scholarly journals Recommendations for Supporting Prospective Study Registration in the Basic Experimental Studies in Humans And Alternative Procedures for Results Dissemination

2021 ◽  
Author(s):  
David Thomas Mellor ◽  
Nicole Pfeiffer
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Study ◽  
Human Subjects ◽  
Behavioral Outcomes ◽  
Experimental Studies ◽  
Basic Research ◽  
Health Related ◽  
Alternative Procedures ◽  
Definition Of

Recently, the NIH has modified the definition of clinical trial so that it applies to a much broader range of studies that previously were classified as clinical research but not specifically as trials. This definition, below, specifically includes research where behavioral outcomes are a focus of the study: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”With the addition of behavioral outcomes, many studies that previously would not have been “clinical trials” are now so classified. Research studies that meet both criteria for “clinical trial” and “basic research” are now referred to as basic experimental studies in humans (BESH). The purpose of this whitepaper is to analyze and investigate ways that existing infrastructure could be improved to support these new requirements in ways that benefit all stakeholders.

scholarly journals Practical and conceptual issues of clinical trial registration for Brazilian researchers

2015 ◽  
Vol 134 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Carolina Gomes Freitas ◽  
Thomas Fernando Coelho Pesavento ◽  
Maurício Reis Pedrosa ◽  
Rachel Riera ◽  
Maria Regina Torloni
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
International Committee ◽  
New Drugs ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Registration Process ◽  
Trial History ◽  
Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

Defining an Adequate Dose of Acupuncture Using a Neurophysiological Approach – a Narrative Review of the Literature

2008 ◽  
Vol 26 (2) ◽  
pp. 111-120 ◽  
Author(s):  
Adrian White ◽  
Mike Cummings ◽  
Panos Barlas ◽  
Francesco Cardini ◽  
Jacqueline Filshie ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Acupuncture Treatment ◽  
Experimental Studies ◽  
Basic Research ◽  
Strong Argument ◽  
Treatment Protocols ◽  
Negative Results ◽  
Adequate Dose ◽  
Definition Of ◽  
Patient’S Perception

Many different styles of acupuncture practice exist, and lack of agreement on the optimal acupuncture treatment for any particular condition may mean that some patients do not receive the best treatment. This uncertainty also makes the negative results of sham controlled trials difficult to interpret. Unless we can be sure that both adequate acupuncture and an inactive sham were used in a particular trial, then that trial should not be interpreted as dismissing acupuncture for that condition. Acupuncture practice clearly involves much more than needling procedures, but there is a strong argument for elucidating the role of those needling procedure first. The components of acupuncture needling procedures have been described in the STRICTA document, but it is also clear that the patient's perception of needling is relevant for the outcome of treatment. We therefore recommend the concept of ‘dose’ of acupuncture needling, which should include both the stimulus given to the patient, and certain aspects of the patient's perceptions and response that are known to be linked to the subsequent therapeutic response. We propose the following definition of dose: the physical procedures applied in each session, using one or more needles, taking account of the patient's resulting perception (sensory, affective and cognitive) and other responses (including motor). The dose may be affected by the state of the patient (eg nervous, immune and endocrine systems); different doses may be required for different conditions. The constituents of an adequate dose can be established initially by clinical opinion and subsequently by empirical evidence from experimental studies, which may be either clinical or basic research studies. Systematic reviews which do not consider the adequacy of the acupuncture treatment may have unreliable conclusions. Out of 47 recent systematic reviews, only six have applied some criteria for adequacy. Five used a rating system or conducted a subgroup analysis, and one excluded studies from the analysis altogether if they did not meet criteria for adequacy. Research into what constitutes an adequate dose of acupuncture has long been neglected and is now urgent. Clinical studies that compare the effects of different treatment protocols are probably the most reliable source of evidence, and may also demonstrate a dose-response relationship.

Novel definition of BCG failure to enhance recruitment into clinical trials.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 246-246
Author(s):  
Daniel Levi Willis ◽  
Eugene K. Lee ◽  
Rian J. Dickstein ◽  
Roosevelt Anderson ◽  
Shanna M. Pretzsch ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Prospective Clinical Trial ◽  
Fish Analysis ◽  
Free Survival ◽  
Bcg Therapy ◽  
Bcg Failure ◽  
Definition Of

246 Background: Designing clinical trials after BCG failure can be problematic without a reasonable control arm. Thus, there is a need for early identification of BCG failure relevant to clinical trial design which allows one arm to continue on BCG. Here we present a definition of BCG failure based on FISH profile at 6th week of induction BCG that would facilitate such trials. Methods: The definition presented is based on findings from our IRB-approved, prospective clinical trial where Urovysion FISH assays were performed serially during the normal course of BCG therapy (SWOG protocol) at various time points (pre-BCG, 6 weeks, 3 and 6 mo.). Herein we incorporated the FISH analysis at 6 weeks in patients with a negative 3 month cystoscopy and correlated the result with recurrence and progression rates at 24 months. A novel definition of BCG failure was proposed by focusing the analysis on 84 patients with high grade disease (cTa: 33, cT1: 44, cTis 7). The 6 week FISH was selected as this would allow the control arm to proceed with BCG maintenance in a timely fashion, taking into account the time required for obtaining FISH results, registration of patients, and randomization. Results: Of the 36 patients with a positive FISH at 6 weeks (and no tumor at 3 months), 17 recurred (PPV = 47%) and 11 progressed (PPV = 31%), while among those with a negative FISH, 5 recurred (NPV = 90%) and 4 progressed (NPV = 92%) (p<0.001). Kaplan Meier estimates of recurrence free survival with a positive 6 week FISH were 67% and 52%, and for progression free survival were 75% and 52%, at 1 and 2 years respectively. Therefore, if patients with a positive 6 week FISH (and negative 3 month cystoscopy) were considered as "molecular" BCG failures, a prospective clinical trial with 101 patients in the control (i.e. BCG maintenance) and experimental arms to detect a 20% difference in recurrence rates (α=0.05) with 80% power. Conclusions: Using the FISH status of patients at the 6 week interval on BCG therapy would allow a clinical trial design that incorporates one arm with continued BCG therapy, while enriching for events of interest, namely recurrence and progression. This would allow meaningful comparisons while negating any ethical concerns regarding a lack of “standard treatment” in BCG failure studies.

Advances and trends in bibliographic research: Examples of new technological applications for the cataloguing of the georeferenced library heritage

2016 ◽  
Vol 49 (3) ◽  
pp. 299-312 ◽  
Author(s):  
Agata Maggio ◽  
Josef Kuffer ◽  
Maurizio Lazzari
Keyword(s):  
Experimental Studies ◽  
Basic Research ◽  
Online Data ◽  
Additional Element ◽  
Gis Applications ◽  
Coos Bay ◽  
Bibliographic Data ◽  
Online Catalogue ◽  
Definition Of ◽  
Global And Local

In the age of digital archives and online data consultation, bibliographic research is considered as a key tool for supporting scientific research and study. The online catalogue allows the achievement of more ambitious aims and global interest thanks to its ability to associate data relating to the geographic contextualization of the catalogued editorial products (deduced from the title and content) with the search for more traditional bibliographic data through the inclusion of a specific and standardized ‘field’. Successively, the locations identified by the cataloguer are georeferenced by using GIS applications, which allows the simultaneous view of the distribution of global and local geographical contexts specific for each item owned by a library, archive or museum. The usefulness of such an application lies in the possibility for the library to have a greater awareness of its collection, thus permitting the acquisition of an additional element of evaluation in the management and planning of purchases and donations. In this way, the ability to filter the information from OPAC search will be combined with the basic research carried out by the user by selecting only the libraries in possession of works related to a specific geographical context, involved in different specific studies (literature, landscape, environment). Although this ability is still limited to a few specific studies, the use of tools that allow an overview of the geographical distribution of places could represent an operating standard through the definition of a special protocol. These tools are now used mostly in experimental studies in which the use of open source software has enabled the creation of maps. This paper shows the state of the art of the applications worldwide presenting experimental case studies (i.e. Coos Bay, Oregon; Basilicata, Italy) and also suggests different applications in the field of national and international protocols of library cataloguing.

scholarly journals Lessons Learned in Clinical Trial Communication During an Ebola Outbreak: The Implementation of STRIVE

2018 ◽  
Vol 217 (suppl_1) ◽  
pp. S40-S47 ◽  
Author(s):  
Amy Callis ◽  
Victoria M Carter ◽  
Aparna Ramakrishnan ◽  
Alison P Albert ◽  
Lansana Conteh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Community Engagement ◽  
Information Needs ◽  
Human Subjects ◽  
Lessons Learned ◽  
Accurate Information ◽  
Community Acceptance ◽  
Institutional Review ◽  
The Impact

Abstract Communication contributed to 4 important aspects of the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE): recruiting participants, supporting Human Subjects Protection, building trust in the community to support the trial, and mitigating the impact of rumors and misinformation. Communication was particularly important because STRIVE was Sierra Leone’s first vaccine clinical trial and was implemented during a public health emergency. Communication efforts began months prior to trial launch, building awareness and support through sensitization sessions with stakeholders and community leaders. Community engagement activities continued throughout the trial to maintain relationships with leaders and stakeholders and disseminate accurate information, fostering trust in the trial. The communication team led recruitment with hundreds of information sessions for potential participants, facilitating the informed consent process. Communication efforts continued post-enrollment, supporting ongoing voluntary participation in the trial. Informal formative activities during the trial yielded insights on participants’ perceptions and information needs. While Centers for Disease Control and Prevention Institutional Review Board–approved activities and materials did not change, this flexible strategy allowed for responsive interactions with participants. The trial success and its community acceptance illustrated STRIVE’s successful communications efforts, owing in large part to this flexibility and commitment to community engagement. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

scholarly journals Knowledge of medical students on clinical trials

2019 ◽  
Vol 8 (7) ◽  
pp. 1484
Author(s):  
Ravi Shankar Kanna ◽  
Jagadeesh Alla ◽  
Krishnakanth K.
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Students ◽  
Basic Research ◽  
Thinking Skills ◽  
Cross Sectional Study ◽  
Critical Thinking Skills ◽  
School Students ◽  
Cross Sectional ◽  
Institutional Ethics

Background: Basic research can help medical school students improve critical thinking skills required by medical practice. In this era of evidence-based medicine, the combination of medical education with clinical research is the key to ensure scientific discoveries are translated into clinical practice. This study’s objective was to know the awareness about clinical trials among undergraduate medical students.Methods: After obtaining approval from the Institutional Ethics Committee of NRI Academy of Medical Sciences, Guntur, India, this cross sectional study was conducted in second year medical students after taking their consent. A sample of 90was considered for statistical analysis. A structured questionnaire was used to measure the objective of this study, which had general, regulatory and ethical questions related to clinical trials. Qualitative data variables were expressed by using frequency and Percentage (%).Results: Out of 90 students, it was observed that in the general questions category, 70% of students were aware of the purpose of conducting clinical trials, 50% were aware of the pre-requisites for a participant before participating in a clinical trial and 50% were aware of the parameters evaluated in a clinical trial. 95% of students did not know the response for regulatory questions. The students’ awareness regarding ethics related to clinical trials was better than the other two categories.Conclusions: The overall awareness of clinical trials was low among students though they demonstrated good awareness regarding few aspects of clinical trials.

Clinical trial designs in anaesthesia

2017 ◽  
Author(s):  
Simon J. Howell
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Control Group ◽  
Or Groups ◽  
Related Quality ◽  
Health Related ◽  
Economic Analyses ◽  
Surrogate Measures ◽  
The Impact

A clinical trial is a research study that assigns people or groups to different interventions and compares the impact of these on health outcomes. This chapter examines the design and delivery of clinical trials in anaesthesia and perioperative medicine covering the issues outlined below. The features of a high-quality clinical trial include well-defined inclusion and exclusion criteria, a control group, randomization, and blinding. Outcome measures may be broadly divided into counting the number of people who experience an outcome and taking measurements on people. The outcome measures selected for a clinical trial reflect the purpose of the study and may include ‘true’ clinical measures such as major postoperative complications or surrogate measures such as the results of a biochemical test. Outcome measures may be combined in a composite outcome. Assessment of health-related quality of life using a tool such as the SF-36 questionnaire is an important aspect of many clinical trials in its own right and also informs the economic analyses that may be embedded in a trial. Determining the number for recruits needed for a clinical trial requires both clinical and statistical insight and judgement. The analysis of a clinical trial requires a similarly sophisticated approach that takes into account the objectives of the study and balances the need for appropriate subgroup analyses with the risk of false-positive results. The safe and effective management of a clinical trial requires rigorous organizational discipline and an understanding of the ethical and regulatory structures that govern clinical research.

Application of Metadata Repository and Master Data Management in Clinical Trial and Drug Safety

2015 ◽  
pp. 33-46
Author(s):  
Chandrakant Ekkirala
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Drug Safety ◽  
Detailed Explanation ◽  
Master Data ◽  
Master Data Management ◽  
Metadata Repository ◽  
Definition Of

This chapter talks about metadata repository, and master data management in clinical trial and drug safety. The chapter begins with the definition of metadata repository and gives an explanation around the same, It talks about a well designed metadata repository and the characteristics associated with the same. A brief around why we need metadata and the reasons for the using the same has also been mentioned. The benefits of a well structured metadata repository was also mentioned in detail. The chapter then gives a detailed explanation on master data management and the usage of MDM in clinical trials. MDM solutions for clinical trials management is also explained in detail.

Defining Research: The Effect of Linguistic Choices on the Intentions to Participate in Clinical Research

2017 ◽  
Vol 27 (7) ◽  
pp. 790-799 ◽  
Author(s):  
Yulia A. Strekalova
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Online Survey ◽  
Research Study ◽  
Related Research ◽  
Ethical Implications ◽  
Health Related Research ◽  
Health Related ◽  
Knowledge Brokers ◽  
Intentions To Participate

Significant barriers to participant recruitment for clinical research (CR) are related to effective communication, and nurse coordinators are entrusted with being knowledge brokers between investigators and prospective participants. This prospective cohort study sought to identify linguistic choices that could inform and facilitate recruitment efforts. Healthy adults ( N = 204) were invited to join an online survey to assess the likelihood of participation in CR based on short and extended definitions of CR. Five short definitions included clinical trial, clinical study, health-related research study, community participatory study, and quality improvement study. The likelihood of participation in CR was the lowest for clinical trial and the highest for health-related research study. However, when only an extended definition was provided, those differences were not observed. A linguistic change from trial to study could lead to positive attitude toward CR and improvements in recruitment. However, ethical implications of linguistic choices should be considered.

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