Mads Melbye. Division of Health Surveillance and Research Statens Serum Institut, Copenhagen, Denmark

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1 Mads Melbye Division of Health Surveillance and Research Statens Serum Institut, Copenhagen, Denmark

2 The Danish registries are unique an investment worth billions of Danish kroner follow the individual from birth to grave follow diseases through generations (gene/environment) millions of individuals results are robust PIN-number Birth characteristics Diseases All microbiological diagnoses Prescribed medication Vaccinations Childcare facility history School performance Family, place of living Education, employment Biological specimens

3 Life course epidemiology Birth Exposures Disease Treatment Death Blood specimens (biomarkers, genetic info, functional aspects)

4 Bi obank Dat a PK Sam pl ei D CPR Sam pletype Sam pledat e St oragetemper at u re BiobankSour ce Pr oject Nam e PK Bi obank Data Sam pl ei D CPR Sam pletype Sam pledat e St oragetem per at u re BiobankSour ce Pr ojec t Nam e PK Bi obank Dat a SampleID CPR Sam pletype Sam pledat e St oragetem per at u re BiobankSour c e Pr ojec t Nam e PK Bi obank Dat a Sam pl ei D CPR Sam pletype Sam pledat e St oragetem per at u re BiobankSource Pr oject Nam e PK Bi obank Dat a Sam pl ei D CPR Sam pletype Sam pledat e St oragetem per at u re BiobankSour c e Pr oject Nam e NationalBiobank.DK National Biobank Biobank Register Biobanks Cancer Society: Diet, Cancer, and Health DNA biobank at Rigshospitalet (all referred patients) Patobanken (all pathological specimens) Civil Registration System National registers Danish National Patient Registry Danish Family Relations Database National biobank At SSI Clinical cancer biobanks Danish Medical Birth Registry National Pathology Registry Biobank Data Biobank Registry Internet PK SampleID 6 mill. specimens from 3 mill. Danes CPR SampleType SampleDate StorageTemperature BiobankSource ProjectName 16 mill. specimens from 5 mill. Danes PC PC Coordinating Centre

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8 Research platform Delivery Diseases/pathology Drug use Vaccinations Childcare institutions Family, address Education, job Readmissions Hospital acquiered inf. Days in hospital Health care costs Income Disability insurance PIN number Lab result MR/CT result X-ray Blood pressure Microbiology Haematology DNA Plasma, serum Sample tissue Spinal fluids Urine Amniotic fluids Saliva time

9 Danish Cohort of 101,000 pregnant women and offspring $ 12 mill. US cohort: Science, 11 juli 2003

10 National Drug Pharmacy Prescription registry 1-2 seconds Central computer (Copenhagen)

11 Examples of the kind of information you can obtain CPR-number of recipient Date of filling the prescription Anathomical therapeutic chemical (ATC) code # daily defined doses (DDD Trade name of the drug Pack size, substance Prize Etc. Etc.

12 What kind of research can be undertaken based on the registry Post licensure studies Studies of the long-term use of a particular drug New indications for already licensed drugs Based on drug use define outcomes (i.e. diabetes, allergy, etc.) Draw back: We only know that they received the medication not whether they took it

13 Examples on pharmacological studies from our group Acyclovir, valacyclovir, famciclovir in pregnancy and risk of adverse outcomes (JAMA 2010) Protom pump inhibitors in pregnancy and risk of adverse outcomes (NEJM 2010) Angiotensin receptor blockers (ARB) and risk of cancer (Circulation 2011) Digoxin and risk of breast cancer (J Clin Oncol 2011) Newer-generation antiepileptic drugs: risk of major birth defects (JAMA 2011) Antibiotic use and inflammatory bowel diseases in childhood (GUT 2011) Use of calcium channel blockers and Parkinson's disease (AJE 2012) Association of treatment with losartan vs candesartan and mortality among patients with heart failure (JAMA 2012) Varenicline and Risk of Serious Cardiovascular Events (BMJ 2013) Use of Azithromycin and Cardiovascular Death (NEJM 2013) Ondansetron Use in Pregnancy and Risk of Adverse Fetal Outcomes (NEJM 2013) Fluconazole during Pregnancy and Risk of Major Birth Defects (NEJM 2013) XXX (embargo) Use in Pregnancy and Risk of Autism in Childhood (NEJM 2013) XXX (embargo) in Pregnancy and Risk of Major Congenital Malformations and Fetal Death (JAMA 2013)

14 Use of Macrolides in mother and child and risk of pyloric stenosis

15 Sick Personalized medicine Drugs Sick Healthy Genetic analysis Biobank specimen

16 Data access and collaboration How do I get access? Identify Danish research milieu Spend time there setting up your study Stay there or go home and work on your dataset (Citrix) Read more: Mads Melbye: mme@ssi.dk