Is it possible for just one researcher to perform a clinical trial of more than 200 participants?
According to the editorial board of the European Journal of Obstetrics & Gynecology and Reproductive Biology, an Elsevier title, the answer would seem to be no. The journal has decided to retract a 2016 paper in which the author claimed to have conducted such a large trial on their own.
Here’s the notice for “Calcium versus oral contraceptive pills containing drospirenone for the treatment of mild to moderate premenstrual syndrome: A double blind randomized placebo controlled trial:”
This article has been retracted at the request of the Editorial Board for the following reason: This single-author publication which reports the conducting of a large 3-arm randomised controlled trial, with no missing data from 210 recruited patients, has been questioned as implausible. The authors have been unable to provide supporting documents to provide an explanation.
The paper, by Nesreen Shehata of Beni-Suef University in Egypt, has been cited eight times, according to Clarivate Analytics’ Web of Science.
‘A complete waste of time and effort with them’
“Soooo disappointed,” Shehata told Retraction Watch, saying that Elsevier sent an email about the impending retraction on May 15 but did not respond to a follow-up email:
I do not agree with this retraction as I did send to editorial board and editor in chief missing data in raw material file in addition to ethical committee approval. They took too long to reply about one year. Then simply said we are not convinced.
Shehata went on:
I accuse the journal of inaccuracy. A complete waste of time and effort with them as they reviewed my work 3 times for 1 year since first submission and it was so inconvenient for me. They should have said from the start we do not trust your work. I could have published elsewhere. Randomized trials are self- funded in my country and my institution does not financially support. I want to decline my work completely from the journal to publish elsewhere feeling so disappointed to loose my work for which I spent time, money and effort. Also I don’t want it to appear online any more under the title of that journal. Editorial board and editor in chief of Journal should be more responsible and take part of their inaccuracy and wasting of my work.
Regardless of whether Shehata did indeed perform the trial single-handedly, we’re prompted to ask: Why did this issue only come up after publication, instead of during peer review?
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Assuming a blinded review process, the reviewers would not have known how many authors were involved. It seems like something that an editor should have caught. But, RW, your posting leaves some open questions. Sure, there was only one person named as an author – but the article says “we” and “our” in several places. Obviously there were support personnel who should have at least been named in the Acknowledgements (there was no Acknowledgements section) if not as authors. I,m curious about what Elsevier asked the author and what it was he was unable to fulfill.
Is the long-standing convention of using “we” and “our” as substitutes for “I” and “my” in scholarly writing finally dead even in European Ob-Gyn? It does seem to have vanished in mathematics sometime in the past 50 years when I wasn’t looking (whereas an esteemed graduate textbook from 1960, the first such that came to hand just now, has “We” as the very first word of Chapter I despite sole authorship; a second, from 1969, holds off a bit—”we” is its fourth word).
I’ve noticed that falsified studies very often lack acknowledgements. Some legitimate studies do too, of course, but it’s become a red flag for me. A big study almost surely involved a lot of people; if you didn’t feel the need to thank a single one, a compelling explanation is that the study didn’t actually happen. (The recent case of the French social-sciences researcher who seems to have been publishing student homework projects, themselves probably falsified by the student authors, comes to mind. If he thanked them they might notice he stole their homework.)
How does a double blind trial work with one researcher?
Generalizing the Biblical principal that “when thou doest alms, let not thy left hand know what thy right hand doeth”, presumably a lone researcher who doeth a double blind trial lets not the left eye see what the right eye seeth.
It. Does. Not.
You certainly need an assistant, but their job can be pretty trivial. E.g. “here’s pill bottles numbered 1-100, flip a coin to figure out which pill to put in each bottle and record it on this sheet that I made for you”. I’ve done some variant on that countless times in research labs, both as the blinder and the blindee. It’s such a small job that it’s not even worth a written acknowledgement.
That’s the way it goes in many 3rd world countries. The researcher is responsible for everything.
In many occasions, the student and his mentor do the whole work with no fund at all. They pay from their own pockets.
Sometimes you cannot get how things go in the 3rd world countries until you’re there conducting research. In addition, many studies are derived from postgraduate students’ theses and there is no uniform standards to keep the data for years as requested. This is a major problem.
I invite 3rd world researchers to submit their research to local or at best’ regional journals to avoid this ruining of their academic reputation because of lack of knowedge of their scientific environment.