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Yale researchers find gaps in clinical trial data sharing | YaleNews

The study, published in The BMJ Open (British Medical Journal), assessed the data-sharing practices of 42 pharmaceutical companies for clinical trials of 40 novel drugs and 22 biologics — products, such as vaccines, derived from living organisms — approved by the U.S. Food and Drug Administration in 2016 and 2017. The evaluation was performed using the Good Pharma Scorecard, a tool developed by researchers at Yale, Stanford, and Bioethics International which consists of transparency measures and a ranking system. Overall, only seven of the 42 companies, 17%, entirely met the tool’s standards for transparency and sharing data. Smaller companies are particularly opaque, according to the study.

Step it up: Higher daily step counts linked with lower blood pressure: Smart watches prove useful as a research tool for insights on physical activity and heart health -- ScienceDaily

Over the course of about five months, participants averaged about 7,500 steps per day. Those with a higher daily step count had significantly lower systolic and diastolic blood pressure. In a secondary analysis, the researchers found the association between step count and blood pressure was no longer significant if BMI was taken into account, which suggests BMI might be a mediating factor in the relationship.

Persistence of Contradicted Claims in the Literature | Dementia and Cognitive Impairment | JAMA | JAMA Network

For the 2 vitamin E epidemiological studies, even in 2005, 50% of citing articles remained favorable. A favorable stance was independently less likely in more recent articles, specifically in articles that also cited the HOPE trial (odds ratio for 2001, 0.05 [95% confidence interval, 0.01-0.19; P < .001] and the odds ratio for 2005, 0.06 [95% confidence interval, 0.02-0.24; P < .001], as compared with 1997), and in general/internal medicine vs specialty journals. Among articles citing the HOPE trial in 2005, 41.4% were unfavorable. In 2006, 62.5% of articles referencing the highly cited article that had proposed beta-carotene and 61.7% of those referencing the highly cited article on estrogen effectiveness were still favorable; 100% and 96%, respectively, of the citations appeared in specialty journals; and citations were significantly less favorable (P = .001 and P = .009, respectively) when the major contradicting trials were also mentioned. Counterarguments defending vitamin E or estrogen included diverse selection and information biases and genuine differences across studies in participants, interventions, cointerventions, and outcomes. Favorable citations to beta-carotene, long after evidence contradicted its effectiveness, did not consider the contradicting evidence.

Study casts doubt on evidence for 'gold standard' psychological treatments -- ScienceDaily

"One of the things that becomes really obvious when you look at the literature is researchers are collecting and analyzing their data in ways that are extremely flexible," Sakaluk said. "If you don't follow certain rules of statistical inference, you can inadvertently trick yourself into claiming effects that aren't really there. For EST research, it may become important to define in advance what researchers are going to do -- like how they'll analyze data -- and go on record in a way that restricts what they're going to do. This would coincide with a movement to encourage researchers to propose what they'd like to do and get reviewers and journal editors to weigh in before -- not after -- scientists do research, and to publish it irrespective of what they find."

Apixaban: Evaluation of the Inclusion of Studies Identified by the FDA as Having Falsified Data in the Results of Meta-analyses: The Example of the Apixaban Trials | Research, Methods, Statistics | JAMA Internal Medicine | JAMA Network

In our reanalysis of the 22 meta-analyses, we found that 10 (46%) yielded results that would change the initial meta-analysis findings. Each affected meta-analysis had a median of 9.5 publications (range, 2-17), and the median meta-analysis publication InCite journal impact factor was 5.830 (range, 3.154-17.202). The median weight of publications with falsified data was 55.7% (range, 13.1%-99.6%). From our reanalysis of the 22 meta-analyses, we found that 32 of 99 analyses (32%) yielded results that would change the conclusions of the initial analysis (Table). Of the 32 affected estimates, 31 (97%) no longer favored apixaban for the prevention of serious medical issues, and 1 (3%) favored the control.

Many leading universities still failing to report clinical trial results - STAT

Specifically, findings were not posted for 31 percent — or 140 —of 450 studies that were to have been disclosed in public registries as a result of transparency requirements in the FDA Amendments Act, according to Universities Allied for Essential Medicines, a student-led organization concerned with access to medicines, and TranspariMED, a nonprofit research advocacy group. Moreover, only 15 of 40 universities previously found to have lax reporting are in full compliance. For instance, MD Anderson Cancer Center, which sponsored the largest number of applicable trials, disclosed only 77 percent of the findings. Similarly, the Mayo Clinic divulged 42 percent of studies. Columbia University had the worst track record, reporting 17 percent of trials, according to the analysis.

Take a vacation -- it could prolong your life -- ScienceDaily

Participants were randomised into a control group (610 men) or an intervention group (612 men) for five years. The intervention group received oral and written advice every four months to do aerobic physical activity, eat a healthy diet, achieve a healthy weight, and stop smoking. When health advice alone was not effective, men in the intervention group also received drugs recommended at that time to lower blood pressure (beta-blockers and diuretics) and lipids (clofibrate and probucol). Men in the control group received usual healthcare and were not seen by the investigators. As previously reported, the risk of cardiovascular disease was reduced by 46% in the intervention group compared to the control group by the end of the trial. However, at the 15-year follow-up in 1989 there had been more deaths in the intervention group than in the control group. The analysis presented today extended the mortality follow-up to 40 years (2014) using national death registers and examined previously unreported baseline data on amounts of work, sleep, and vacation. The researchers found that the death rate was consistently higher in the intervention group compared to the control group until 2004. Death rates were the same in both groups between 2004 and 2014.

"Caffeine helps meetings!" or "coffee addicts function badly without coffee?"

Researchers found that people gave more positive reviews for their group's performance on a task -- and their own contribution -- if they drank caffeinated coffee beforehand. A second study showed that people talked more in a group setting under the influence of caffeinated coffee -- but they also were more on-topic than those who drank decaf. Coffee seems to work its magic in teams by making people more alert, said Amit Singh, co-author of the study and a doctoral student in marketing at The Ohio State University's Fisher College of Business. "We found that increased alertness was what led to the positive results for team performance," Singh said. "Not surprisingly, people who drank caffeinated coffee tended to be more alert." Singh conducted the study with Vasu Unnava and H. Rao Unnava, both formerly at Ohio State and now with the Graduate School of Management at the University of California, Davis. The study appears online in the Journal of Psychopharmacology. While many studies have looked at how caffeine affects individual performance, this is the first to examine the impact it has on teams, Singh said. The first study involved 72 undergraduate students who said they were coffee drinkers. They were instructed not to drink coffee before the experiment. Half of them first participated in what they were told was a coffee-tasting task. They were split into groups of five. After drinking a cup of coffee and rating its flavor, they were given 30 minutes of filler tasks to give the caffeine a chance to kick in. The other half of the participants did the coffee tasting at the end of the experiment.