sequential parallel and effectiveness design will be explored. The proper strategies for pragmatic and ethical conduction of clinical trials will be also discussed in-depth.

‣ Understanding Patient Values and the Manifestations in Clinical Research with Traditional Chinese Medicine—With Practical Suggestions for Trial Design and Implementation

Mu, Wei; Shang, Hongcai
Fonte: Hindawi Publishing Corporation Publicador: Hindawi Publishing Corporation
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
57.10067%
Objective. To define patient values, identify their manifestations in a randomized clinical trial, and investigate the possible implications for clinical research of traditional Chinese medicine. Methods. We categorized patient values manifestations into patient choice, preference, compliance, and patient-reported outcomes and summarized the underlying personal values through purposeful electronic searches for relevant reports. By hypothesizing a set of positive versus negative circumstances occurring in the enrollment, intervention allocation, treatment, and the follow-up stage of a trial, it is possible to discuss the potential implications of patient values manifestation on a trial with traditional Chinese medicine. Results. Patient values and its manifestations are ubiquitous in the process of clinical research with traditional Chinese medicine. These values may provide motivation for participation or engender the internal and external validity of the study. Conclusions. Trialists should attach sufficient importance to the needs and concerns of individual participant. To incorporate patient values into the design and conduct of a clinical study with traditional Chinese medicine, researchers are recommended to adopt participant-friendly design and use patient-reported outcomes...

‣ Comparative Effectiveness Research: An Empirical Study of Trials Registered in ClinicalTrials.gov

Murthy, Srinivas; Bourgeois, Florence Tanya; Mandl, Kenneth David
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
56.74959%
Background: The $1.1 billion investment in comparative effectiveness research will reshape the evidence-base supporting decisions about treatment effectiveness, safety, and cost. Defining the current prevalence and characteristics of comparative effectiveness (CE) research will enable future assessments of the impact of this program. Methods: We conducted an observational study of clinical trials addressing priority research topics defined by the Institute of Medicine and conducted in the US between 2007 and 2010. Trials were identified in ClinicalTrials.gov. Main outcome measures were the prevalence of comparative effectiveness research, nature of comparators selected, funding sources, and impact of these factors on results. Results: 231 (22.3%; 95% CI 19.8%–24.9%) studies were CE studies and 804 (77.7%; 95% CI, 75.1%–80.2%) were non-CE studies, with 379 (36.6%; 95% CI, 33.7%–39.6%) employing a placebo control and 425 (41.1%; 95% CI, 38.1%–44.1%) no control. The most common treatments examined in CE studies were drug interventions (37.2%), behavioral interventions (28.6%), and procedures (15.6%). Study findings were favorable for the experimental treatment in 34.8% of CE studies and greater than twice as many (78.6%) non-CE studies (P<0.001). CE studies were more likely to receive government funding (P = 0.003) and less likely to receive industry funding (P = 0.01)...

‣ Informed Consent and Placebo Effects: A Content Analysis of Information Leaflets to Identify What Clinical Trial Participants Are Told about Placebos

Bishop, Felicity L.; Adams, Alison E. M.; Lewith, George T.; Kaptchuk, Ted Jack
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
56.97191%
Background: Placebo groups are used in randomised clinical trials (RCTs) to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects. Methods and Findings: We conducted a content analysis of 45 Participant Information Leaflets (PILs) using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database). Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%), but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50∶50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001) and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45...

‣ Design and Initial Results of a Multi-Phase Randomized Trial of Ceftriaxone in Amyotrophic Lateral Sclerosis

Berry, James Dale; Shefner, Jeremy M.; Conwit, Robin; Schoenfeld, David Alan; Keroack, Myles; Felsenstein, Donna; Krivickas, Lisa; David, William Samuel; Vriesendorp, Francine; Pestronk, Alan; Caress, James B.; Katz, Jonathan; Simpson, Ericka; Rosenfeld,
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
56.831904%
Objectives: Ceftriaxone increases expression of the astrocytic glutamate transporter, EAAT2, which might protect from glutamate-mediated excitotoxicity. A trial using a novel three stage nonstop design, incorporating Phases I-III, tested ceftriaxone in ALS. Stage 1 determined the cerebrospinal fluid pharmacokinetics of ceftriaxone in subjects with ALS. Stage 2 evaluated safety and tolerability for 20-weeks. Analysis of the pharmacokinetics, tolerability, and safety was used to determine the ceftriaxone dosage for Stage 3 efficacy testing. Methods: In Stage 1, 66 subjects at ten clinical sites were enrolled and randomized equally into three study groups receiving intravenous placebo, ceftriaxone 2 grams daily or ceftriaxone 4 grams daily divided BID. Participants provided serum and cerebrospinal fluid for pharmacokinetic analysis on study day 7. Participants continued their assigned treatment in Stage 2. The Data and Safety Monitoring Board (DSMB) reviewed the data after the last participants completed 20 weeks on study drug. Results: Stage 1 analysis revealed linear pharmacokinetics, and CSF trough levels for both dosage levels exceeding the pre-specified target trough level of 1 µM (0.55 µg/mL). Tolerability (Stages 1 and 2) results showed that ceftriaxone at dosages up to 4 grams/day was well tolerated at 20 weeks. Biliary adverse events were more common with ceftriaxone but not dose-dependent and improved with ursodeoxycholic (ursodiol) therapy. Conclusions: The goals of Stages 1 and 2 of the ceftriaxone trial were successfully achieved. Based on the pre-specified decision rules...

‣ Combination of Diabetes Risk Factors and Hepatic Steatosis in Chinese: The Cardiometabolic Risk in Chinese (CRC) Study

Liang, Jun; Wang, Yu; Li, Hongyan; Liu, Xuekui; Qiu, Qinqin; Qi, Lu
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
56.782188%
Aims Hepatic steatosis has been related to insulin resistance and increased diabetes risk. We assessed whether combination of diabetes risk factors, evaluated by the Finnish Diabetes Risk Score, was associated with risk of hepatic steatosis in an apparently healthy Chinese population. Research Design and Methods The study samples were from a community-based health examination survey in central China. In total 1,780 men and women (18–64 y) were included in the final analyses. Hepatic steatosis was diagnosed by ultrasonography. We created combination of diabetes risk factors score on basis of age, Body Mass Index, waist circumference, physical activity at least 4 h a week, daily consumption of fruits, berries or vegetables, history of antihypertensive drug treatment, history of high blood glucose. The total risk score is a simple sum of the individual weights, and values range from 0 to 20. Results: Hepatic steatosis was present 18% in the total population. In multivariate models, the odds ratios of hepatic steatosis were 1.20 (95%CI 1.15–1.25) in men and 1.25 (95%CI 1.14–1.37) in women by each unit increase in the combination of diabetes risk factors score, after adjustment for blood pressure, liver enzymes, plasma lipids, and fasting glucose. The area under the receiver operating characteristic curve for hepatic steatosis was 0.78 (95%CI 0.76–0.80)...

‣ Clinical Research Quo Vadis? Trends in Reporting of Clinical Trials and Observational Study Designs Over Two Decades

Wyler von Ballmoos, Moritz C.; Ware, James H.; Haring, Bernhard
Fonte: Elmer Press Publicador: Elmer Press
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
56.960464%
Background: Multiple classifications have been developed that classify the medical literature into different levels of evidence to facilitate the evaluation of study results and practice of evidence-based medicine. The suggested hierarchies of evidence are generally based on the type of study design; randomized, controlled clinical trials constitute the top level of evidence while case reports rank the lowest among epidemiologic study designs. However, little is known about the frequency with which different study designs appear in the medical literature overall. The purpose of this study was to describe trends in the frequency of reports of randomized control trials (RCTs) as compared to other study designs in the medical literature over two decades. Methods: Data about the prevalence of various types of study designs in the medical literature over the last two decades (years 1990 - 2009) were abstracted from PubMed, validated and subjected to cross-sectional and longitudinal analysis. Results: In the last 20 years, the annual rate of publication of journal articles has more than doubled. During this period, the percentage of observational studies increased from 29.9% to 40.5%, the percentage of reports of RCTs increased minimally...

‣ Application of Bayesian Modeling in High-throughput Genomic Data and Clinical Trial Design

Xu, Yanxun
Fonte: Universidade Rice Publicador: Universidade Rice
Português
Relevância na Pesquisa
56.922456%
My dissertation mainly focuses on developing Bayesian models for high-throughput data and clinical trial design. Next-generation sequencing (NGS) technology generates millions of short reads, which provide valuable information for various aspects of cellular activities and biological functions. So far, NGS techniques have been applied in quantitatively measurement of diverse platforms, such as RNA expression, DNA copy number variation (CNV) and DNA methylation. Although NGS is powerful and largely expedite biomedical research in various fields, challenge still remains due to the high modality of disparate high-throughput data, high variability of data acquisition, high dimensionality of biomedical data, and high complexity of genomics and proteomics, e.g., how to extract useful information for the enormous data produced by NGS or how to effectively integrate the information from different platforms. Bayesian has the potential to fill in these gaps. In my dissertation, I will propose Bayesian-based approaches to address above challenges so that we can take full advantage of the NGS technology. It includes three specific topics: (1) proposing BM-Map: a Bayesian mapping of multireads for NGS data, (2) proposing a Bayesian graphical model for integrative analysis of TCGA data...

‣ The value of value of information: best informing research design and prioritization using current methods

Eckermann, S.; Karnon, J.; Willan, A.
Fonte: Adis International Ltd Publicador: Adis International Ltd
Tipo: Artigo de Revista Científica
Publicado em //2010 Português
Relevância na Pesquisa
67.081665%
Value of information (VOI) methods have been proposed as a systematic approach to inform optimal research design and prioritization. Four related questions arise that VOI methods could address. (i) Is further research for a health technology assessment (HTA) potentially worthwhile? (ii) Is the cost of a given research design less than its expected value? (iii) What is the optimal research design for an HTA? (iv) How can research funding be best prioritized across alternative HTAs? Following Occam's razor, we consider the usefulness of VOI methods in informing questions 1–4 relative to their simplicity of use. Expected value of perfect information (EVPI) with current information, while simple to calculate, is shown to provide neither a necessary nor a sufficient condition to address question 1, given that what EVPI needs to exceed varies with the cost of research design, which can vary from very large down to negligible. Hence, for any given HTA, EVPI does not discriminate, as it can be large and further research not worthwhile or small and further research worthwhile. In contrast, each of questions 1–4 are shown to be fully addressed (necessary and sufficient) where VOI methods are applied to maximize expected value of sample information (EVSI) minus expected costs across designs. In comparing complexity in use of VOI methods...

‣ Exploring the Impact of Language Services on Utilization and Clinical Outcomes for Diabetics

Trebino, Lisa; Hacker, Karen Ann; Hicks, LeRoi S.; Friedman, Elisa; Blanchfield, Bonnie B.; Gazelle, Guy Scott; Choi, Yoon Susan
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
56.819346%
Background: Significant health disparities exist between limited English proficient and English-proficient patients. Little is known about the impact of language services on chronic disease outcomes such as for diabetes. Methods/Principal Findings: To determine whether the amount and type of language services received during primary care visits had an impact on diabetes-related outcomes (hospitalization, emergency room utilization, glycemic control) in limited English proficient patients, a retrospective cohort design was utilized. Hospital and medical record data was examined for 1425 limited English proficient patients in the Cambridge Health Alliance diabetes registry. We categorized patients receiving usual care into 7 groups based on the amount and combination of language services (language concordant providers, formal interpretation and nothing) received at primary care visits during a 9 month period. Bivariate analyses and multiple logistic regression were used to determine relationships between language service categories and outcomes in the subsequent 6 months. Thirty-one percent of patients (445) had no documentation of interpreter use or seeing a language concordant provider in any visits. Patients who received 100% of their primary care visits with language concordant providers were least likely to have diabetes-related emergency department visits compared to other groups (p<0001) in the following 6 months. Patients with higher numbers of co-morbidities were more likely to receive formal interpretation. Conclusions/Significance: Language concordant providers may help reduce health care utilization for limited English proficient patients with diabetes. However...

‣ When Ethics Constrains Clinical Research: Trial Design of Control Arms in “Greater Than Minimal Risk” Pediatric Trials

de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G.
Fonte: Mary Ann Liebert, Inc. Publicador: Mary Ann Liebert, Inc.
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
57.113545%
For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

‣ Sociodemographic and motivational characteristics of parents who volunteer their children for clinical research: a controlled study.

Harth, S C; Thong, Y H
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em 26/05/1990 Português
Relevância na Pesquisa
66.626123%
OBJECTIVE--To determine the sociodemographic and motivational characteristics of parents who volunteer their children for clinical research. DESIGN--A questionnaire was administered to parents who volunteered their children for a randomised, double blind, placebo controlled trial of a drug to treat asthma and to a control group of parents whose children were eligible for the trial but had refused the invitation. SETTING--A children's hospital in Australia. SUBJECTS--68 Parents who had volunteered their children and 42 who had not; a response rate of 94% and 70%, respectively. MAIN OUTCOME MEASURES--Responses of parents to questionnaire designed to assess their perceptions, attitudes, and health seeking behaviour as well as sociodemographic data. RESULTS--Volunteering parents were less well educated with only 15% (10/68) of mothers and 16% (11/68) and of fathers having had a tertiary or university education compared with 26% (11/42) of mothers and 45% (19/42) in the non-volunteering group. Fewer volunteering parents had professional or administrative jobs than did non-volunteering parents (mothers 6% (4/68); fathers 9% (6/68) v mothers 14% (6/42); fathers 31% (13/42)). Volunteering parents had less social support, and they displayed greater health seeking behaviour and consumed more habit forming substances. They were motivated by a desire to help others and to contribute to medical research...

‣ How to design and write a clinical research protocol in Cosmetic Dermatology*

Bagatin,Ediléia; Miot,Helio A.
Fonte: Sociedade Brasileira de Dermatologia Publicador: Sociedade Brasileira de Dermatologia
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/02/2013 Português
Relevância na Pesquisa
67.26611%
Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment.

‣ Reasons behind the participation in biomedical research: a brief review

Dainesi,Sonia Mansoldo; Goldbaum,Moisés
Fonte: Associação Brasileira de Saúde Coletiva Publicador: Associação Brasileira de Saúde Coletiva
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/12/2014 Português
Relevância na Pesquisa
56.884717%
INTRODUCTION: Clinical research is essential for the advancement of Medicine, especially regarding the development of new drugs. Understanding the reasons behind patients' decision of participating in these studies is critical for the recruitment and retention in the research. OBJECTIVES: To examine the decision-making of participants in biomedical research, taking into account different settings and environments where clinical research is performed. Methods: A critical review of the literature was performed through several databases using the keywords: "motivation", "decision", "reason", "biomedical research", "clinical research", "recruitment", "enrollment", "participation", "benefits", "altruism", "decline", "vulnerability" and "ethics", between August and November 2013, in English and in Portuguese. RESULTS: The review pointed out that the reasons can be different according to some characteristics such as the disease being treated, study phase, prognoses and socioeconomic and cultural environment. Access to better health care, personal benefits, financial rewards and altruism are mentioned depending on the circumstances. CONCLUSION: Finding out more about individuals' reasons for taking part in the research will allow clinical investigators to design studies of greater benefit for the community and will probably help to remove undesirable barriers imposed to participation. Improving the information to health care professionals and patients on the benefits and risks of clinical trials is certainly a good start.

‣ Research Question, Study Design and Continuous Research Education and Training Exercises (CREATE) Program

BURT, T; Sharma, P; Mittal, S
Fonte: Universidade Duke Publicador: Universidade Duke
Tipo: Artigo de Revista Científica Formato: 35 - 43 (9)
Publicado em 01/01/2012 Português
Relevância na Pesquisa
57.217207%
The clinical research project starts with identifying the optimal research question, one that is ethical, impactful, feasible, scientifically sound, novel, relevant, and interesting. The project continues with the design of the study to answer the research question. Such design should be consistent with ethical and methodological principles, and make optimal use of resources in order to have the best chances of identifying a meaningful answer to the research question. Physicians and other healthcare providers are optimally positioned to identify meaningful research questions the answer to which could make significant impact on healthcare delivery. The typical medical education curriculum, however, lacks solid training in clinical research. We propose CREATE (Continuous Research Education And Training Exercises) as a peer- and group-based, interactive, analytical, customized, and accrediting program with didactic, training, mentoring, administrative, and professional support to enhance clinical research knowledge and skills among healthcare professionals, promote the generation of original research projects, increase the chances of their successful completion and potential for meaningful impact. The key features of the program are successive intra- and inter-group discussions and confrontational thematic challenges among participating peers aimed at capitalizing on the groups’ collective knowledge...

‣ Reasons behind the participation in biomedical research: a brief review

Dainesi,Sonia Mansoldo; Goldbaum,Moisés
Fonte: Associação Brasileira de Pós -Graduação em Saúde Coletiva Publicador: Associação Brasileira de Pós -Graduação em Saúde Coletiva
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/12/2014 Português
Relevância na Pesquisa
56.884717%
INTRODUCTION: Clinical research is essential for the advancement of Medicine, especially regarding the development of new drugs. Understanding the reasons behind patients' decision of participating in these studies is critical for the recruitment and retention in the research. OBJECTIVES: To examine the decision-making of participants in biomedical research, taking into account different settings and environments where clinical research is performed. Methods: A critical review of the literature was performed through several databases using the keywords: "motivation", "decision", "reason", "biomedical research", "clinical research", "recruitment", "enrollment", "participation", "benefits", "altruism", "decline", "vulnerability" and "ethics", between August and November 2013, in English and in Portuguese. RESULTS: The review pointed out that the reasons can be different according to some characteristics such as the disease being treated, study phase, prognoses and socioeconomic and cultural environment. Access to better health care, personal benefits, financial rewards and altruism are mentioned depending on the circumstances. CONCLUSION: Finding out more about individuals' reasons for taking part in the research will allow clinical investigators to design studies of greater benefit for the community and will probably help to remove undesirable barriers imposed to participation. Improving the information to health care professionals and patients on the benefits and risks of clinical trials is certainly a good start.