PMCF surveys or ‘end user’ surveys are a valid method of collecting post-market clinical data. They can be used to gain information on a device and its use from both healthcare professionals and patients by providing a set of questions to be answered.
PMCF surveys or ‘end user’ surveys are a valid method of collecting post-market clinical data. They can be used to gain information on a device and its use from both healthcare professionals and patients by providing a set of questions to be answered. These questions should be carefully considered for each device. The nature of the product and the target population will inform the types of questions asked.
These are not the usual ‘marketing’ survey. This is a clinical data generation tool.
The nature of the survey can vary. They can be general or specific – for the lower-risk devices and established technologies then a more general survey on user feedback can be utilized. For products in the high-risk categories a manufacturer should consider a more specific survey activity.
General surveys tend to be retrospective design – asking the end-user to recall information on the device and its use.
Specific surveys can be patient level and case specific – this can be a single survey or a series of surveys that follow the usage of the devices (prospective). This could be direct to the patient or via a healthcare professional using patient records. The data obtained from this type of activity will be of higher quality – usually producing clinical data on the devices under review via patient outcome data and clinical indication data.
Where a manufacturer has direct access to their end-users, either healthcare professionals or patients.
They are an agile tool, they have the potential to reach different user groups, and they are not limited by group size.
Surveys can be resource efficient both in terms of financial commitment and staff resource. In addition to this, they can be conducted in a remote setting This reduces the need for research personnel to be actively involved in collecting the data, it also reduces the burden on patients in terms of attending additional appointments. Although it should be noted, that the more specific surveys, particularly the case studies and series of surveys will likely require more time and more financial input, likewise an in-person or phone-based survey will have resource implications.
Review the PMCF and identify the gaps in the data – seek to align the objectives and the questions of the survey with these gaps. It is important to maintain a clear focus on this activity to ensure it feeds in appropriate data to the PMCF.
There may be a need for more than one survey over time, however this should be part of the ongoing development of the PMCF plan and analysis of the data gaps identified.
Fully documented data traceability
All data inputs automatically include automatic user identification to ensure fully documented traceability from source to sponsor via using State of The Art technology -> Blockchain.
Easy GDPR compliance
Easily comply with GDPR requirements for informed consent and data protection. Our in house data protection officer monitor the compliance for all the studies.
There 4 main methods of PMCF activity in order to collect the data: traditional clinical studies, registries, Observational data collection, surveys.
Depending on the medical device, each method has its own considerations on data quality and PMCF design as well as risks and benefits. The Webinar below outlines the team effort, and also the pros and cons of using surveys for PMCF, how to distinguish between Marketing Surveys, Clinical Surveys and Subject Surveys, and what needs to be considered from an Investigator’s perspective. This case study will be explained from our senior clinical project manager and ophthalmologist.
Interdisciplinary team set-up
Dr. Marko Lukic, Ph.D. FEBO FASRS is a consultant ophthalmologist specializing in retina and uveitis. He is affiliated with Moorfields Eye Hospital NHS Foundation Trust, where he serves as a consultant ophthalmologist in medical retina digital imaging clinics. Dr. Lukic completed two fellowships at Moorfields Eye Hospital: in 2016 Clinical Medical Retina Fellowship and the 2017 Clinical Research in Retina Fellowship. During his clinical research fellowship, dr Lukic participated as an investigator in more than 15 clinical trials. Dr. Lukic passed the ICO subspecialist exam in the retina in October 2020 and finished his Ph.D. in November 2021 at the Medical School of the University of Split, Croatia.
Dr. Lukic has been designated as a Fellow of the American Society of Retina Specialists since May 2022.
Dr. Lukic’s research interest is real-life data in diabetic macular oedema and wet age-related macular degeneration. His continuous research work resulted in manuscripts published in highly ranked journals like Nature Medicine, AJO, Retina, EJO, etc. He serves as a reviewer in highly rated ophthalmology journals. Dr. Lukic has been part of the team of experts who participated in a collaborative project between Moorfields Eye Hospital and Google’s Deep Mind to develop an artificial intelligence system to recognise various retinal conditions based on deep learning protocol. Dr. Lukic lectures ophthalmology at the Medical School of Zagreb and serves as a medical retina tutor to optometrists at the University College of London, UK.
Dr. Lukic is the owner and director of the European Medical Consultants, one of the leading European companies specializing in teleophthalmology. Dr. Lukic sits on the advisory board of Eclevar and serves as an external expert for Specsavers Nordic.