The Landscape of Clinical Trial Data Sharing Initiatives

Transcription

1 2 T R I A L D ES I G N & R EG I S TRAT I O N P A R T I C I P ANT EN R O L L M EN T M E T A D ATA R EG I STRAT I O N EL EM EN TS DATA S H A R I N G P L A N I N D I V I D U A L P A R T I C I PA NT D A T A L AY S UMMA R I ES S U M M A R Y D A T A S UMMA RY- LEV EL R ES U LTS P UB L I C AT I O N P OST- P UB L I C AT I O N DATA P ACKAG E F UL L DATA PACKA GE P OST- R EG UL ATO RY DATA P ACKAG E not int e n d e d t o s u p p o r t r e g u l a t ory a p p l i c a t i o n s and r e g a r d l e s s o f p u b l i c a t i o n t i m i n g r ela tiv e t o s t u d y c o m p l e t i o n, t h o u g h p u b l i c a tion is mos t likely t o o ccur aft e r s t u d y c o m p l e t i o n. o r 18 m o n t h s aft e r s t u d y c o m p l e t i o n, w h i c h e v e r is la t er; 18 m o n t h s aft e r a b a n d o n m e n t o f the p r oduct o r i n d i c a t io n. T his a p p l i e s t o all s t u d i e s int e n d e d and t o s u p p o r t r e g u l a t ory a p p l i c a t i o n s, e v e n if a b a n d o n m e n t o c c u r s p r i o r t o a c t u a l r e g u l a t ory a p p l i c a t io n. YES 5/16/2015 Clinical Trial Life Cycle: When to Share Data IOM Report C L I N I C A L T R I A L M I L E S T ONE The Landscape of Clinical Trial Data Sharing Initiatives 1 2 S TUDY CO M P L ET I O N O R T ER M I N AT I O N 3 4 R E G U L A TO R Y A P P L I C A T I O N? N O 5 B 5 A Ravi Shankar W H E N T O S H A R E WHA T T O S H A R E At t r i a l re g i s t rat i o n 1 2 m o n t h s afte r s t u d y c o m p l e t i o n 6 M o n t h s afte r p u b l i c a t i o n * 1 8 m o n t h s afte r s t u d y c o m p l e t i o n 1 8 m o n t h s aft e r p ro d u c t a b a n d o n m e n t O R 3 0 d a y s aft e r re g u l a t ory a p p r o v al* * Research Scientist Stanford University School of Medicine KEY : * N o l ate r t h an 6 m o n t h s aft e r pu bl i c at i o n a p p l i e s t o all s t u d i e s, w h e t h e r int e n d e d o r ** S h ar i n g the pos t - r e g u l a t ory d a t a pac k age s h ou l d o c cur 3 0 d a y s aft e r a p p r o v a l The push to data transparency is promoting a number of data sharing initiatives by Pharmaceutical companies Government health agencies Non-profit consortiums Pharmaceutical Companies 1

2 EFPIA and PhRMA commit to clinical trials data transparency Data access process that pharmaceutical companies employ Company provides list of trials with data access Researcher selects trials required Researcher submits research proposal Company performs technical review of the proposal Independent Review Board considers request If approved, company provides researcher access to data Researcher discloses research results EFPIA maintains a list of data portals of member companies ClinicalStudyDataRequest.com a mult-sponsor consortium 2

3 A growing number of companies share data at clinicalstudydatarequest.com Step-by-step guide on how to request access to data from different sponsors Search for clinical studies from all sponsors List of studies from the search 3

4 Information on a particular study Select studies of interest and submit a research proposal Sections of the research plan Metrics on research proposals requesting access to patient level data 4

5 Metrics on research proposals requesting access to patient level data cont d List of approved research proposals Further details on a specific proposal The YODA Project 5

6 Data holders partnering in the YODA project Search for available clinical studies from all data holders Medtronic has provided individual participant-level data (IPD) for each of their 17 clinical trials evaluating the efficacy or safety of rhbmp-2. Johnson & Johnson has made available data from 96 clinical trials for pharmaceutical and medical device products, with the goal of expanding in the future to include consumer products. Data request review process Data request review process cont d 6

7 Summary of data requests Details of approved data requests Details of an approved research proposal AbbVie 7

8 AbbVie How to get data access AbbVie clinical trial & data sharing metrics Search for AbbVie studies in ClinicalTrials.gov Once approved, data can be downloaded to the requestor s system. Amgen Amgen How to get access to data Search for Amgen studies in ClinicalTrials.gov Submit research proposal to datasharing@amgen.com The proposal will be reviewed by internal and external review boards. Once approved, data can be downloaded to the requestor s system. 8

9 Biogen Biogen How to get access to data Search for Biogen studies in ClinicalTrials.gov Submit research proposal to WIRB-Copernicus Group (WCG) at The proposal will be reviewed by the data request review committee of WCG. Once approved, data can be downloaded to the requestor s system. Bristol-Myers Squibb Bristol-Myers Squibb How to get access to data Search for BMS studies in ClinicalTrials.gov Submit research proposal at: The proposal will be reviewed by the Duke Clinical Research Institute. Once approved, data can be downloaded to the requestor s system. 9

10 EMD Serono ment_to_responsible_clinical_trial_data_sharing.html EMD Serono How to get access to data Search for EMD Seono studies in ClinicalTrials.gov Submit research proposal via an online submission form. The proposal will be reviewed by an external board. Once approved, data will be available on EMD Serono s server that includes a statistical environment. Merck Merck How to get access to data 10

11 Merck Search for trials that have data access Merck Details of a specific trial 601 clinical trials Novo Nordisk Novo Nordisk How to get access to data Search for Novo Nordisk trials completed after 2001, in Submit research proposal by to irbsecretariat@novonordisk.com. The proposal will be reviewed by an external board. Once approved, data will be available on Novo Nordisk s server that includes a statistical environment. 11

12 Novo Nordisk Search for trials with data access Shire clinical trials Shire How to get access to data Search for Shire trials in Shire Search for trials with data access Submit research proposal by to The proposal will be reviewed by Shire. Once approved, data can be downloaded to the requestor s system. 12

13 Celgene Celgene How to get access to data Search for Celgene studies in ClinicalTrials.gov Once approved, data will be available on Celgene s analysis workspace. Pfizer Pfizer How to get access to data Search for Pfizer trials with data access in sults/ Submit research proposal at The proposal will be reviewed by an independent review panel. Pfizer will provide access to data using a secure portal designed by and hosted by SAS. 13

14 Pfizer Search for trials with data access Pfizer Summary of data requests 300+ clinical trials with data access 300+ clinical trials National Institute of Allergy and Infectious Diseases ImmPort the Immunology Database and Analysis Portal Government Health Agencies 14

15 Data available from many consortiums Collaborative Network for Clinical Research on Immune Tolerance Network Atopic Dermatitis Research Network (ADRN) Clinical Trials in Organ Transplantation (CTOT) Clinical Trials in Organ Transplantation in Children (CTOT-C) Population Genetics Analysis Program Protective Immunity for Special Populations HLA Region Genomics in Immune-mediated Diseases Maintenance of Macaque Specific Pathogen-Free Breeding Colonies Modeling Immunity for Biodefense Reagent Development for Toll-like and other Innate Immune Receptors Adjuvant Development Program Innate Immune Receptors and Adjuvant Discovery Program Human Immunology Project Consortium Non-human Primate Transplantation Tolerance Cooperative Study Group Centers of Excellence for Influenza Research and Surveillance (DMID funded) Vaccine Resource Center (NIAID Intramural) Consortium for Food Allergy Research (CoFAR) Renal and Lung Living Donors Evaluation Study (RELIVE) Accelerating Medicines Partnership, Autoimmune section Gates Foundation (?) March of Dimes (?) ImmPort Registered users can download datasets of a specific trial National Institute of Allergy and Infectious Diseases Immune Tolerance Network (ITN) TrialShare ITN TrialShare Registered users can download datasets of a specific trial 15

16 National Heart, Lung and Blood Institute BioLINCC Biologic Specimen and Data Repository BioLINCC Search for trials with data access BioLINCC Submit requests at the website for accessing datasets of a specific trial National Institute of Diabetes and Digestive and Kidney Diseases NIDDK Central Repository 16

17 NIDDK Repository Search for trials with data access NIDDK Repsitory Submit requests at the website for accessing datasets of a specific trial National Institute of Mental Health NDCT National Database for Clinical Trials related to Mental Illness NDCT Search for trials with data access 17

18 NDCT Submit requests at the website for accessing datasets of a specific trial National Institute on Drug Abuse NIDA Data Share NIDA Search for trials with data access NIDA Download datasets of a specific trial by clicking on the Data Files 18

19 ADCS Alzheimer s Disease Cooperative Study Non-profit Consortiums ADCS How to get access to data Search for ADCS trials in ADCS Search for trials with data access Submit research proposal by to ADCSdataacces@ucsd.edu. The proposal will be reviewed by ADCS Publications Comittee. Once approved, data can be downloaded to the requestor s system. 19

20 PRO-ACT Pooled Resource Open Access ALS Clinical Trials Database PRO-ACT Registered users can download datasets CAMD Coalition Against Major Diseases CAMD A collaboration of private and public institutions 20

21 CODR CAMD Alzheimer s Disease Database Project Data Sphere Project Data Sphere How to get access to data Initiative of CEO Roundtable of Cancer s Life Sciences Consortium. Project DataSphere Search for trials data available for analyses Cancer clinical trial data provided by members of Life Sciences Consortium ( Register to receive broad access to the data. SAS provides analytic tools that researches use to analyze data in Project Data Sphere s workspace. 21

22 isaec International SAE Consortium isaec Data Portal Registered users get access to datasets Sage Bionetworks support open science through public-private partnerships Sage Bionetworks Case Studies 22

23 DREAM Challenges, a non-profit, collaborative community research effort DREAM Challenges From challenges to research to publications Prostate Cancer DREAM Challenge a community research effort with open clinical trials data The Landscape of Clinical Trial Data Sharing Initiatives this is just the beginning 23