Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide

Rayan Taher; Charlotte L. Hall; Aislinn D.Gomez Bergin; Neha Gupta; Clare Heaysman; Pamela Jacobsen; Thomas Kabir; Nayan Kalnad; Jeroen Keppens; Che Wei Hsu; Philip McGuire; Emmanuelle Peters; Sukhi Shergill; Daniel Stahl; Ben Wensley Stock; Jenny Yiend

doi:10.1186/s13063-024-08421-1

Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide

Rayan Taher, Charlotte L. Hall, Aislinn D.Gomez Bergin, Neha Gupta, Clare Heaysman, Pamela Jacobsen, Thomas Kabir, Nayan Kalnad, Jeroen Keppens, Che Wei Hsu, Philip McGuire, Emmanuelle Peters, Sukhi Shergill, Daniel Stahl, Ben Wensley Stock, Jenny Yiend^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

Background: The field of digital mental health has followed an exponential growth trajectory in recent years. While the evidence base has increased significantly, its adoption within health and care services has been slowed by several challenges, including a lack of knowledge from researchers regarding how to navigate the pathway for mandatory regulatory approval. This paper details the steps that a team must take to achieve the required approvals to carry out a research study using a novel digital mental health intervention. We used a randomised controlled trial of a digital mental health intervention called STOP (Successful Treatment of Paranoia) as a worked example. Methods: The methods section explains the two main objectives that are required to achieve regulatory approval (MHRA Notification of No Objection) and the detailed steps involved within each, as carried out for the STOP trial. First, the existing safety of digital mental health interventions must be demonstrated. This can refer to literature reviews, any feasibility/pilot safety data, and requires a risk management plan. Second, a detailed plan to further evaluate the safety of the digital mental health intervention is needed. As part of this we describe the STOP study’s development of a framework for categorising adverse events and based on this framework, a tool to collect adverse event data. Results: We present literature review results, safety-related feasibility study findings and the full risk management plan for STOP, which addressed 26 possible hazards, and included the 6-point scales developed to quantify the probability and severity of typical risks involved when a psychiatric population receives a digital intervention without the direct support of a therapist. We also present an Adverse Event Category Framework for Digital Therapeutic Devices and the Adverse Events Checklist—which assesses 15 different categories of adverse events—that was constructed from this and used in the STOP trial. Conclusions: The example shared in this paper serves as a guide for academics and professionals working in the field of digital mental health. It provides insights into the safety assessment requirements of regulatory bodies when a clinical investigation of a digital mental health intervention is proposed. Methods, scales and tools that could easily be adapted for use in other similar research are presented, with the expectation that these will assist other researchers in the field seeking regulatory approval for digital mental health products.

Original language	English
Article number	604
Journal	Trials
Volume	25
Issue number	1
DOIs	https://doi.org/10.1186/s13063-024-08421-1
Publication status	Published - Dec 2024

Keywords

Adverse events
Digital mental health
Digital mental health interventions
Medical device
MHRA
Notification of No Objection
Regulatory approval
Safety
SaMD
Software as a medical device

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10.1186/s13063-024-08421-1

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Taher, R., Hall, C. L., Bergin, A. D. G., Gupta, N., Heaysman, C., Jacobsen, P., Kabir, T., Kalnad, N., Keppens, J., Hsu, C. W., McGuire, P., Peters, E., Shergill, S., Stahl, D., Stock, B. W., & Yiend, J. (2024). Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide. Trials, 25(1), Article 604. https://doi.org/10.1186/s13063-024-08421-1

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abstract = "Background: The field of digital mental health has followed an exponential growth trajectory in recent years. While the evidence base has increased significantly, its adoption within health and care services has been slowed by several challenges, including a lack of knowledge from researchers regarding how to navigate the pathway for mandatory regulatory approval. This paper details the steps that a team must take to achieve the required approvals to carry out a research study using a novel digital mental health intervention. We used a randomised controlled trial of a digital mental health intervention called STOP (Successful Treatment of Paranoia) as a worked example. Methods: The methods section explains the two main objectives that are required to achieve regulatory approval (MHRA Notification of No Objection) and the detailed steps involved within each, as carried out for the STOP trial. First, the existing safety of digital mental health interventions must be demonstrated. This can refer to literature reviews, any feasibility/pilot safety data, and requires a risk management plan. Second, a detailed plan to further evaluate the safety of the digital mental health intervention is needed. As part of this we describe the STOP study{\textquoteright}s development of a framework for categorising adverse events and based on this framework, a tool to collect adverse event data. Results: We present literature review results, safety-related feasibility study findings and the full risk management plan for STOP, which addressed 26 possible hazards, and included the 6-point scales developed to quantify the probability and severity of typical risks involved when a psychiatric population receives a digital intervention without the direct support of a therapist. We also present an Adverse Event Category Framework for Digital Therapeutic Devices and the Adverse Events Checklist—which assesses 15 different categories of adverse events—that was constructed from this and used in the STOP trial. Conclusions: The example shared in this paper serves as a guide for academics and professionals working in the field of digital mental health. It provides insights into the safety assessment requirements of regulatory bodies when a clinical investigation of a digital mental health intervention is proposed. Methods, scales and tools that could easily be adapted for use in other similar research are presented, with the expectation that these will assist other researchers in the field seeking regulatory approval for digital mental health products.",

keywords = "Adverse events, Digital mental health, Digital mental health interventions, Medical device, MHRA, Notification of No Objection, Regulatory approval, Safety, SaMD, Software as a medical device",

author = "Rayan Taher and Hall, {Charlotte L.} and Bergin, {Aislinn D.Gomez} and Neha Gupta and Clare Heaysman and Pamela Jacobsen and Thomas Kabir and Nayan Kalnad and Jeroen Keppens and Hsu, {Che Wei} and Philip McGuire and Emmanuelle Peters and Sukhi Shergill and Daniel Stahl and Stock, {Ben Wensley} and Jenny Yiend",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",

year = "2024",

month = dec,

doi = "10.1186/s13063-024-08421-1",

language = "English",

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journal = "Trials",

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Taher, R, Hall, CL, Bergin, ADG, Gupta, N, Heaysman, C , Jacobsen, P, Kabir, T, Kalnad, N, Keppens, J, Hsu, CW, McGuire, P , Peters, E, Shergill, S, Stahl, D, Stock, BW & Yiend, J 2024, 'Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide', Trials, vol. 25, no. 1, 604. https://doi.org/10.1186/s13063-024-08421-1

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T2 - a case study and academic’s guide

AU - Taher, Rayan

AU - Hall, Charlotte L.

AU - Bergin, Aislinn D.Gomez

AU - Gupta, Neha

AU - Heaysman, Clare

AU - Jacobsen, Pamela

AU - Kabir, Thomas

AU - Kalnad, Nayan

AU - Keppens, Jeroen

AU - Hsu, Che Wei

AU - McGuire, Philip

AU - Peters, Emmanuelle

AU - Shergill, Sukhi

AU - Stahl, Daniel

AU - Stock, Ben Wensley

AU - Yiend, Jenny

N1 - Publisher Copyright: © The Author(s) 2024.

PY - 2024/12

Y1 - 2024/12

N2 - Background: The field of digital mental health has followed an exponential growth trajectory in recent years. While the evidence base has increased significantly, its adoption within health and care services has been slowed by several challenges, including a lack of knowledge from researchers regarding how to navigate the pathway for mandatory regulatory approval. This paper details the steps that a team must take to achieve the required approvals to carry out a research study using a novel digital mental health intervention. We used a randomised controlled trial of a digital mental health intervention called STOP (Successful Treatment of Paranoia) as a worked example. Methods: The methods section explains the two main objectives that are required to achieve regulatory approval (MHRA Notification of No Objection) and the detailed steps involved within each, as carried out for the STOP trial. First, the existing safety of digital mental health interventions must be demonstrated. This can refer to literature reviews, any feasibility/pilot safety data, and requires a risk management plan. Second, a detailed plan to further evaluate the safety of the digital mental health intervention is needed. As part of this we describe the STOP study’s development of a framework for categorising adverse events and based on this framework, a tool to collect adverse event data. Results: We present literature review results, safety-related feasibility study findings and the full risk management plan for STOP, which addressed 26 possible hazards, and included the 6-point scales developed to quantify the probability and severity of typical risks involved when a psychiatric population receives a digital intervention without the direct support of a therapist. We also present an Adverse Event Category Framework for Digital Therapeutic Devices and the Adverse Events Checklist—which assesses 15 different categories of adverse events—that was constructed from this and used in the STOP trial. Conclusions: The example shared in this paper serves as a guide for academics and professionals working in the field of digital mental health. It provides insights into the safety assessment requirements of regulatory bodies when a clinical investigation of a digital mental health intervention is proposed. Methods, scales and tools that could easily be adapted for use in other similar research are presented, with the expectation that these will assist other researchers in the field seeking regulatory approval for digital mental health products.

AB - Background: The field of digital mental health has followed an exponential growth trajectory in recent years. While the evidence base has increased significantly, its adoption within health and care services has been slowed by several challenges, including a lack of knowledge from researchers regarding how to navigate the pathway for mandatory regulatory approval. This paper details the steps that a team must take to achieve the required approvals to carry out a research study using a novel digital mental health intervention. We used a randomised controlled trial of a digital mental health intervention called STOP (Successful Treatment of Paranoia) as a worked example. Methods: The methods section explains the two main objectives that are required to achieve regulatory approval (MHRA Notification of No Objection) and the detailed steps involved within each, as carried out for the STOP trial. First, the existing safety of digital mental health interventions must be demonstrated. This can refer to literature reviews, any feasibility/pilot safety data, and requires a risk management plan. Second, a detailed plan to further evaluate the safety of the digital mental health intervention is needed. As part of this we describe the STOP study’s development of a framework for categorising adverse events and based on this framework, a tool to collect adverse event data. Results: We present literature review results, safety-related feasibility study findings and the full risk management plan for STOP, which addressed 26 possible hazards, and included the 6-point scales developed to quantify the probability and severity of typical risks involved when a psychiatric population receives a digital intervention without the direct support of a therapist. We also present an Adverse Event Category Framework for Digital Therapeutic Devices and the Adverse Events Checklist—which assesses 15 different categories of adverse events—that was constructed from this and used in the STOP trial. Conclusions: The example shared in this paper serves as a guide for academics and professionals working in the field of digital mental health. It provides insights into the safety assessment requirements of regulatory bodies when a clinical investigation of a digital mental health intervention is proposed. Methods, scales and tools that could easily be adapted for use in other similar research are presented, with the expectation that these will assist other researchers in the field seeking regulatory approval for digital mental health products.

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KW - Digital mental health

KW - Digital mental health interventions

KW - Medical device

KW - MHRA

KW - Notification of No Objection

KW - Regulatory approval

KW - Safety

KW - SaMD

KW - Software as a medical device

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AN - SCOPUS:85203320984

SN - 1745-6215

VL - 25

JO - Trials

JF - Trials

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M1 - 604

ER -

Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide

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