The era of full clinical data transparency is here, and that includes medical devices: EMA issued their policy on the publication of clinical data effective as of the beginning of this year, and is currently requesting feedback on the application of the transparency rules of the EU clinical trial regulation, addressing medicinal clinical data. Although generally speaking medical device study policies and regulations tend to be behind on the ones for medicine, for sure this will not be the case this time: The FDA/ NIH proposals on publication of clinical study results of studies registered at ClinicalTrials.gov includes medical devices, and – as I previously blogged – the current version of the EU MDR has strong elements on clinical data transparency similar to EMA. Furthermore J&J recently announced that they will make their clinical data of approved devices available to the public.
There are several indisputable reasons as to why it is necessary to strive for full transparency regarding clinical data, not the least being that it allows for clinicians, patients, and policy makers to make well-informed decisions about health care, thereby guarding patient’s safety and well being. Then why is there so much debate regarding this development, and what are factors that need weighing when deciding to go public with clinical data?
Privacy of study subjects and the confidentiality of their medical data are well guarded in most clinical studies and clinical data are typically only shared in an anonymous way. Incidents, however, are known to happen where personal data gets out into the open, and technologies on data-bases are evolving quickly. The latter making collection of more complex clinical data easier, but also full anonymisation of the data more challenging. In addition, there are situations where certain data, for example on life threatening adverse events, need to be collected and reviewed in a non-anonymous way for an adequate interpretation. On top of that clinical studies are becoming more and more global, and what type of data is considered to be private, and the level of data protection is different across the globe.
Bottom line is that raw clinical study data may contain personal information, and care needs to be taken to ensure that the clinical data that are published for transparency reasons are fully anonymous according to the most stringent criteria. Especially now that many journals require that authors share raw clinical data supporting their manuscript and that reports should include adverse events as is suggested in the FDA/ NIH proposals.
Clinical research, driven by industry as well as university, flourishes on new ideas and inventions, its development, and resulting publications. Although inventions can be patented, intellectual property for medical devices is even harder to protect than for medicines, and the requirement to publish clinical data of any interventional trial regardless the study phase or whether the product under study has been approved, as proposed for studies registered at ClinicalTrials.gov, may well become counterproductive if not addressed well. Such requirement could reduce the willingness to register early phase clinical studies and/ or slow down developmental activities.
Clinical data interpretation
Correct interpretation of clinical study data is not an easy thing to do. Complete books are written on this topic, and insight are still evolving: the exact objective of the study, analyses methods, size of the study and size of the study product effect being only a few of the factors that influence interpretation of study data and therefore its conclusion. Even researchers are facing challenges in this respect, so one can only guess what happens when people looking at clinical data or a study report do not have the full picture and/ or expertise to interpret the data the right way. Especially in the early phases of a product development such can be tricky as you may kill a potentially promising therapy when misinterpreting or a misrepresenting the study results. Therefore it will be key that the layman’s summary, as for example required per draft MDR, is concise as well as unambiguous.
In conclusion, clinical data transparency is an indisputable requirement that is becoming more and more embedded in policies and regulations including those for medical devices. Since many medical devices clinical studies are registered at ClinicalTrial.gov, clinical study sponsors (industry as well as physicians) need to consider carefully now what and how they want to present their clinical study data to the public, and whether they want to provide feedback on the clinical data transparency proposals that are open for public consultation to ensure proper weighing of the above mentioned factors. Please feel free to contact me at any time in case you want to discuss the above.