In clinical research on medical devices, demonstrating the real effectiveness of a technology can be challenging. Unlike medicinal products, it is often difficult to isolate the specific effect of a device from factors such as the placebo effect, procedural techniques, or patient interaction.
In this context, sham devices in clinical investigations are gaining increasing importance.
Sham devices, or simulated medical devices, help strengthen the level of evidence by reproducing the experience of an active device without delivering its therapeutic effect. This methodological approach, inspired by placebo-controlled drug trials, is attracting growing interest while also raising ethical and regulatory questions.
As highlighted in a DeviceMed analysis, the use of sham devices in clinical investigations aims to isolate the true effect of the medical device while controlling biases related to the intervention context.
Sham devices in clinical investigations: understanding the concept of simulated devices
Sham devices in clinical investigations refer to simulated or inactive devices designed to replicate the use of an active device without providing its intended therapeutic benefit.
In practice, a sham can take several forms:
- Device sham: an identical but inactive device
- Procedure sham: reproduction of the intervention without the key therapeutic step
- Sub-threshold sham: device activated at a level insufficient to produce a clinical effect
- Digital sham: software or interface simulation without actual algorithmic action
The objective is to replicate as closely as possible the perception of the patient or investigator in order to avoid evaluation bias. This approach is particularly relevant when primary endpoints rely on patient-reported outcomes, such as pain or quality of life.
In drug trials, placebo controls have long been a methodological standard. However, in the field of medical devices, implementing a sham comparator is often more complex from a technical and logistical perspective.
Why sham devices improve the scientific robustness of clinical studies
One of the main benefits of sham devices in clinical investigations is their ability to reduce major methodological biases.
For many medical devices, especially those involving procedural or interventional techniques, patient and investigator expectations can influence observed outcomes. Sham procedures make it possible to distinguish the specific effect of the device from the placebo effect associated with the intervention itself.
Studies using sham devices therefore allow:
- isolation of the device’s true therapeutic effect
- reduction of placebo-related bias
- improvement of scientific validity
- demonstration of the effectiveness of procedures, even in surgical contexts
https://www.bmj.com/content/348/bmj.g3253
Similarly, a study published in the scientific literature highlights that sham procedures can be used to distinguish the real effect of an intervention from the placebo effect associated with the act itself, particularly in procedural or surgical interventions.
https://pubmed.ncbi.nlm.nih.gov/17878472
In the current context of strengthened clinical requirements for medical devices, particularly with the European Medical Device Regulation (MDR 2017/745), methodological robustness remains a key factor in demonstrating clinical benefit.
Ethical considerations related to the use of sham devices
Despite their scientific value, sham devices in clinical investigations raise important ethical concerns.
Participants assigned to the sham group may be exposed to a procedure without direct therapeutic benefit. This situation requires strong methodological justification and a rigorous assessment of the benefit-risk balance.
According to clinical research principles, the use of a sham device must meet several conditions:
- the scientific question cannot be addressed otherwise
- the simulated procedure involves minimal risk
- participants are fully informed and provide consent
- exposure to the sham intervention is strictly limited
These requirements are part of the broader European regulatory framework governing clinical investigations, aimed at protecting participants while ensuring the reliability of scientific data.
When should sham devices be considered in clinical investigations?
In practice, sham devices in clinical investigations are considered in several specific situations:
- when the primary endpoint is subjective (pain, quality of life)
- when the procedure itself may induce a strong placebo effect
- when blinding is difficult to maintain
- when no appropriate comparator exists
In these cases, the use of a sham can help generate more robust clinical evidence, supporting regulatory evaluation and market access for medical devices.
As clinical evidence requirements continue to increase, sham devices are likely to play an increasingly important role in clinical investigation methodologies, particularly for innovative devices and digital health technologies.
Conclusion
The increasing use of sham devices in clinical investigations reflects a broader evolution in clinical research requirements for medical devices.
Beyond regulatory expectations, sham-controlled studies strengthen the quality and credibility of clinical evidence. However, their implementation requires careful consideration of ethical, methodological, and operational aspects.
At BluePharm, we support healthcare stakeholders in designing robust clinical strategies aligned with evolving regulatory expectations, including the appropriate use of sham devices in clinical investigations.
