Clinical Research From Commitment to Action Lisboa November 9, 2016

Transcription

1 Clinical Research From Commitment to Action Lisboa November 9, 2016 Jeffrey Yachnin MD, PhD Clinical Trials Unit Department of Oncology Karolinska University Hospital Namn Efternamn November 16,

2 sailors with scurvy: 6 treatments 1.1 l cider 25 ml Vitriol (diluted sulphuric acid) 18 mls vinegar (3 times daily) Half liter of seawater Paste mustard seeds, garlic, dried radish root... 2 oranges and 1 lemon for 6 days Namn Efternamn November 16,

3 Number of Drugs in Development Berggren et al Nature Rev Drug Discovery 2012 Namn Efternamn November 16,

4 20 Year Anniversary Clinical Trials Unit Department of Oncology 456 studies 17,000 screened 6,700 patients included Namn Efternamn November 16,

5 Studies Open For Inclusion Studies in Follow-Up Academic Sponsor Patient Inclusion New Studies % As of Oct 1, 2016

6 Clinical Trials Unit Department of Oncology Early Clinical Trials Unit Phase II IV Unit Tissue and blood coordinators Clinical Trials Office Namn Efternamn November 16,

7 Clinical Trials Unit Department of Oncology 1 physician 1 head nurse 17 research nurses 6 employees Clinical Trials Office 2 blood and tissue sample coordinators 1 economist Namn Efternamn November 16,

8 Clinical Trials Unit Department of Oncology Salaries Rent Computers Telephones Cleaning 10% overhead to the hospital Namn Efternamn November 16,

9 Clinical Trials Office Coordination of Studies Applications Database creation and management ecrf Randomization Safety reporting Monitoring Namn Efternamn November 16,

10 Clinical Trials Office Namn Efternamn November 16,

11 Clinical Trials Office Namn Efternamn November 16,

12 Clinical Trials Office Namn Efternamn November 16,

13 Priority Council Section Head Clinical Trials Unit (Chairman) Head Research Nurse Clinical Trials Unit Section Heads from the diagnosis groups Nursing Representative Chairman of the Department of Oncology Representative from Karolinska Institute Representative from Radiation Oncology Namn Efternamn November 16,

14 Priority Council Meeting every 2 weeks Up to 4 studies/meeting 15 minutes/study PI or co-investigator present the proposal Namn Efternamn November 16,

15 Priority Council Scientific value? Resources? Ethics? Competing studies? Study Design? Sub-studies? Namn Efternamn November 16,

16 Value of Clinical Research From which perspective? Patients (now and in the future) Doctors/Nurses/Scientists Health Authorities Pharmaceutical/Medical Technology industries Namn Efternamn November 16,

17 Value of Clinical Research... all clinical trials, including those with academic sponsors, must be fully financed Simple economics... you can`t get a dividend if you don`t make an investment Scot Trial in Colorectal Cancer SOLD Breast Cancer Trial Namn Efternamn November 16,

18 Value of Clinical Research Drug costs for oncology at Karolinska approx. 30 million EUR/year Estimated annual savings from drug costs from clinical trials 2.5 million EUR Namn Efternamn November 16,

19 Three Critical Elements in Implementation Establish geographic infrastructure (physically close) Integration of clinical research Guidelines and standards that apply to all studies Remember its the people not the organisation that are critical Start training younger colleagues distribute PI responsibilities Clinical PIs!!!! Take into account changing social structure Cross-Country Referral Solve problems at grassroots, not political solutions Namn Efternamn November 16,

20 Key Annual Performance Indicators For Clinical Research Number of patients included in clinical trials (10% increase) Number of new clinical trials opened Percentage of academic sponsors Amount of external funding Namn Efternamn November 16,

21 Namn Efternamn November 16,

22 Getting Started With Academic Studies Resource Distribution Big Pharma manufacturing R & D marketing Namn Efternamn November 16,

23 Thank-you Namn Efternamn November 16,