PMCF – What’s the use of a survey?
Post Market Clinical Follow-up (PMCF) is the subject of much debate. PMCF is defined as a continuous process that generates new data to feed into the clinical evaluation (Art. 61 & Annex XIV Part A). However, there are no defined rules on how it should be carried out or what activities companies should be conducting.
PMCF is a proactive collection and evaluation of real-world clinical data, with the aim of confirming the safety and performance throughout the expected lifetime of the device. It is guided by the questions and gaps that are present in the life-cycle of each device – the PMCF plan should be created specifically to address the needs of that device – there is no ‘one size fits all’.
In this blog we will look specifically at surveys in the PMCF space.
Surveys can be used to gain real world data 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, the current state of the art and the target population will inform the types of survey conducted. As with all PMCF activities, generating sufficient quality and quantity of clinical data is of particular importance, therefore, the design and implementation of a PMCF survey are critical.
Why are they often a good choice?
Surveys 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 in terms of financial commitment and staff resource. In addition to this, they can be conducted in a remote setting. For example:
- Reduced need for research personnel to be actively involved in collecting the data.
- Reduced burden on patients in terms of attending additional appointments.
- Increase of data collection, allowing for quicker analysis and review of data.
Challenges to look out for:
- Not all surveys are equal! The design of the survey is critical to assuring the quality and quantity of data.
- Whom the survey is addressed to: clinic, physician, healthcare professional, patient, or patient’s relatives/caregiver.
- By whom are the data collected:
- by clinic, physician, or healthcare professional on patient level, when the end-user is the patient, like a case series.
- by clinic, physician, or healthcare on “user” level when the end-user is part of this group.
- by patient, or caregiverwhen they are the end-users, so patient reported outcome measure (PROM).
- Access to the end-users – this can be limited /restricted e.g. if a distributor is used.
- Bias – the structure of the survey is important in minimizing bias. More of a concern with subjective healthcare professional responses and specific patient selection to only ask the patients with most successful outcome for example.
- Lack of responses – the survey needs to be accessible and simple to complete. Users may get ‘fatigue’ in completing them if they are too long, too complicated or not relevant.
- The survey may not produce sufficient evidence – this should be considered as part of the broader PMCF plan.
- Loss of focus – as set out above the survey needs a clear direction – if too many objectives are attempted the survey may not be clear enough, and the data returned may be skewed.
- General Data Protection Regulation (GDPR) compliance is critical.
- Ethical review and approval may be required – individual countries can have different requirements.
Are the. necessary consents and approvals in place ?
Are you covering. the intended purpose and clinical claims?
What are the data gaps ?
What is the sample size needeed?
Does the design support the benefit-risk analysis ?
What is the method of analysis going to be ? Is this justified ?
Thank you for taking the time to read this overview of PMCF surveys. We hope it was of interest, we will be covering more PMCF activities in future blogs!
ECLEVAR MEDTECH is a global CRO, headquartered in Paris. We support medical device and IVD manufacturers in the MDR and IVDR transition. Our team works as an extension team of medical affairs and regulatory affairs sponsors. We offer customized service, personalized to the need of our clients. Whether you are looking for a full-service CRO or staffing clinical or regulatory experts, our management team with more than 20 years of experience will drive you to an effective solution.
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