Requirements to run clinical trials: Research fee calculation, patient consent Kyoung Hwa Ha

Contents What is a cohort study? What’s the process of cohort study?

What is a cohort study? “group of people with defined characteristics who are followed up to determine incidence of, or mortality from, some specific disease, all causes of death, or some other outcome” Source: Morabia A. A History of Epidemiologic Methods and Concepts (2004)

DCCT/EDIC Source: Nathan et al., Diabetes Care 2014;37:9-16 The DCCT was designed to test the glucose hypothesis and determine whether the complications of type 1 diabetes could be prevented or delayed ( ) The EDIC observational follow-up study determined the durability of the DCCT effects on the more-advanced stages of diabetes complications including CVD (1994-present) DCCT : Diabetes Control and Complications Trial; EDIC : Epidemiology of Diabetes Interventions and Complications

KNDP The KNDP was designed to identify evidence based, epidemiologic characteristics of Korean patients with type 2 diabetes mellitus and the factors that affect clinical courses (2006-present) KNDP : Korean National Diabetes Program Source:

CMERC-HI The CMERC-HI was designed to study the known and novel etiologies and related factors for predicting clinical outcomes in Korean patients with high risk CVD (2013-present) CMERC-HI : Cardiovascular and Metabolic disease Etiology Research Center – High risk cohort Source:

What’s the process of cohort study? Recruitment Informed Consent Examination Follow-upIRB Approval

Risks to subjects are minimized. Risks to subjects are reasonable in relation to anticipated benefits. Selection of subjects is equitable. Informed consent will be sought from each perspective subject. Informed consent will be appropriately documented. Data safety monitoring. Adequate provisions to protect the privacy of subjects and maintain the confidentiality of data.

IRB Approval Source:

IRB Approval Source:

IRB Approval Source:

Recruitment Recruitment & Enrollment of participants will involve stages below : 1)an initial contact designed to reach persons in the intended target population, including to identified clinical populations, advertisement in local newspapers, community, and a website; 2)an initial eligibility interview by telephone to determine if interested individuals qualify for the study; 3)for those who qualify on the telephone evaluation; a screening clinic visit at which additional eligibility assessments are preformed; and 4)for those who still qualify after the screening clinic visit, an enrollment clinic visit at which the majority of the baseline data are collected the exams performed. Source: Nevitt et al., Study design protocol - Osteoarthritis Initiative (2006)

Informed Consent Informed consent will be sought for the broadest possible range of future medical research proposals, including the use of biological/genetic markers measured in blood samples and other biomaterials, with full respect of current laws and regulations for human data protection.  Nature of research project  Study procedures  Risks, benefits, and alternatives  Including medical, psychosocial, economic realms  Confidentiality  Voluntary participation assurance  Comprehensible consent forms  Subjects who lack decision-making capacity Source:

Informed Consent

Informed Consent and Selection Bias Source: BMJ 2009;338:b866

Informed Consent and Selection Bias Source: BMJ 2009;338:b866

Informed Consent and Selection Bias Source: BMJ 2009;338:b866

Examination & Follow-up Baseline interviews, questionnaire and examinations will be performed by using a examination protocol. A follow-up will be preformed by using methods below :  Passive surveillance – Hospitals – Disease Registries – Clinics or physician offices – Surveillance systems  Active surveillance – Systematic evaluations for outcome of interest – Regular time intervals – In all study subjects

Thank you for your attention.