pISSN 1226-6051
eISSN 2508-786X

Table. 2.

Table. 2.

Summary of open-ended comments on four themes: clarity, applicability, local environmental impact, and adoption time

Theme*KeywordsContents
Appropriateness of the guideline contents
ClarityConceptOverall concept, terminology (region, multiregional clinical trial and multinational clinical trial)
ReadabilityLow readability
SpecificitySpecific examples, design, outcomes, region subpopulation size, each country’s requirement

ApplicabilitySpecificityGeneral contents, specific policy, recommend further discussion with authorities
Domestic circumstanceNot fits to domestic situation, different insurance system, the capacity problem of domestic companies
DefinitionNeed race classification

Perspectives on adopting the guideline
Local environmental impactSpecificityHow to unify the countries request
Domestic circumstanceHard to obey global criteria
ExclusionLow demand, lessen work, lessen manpower
BurdenNeed fund, industrial cost, low commercialize rate
Preparation timeExecutive process, promotion, feedback, application, buffering, guideline publication, pilot-test, regulation acceptance, for grace, gradual adoption, regulation acceptance, education, standardization, review
Sufficient discussionOpinion convergence, modification, for quality of clinical trial, for regulatory acceptance, standardization, about risks, about various aspects
Period for adoptionInternational trendInternational competitiveness, for Korea leadership as developed country of clinical trials, fast deals with outside situation, following other countries direction for less confusion, obeying global standardization
Needs or necessitiesIncreasing number of MRCTs, domestic drug development, more clinical trials, global competition, already implementing, for clinical trial industry growth, clinical trial unify, for domestic drug development
Domestic environmentNeed protection for Korea industry, need to assess the objective level of Korea, assess the appropriateness, considering domestic drug development system

Keywords were identified from the open-ended questions using content analysis

Korean J Clin Pharm 2019;29:267-77 https://doi.org/10.24304/kjcp.2019.29.4.267
© 2019 Korean J Clin Pharm