This paper is intended to support hand surgeons who, at the beginning of their research career, are planning a clinical study. Besides establishing the research methodology of the study, the organizational planning of the work itself is essential. A feasibility analysis carried out before or during the writing of the study protocol helps to estimate the required resources and duration of a project. We highlight some tips and tricks as well as provide checklists that outline the important points to consider before starting a study.
AkpinarIOhinmaaAThordingL, et al.
The costs of industry-sponsored medical device clinical trials in Alberta. Pharmacoecon Open. 2019,
3: 591–7.
2.
ArumugamAPhillipsLRMooreA, et al.
Patient and public involvement in research: a review of practical resources for young investigators. BMC Rheumatol. 2023,
7: 2.
3.
BeeverDSwabyL.An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units. Trials. 2019,
20: 556.
4.
BertramWMooreAWyldeVGooberman-HillR.Optimising recruitment into trials using an internal pilot. Trials. 2019,
20: 207.
5.
BoeckstynsMEHGiddinsGMealsRTangJB.Publication ethics. J Hand Surg Eur. 2020,
45: 770–4.
6.
BoginV.Lasagna’s law: a dish best served early. Contemp Clin Trials Commun. 2022,
26: 100900.
7.
ChapmanSJSheltonBMahmoodHFitzgeraldJEHarrisonEMBhanguA.Discontinuation and non-publication of surgical randomised controlled trials: observational study. BMJ. 2014,
349: g6870.
8.
CrockerJCPratt-BoydenKHislopJ, et al.
Patient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views, and experiences. Trials. 2019,
20: 119.
9.
CrockerJCRicci-CabelloIParkerA, et al.
Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis. BMJ. 2018,
363: k4738.
10.
DjulbegovicB.Articulating and responding to uncertainties in clinical research. J Med Philos. 2007,
32: 79–98.
11.
International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. 2023. https://www.icmje.org/ (accessed 15 January 2024).
12.
International Organization for Standardization. ISO 14155:2020. Clinical investigation of medical devices for human subjects—Good clinical practice. International Organization for Standardization. 2020. https://www.iso.org/standard/71690.html (accessed 15 January 2024).
LasagnaL.Problems in publication of clinical trial methodology. Clin Pharmacol Ther. 1979,
25: 751–3.
15.
MarksMHerrenD.The future for evidence based data in hand surgery. In: GiddinsGLeblebicioğluG (Eds.) Evidence based data in hand surgery and therapy.
Budapest, Hungary,
Federation of European Societies for Surgery of the Hand Instructional Courses, 2017: 595–605.
16.
MartinLHutchensMHawkinsCRadnovA.How much do clinical trials cost?Nat Rev Drug Discov. 2017,
16: 381–2.
17.
NeumeisterSHagertEChungKC, et al.
Revisions after trapeziometacarpal joint resection arthroplasty: a systematic literature review. Plast Reconstr Surg. 2024. doi: 10.1097/PRS.0000000000011323.
18.
OwyangDBakhshABrewerDBoughtonORCobbJP.Patient and public involvement within orthopaedic research: a systematic review. J Bone Joint Surg Am. 2021,
103: e51.
19.
ShepardSAndersonJMHeigleB, et al.
Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials. J Orthop Surg Res. 2023,
18: 256.
