Clinical Trial Framework in Denmark Alejandra Mørk November 2013
CLINICAL TRIAL FRAMEWORK IN DENMARK Access to high quality clinical sites and clinical trial competence Efficient approval process for clinical trial applications Import of investigational drugs to the EU Medical Devices Clinical investigations meeting ISO standards Import of investigational drugs to the EU 2
CRO CONTEXT IN DENMARK COMPANIES SELECTION COUNTRIES SITES DENMARK DANISH CROs DANISH SUBSIDIARIES OF INTERNATIONAL PHARMA 3
CRO CONTEXT IN DENMARK DENMARK INTERNATIONAL CRO S SELECTION COUNTRIES SITES DANISH CROs DANISH SUBSIDIARIES OF INTERNATIONAL CROs 4
CRO CONTEXT IN DENMARK DENMARK FEASIBILITY PROPOSAL AND QUOTATION CONDUCT OF STUDY AT DANISH SITE DANISH CROs DANISH SUBSIDIARIES OF INTERNATIONAL CROs 5
FEASIBITLITY: WHY ARE SITES IN DENMARK ATTRACTIVE? SITES WITH RELEVANT PROCEDURES RELIABLE INFORMATION ABOUT NUMBER OF PATIENTS AND ACCESS TO PATIENTS DENMARK NUMBER OF SITES AND PATIENTS TRACK RECORD FOR SITE AND FOR INVESTIGATORS RESPONSE TIME ON FEASIBILITY TIME FOR APPROVAL BY CA AND EC DANISH CROs DANISH SUBSIDIARIES OF INTERNATIONAL CROs INVESTIGATOR AND HOSPITAL FEEs COMPLEXITY AS TO SITE AND INVESTIGATOR AGREEMENTS 6
HIGH QUALITY CLINICAL SITES AND CLINICAL TRIAL COMPETENCE Internationally acknowledged scientific competence Scientific publications per inhabitant second in Europe - after Switzerland* Quotations: Second in Europe - after Switzerland Denmark is especially strong within the clinical research area * Pharmaceutical research specifically 7
HIGH QUALITY CLINICAL SITES AND CLINICAL TRIAL COMPETENCE Clinical Research In 2010, doctors and companies commenced a total of 452 clinical trials in Denmark. The following lists the 10 diagnostic groups most frequently investigated under these clinical trials: Condition category Number of studies in 2010 Cardiovascular diseases 66 Cancer 55 Diabetes 38 Pain 32 Gastrointestinal diseases 25 Respiratory tract (lung and bronchial) diseases 15 Skin diseases 14 Viral diseases 14 Rheumatic diseases 14 CNS diseases 13 8
HIGH QUALITY CLINICAL SITES Clinical Research Distribution of the number of drug trials and number of trial subjects on therapeutic areas (2011) Oncology Metabolism and nutrition Surgical Cardiovascular 9
HIGH QUALITY CLINICAL SITES AND CLINICAL TRIAL COMPETENCE Predictable recruitment Tracking of patients Database/Registry National Patient Registry (Landspatientregistret) Registry for Cause of Death (Dødsårsagsregistret) Cancer registry (Cancerregisteret) Contains information on All diagnosis, surgery procedures for all patients dismissed from hospital departments Cause, time and location of death All persons diagnosed with cancer (diagnosis, time, location) Strong infrastructure Patients generally motivated for participation Registries National Patient Registry Cause of Death Registry Danish Cancer Registry Healthcare workforce mobility registry Child health database Danish National Diabetes Registry Registry of Legally Induced Abortions Medical Licences Registry Central Office of Civil Registration DUSAS (Danish patients treated at foreign hospitals and activities in specialist practice) Danish Medical Birth Registry Rehabilitation IVF registry Municipal health schemes Registry of Congenital Malformations National alcoholism rehabilitation registry National pathology registry National military service registry Registry of substance abusers undergoing Rehabilitation National health insurance registry Compulsory psychiatric admission Human tissue utilisation registry Registry of healthcare providers Pharmaceutical statistics registry 10
EASY ACCESS TO COMPETENT CLINICAL SITES AND INVESTIGATORS Hospitals across Denmark have over the last 3 years worked together to establish ONE ENTRANCE - to ease the access and provide guidance for assessing the possibilities for conducting clinical studies at Danish hospitals This is a service not a limitation; One can still contact hospitals and investigators directly 11
EASY ACCESS TO COMPETENT CLINICAL SITES AND INVESTIGATORS One point of entrance - a co-ordinated service covering all hospitals in Denmark - advice to relevant clinical sites - advice to relevant investigators including contact details Guidance and facilitation of agreements with hospitals and investigators - same contract for all sites 12
EASY ACCESS TO COMPETENT CLINICAL SITES AND INVESTIGATORS Feasibility of individual clinical trials - access to patients - inclusion/exclusion criteria - clinical practice Recruitment - Portal for recruitment of patients will be available from September 2013: www.sundhed.dk 13
FEASIBITLITY: WHY ARE SITES IN DENMARK ATTRACTIVE? It would be helpful with updated information from Danske Regioner demonstrating commitments and providing updated documentation 14
PROPOSAL AND QUOTATION Denmark perceived as an expensive country Demonstrate that we are effective - More sites and patients relative to population - Investigators with good reputation - Predictable recruitment - Low rate of queries - Flexible and supportive hospital organisation and management 15
ÉN INDGANG Tanken om én indgang er rigtig fin, men i praksis hos CROer kan det give den udfordring, at de enkelte sponsorer gerne vil have, at man går direkte ud til bestemte KOLer og IKKE nødvendigvis én indgang. At forklare Set Up et om Én indgang til Sponsor koster tid, og med de korte frister vi kan have for at indsamle respons på Feasibilities, kan det være DK mister muligheden for at komme med som land. Skal Én indgang fungere optimalt, er det afgørende, at der besvares på de feasibilities, som vi kommer med. Vi skal på vegne af sponsor indhente konfidentialitetserklæringer (CDA) fra dem som vi diskuterer et potentiel studie med. Dvs. skal Én indgang involveres, så er vi nødt til at indhente denne fra dem også rent praktisk ved jeg ikke, hvordan vi skal løse dette. Da sponsor har outsourcet IP gaven til os og vi egentlig outsourcer den videre. Et andet spm.: Er nok at henvende sig til en af kontakterne i Én indgang med en forespørgsel, og denne person så sender videre til de andre regionskontakter, eller skal man kopiere alle regionskontakterne ind? Og igen her vil det næste spm. så være hvordan CDA problematikken skal løses? 16
ÉN INDGANG Helt generelt mht CRO-landskabet ser jeg det mere som en samlet udfordring for både pharma og CRO at bibringe mere forretning/klinisk afprøvning til Danmark. I den henseende er vi alle i samme båd eftersom vi alle (både CROer, forskningsvirksomheder og datterselskaber) bør stå fælles front mht., at vi alle har en interesse i at trække mere klinisk afprøvning til Danmark, og at vi også samlet set vil nyde godt af at opfylde dette mål. Nogle flere selling points: - Korte behandlingstider hos EC og Sundhedsstyrelsen - Mere prestige omkring klinisk forskning på hospitalsafdelingerne - Større anstrengelser for at få de tidlige faser til Danmark vi har alle en interesse i at få en større bredde på forskningen i DK; dvs. flere speciale-studier/mere videnskabeligt interessante projekter/små og relativt sjældne patientgrupper/orphan drugs etc. klinisk afprøvning tænkt ind i bygningen af de nye super sygehuse osv. Jeg ved at dette ikke addresserer noget specifikt omkring CRO-landskabet, men jeg ser som sagt, at vi i højere grad har en fælles udfordring, det være sig som CRO, forskende virksomhed i DK eller pharma datterselskab. 17
STRONG TRACK RECORD KEEP TIMELINES GOOD QUALITY OF DATA COMPETENCE FLEXIBILITY AVAILABILITY GOOD SPIRIT IN THE COLLABORATION 18