Geneliefe Clinical Research has experience in conducting Medical device and drug device combination clinical studies.
The Clinical Trials of medical device’s are complex in comparison to drug. So, one has to design the study to overcome the constrains in medical device clinical trials, especially pertaining to comparability and establishment of universal outcomes. There is no perfect control in a medical devices study. Moreover, as there is no “Absolute safety and efficacy” available from experimentation in healthy human subjects, the outcomes of studies remain majorly study specific. Applicability of the trial outcomes to real world is grossly limited.
One of the major problems in Medical Device clinical trials as discussed is lack of a perfect control. Even if some control is selected, the control may have different indications. For example, Stent implant angioplasty and coronary artery bypass graft are the common comparable entities. Both of these treatments and thereby the device “Stent” is studied against a control of CABG.
This makes the point that innovative study designs can overcome some major constrains in Medical Device Clinical trials and can yield reliable and more accurate clinical data which can be used as a standard reference in day to day clinical practice.
What can be different designs of studies? There can be several design options. The first is variation of the hypothesis. In many Medical Device Clinical Trials, the study hypothesis is developed in a way that specific outcomes are tested. For example, in many studies, the hypothesis is designed to register an “Event Free Survival” or “proportion of population free from events in a defined period”.
The second important postulate of an innovative study design is inclusion of subsets. In many conditions it is seen that the study design exclude many subsets of the populations, which make the results differ from “real world” scenario. Instead, the predetermined subsets inclusion can give a study a wider acceptance and better power. In fact, based upon this one postulate, the study can be an union matrix study, a multi-arm study, overlapping matrix study etc. These designs are uncommon to use but an intelligent statistician will take efforts to make these ambitious designs. These types of designs may have several expressions such as compartmental design (Tight Subset matrix), blocks design (Loose Subsets Matrix) , clusters design(Loose subsets with stratified or multiple overlapping) ; and the study cohort can be stratified to establish relative betterment.
Use of Standard or Specifically developed scores can be one of the important tools in design for Medical Device Clinical Trials. The Standard Scores Such as Comorbidity Index, Medina Score for Cardiology bifurcation lesion or Study specific scores such as SYNTAX Scores can be highly useful in designing a study and meet specific comparability needs.
Genelife Clinical Research has capability and experience to submit IDE and 510K. We have assisted clients with integrating the various medical device regulatory requirements into their quality management system such as ISO 13485, 21CFR820, Canadian Medical Devices Conformity Assessment (CMDCAS) and Medical Device Directive (MDD). This approach ensures that the quality management system is scalable and can serve the global needs for medical device market approval and distribution.