Research on medical devices ?
To understand how medical devices need to be evaluated and why the research is so different from other domains such as pharmaceutical research, we need to consider 3 players in the evaluation process: the operator, the product and the patient.
The operator and patient are interested to know the benefits but fear the side effects. Benefits can be translated in performance or efficacy. The side effects in safety. Once this is well understood we can find out more easily the specific needs of and judge the evaluation process for medical devices. We also learn why we don't need to rely on the template of 'the standard way of reporting results.
Let us take for example the clinical research on an anti-neoplastic agent. Seldom the benefits for and safety of the operator, the clinician, is taken up in the study. In contrast, more emphasis is put on the patient. The end points to study are usually survival and response rate (efficacy) and acute and late side effects (safety data). Due to the large pharmacokinetic and pharmacodymamic variations and because the end-points are often remote in time, a large number of patients have to be studied for a long time.
This is all the more true for comparison studies evaluating different products in equivalent populations of patients. In time, pharmaceutical research protocols became very similar and rules in reporting the results became necessary to compare the published results. As a consequence, physicians took over the criteria and judged every scientific publication according to these presets. In addition, several levels of evidence were proposed.
Should research on medical devices be published in the same way as we do for pharmaceutical studies? Certainly not. If we like to study for example the efficacy and safety of urine stoma bags, we use somewhat similar end-points: efficacy but much less safety. Few reviewers of such a manuscript will ask for safety and comfort data for the clinician. Again, if we like to study for example a biopsy instrument we will consider mainly efficacy for the operator and safety for the patient. Less attention is given to safety for the operator and efficacy in the patients etc.
And although we know that the type of clinical trial depends on the scientific questions asked, sometimes regulatory instances request data that are simply not there. A painful example is the request for a double blind study on medical devices. Seldom, the investigator that is also the operator of the device can accept a blinded procedure because it simply is not possible.
Clearly, the type of scientific question depends on the type of medical device to evaluate. As a consequence, this variation in scientific questions is much more variable in medical devices compared to pharmaceutical research on drugs. An evaluation of scissors is almost immediately made when the first cuts are made. There are no immediate or late side effects to consider. The benefit for the patient is remote. Only the comfort for the operator is the key issue here and how long this comfort lasts if the pair of scissors can be reused. An evaluation of scissors is made almost instantaneously. In summary, the design of the study and the reporting is as much variable as there are different kinds of medical devices and the indications for use to judge.
We don't want to read a paper on medical devices in the format of a pharmaceutical paper and publications on medical devices are extremely different from each other, depending on the exact scientific questions that need to be addressed. Again, in the example of the scissors, some might do well for paper cutting but not for human tissues. Evidently, the research questions should be clearly defined and adequately addressed in the study design.
Importance of medical devices in oncology
Medical oncologists are more trained in pharmacology than in medical devices. This is historically imposed in view of the enormous wealth of chemical products used in oncology and the progress made in recent years in chemotherapy and personalized medicine. Nevertheless, surgery and radiotherapy, where medical devices are much more important than pharmaceutical products, remain the most powerful tools to treat patients. Medical devices however are not confined to surgery and radiotherapy alone; they are receiving more interest in the general oncology. The venous access ports, prostheses, and various aids after mutilation are examples of this and have an enormous impact on the quality of life of these patients.
But there is another extremely exiting era to come for oncology in which medical devices might become even more important than pharmaceuticals. We might illustrate these developments by the way medical devices have affected cardiology. In the seventies, there was not much hope for a patient with a coronary stenosis. Pills could relief the vascular spasms somewhat but besides that there was little else. There was no significant medical impact on survival. As a consequence, researchers looked at prevention by reducing salts and fat and advocating moderate physical activity after cardiac insult or, even better, before the event: in healthy people. The first impact on survival was seen. However, by the introduction of medical devices and technical procedures to detect and treat preclinical conditions, we saw a major impact on cardiovascular mortality and survival. Nowadays, medical devices play a major role in the prevention and treatment of cardiac illnesses.
Similar things are bound to happen in oncology. For metastatic disease of solid cancers, there is not much hope for adults. Comparison studies between cytostatic regimes that still include placebo hardly show significant differences in survival and when they do so the survival benefit is mostly a matter of weeks to months. Comparative studies between different treatment protocols show similar and often discouraging results. Newer cytostatics and targeted therapies don’t add much in contemporary research although funded hopes that progress may remain. The same is probably true for the adjuvant settings. The benefits are often small and frustrating in comparison to side effects. Clearly, the pharmaceutical era is leveling off at a benefit level that didn’t change much the fate of the cancer patient.
New hope came from prevention studies and in particular early detection and screening. Chemoprevention showed impact in most studies but changes in lifestyle seem much more powerful as exemplified in lung cancer. As seen in cardiology, changes in lifestyle remains a proven protection against many adult solid cancers.
For breast and colon cancer, the early detection clearly showed benefit with increasing cure rates for small cancers. Screening mammography and colonoscopy were able to significantly reduce mortality. Cure rates for breast cancer have increased from 50 to beyond 80 per cent when cancers are found early. Similar rates have been seen in colon cancer. All this was possible by the correct use of medical devices such as mammography, ultrasound, coloscopy, colposcopy, CT, MRI, biopsy tools, stereotaxis, etc. In other words, since about 30 years now, medical devices have entered oncology and found a perfect fitting in clinical routine. The results were striking and have never been seen before. Medical devices have more impact on diagnostic accuracy and treatment outcome than any medicinal approach.
It is surprising then, that research on medical devices is often evaluated the same way as pharmaceuticals. The medical community should be better off if we could create the exact tools to evaluate correctly medical devices, in particular medical tools used in oncology.
In view of the importance that medical devices have in oncology and the consideration that the impact will increase further more in the near future combined with the specific needs for proper evaluation tools, it seems almost imperative that a suitable environment should be created to enhance science and diffusion of results in to routine clinical practice. In this way the entrance of still more useful and efficient tools can be facilitated. Industrial researchers could communicate better with clinicians, technicians and nurses to improve their products.
The argument that there are already too much societies and that some societies cover already a part of the requests doesn’t diminish the need for a dedicated society where all professionals and even patients can find a trustful home and discussion platform. In July 2008, the creation of the Society was a fact. Numerous scientists and interventionalists applauded the event. And piece by piece the platform was built.
The main goal of the society is to enhance scientific research on medical devices that are being or going to be used for cancer patients or individuals at increased risk for cancer. Another goal is to improve communication between industry, research and clinical use in either direction.
The Society consists of active and associate members. Active members are professionals that work most of their time with medical devices in the care of cancer patients. Associate members are individuals, societies and companies that support the Society in reaching the goals.
A dedicated annual meeting on topics of medical devices for cancer patients is one of the activities of the society. Since the worldwide interest, meetings are being organized in different continents and countries with the help of Ipsum Events, the exclusive partner of IOS.
The Journal of Interventional Oncology is the forum of choice to communicate scientific messages either in the form of original work, reviews, tutorials, editorials, short communications and letters etc.
A multimedia website will add information to the Journal in the form of images, tutorials, demonstrations, virtual meetings, product information, etc. This multimedia is accessible through subscription to the Journal.
Together, they are a powerful team to realize the goals in focusing on “tools, science and cancer”. The inaugural issue was the result of endless preparatory work and the birth of a platform, the medical society was looking for. Now we are heading for the third active year of IOS in 2013.