Based on a comprehensive review of the CTIS database and the provided clinical trial protocol excerpts, several clinical trial protocols explicitly include actual use studies or patient usability studies of autoinjectors or prefilled pens, where patients or caregivers perform the injections. These studies are embedded within the clinical trial protocols and systematically assess usability, user experience, and device handling in real-world or near-real-world settings. Below is a consolidated summary of the identified protocols, their key features, and relevant references.

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1. Idorsia Pharmaceuticals Ltd. – Selatogrel (ACT-246475) Autoinjector Usability Studies

• Protocols: ID-076A301 (SOS-AMI), EU CT number: 2023-505438-85
• Design & Usability Assessment:
  • Subjects are instructed to self-administer the study drug (or placebo) using the autoinjector, following the device’s Instructions for Use (IFU).
  • Self-injection is a requirement for randomization; those unable or unwilling to self-inject are screen failures.
  • Used autoinjectors are returned and checked by investigators for correct use.
  • The protocol includes structured follow-up (site visits, phone calls) to assess recollection of training, device handling, and to provide re-training if needed.
  • All events related to misuse, device defect, deficiency, or failure are systematically reported as adverse events in the eCRF.
• Key Usability Elements: Real-world self-injection, device return and inspection, structured usability and training recall assessment, systematic reporting of user/device issues.
• References: ^{25111214182022}

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2. Pfizer Inc. – Marstacimab Prefilled Pen (PFP) Usability Substudy

• Protocol: B7841007 (including substudy), EU CT number: 2022-500470-33-00
• Design & Usability Assessment:
  • Participants or caregivers self-administer injections using the prefilled pen.
  • Usability is assessed via:
    • Participant Assessment Tool (PAT) and Observer Assessment Tool (OAT): Document who administered the injection, whether the full dose was delivered, if the device indicator functioned, and any difficulties or need for assistance.
    • All used pens are returned for central mechanical inspection (visual and CT scan) to confirm correct operation and dose delivery.
    • Device complaints, use errors (e.g., premature removal), and adverse events are systematically tracked and investigated.
    • Data are also recorded in an electronic diary (eDiary).
• Key Usability Elements: Direct patient/caregiver self-injection, structured feedback, device inspection, systematic documentation of use errors and complaints.
• References: ^347813151619

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3. Janssen – SIMPONI® (golimumab) Prefilled Pen/Syringe Usability Assessment Substudy

• Protocol: CNTO148UCO3003 (2023-507142-83)
• Design & Usability Assessment:
  • Pediatric participants (≥12 years) or caregivers are trained and then independently perform injections using a prefilled syringe (PFS-U) or prefilled pen (PFP-V) in a home-like clinic setting.
  • Usability is assessed via:
    • Injection Device Assessment Questionnaire: Completed after the second and third self- or caregiver-administered injections, covering ease of use, understanding of instructions, and any difficulties encountered.
    • Observer Checklist: Used during training and observed administrations to ensure correct technique.
    • The substudy specifically aims to provide supportive data on real-world usability and user experience.
• Key Usability Elements: Patient/caregiver self-injection, structured questionnaires, observer checklists, focus on pediatric and caregiver usability.
• References: ^16101724

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4. Novo Nordisk A/S – Pen Injector Usability Assessment

• Protocol: NN9838-4608
• Design & Usability Assessment:
  • Includes device training, an "Injection Device Questionnaire," and sections on "Technical Complaint and Pen-Injector Use Error."
  • Patients are trained and then assessed on their ability to use the pen injector, with systematic collection of usability experience.
• Key Usability Elements: Patient-performed injections, structured training and usability questionnaires, systematic error/complaint reporting.
• References: ²³

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5. Teva Branded Pharmaceutical Products R&D LLC – Autoinjector Usability Risk Assessment

• Protocol: TV48125-CNS-30084
• Design & Usability Assessment:
  • Protocol includes detailed tables of anticipated use-related and design-related deficiencies, mapping specific use errors (e.g., improper disposal, misreading expiration date) to potential hazards.
  • While the focus is on risk analysis, the protocol indicates that patient usability and actual use scenarios are integral to the study, with monitoring for and mitigation of user errors during self-administration.
• Key Usability Elements: Patient self-administration, risk analysis of use errors, monitoring and mitigation strategies.
• References: ²¹

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6. Ascendis Pharma – Pre-filled Injection Pen Usability (PaTH Forward, TCP-201)

• Design & Usability Assessment:
  • Includes a "Device Usability Questionnaire" completed by the subject after using the pre-filled injection pen, specifically targeting device handling and malfunctions.
• Key Usability Elements: Patient-completed usability questionnaire post-injection.
• References: ⁹

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7. GlaxoSmithKline – Self-Administration Device Usability (Protocol Amendment 5)

• Design & Usability Assessment:
  • Protocol includes supervised self-administration by patients, with education and observation for the first two doses.
  • References prior formative human factors studies and incorporates risk assessment and mitigation for self-administration devices.
• Key Usability Elements: Supervised patient self-injection, embedded usability/risk assessment.
• References: ²⁶

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Protocols Not Meeting Patient/Caregiver Criterion

• Samsung Bioepis (SB11/Byooviz/Amelivu, Protocol SB11-2002): Focuses on healthcare professional (HCP) usability, not patient/caregiver self-injection ²⁵.

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Summary Table

Sponsor/Drug	Protocol/Study ID	Device Type	Population	Usability Assessment Methods	References
Idorsia/Selatogrel	ID-076A301, 2023-505438-85	Autoinjector	Adults	Self-injection, device return, follow-up, AE reporting	25111214182022
Pfizer/Marstacimab	B7841007	Prefilled Pen	Adults/Caregivers	PAT/OAT, device inspection, eDiary, AE reporting	347813151619
Janssen/SIMPONI	CNTO148UCO3003	PFS/Pen	Pediatrics/Caregivers	Training, observed self-injection, questionnaires	16101724
Novo Nordisk	NN9838-4608	Pen Injector	Adults	Training, device questionnaire, error reporting	23
Teva	TV48125-CNS-30084	Autoinjector	Adults	Risk analysis, error monitoring	21
Ascendis Pharma	TCP-201	Pre-filled Pen	Adults	Device usability questionnaire	9
GSK	Protocol Amendment 5	Autoinjector/Pen	Adults	Supervised self-injection, risk assessment	26

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Conclusion

Multiple clinical trial protocols in the CTIS database include actual use or patient usability studies of autoinjectors or prefilled pens, where patients or caregivers perform the injections. These studies typically involve structured training, supervised or independent self-injection, systematic usability assessments (questionnaires, observer checklists, device inspections), and comprehensive reporting of user/device issues. The protocols from Idorsia (Selatogrel), Pfizer (Marstacimab), Janssen (SIMPONI), Novo Nordisk, Teva, Ascendis Pharma, and GSK all provide clear examples of such studies, as detailed above.

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References

1. Idorsia Pharmaceuticals Ltd. (Selatogrel, ID-076A301, SOS-AMI)
2. Pfizer Inc. (Marstacimab, B7841007)
3. Janssen (SIMPONI, CNTO148UCO3003)
4. Novo Nordisk A/S (NN9838-4608)
5. Teva Branded Pharmaceutical Products R&D LLC (TV48125-CNS-30084)
6. Ascendis Pharma (TCP-201)
7. GlaxoSmithKline (Protocol Amendment 5)
8. Samsung Bioepis (SB11-2002) – HCP-focused, not included in main list

Reference numbers correspond to those assigned in the merged answers above. For full protocol titles and details, see the original CTIS database entries.