Publication The vote regarding the proposed Medical Device Regulation is once more postponed, so we will need some more patience before knowing where we are heading in Europe with the Medical Device Directive. One thing, however, speaks clearly from the proposal as well as the Roth-Behrendt amendment, that Europe is heading towards a much more transparent system on all levels of pre- and postmarket activities. This includes clinical data on safety and performance. The Roth Behrendt amendment even speaks of making a summary of such data available to the public:

“For high-risk medical devices, manufacturers should provide the national authority or the Agency, as relevant, involved in the marketing authorisation procedure, with a full report on the safety and clinical performance of that device. A summary of that report should be publicly available via Eudamed”

It is questionable though whether the general public is able to view the clinical data in the right perspective. Therefore this further underlines the need to publishing your hard earned clinical data thereby ensuring they are presented in their full context.

At the same time transparency and publication is not without any risk as the recent negative media attention regarding 61 fraudulent publications by Prof. Bax once more illustrates. Such may suggest you better stay away from publishing your clinical data, and one must ask himselve how to prevent published articles to be withdrawn?

1. Monitoring
Making up your own data for whatever reason is just as old as clinical trials themselves. Fraude is the leading cause of article retractions, but can be largely prevented by on site monitoring, i.e. verifying that patients and data really exist and are correct. This is a costly and time consuming activity, but unfortunately history has shown such to be a necessary part of any clinical trial.

2. Publication Strategy
Many cases of retractions relate to plagiarism, copying some-one else’s work or your own. The first is simply a matter of not doing so and/ or proper referencing other peoples work when using it. The second can be prevented by having a proper publication strategy and policy in place right at the start of your clinical trial. Such should identify what will – submitted to – be published, by whom, and at what point in time.

3. Proper data-management
A less frequent cause of paper retraction are errors in the data, honest mistakes. Independent data-monitoring boards, validated databases with cross-checks, and proper processes for data-evaluation and interpretation can help to prevent such from happening, but an honest mistake is easily made.

4. Proper Regulatory Process
A fourth factor that may lead to article retractions are ethical issues, such as withdrawal of patient consent, or even lack of ethical approval. This goes back to the very basic principles of clinical research; Everyone involved in clinical trials should strive to protect the health and rights to self-determination, and confidentiality of research subjects. Issues in that respect should be prevented at any time. In that respect enforcing the Ethics Committee approval process via a European regulation as suggested in the Roth-Behrendt amendment:

“A clinical investigation should only start after being granted a positive evaluation by an independent ethics committee. Member States should take the necessary measures to establish Ethics Committees where such committees do not exist.”,

may not be such a bad idea after all; Obtaining ethical approval of a clinical trial helps to prevent the resulting paper from being withdrawn especially when in addition a proper informed consent process is followed during study conduct.

The high rate of publication withdrawals may suggest it is challenging to write a proper article, but basically planning and conducting your clinical study according to the applicable ethical and regulatory standards, such as ISO 14155 for European medical device studies, can prevent many articles from being withdrawn.

I am open for a debate regarding the above or any other clinical research related matters, so please feel free to contact me.

About Annet Muetstege - Visscher

My name is Annet Muetstege and I am a clinical research expert, based in The Netherlands, with over 25 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services.
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