The differences between pharmaceutical and medical devices studies at a site are often no more pronounced than in the care and ongoing management of clinical trial participants themselves. The entire participant journey, from recruitment to trial conduct and even post trial support and follow up is influenced significantly by the investigation or application of a medical device in human research.
Simply put medical device studies can often much be harder to recruit for. Potential participants require both an indication for, and willingness to, undergo what can be invasive surgical intervention for implantable medical devices. There are commonly times when the perfect participant is identified and screened appropriately only to decline involvement in the study due to a reasonable unwillingness to undergo surgery or stay in hospital or have a general anaesthetic, etc.
Alternatively, this is can be a negligible concern for a subset of the recruitable population who hope to instead take advantage of, at times generous sponsor provisions of both device and reimbursement of associated healthcare or procedural fees which can afford a valuable contribution to needy patients within your geography or clinic. This can be significantly advantageous for a willing and appropriate population who meet the predefined inclusion criteria for a medical device study as ultimately for a site, reimbursement trial design preparations are the single biggest influence on recruitment and hence should be appreciated in the feasibility stage of a study.
As always, the key to successful recruitment is empathising with, and appropriately engaging your targeted enrolees. Both a sound knowledge of the device, the procedures and any anticipated or potential outcomes serves as the most effective reassurance one can provide and can improve recruitment and retention by a significant measure as a result.
With device studies, there is both the obvious physiological duty of care but also a novel tech know-how requirement that highlights both the novel interest in conducting these studies and additionally the areas that can present confusion, non-compliance, attrition and poor data outcomes. We must encourage a responsible transference of clinical education between our site and our participants to minimise these inherent risks that are unique to many device studies. This is often facilitated by a coordinated approach in device studies as the participant has multiple, specific study contacts, sometimes external to your site. Pre-op preparation, procedural education and device training is a very contrasting requirement, we may need to supply user manuals, alert cards or access to distinct sponsor representatives to facilitate ‘trouble shooting’ during study conduct. Similarly, post-op care including wound assessment, dressings, treatment of complications and recommendations for ongoing care are often wholly unique to implantable medical devices. Study specific SOPs, institutional management plans and absolute oversight by both the PI, co-investigators and/or implanting physician is necessary in addition to associated resources required for both wound management, removal of sutures and any number of other procedures related to direct participant care.
The post-study obligation to a clinical trial participant in a device trial may also be considerably dissimilar to a pharmaceutical investigation and may require continued support for up to 10 years after the last study visit. This can be due to device complication, deficiency or even ethical concern associated with the development of new information associated with the device over time. As always, for a site the primary concern is advocacy for the participants, even well after a device study has finished per protocol and this reflects both the obvious clinical duty of care a site has and the responsible human research liability that both the site and sponsor has to provide participants appropriate medical treatment and technical support, should it be required.