COVID-19 challenges of publishing statistically relevant studies

COVID-19 is a tricky period in which to attempt to publish new studies. Criticism came from reviewers and those reading the articles whether or not one showed negative results or positive results from the study. In fact, due to the ongoing situation with the pandemic, much criticism has been given to any potential positive results since other articles had been published with results that were not accurate. It has been a very difficult time period then for perhaps well designed studies even to get published due to the bias in the media against…

Can one control for selection bias in analyses? Unfortunately selection bias is inherent to many studies, even the gold standard clinical trial designs, but these problems can be attempted to be controlled for in analyses. In COVID-19 research especially, there are selection bias issues related to selection of patients in studies, often the less sicker of patients and also those who are willing to volunteer. All these and other issues can cause selection bias in COVID-19 research. …

Missing data

Missing data is a phenomenon that happens in almost all studies whether in observational or clinical trials. It most often occurs in studies that involve long-term follow up, where people miss different follow up visits or exit the study for various reasons. This results in problems with analyzing data, especially if there is a lot of missingness or if there is a pattern to the missingness and it did not occur randomly.

Missing data happened in COVID-19 data and continues to do so. Initially missing data happened in the beginning when it was hard to collect all measurements…

Issues in COVID-19 research and statistical analyses (Part II)

In the article previous to this, Part I, we discussed design and statistical issues related to clinical trial designs for COVID-19 research. As part of the discussion about clinical trial designs comes along interpretation of results. As clinical trials for COVID-19 vaccine trials have continued into Phase III, eventually early promising results were released about efficacy about certain vaccines. This information was released to the general public but this also brought about a lot of confusion.

The general public simply was unable to grasp the results of the efficacy or effectiveness…

Earlier we discussed the issues in COVID-19 research related to observational studies that were used as the study design for the research, especially the early time frame of COVID-19 in the U.S. like the spring of 2020. We discussed some of the overarching issues that had plagued some of these designs for this research. The other study design that was thought to be better than observational studies for interventions have been clinical trials. After the push back last spring from major journals of not accepting observational studies, more people designed randomized trials to test interventions for COVID-19. Many researchers worked…

Issues in COVID-19 research and statistical analyses

Doing research in COVID-19 presents many types of problems for having statistical analyses free from biases. In studies that were organized as observational studies to compare treatments or differences on some outcome between COVID-19 patients and either some type of control or less sick COVID-19 patients, many inherit biases came to play. In general, these studies tend to suffer from baseline differences between comparison and control groups which lead to confounding and other biases, which can also be present in these study designs. …

Safety Profiles of Current Covid-19 Vaccines

As of right now, this is what we know about serious safety concerns raised about these COVID-19 vaccines: the mRNA vaccines, Pfizer© and Moderna©, the Johnson & Johnson©vaccine, and the Oxford/Astrazeneca© vaccine. These are the current vaccines with emergency use authorization (EUA) in the United States. Data continues accruing about their safety.

Earlier we had raised concerns about the mRNA vaccines in terms of allergies. The Pfizer© vaccine for COVID-19 has come under scrutiny for components in their vaccine which could lead to severe reactions by recipients of the vaccine and therefore could lead to anaphylaxis. Allergies to these components…

Much of the new these days focuses around the vaccines that are out on the market due to emergency authorizations for their use due the continued spread and decimation caused by COVID-19. One of the major concerns that have been raised besides safety are also how the vaccines can withstand the new variants of the virus that have popped up in recent months in various countries, including the U.S.. The most notable one has been the B.1.1.7 but there is also one out of South Africa that lends itself to some alarm. (FIND name). …