Although retractions may sometimes suggest otherwise, publication of clinical data is how to obtain the return on a clinical trial investment. The clinical trial investment is substantial as the process to collect clinical evidence from research sites is involved and a lengthy one: A reasonably sized medical device study with 3 month patient follow-up will easily cost over 1 million Euros and minimally 2.5 years. With this information known, it is hard to believe that less than 50% of the clinical studies registered on clinicaltrials.gov makes it to publication several years after completion. And I am convinced that the phrase “Publish or Perish” used in Academia to refer to the pressure to publish also applies for Medical Device Industry.
Industry may argue it is preferable not to publish the collected clinical data if results are not favoring their products. This, however, contributes to publication bias and attracts a lot of negative attention lately. Also such argument to my opinion is outweighed by several strong reasons to actively pursue publication of the hard-earned clinical data that include but are not limited to:
1. Market Adoption
Medical devices can be brought to the European market with clinical data substantiating device safety and performance only. This can be done using a clinical evaluation report based on company clinical trial data. When aiming to bring a product to standard of care, however, multiple publications on product efficacy and cost-effectiveness are required to overcome structural and behavioral barriers. In other words, internal reports on safety and performance are insufficient to obtain reimbursement or to become part of treatment guidelines such as the ones from NICE: Publications are required to bridge the gap to full market adoption.
2. Medical Scientific Value
Regardless whether a publication concerns an abstract for a congress or a full paper for a journal, typically the content is reviewed by one or more peers for its news value and scientific credibility. During this process a paper may pass several revisions before it is accepted for publication. This increases the credibility of the concerning clinical data and conclusions. The more thorough this process is followed for a given conference or journal the more credible your clinical data becomes once accepted and published.
3. Increased Exposure
Publication in journals and presentations at conferences will expand your bandwidth beyond your own relationship circle and provides access to the interested readers and audience. Careful selection of the journals and conferences to publish your clinical data supports product and therapy visibility in a powerful manner.
4. Better Heath Care
Full publication and disclosure of the complete trial results is essential for clinicians, patients, policy makers and others to be able to make well-informed decisions about medical care. With that in mind, clinical study registrations have been initiated since 2005 to create full transparency with respect to performance and reporting of clinical trials. The clinical trial environment changed substantially since then with pharmaceutical companies even going as far as – claiming – to make all their clinical study reports publicly available. And more to the topic of medical devices, the European ENVI Committee explicitly referencing transparency and adequate access to information in their latest reports. Such transparency to my opinion contributing to the credibility of companies aiming for better patient outcomes.
Although the four reasons to publish clinical literature listed above, provide sufficient ground to ensure publication of clinical trial data, the low rate of clinical trials resulting in publications leads me to believe that such is easier said than done. As previously blogged, I know that lack of resources may well contribute to this phenomenon as study managers move on to new clinical trials and physicians lack time with their focus being with patient care. Embedding a post market publication strategy, including allocation of sufficient resources, in your clinical evidence plans therefore will help you to achieve such goal.
Feel free to contact me at email@example.com if you want to exchange thoughts on the above or any other topic regarding the process of clinical evidence collection in medical devices.