coordination centre for clinical trials (kks)tasks assumed by kks * only projects with contracted...
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Coordination Centre for
Clinical Trials (KKS)
Structures and Functions
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2
Support provided by KKS
• Academic, non commercial trials
• Support of all aspects of clinical research
– Sustainable, quality-assured study projects
• Optional services
– For members of the University Hospital and for others
• Independence from University departments
– No own academic ambitions
• Cost recovery
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01.2014 (FTE / Function)
Head (1)
Administration (2)
HR (0,5)
Scientific PM (5,5)
IT (3)
Pharmaco- vigilance (3,5)
Biometrics (1)
Training (1)
Clinical Monitoring
(12,9)
Site Management
(1,5)
Data- Management
(4,5)
IEC / CA Procedures
(0,5)
Cooperations: FIM HD - First in Men Heidelberg; joint unit with different
clinical partners
IMBI Institute for Medical Statistics and Informatics
NCT National Centre for Cancer
SDGC Study Centre of German Society for Surgery; joint unit with Dept. Of Surgery
SpoQS sponsor Quality Management (2) by order of the Medical Faculty
QM (1,5)
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Personnel Development
5
13 15 15 15
18 20
23
27 29
39 39
42
45
3
10 11 12 12
15 17
20
24 26
33 33
36
39
0
5
10
15
20
25
30
35
40
45
50
Personen [n]
FTE [n]
2000 2005 2010 2013
Headcounts
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Output Figures
* only projects with contracted KKS-participation are considered
overall 238 studies since 2000
Active Studies Ø Tasks/ Project [n] Projects [n]
7 15
27
37 45
59 58 64
75
89 88 93
99 100
2,1 1,6
1,7
2,0 2,1 2,2 2,3 2,7 2,8 2,9 3,0 3,0 3,1 3,1
0
1
2
3
4
5
6
7
8
9
10
0
20
40
60
80
100
120
2000 2005 2010
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Output Figures
* only projects with contracted KKS-participation are considered
Legal Framework 2013*
AMG = Arzneimittelgesetz (German Drug Law), MPG = Medizinproduktegesetz (German Medical Device
Law), BtMG = Betäubungsmittelgesetz (Narcotics Law), BFS = Bundesamt für Strahlenschutz (German
Federal Office for Radiation Protection), FREI = Not regulated by specific law
157
27
1 9
62 64
6 3
34
0
20
40
60
80
100
120
140
160
180
AMG MPG BtMG BFS FREI
2000ff
2013
[n]
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Output Figures
Tasks Assumed by KKS
* only projects with contracted KKS-participation are considered
PM = Project Management MO = Clinical Monitoring
SN = Study Nurse Activities BM = Biometry
DM = Data Management QA = Quality Assurance
PV = Pharmacovigilance
49
60
19
30
35
7
21 16
60
75
3
38
47
11
43
35
0%
10%
20%
30%
40%
50%
60%
70%
80%
PM MO SN BM DM QA PV IT
Aufgaben / Anzahl aller Projekte seit 2000
Aufgaben / Anzahl aller Projekte in 2013
Tasks / Studies since 2000
Tasks / Studies in 2012
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Output Figures
Funding
57%
24%
19%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2000 2005 2010
Industrie IIT mit Industriebet. IIT Industry IIT supp. by Industry IIT/ academic
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Consultations
Output Figures
Expenditure 2013 • N=237
• ∑ 312 h, Ø 1.3 h,
Several staff members (BM, PM,
IT, QA etc.) involved, when
necessary
• Specific services, such as
providing templates, etc.
Compensation • Generally free of charge
Contents • General
– AMG, insurance, etc.
• Project-related
10
40
67 67 57
73
143 149
176 176 165 162
226 237
0
50
100
150
200
250
2000 2005 2010
[n]
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Output Figures
Training Offers
4 5 11
9 9 12
15 25
33 31
34
36
47
106 136
304
516
231 287
373
488
779 790
909 856
1189
0
200
400
600
800
1000
1200
1400
0
5
10
15
20
25
30
35
40
45
50
2000 2005 2010
Courses [n] Participants [n]
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Personnel Development
Personnel
Growth through
• Extension of existing tasks
• New tasks
• More comprehensive projects
Competence through
• Long-term employment
• Structured initial training and
professional development
• Internal and external further
education
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Funding Shares
Finances
0%
20%
40%
60%
80%
100%
2000 2005 2010
BMBF-FundingOverhead
Faculty
Third Part Funds
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Grant Applications negative [n]
Next step
positive
in review
Status 29.05.2013
4 5 6
11
5
10
3 4
2 4 1
3
5
1
5
8
1
17 15
13 18
18
31
10
9
0
5
10
15
20
25
30
35
40
45
2006 2007 2008 2009 2010 2011 2012 2013 2014
abgelehnt
eingereicht
weitere Stufe erreicht
gefördert
21 21 22
25
32
41
[n]
21
26
submitted
next level
sponsored
refused
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Safety Reports
24
74
238
368
343
13
131
233
377
2 7 12 23
10
0
50
100
150
200
250
300
350
400
2009 2010 2011 2012 2013
SAE
Follow Up
SUSAR
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Clinical Monitoring / CRA
• (on-site) support and monitoring of clinical trials
– Adding to competence of investigators and
coordinating investigators (LKPs)
– Continuous quality control, adapted to each study
and risk assessment
Objective
– Support of trial site
– Protection of trial subjects
– Best data quality and integrity
– Compliance with protocol and regulatory
requirements
KKS Services
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Scientific Study Support / PM
• Unbureaucratic, confidential project consultation
• Study design and trial protocol development
• Project management
– Ethics, regulatory affairs, (drug) safety
• Broad experience, independent of indication
– AMG, MPG, non-AMG/ non-MPG, RöV, StrV, etc.
– Comprehensive templates
• Document review
• Submission procedure to DFG, BMBF, EU etc.
• Consultation regarding research structure and
contracts
KKS Services
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Site Management Organization (SMO)
• On-site support of the clinical trial
– Scheduling of patient visits, conduct, documentation
– Sample logistics
– Preparation/ support of visits of (external) monitors
and auditors
– Updating of central documents (ISF)
Objective
– Well-planned and timely executed clinical trials
– Relief of medical personnel
KKS Services
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Biometry
• Conceptual consultation
– Study design, sample size, etc.
• Biometric parts of the protocol
• Randomization procedures
• Statistical Analysis Plan, analyses
– Sensitivity analyses for model assumptions and
missing values
• Participation in the integrated final report
KKS Services
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Data Management
• Implementation of the clinical trial protocol
– Variable lists
– Case Report Forms (paper based, RDE)
• Data entry masks
– Development, validation and data entry
– Training for RDE systems
• Data Validation Plan (DVP)
– Incl. query tracking
• Central randomization
• Support for the analysis
KKS Services
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Quality Management
• SOP system – Development, refinement and maintenance
– Staff Training (incl. documentation)
– Harmonized with the KKS Network and the TMF (Telematic Platform for Medical Research)
• Improvement of the staff's professional skills – On-the-job training and development plans
– Internal and external training
• Consultancy services for trial centers
• QA review of essential documents
• Internal Audits
KKS Services
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IT Services
• Validated systems for – Primary data entry in electronic format (RDE)
– Data management
– Statistical analyses
• Processes defined in SOPs
• Conceptual tasks regarding „IT-landscape“
Clinical Research in Heidelberg
KKS Services
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Pharmacovigilance
Main Tasks • Workflow Definition
(Safety Manual)
• Preparation of study-specific data base
• SAE Management
• Follow-up of SAEs (obtaining of missing information)
• SUSAR Reporting to CA, IEC and study sites
• Preparation of Development Safety Update Reports (DSUR)
KKS Services
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Training
• Continual training offers – Impart practical knowledge
– Qualification of attendees
– Improvement of training situation in clinical research
• Curricula of several days or weeks for – Investigators
– Study Nurses
– Clinical Monitors
• Topical lectures and training – E.g. on recent amendment to the German Drug Law, drug
safety, sponsor‘s role
• Lecture Series on Clinical Trials – Continual education as required by ICH GCP
KKS Services
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Compulsory Consultation
• Support the principal/coordinating investigator (LKP) in
1. Designing clinical trials in compliance with German Drug Law,
GCP Ordinance, data protection law, etc.
2. Completely define the responsibilities associated with
the clinical trial
3. Avoiding funding shortfall
• Protection of the faculty‘s interests
Indirect
• Synergetic effects for parallel projects
• Enhancement of the reputation and competitiveness of
clinical research
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Supervision of the Sponsor‘s Activities
Coordinating
Investigator
(LKP according AMG)
IEC
KKS Approval;
IEC Application
Administration/
Legal Department
KKS
Contracts Interchange
According to the Medical Faculty Executive Committee Resolution since 2007
2. Internal
Audit
1. Compulsory
Consultation
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Auditing
• Support for external audits and inspections
• Recommendations for corrective actions
• Audits on behalf of Medical Faculty
– Focus: trials regulated by the German Drug Law
with principal/coordinating investigator in
Heidelberg
– Supervision of the sponsor‘s activities
KKS Services
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FIM Heidelberg
First in Man Studies ...
• „One stop shopping“ strategy (planing, conducting and reporting)
• Multidisciplinary
– KLIPS (Phase I Study Site on Clinical Pharmacology)
– KKS (Coordination Centre for Clinical Trials)
– IMBI (Medical Biometrics and Statistics)
– NCT, DKFZ (pre- and clinical oncology)
– Further clinical partners
• Contact http://fim-hd.kks-hd.de
Email: [email protected]
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National
•
• SDGC, Chir-Net
• TMF (German meta-organisation for networked medical research)
• Competence Networks
International
• European network
(Inter)national Activities
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Interaction with funding organisations, currently regarding
• Pay scale grouping in grant applications – TV-Ä*, TV-L#
• Applicability of GCP in psychotherapy trials
• Financing plans for clinical trials – Overhead costs, full costs
• Review process and statement for grant notification – E.g. Integrated Research and Treatment Centers (IFB):
43 applications, only 3 accepted, reasons?
Exchange with ministries
• Comments on draft laws – Currently: German Radiation Protection Ordinance, X-Ray Ordinance,
Drug Guidelines (AMR)
*Sector pay scale for University Hospitals # Public Sector Collective Agreement on Länder
Activities
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Coordination Centre for
Clinical Trials (KKS)
Head Steffen P. Luntz, MD
Voßstr. 2/ Building # 4410
69115 Heidelberg
Tel.: +49 (0) 6221 / 56-34502
Fax: +49 (0) 6221 / 56-1331
www.kks-hd.de
Contact