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Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Institutes of Health’s National Center for Advancing Translational Sciences established the Trial Innovation Network (TIN). The TIN offers a scientific consultation process, providing access to clinical trial and disease experts who provide input and recommendations throughout the trial’s duration, at no cost to investigators. This approach aims to improve trial design, accelerate implementation, foster interdisciplinary teamwork, and spur innovations that enhance multicenter trial quality and efficiency. The TIN leverages resources of the Clinical and Translational Science Awards (CTSA) program, complementing local capabilities at the investigator’s institution. The Initial Consultation process focuses on the study’s scientific premise, design, site development, recruitment and retention strategies, funding feasibility, and other support areas. As of 6/1/2024, the TIN has provided 431 Initial Consultations to increase efficiency and accelerate trial implementation by delivering customized support and tailored recommendations. Across a range of clinical trials, the TIN has developed standardized, streamlined, and adaptable processes. We describe these processes, provide operational metrics, and include a set of lessons learned for consideration by other trial support and innovation networks.
The Pediatric Heart Network Normal Echocardiogram Database Study had unanticipated challenges. We sought to describe these challenges and lessons learned to improve the design of future studies.
Methods:
Challenges were divided into three categories: enrolment, echocardiographic imaging, and protocol violations. Memoranda, Core Lab reports, and adjudication logs were reviewed. A centre-level questionnaire provided information regarding local processes for data collection. Descriptive statistics were used, and chi-square tests determined differences in imaging quality.
Results:
For the 19 participating centres, challenges with enrolment included variations in Institutional Review Board definitions of “retrospective” eligibility, overestimation of non-White participants, centre categorisation of Hispanic participants that differed from National Institutes of Health definitions, and exclusion of potential participants due to missing demographic data. Institutional Review Board amendments resolved many of these challenges. There was an unanticipated burden imposed on centres due to high numbers of echocardiograms that were reviewed but failed to meet submission criteria. Additionally, image transfer software malfunctions delayed Core Lab image review and feedback. Between the early and late study periods, the proportion of unacceptable echocardiograms submitted to the Core Lab decreased (14 versus 7%, p < 0.01). Most protocol violations were from eligibility violations and inadvertent protected health information disclosure (overall 2.5%). Adjudication committee reviews led to protocol changes.
Conclusions:
Numerous challenges encountered during the Normal Echocardiogram Database Study prolonged study enrolment. The retrospective design and flaws in image transfer software were key impediments to study completion and should be considered when designing future studies collecting echocardiographic images as a primary outcome.
Owing to nutritional transition in Cameroon, one in two adults is overweight and one in five is obese, and 8·1 % of children are overweight and 2·1 % are obese. Given this phenomenon, dietary intake assessment is needed to establish appropriate preventive nutrition-sensitive strategies. Our aim was to develop and test the validity of two food portion photograph books (FPPB) to be used as visual aids for adults and children taking part in a 24-h dietary recall. To design FPPB, interviews and focus group discussions were undertaken with women to obtain consensus on the local categorisation of foods. For each cooked and weighed food, three photographs of the average small, medium and large serving portion sizes were taken, and four intermediary portion sizes were calculated. To validate the FPPB, a sample of adults (361) and children (224) were asked, at meal times, to self-serve a food portion prepared in the household and the portion sizes were weighed; 24 h after the measurement, the same subjects were shown the appropriate FPPB and were asked to indicate the food and the portion they consumed. In adults, of the 821 portions tested, 77 % were accurately estimated, whereas in children 74 % of the 556 portions tested were accurately estimated. For both groups, the small- and medium-sized portions were frequently selected and accurately estimated (>70 %). Our findings suggest that the adult and children’s FPPB can be used in Cameroon to estimate food portion sizes, and thus nutritional intake in the frame of the 24-h dietary recall.
of Korteweg-de Vries type are considered, where u = u(x, t), v = v(x, t) are real-valued functions and where x, t∈R. Here, subscripts connote partial differentiation and
are quadratic polynomials in the variables u and v. Attention is given to the pure initial-value problem in which u(x, t) and v(x, t) are both specified at t = 0, namely,
for x ∈ ℝ. Under suitable conditions on P and Q, global well-posedness of this problem is established for initial data in the L2-based Sobolev spaces Hs(ℝ) × Hs(ℝ) for any s > ‒3/4.
The object of this paper is to show why recent research in the psychology of deductive and probabilistic reasoning does not have "bleak implications for human rationality," as has sometimes been supposed. The presence of fallacies in reasoning is evaluated by referring to normative criteria which ultimately derive their own credentials from a systematisation of the intuitions that agree with them. These normative criteria cannot be taken, as some have suggested, to constitute a part of natural science, nor can they be established by metamathematical proof. Since a theory of competence has to predict the very same intuitions, it must ascribe rationality to ordinary people.
Accordingly, psychological research on this topic falls into four categories. In the first, experimenters investigate conditions under which their subjects suffer from genuine cognitive illusions. The search for explanations of such performance errors may then generate hypotheses about the ways in which the relevant information-processing mechanisms operate. In the second category, experimenters investigate circumstances in which their subjects exhibit mathematical or scientific ignorance: these are tests of the subjects' intelligence or education. In the third and fourth categories, experimenters impute a fallacy where none exists, either because they are applying the relevant normative criteria in an inappropriate way or because the normative criteria being applied are not the appropriate ones.
There is a familiar risk of antinomy if from x is E and p(x is H/x is E) = r it is permissible to infer p(x is H) = r, and what Carnap (1950) called “The requirement of total evidence” will not prevent such antinomies satisfactorily. What is needed instead is a properly developed theory of evidential weight.