IntroductionAlthough the previous lanreotide autogel/depot syringe had been well received, feedback indicated that improvements could be made to make it more user-friendly. Additionally, the view that patients should have greater involvement in the research and development process is echoed by the International Neuroendocrine Cancer Alliance. A series of studies aimed to develop and validate a new syringe that works better for patients, caregivers and healthcare professionals (HCPs) by involving these groups at key stages in the development and testing process.MethodsThe multicentre, international, human factor studies, consisted of four formative studies and one validation study. The formative studies collected patient, caregiver and HCP feedback on the lanreotide autogel/depot syringe on the market at the time, and on newly designed prototypes. The validation study was conducted to evaluate the final syringe to confirm that it can be used effectively and safely in the intended environment, by the intended user, for the intended purpose.ResultsOverall, 213 individuals participated in the studies; 145 contributed to the formative studies and 68 to the validation study. The validated new-generation syringe included several important updates compared with the lanreotide autogel/depot syringe currently on the market, including the flanges, which are now larger and have a better grip; the overcap, which is white, ridged, opaque and bigger; the plunger supports and the thermoformed tray. No participant hurt themselves or others during the validation study (although several misuses were reported), and all participants succeeded in delivering a complete dose and activating the safety system.ConclusionWith collaboration, a new syringe was developed to meet the needs of patients, caregivers and HCPs, whilst ensuring lanreotide was delivered effectively and safely. These studies highlight the importance of involving patients, caregivers and HCPs in clinical evaluation studies to develop medical products that address their concerns and meet their needs.FundingIpsen.Plain Language SummaryPlain language summary available for this article.Electronic Supplementary MaterialThe online version of this article (10.1007/s12325-019-01112-3) contains supplementary material, which is available to authorized users.

Lanreotide autogel/depot, a somatostatin analogue used to treat patients with acromegaly and gastroenteropancreatic neuroendocrine tumours (GEP-NETs), is currently supplied as a sterile, ready-to-use, single-dose prefilled syringe and is administered subcutaneously. To further enhance patient care, we performed several studies to i) gain insights into patient, caregiver and healthcare professional (HCP) use of the current delivery system (DS) and ii) evaluate use of a new improved DS developed from this patient-centred approach. From June 2015 to September 2016, 4 formative studies were conducted in Europe and the US in participants representing patients with acromegaly (n=33) or GEP-NETs (n=21), caregivers (n=3), nurses (n=73), and other relevant HCPs (n=2). These studies provided feedback on the current DS; identified challenges/areas for improvement; evaluated a prototype new DS; and identified critical tasks. A human factor (HF) validation study was then performed in the US and Germany (May/June 2017) to determine whether the new DS could be used safely and effectively in its intended setting. Inclusion criteria included: patients with acromegaly, or non-diagnosed participants with enlarged hands and fingers/dexterity issues and willingness to self-inject (acromegaly representatives); a caregiver of/patient with a GEP-NET, or non-diagnosed participants willing to inject self/someone else (GEP-NET representatives/caregivers). Critical tasks were assessed by asking participants to perform two injections with the new DS into their chosen site on a mannequin. Results of the HF validation study are reported. Formative study-led improvements to the new DS included: ergonomics (larger flanges to improve handling; robust over-cap to improve needle shield removal); robustness of injection process (plunger support); intuitiveness of use (tray to protect the DS and prevent accidental plunger depression; recessed areas to improve handling); needle exposure (white opaque over-cap, improved retractable needle system after injection). The HF validation study comprised US participants (N=35) (including HCPs who did [n=16] or did not [n=19] receive training prior to testing) and German participants (N=33) (including acromegaly representatives [n=15] and GEP-NET representatives/caregivers [n=18]; all received training before testing). Among HCPs, 13 task errors were noted in untrained participants and 3 in trained participants. Among German participants, 18 task errors were noted in acromegaly representatives and 16 in GEP-NET representatives/caregivers. No task errors were specific to the new DS. A new delivery system for lanreotide depot/autogel was developed in conjunction with patients, caregivers and HCPs. It is hoped that the ergonomic, robust and intuitive delivery system will further improve patient care. Sponsored by Ipsen

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