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The final rule for reporting clinical trial results has now been issued by the Department of Health and Human Services. It aims to increase accountability in the clinical research enterprise, making key information available to researchers, funders, and the public. Title VIII of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA) expanded the legal mandate for sponsors and others responsible for certain clinical trials of FDA-regulated drug, biologic, and device products to register their studies and report summary results information to ClinicalTrials.gov, 1 which is managed by the National Library of Medicine at the National Institutes of Health (NIH). The statute expanded registration requirements and provided a legally defined timeline with specific requirements for the systematic reporting of summary trial results. Although statutory components took effect before 2010, the FDAAA directed the Department of Health and Human Services . . .

Clinical trials that end prematurely (or \"terminate\") raise financial, ethical, and scientific concerns. The extent to which the results of such trials are disseminated and the reasons for termination have not been well characterized. A cross-sectional, descriptive study of terminated clinical trials posted on the ClinicalTrials.gov results database as of February 2013 was conducted. The main outcomes were to characterize the availability of primary outcome data on ClinicalTrials.gov and in the published literature and to identify the reasons for trial termination. Approximately 12% of trials with results posted on the ClinicalTrials.gov results database (905/7,646) were terminated. Most trials were terminated for reasons other than accumulated data from the trial (68%; 619/905), with an insufficient rate of accrual being the lead reason for termination among these trials (57%; 350/619). Of the remaining trials, 21% (193/905) were terminated based on data from the trial (findings of efficacy or toxicity) and 10% (93/905) did not specify a reason. Overall, data for a primary outcome measure were available on ClinicalTrials.gov and in the published literature for 72% (648/905) and 22% (198/905) of trials, respectively. Primary outcome data were reported on the ClinicalTrials.gov results database and in the published literature more frequently (91% and 46%, respectively) when the decision to terminate was based on data from the trial. Trials terminate for a variety of reasons, not all of which reflect failures in the process or an inability to achieve the intended goals. Primary outcome data were reported most often when termination was based on data from the trial. Further research is needed to identify best practices for disseminating the experience and data resulting from terminated trials in order to help ensure maximal societal benefit from the investments of trial participants and others involved with the study.

A decade after ClinicalTrials.gov launched a database for reporting results of clinical trials, the database includes results of approximately 36,000 trials. The authors discuss laws, regulations, and policies relevant to results reporting, trends over time in the frequency of reporting, and adherence to requirements for the completeness and quality of the results reported.

This article reviews the history and current status of clinical trial registrations and results data posted on the National Library of Medicine's Web site ClinicalTrials.gov. The ClinicalTrials.gov trial registry was launched more than a decade ago. Since that time, it has been evolving in response to various policy initiatives. The registry now contains information on more than 100,000 clinical studies and has emerged as a key element of many public health policy initiatives aimed at improving the clinical research enterprise. In 2008, a database for reporting summary results was added to the registry. In this article, we present an update on relevant policies, summarize the structure and contents of the results database, and show how ClinicalTrials.gov data can be used to gain insight into the . . .

•In fMRI studies, respiratory signals are unavailable or do not have acceptable quality.•Pediatric population populations are challenging groups in fMRI studies.•This work demonstrates the ability to compute the respiratory signal variation directly from fMRI.•The proposed method will lower the cost and reduce complexity of fMRI studies. In many functional magnetic resonance imaging (fMRI) studies, respiratory signals are unavailable or do not have acceptable quality due to issues with subject compliance, equipment failure or signal error. In large databases, such as the Human Connectome Projects, over half of the respiratory recordings may be unusable. As a result, the direct removal of low frequency respiratory variations from the blood oxygen level-dependent (BOLD) signal time series is not possible. This study proposes a deep learning-based method for reconstruction of respiratory variation (RV) waveforms directly from BOLD fMRI data in pediatric participants (aged 5 to 21 years old), and does not require any respiratory measurement device. To do this, the Lifespan Human Connectome Project in Development (HCP-D) dataset, which includes respiratory measurements, was used to both train a convolutional neural network (CNN) and evaluate its performance. Results show that a CNN can capture informative features from the BOLD signal time course and reconstruct accurate RV timeseries, especially when the subject has a prominent respiratory event. This work advances the use of direct estimation of physiological parameters from fMRI, which will eventually lead to reduced complexity and decrease the burden on participants because they may not be required to wear a respiratory bellows.

Lower back pain (LBP) occurs in 80% of adults in their lifetime; resulting in LBP being one of the biggest causes of disability worldwide. Chronic LBP has been linked to the degeneration of the intervertebral disc (IVD). The current treatments for chronic back pain only provide alleviation of symptoms through pain relief, tissue removal, or spinal fusion; none of which target regenerating the degenerate IVD. As nucleus pulposus (NP) degeneration is thought to represent a key initiation site of IVD degeneration, cell therapy that specifically targets the restoration of the NP has been reviewed here. A literature search to quantitatively assess all cell types used in NP regeneration was undertaken. With key cell sources: NP cells; annulus fibrosus cells; notochordal cells; chondrocytes; bone marrow mesenchymal stromal cells; adipose‐derived stromal cells; and induced pluripotent stem cells extensively analyzed for their regenerative potential of the NP. This review highlights: accessibility; expansion capability in vitro; cell survival in an IVD environment; regenerative potential; and safety for these key potential cell sources. In conclusion, while several potential cell sources have been proposed, iPSC may provide the most promising regenerative potential. Cell sources and lineages proposed for regeneration of the intervertebral disc. This review highlights: accessibility; expansion capability in vitro; cell survival in an IVD environment; regenerative potential; and safety for these key potential cell sources. In conclusion, while several potential cell sources have been proposed, induced pluripotent stem cells may provide the most promising regenerative potential.

Evaluation research increasingly needs alternatives to target or gross rating points to comprehensively measure total exposure to modern multichannel public education campaigns that use multiple channels, including TV, radio, digital video, and paid social media, among others. Ratings data typically only capture delivery of broadcast media (TV and radio) and excludes other channels. Studies are needed to validate objective cross-channel metrics such as impressions against self-reported exposure to campaign messages. This study aimed to examine whether higher a volume of total media campaign impressions is predictive of individual-level self-reported campaign exposure in California. We analyzed over 3 years of advertisement impressions from the California Tobacco Prevention Program's statewide tobacco education campaigns from August 2019 through December 2022. Impressions data varied across designated market areas (DMAs) and across time. These data were merged to individual respondents from 45 waves of panel survey data of Californians aged 18-55 years (N=151,649). Impressions were merged to respondents based on respondents' DMAs and time of survey completion. We used logistic regression to estimate the odds of respondents' campaign recall as a function of cumulative and past 3-month impressions delivered to each respondent's DMA. Cumulative impressions were positively and significantly associated with recall of each of the Flavors Hook Kids (odds ratio [OR] 1.15, P<.001), Dark Balloons and Apartment (OR 1.20, P<.001), We Are Not Profit (OR 1.36, P<.001), Tell Your Story (E-cigarette, or Vaping, product use Associated Lung Injury; OR 1.06, P<.05), and Thrown Away and Little Big Lies (OR 1.05, P<.01) campaigns. Impressions delivered in the past 3 months were associated with recall of the Flavors Hook Kids (OR 1.13, P<.001), Dark Balloons and Apartment (OR 1.08, P<.001), We Are Not Profit (OR 1.14, P<.001), and Thrown Away and Little Big Lies (OR 1.04, P<.001) campaigns. Past 3-month impressions were not significantly associated with Tell Your Story campaign recall. Overall, magnitudes of these associations were greater for cumulative impressions. We visualize recall based on postestimation predicted values from our multivariate logistic regression models. Variation in cumulative impressions for California Tobacco Prevention Program's long-term multichannel tobacco education campaign is predictive of increased self-reported campaign recall, suggesting that impressions may be a valid proxy for potential campaign exposure. The use of impressions for purposes of evaluating public education campaigns may help address current methodological limitations arising from the fragmented nature of modern multichannel media campaigns.

Purpose Mild cognitive impairment (MCI) can be the prodromal phase of Alzheimer's disease (AD) where appropriate intervention might prevent or delay conversion to AD. Given this, there has been increasing interest in using magnetic resonance imaging (MRI) and neuropsychological testing to predict conversion from MCI to AD. Recent evidence suggests that the choroid plexus (ChP), neural substrates implicated in brain clearance, undergo volumetric changes in MCI and AD. Whether the ChP is involved in memory changes observed in MCI and can be used to predict conversion from MCI to AD has not been explored. Method The current study used data from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database to investigate whether later progression from MCI to AD (progressive MCI [pMCI], n = 115) or stable MCI (sMCI, n = 338) was associated with memory scores using the Rey Auditory Verbal Learning Test (RAVLT) and ChP volumes as calculated from MRI. Classification analyses identifying pMCI or sMCI group membership were performed to compare the predictive ability of the RAVLT and ChP volumes. Finding The results indicated a significant difference between pMCI and sMCI groups for right ChP volume, with the pMCI group showing significantly larger right ChP volume (p = .01, 95% confidence interval [−.116, −.015]). A significant linear relationship between the RAVLT scores and right ChP volume was found across all participants, but not for the two groups separately. Classification analyses showed that a combination of left ChP volume and auditory verbal learning scores resulted in the most accurate classification performance, with group membership accurately predicted for 72% of the testing data. Conclusion These results suggest that volumetric ChP changes appear to occur before the onset of AD and might provide value in predicting conversion from MCI to AD. Choroid plexus (ChP) volumes and Rey Auditory Verbal Learning Test—Immediate (RAVLT‐I) scores were compared between participants who later progressed from MCI to Alzheimer's disease (pMCI) and those who remained stable (sMCI). The right ChP was larger in the pMCI group, and the left ChP and RAVLT‐I were the best‐performing classifiers for predicting group membership.

Given these potential benefits, observational studies are already being registered for various reasons, and there is increasing attention given to this practice. For example, the state of Maine requires registration and reporting of results of postmarketing observational studies of medications and biological products marketed in Maine20 and the corporate policies of some drug manufacturers address disclosure of observational studies.21 Recently, an international workshop was held on the topic,6 and several medical journals published editorials on the registration of observational studies.7,8,22 Some have suggested that ethics review boards should require prospective registration of any study involving human participants, 12 whereas others have proposed that observational studies under the mandate of the FDA should be subject to the same requirements for registration and reporting of results as those for clinical trials.17,23 The European Medicines Agency recently issued a work plan to create a registry of post-authorization safety studies that would include observational studies, 24 and a draft report by the Agency for Healthcare Research and Quality considered the utility of creating a \"registry of patient registries.\"25 With growing interest in this topic, an understanding of current practices in registration is useful. An increasing number of clinical trial registries exist and, despite their names, some include observational studies. For example, ClinicalTrials.gov (http://clinicaltrials.gov), established by the US National Library of Medicine on behalf of the US National Institutes of Health, is the largest publicly accessible registry, with over 87 000 ongoing and completed interventional and observational studies as of March 2010. There are 10 registries in the World Health Organization's Registry Network, which range in size from 25 to more than 8400 registered studies as of March 2010. Of these registries, five explicitly state that observational studies can be registered (Appendix 1, available at www.cmaj.ca /cgi /content /full /cmaj .092252/DC1). A structured search tool for identifying observational studies is provided at ClinicalTrials.gov, where such studies represent 17% (n = 14 595) of all registrations, and at the Australian New Zealand Clinical Trials Registry, where 5% (n = 214) of registered studies are observational. There is interest in the prospect of registering observational studies, as reviewed earlier and as shown by the number of such studies registered at ClinicalTrials.gov. We believe that making both observational and interventional studies available in a single registry will provide researchers and others with a more comprehensive view of the growing evidence base. Based on the clinical trial experience, there is a preexisting (but evolving) model and infrastructure for registration, and study sponsors are already registering observational studies on a voluntary basis. Given that much of the ethical and scientific rationale for registration of interventional studies appears to apply to prospective observational studies, we believe that further discussion among stakeholders (e.g., researchers, regulatory authorities and the public) is warranted. Such discussion is necessary to address specific issues regarding implementation, including assessing and defining common data elements that would meet the needs of the stakeholders. In the future, the data elements for registration of observational studies in ClinicalTrials.gov could be modified to better meet these needs.

More than a decade ago, the International Committee of Medical Journal Editors established a policy requiring trial registration. This article reviews the current state of this endeavor. Laws and policies to establish a global trial reporting system have greatly increased the transparency and accountability of the clinical research enterprise. The three components of the trial reporting system are trial registration, reporting of aggregate results, and sharing of individual participant data. 1 Trial registration is foundational to our understanding and interpretation of trial results, because it requires that information be provided about all relevant clinical trials (to put results in a broad context) and their prespecified protocol details (to ensure adherence to the scientific plan). In this article, we describe the current trial registration landscape and summarize evidence of . . .