1. Georgetown University Medical Center
Adaptive Design Scientific Working Group (ADSWG) and Collaboration Opportunities
Robert A. Beckman, MD
Chair, ADWSG
Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics
Georgetown University Medical Center

2. ADSWG
Membership: approximately 200+ members from pharma, biotech, academia, and health authorities in the US, Europe, and Japan

3. ADSWG Vision/Mission Statement
DIA Adaptive Design Scientific Working Group
ADSWG Vision/Mission Statement
Vision: Ensure that innovative designs including adaptive designs, when applied appropriately, are well recognized and broadly utilized to improve drug development and global health initiatives for the benefit of patients around the world.
Mission:
To facilitate the understanding, adoption, and appropriate use of innovative designs of different levels of complexity and contribute to progress in methodology by:
Creating a scientific forum for the discussion and development of innovative designs, their analysis and implementation
Providing education on and promoting the dissemination of methods and best practices by writing white papers and publications, and sharing experiences.
To engage in dialogue and advocacy efforts with industry leaders, the scientific community and regulators to facilitate world-wide utilization of innovative designs
To foster diversity in membership and leadership across:
Geographical locations
Institutions (e.g. academia, government, industry)
Areas of expertise (e.g. statistics, medicine, pharmacometrics, operations)

4. Organizational: 2018 Updates
Leadership
Bob Beckman, Georgetown, Chair
Cristiana Mayer, Janssen, Vice Chair
Zoran Antonijevic, Z-Adaptive Designs, Past chair
Yi Liu, Nektar, and Rui Tang, Shire, secretaries
Thanks to Sandeep Menon, Pfizer, for service as vice chair
Activities
Presentations and publications from working subgroups
Annual F2F, usually at JSM
Periodic update meetings of subteam leads and team leadership to be reinstituted

5. Yi Liu Director, Nektar Theapeutics
8 years in Takeda leading methodology group
PhD of Statistics from The Ohio State University
Research interest: innovative and efficient trial designs for early phases as well as late phases including adaptive randomization, sample size re-estimation, seamless phase II/III designs; problems with efficacy measure in the presence of subgroups; and non-proportional hazard issues for time-to-event endpoint
I like to play ErHu- Chinese violin in my spare time

6. Rui (Sammi ) Tang DIA (Drug Information Association)
The Biostatistics Team Leader for multiple TAs : Oncology, Transplants, Ophthalmology and Complications of Prematurity (CoP), Shire pharmaceutical.
Sammi’s research interests are primarily in the area of adaptive clinical trial design and biomarker subgroup related statistical issues in precision medicine. She has authored more than 20 articles in peer-reviewed scientific journals on methodology, study design, and data analysis and reporting and is a co-inventor of several patents.
DIA (Drug Information Association)
Leading team: small population rare disease work stream NEED current
SCT (Society of Clinical Trials) Program committee and membership committee 2014-current
ICSA (International Chinese Statistical Association) Organizing committee 2016-current
APBC (Asian Pacific Bioinformatics Conference) program committee local organizer
Co-founder and Vice Present of DahShu, a non-profit organization to promote Data Sciences current

7. Cristiana Mayer
Director of biostatistics in infectious diseases therapeutic area at Janssen R&D
Co-Lead of the DIA ADSWG Simulation Report subteam
Head of the Adaptive Clinical Trials Center of Excellence at Janssen R&D, JNJ
20 years at Johnson & Johnson
Worked in 6 different TAs in both “clinical statistics” and “statistical modeling and methodology” groups
Originally from Italy … Ciao 

8. Working Subgroups (Leaders)
Adaptive dosing (ADONIS) (Norris/Mould/Karnoub);
Expedited Approvals (Campbell, Gould (BSWG)) (accepting new members and future leader by succession planning)
Global Health (new)---(Thorlund, Meng)----needs new members
KOL Lecture Series (Bai, Loewy, needs additional membership)
Medical Outreach (Bray (BSWG); Wenkert initiating ADSWG focus, needs more ADSWG members)
Simulation report (Mayer, Perevozskaya)
Small populations (Chen, Beckman)
Alpha allocation (Chen). Closed to new members
Master Protocols (Amit/Redman). Closed to new members
Nature and Extent of Evidence Needed for Rare Diseases (NEED) (Tang, Ghadessi, Zhou)
Pathway Design (Chen). Closed to new members.
Predictive Biomarker Subgroup Methodologies (Burman, Koenig, Posch).
Survey (drugs) (Hartford, Morgan; needs new leadership by 2019)
Survey (devices) (Thomann, LaLonde, BSWG, needs ADSWG members)
Website (Pritchett, Loewy; needs additional membership)

9. Expedited Approvals Team Objectives
ADSWG-BSWG Expedited Approvals Subteam Co-leads: Bob Campbell (ADSWG) and Larry Gould (BSWG)
WG initiation
Launched as Medicines Adaptive Pathways to Patients [MAPPs] subteam in January 2016
First focus was co-authoring contributions for article on linking platform trials (PIPELINES paper)
Renamed as Expedited Approvals Subteam to reflect scope beyond European MAPPs initiative.
Expedited Approvals Team Objectives
Develop and publish on statistical approaches for evidence generation relevant to Expedited Approvals and other novel development approaches across product life cycles.
Establish and promote the role for Bayesian statistics and Adaptive Design as key drivers of Expedited Approvals
Engage in the subteam patient advocacy, payer, and medical reviewer perspectives
Facilitate visibility and networking among teams and initiatives working on different aspects of efficient and ethical drug development challenge
Subteam members (in alphabetical order):
Zoran Antonijevic, MTEK Sciences
Matt Austin, Amgen
Robert Beckman, Georgetown University
Carl-Frederich Burman, Astra-Zeneca
Robert Campbell, Brown Univ (co-lead)
Cong Chen, Merck
Jennifer Clark, FDA
Jyotirmoy Dey, Abbvie
Vladimir Dragalin, Johnson & Johnson
Larry Gould, Merck (co-lead)
Qi Jiang, Amgen
John Loewy, Data ForeThought
Sandeep Menon, Pfizer
Eva Miller,
David Norris,
Nitin Patel, Cytel
Martin Posch, Medical University of Vienna
Rui Tang, Shire
Kiichrio Toyoizumi, Shionogi
Joey Zhou,
Current project
A framework for modeling impacts of FDA Accelerated Approvals on patients
Initial draft reviewed and discussed in May 2018
Team members to provide contributions/revisions for September 2018
Subteam to meet in Q3 to decide on steps to finalize this manuscript
Publication targeted in 2019

10. Team Charter: ADSWG Adaptive Dose (N-of-1) Individualization Subteam (“ADONIS”)
ADONIS initiation
Founded at JSM 2017 by David Norris
Diane Mould initially co-chaired, spurring membership growth esp. in pharmacometrics
Maha Karnoub took on Diane Mould’s duties as co-chair in Jan 2018
Our work is coordinated on the Open Science Framework (OSF)
ADONIS Members
Members (in alphabetical order):
Mariam Ahmed, FDA
Hesham Al-Sallami, U. of Otago
Kyounghwa Bae, Janssen R&D
Dean Bottino, Takeda
Daniela Conrado, C-Path
Immanuel Freedman, Freedman Patent
Vijay Ivaturi, U. Maryland
Maha Karnoub (Co-chair), Celgene
Jeffrey Kaufman, Adenoid Cystic Carcinoma Research Foundation
Alan Maloney, Independent Consultant
James McGree, Queensland University of Technology
Diane Mould, Projections Research
Hussein Mulla, University of Leicester
David Norris (Co-chair), Precision Methodologies, LLC
Joel Owen, Cognigen
Rui Qin, Janssen
Karl Schwartz, Patients Against Lymphoma
Camille Vong, Pfizer
Ling Wang, Pfizer
ADONIS Objectives
We bring together researchers and leaders from industry, academia, the regulatory sphere and the clinic—including patients and advocates—to advance a practical science of Adaptive Dose Individualization (ADI)
We foster the organic development of member-driven initiatives.
We welcome members wanting to shape a pragmatic agenda for the Subteam, to pursue meaningful progress in an area where this has been demonstrably lacking.

11. ADONIS: Updates as of July 2018
Successful submission of JSM2018 Panel Session
Steady membership growth to N=18, now representing:
Biostats, Pharmacometrics, Patient Advocacy
Pharma, CROs, Academia, Nonprofits
Engagement around issues including
Projects initiated & ongoing:
Informed consent for ADI trials
Phase I ethics
Priorities for Year 2:
Expand membership to include Bioethicists and other fresh perspectives
External presentation & scholarly publication of ongoing efforts
Foster new efforts by members

12. KOL Lecture Series (Bai, Loewy)
10 monthly lectures arranged this year (all except August and September)
Lectures heavily attended to capacity of conference line
New people needed to help with this demanding activity

13. Team Charter: ADSWG Simulation Report (SimRep) Subteam
WG initiation
ADSWG has re-instated a Simulation Report Subteam (SimRep) team with new core members in September 2015
Most of previous co-authors of the 2010 draft paper on the simulation report joined the re-established team in January 2016
SimRep Objectives
To facilitate the selection of most appropriate adaptive designs and the development of complete documentation by
Creating a unifying framework for the development of a simulation report for industry
Ensuring a consistently complete plan of simulation studies and transparent reporting of simulation results to support plans for implementation and trial conduct
Facilitating the communications with regulatory agencies around the operational characteristics of the AD designs
Sharing examples of simulation reports including specific selected types of AD
Communicating paper and ADSWG recommendations with possibly some lessons learned to the scientific community
SimRep Members
Members (in alphabetical order):
Alun Bedding, Roche
Greg Cicconetti, AbbVie
Vladimir Dragalin, Janssen R&D
Parvin Fardipour, ICON
Alan Hartford, AbbVie
Sergei Leonov, ICON
Cristiana Mayer (Co-lead), Janssen R&D
Inna Perevozskaya (Co-lead), GSK
Yili Pritchett, Astellas
Annie Lin (FDA CBER)
Jessica Hu (FDA CBER)
Jingjing Ye, FDA CDER

14. SimRep Subteam: Updates as of July 2018
Target Journal is SBR
Final manuscript submitted at the end of December 2017
Peer reviewers’ comments received on July 1, 2018
Subteam to meet and address comments for prompt revision of the manuscript
Publication targeted in early 2019

15. Small Populations (57 members, has subgroups)
Mission:
The group studies clinical trial designs, analysis methodologies, and development strategies relevant to small populations with emphasis on proof of concept and registrational studies. Small populations include those corresponding to rare diseases, but also biomarker-defined subgroups of common diseases, especially cancer.

16. Subgroups Adaptive Alpha Allocation (Cong Chen)
Master Protocols (Amit, Redman)
Nature and Extent of Evidence Required for Decision in Small Populations (NEED) (Rui Tang, Mercedeh Ghadessi, Joey Zhou)
Pathway Design (Cong Chen)
Predictive Biomarker Subgroup Methodologies (Burman, Posch)

17. Small Populations Projects/Goals (Ongoing)
Adaptive alpha allocation:
Informational design
Informational design applied to rare diseases
Optimal alpha allocation between full population and subgroup
Master protocols:
Master protocols in the exploratory and the confirmatory setting.
Randomization methods for patients positive for multiple subgroup markers
Concurrent vs shared vs historical controls in master protocols

18. Small Populations Projects/Goals (II)
Nature and Extent of Evidence for Decision (NEED)
Characterize issues/problems with rare disease development and review recent approvals (done)
Investigate how historical controls can be acceptably used for confirmatory studies in the context of rare disease (ongoing)
Investigate the use of the informational design to adaptively choose a pivotal endpoint in the context of rare diseases (ongoing)
Pathway Design:
Confirmatory basket trial design
PIPELINES: linked systems of platform trials (in collaboration with Expedited Approvals Group)
Predictive Subgroup Methodologies:
Application of decision analysis to optimization of phase 3 programs
Consideration of decision analysis with utility functions from different stakeholders
Consideration of clinical significance of findings

19. Team Charter: ADSWG Nature and Extent of Evidence Needed for Rare Diseases (NEED) Subteam
WG initiation
ADSWG has re-instated a NEED team with new core members in early 2017
Active discussions since then for historical control in rare disease bi-monthly
Currently in final stage of summarization recommendation in publication
NEED Objectives
Characterize issues/problems with rare disease development and review recent approvals (done)
investigate how historical control can be used in the context of rare disease including but not limited to confirmatory trial (ongoing)
Investigate the use of the informational design to adaptively choose a pivotal endpoint in the context of rare diseases
NEED Members
Members (no particular order):
Chaoqun Mei, University of Wisconsin-Madison
Lixia Zhang, BERG health
Chenkun Wang, Vertex
ChunQin(C.Q.) Deng, United Therapeutics Corp
Kiichiro Toyoizumi, Shionogi Inc.
Jeffrey Schwartz, Pfizer
Mercedeh Ghadessi (Co-lead), Bayer
Rong Liu, Bayer
Rui (Sammi Tang) (Co-lead) , Shire
Joey Zhou (Co-lead), Q2BI
Robert O'Neill (Advisor) , FDA
Robert Beckman, Georgetown University

20. NEED Subteam: Updates as of July 2018
Comprehensively investigated how historical controls can be acceptably used for confirmatory studies in the context of rare disease, providing guidance on data collection standardization, statistical methodology, study design, as well as process flow charts
Refining the paper with team comments 3rd round review
Sending to some experts for review
Discussion for target Journal
Targeting Final manuscript/white paper submission by end of 2018
Presenting in DIA forum or other statistical meetings

21. Resource Needs: Notes / Issues
Subteam: Drugs & Biologics Survey Subteam Chair: Alan Hartford Co Chair: Caroline Morgan
Subteam Objectives
To gather information on the perception and use of adaptive designs for clinical development programs in the drugs and biologics industry and academia, in order to identify any persistent barriers to implementing such designs and provide recommendations to overcome these challenges.
Participants
Alan Hartford
Caroline Morgan
Li Chen
Alun Bedding
Lingyun Liu
Silke Jörgens
Mitch Thomann
Xiaotian Chen
Eva Miller
Liaison for survey team working on devices:
Fanni Natanegara
Subteam Deliverables
Industry survey sent out June 2016 – Sep 2016
Initial analysis of survey results Feb 2017
Registry Review completed March 2017
Literature review completed April 2017
Manuscript submitted to TIRS July 2018
JSM 2017 session organized and chaired by Eva Miller with speakers Alan Hartford, Mitch Thomann, Xiaotian Chen, Lingyun Liu, and Alun Bedding
ASA BIOP Reg-Ind Stats Workshop 2017 session organized by Eva Miller, Mitch Thomann, Xin Fang (FDA), Sherry Liu (FDA) and chaired by Eva Miller with speakers Alan Hartford, Min Lin (FDA), Xiting Yang (FDA), discussant Caroline Morgan
KOL Lecture Series on ADs, Silke Jörgens, March 2018
SCT 39th Annual Meeting, session organized by Li Chen with Eva Miller as speaker
Resource Needs: Notes / Issues
Survey distribution – SurveyMonkey (ASA Biopharm Section provided their Gold membership for SurveyMonkey access)
Meeting Schedule
Were approximately bi-weekly meetings (up until manuscript was in team review)
DIA: Adaptive Design Scientific Working Group

22. Some ADSWG Presentations
Numerous; I have only a partial record of the Small Populations Subgroup Presentations:
DIA Annual Meeting, , 2018 (Janet Li, Master Protocols Subteam)
Trends and Innovations in Clinical Trial Statistics, 2014, 2016 (Quintiles, University of North Carolina)
Symposium on Small Populations, Medical University of Vienna, 2014
DIA/International Association for Bayesian Analysis Joint Adaptive Design and Bayesian Statistics Conference, 2015
Boston Oncology Summit
ASA Trenton Biostatistics Meeting 2017
INSPIRE meeting, University of Warwick, 2017
FDA Industry Joint Workshops
Deming Conference
BASS Conference
EMA Workshop on Histology-Independent Indications
CEN-ISBS Conference 2017
Others not listed!!

23. ADSWG Book Project Platform trials CRC Press
Authors from academia, industry, and government
To be published this year

24. ADSWG Book Project: Participants from ADSWG
Authors:
Ohad Amit
Carl-Fredrik Burman
Cong Chen
Olivier Collignon
Valerii Fedorov
Qi Jiang
Sebastian Jobjornsson
Franz Koenig
Sergei Leonov
Janet Li
Ed Mills
Martin Posch
Satrajit Roychoudhury
Anja Schiel
Nigel Stallard
Kristian Thorlund
Sammy Yuan
Authors/Editors:
Zoran Antonijevic
Bob Beckman

25. Upcoming Conferences
Basket and Umbrella Trials for Oncology, Sheraton Hotel Philadelphia, October 17 and 18, 2018, cbi-net
ADSWG Participants: Redman/Beckman (chair)
DIA Master Protocols Workshop, Washington, DC, November 8, 2018
Scott Berry, Lisa Lavange, Craig Lipset organizers
Joint ADSWG/BSWG conference/workshop on adaptive designs TBD---collaboration opportunity---still in planning

26. Opportunities for Members and Collaborators
Observe within a subgroup
Contribute to a subgroup
Lead a subgroup (opportunity for drug survey team leadership, 2019)
Form your own new subgroup
To join, Bob or Zoran or Cristiana, and copy Rui (Sammi) (who maintains membership list):
(Bob)

27. Other Opportunities for Collaboration
Some subworking groups may fuse or have fused
Global health: could have Bayesian sub-group
Medical outreach
Expedited approvals
Medical device survey
Building case examples (currently hosted by the DIA website)
New opportunities for collaboration will hopefully be suggested by BSWG and ADSWG members!
It would be great to form NEW JOINT working groups

28. Backups

29. Small Populations Publications (2018)
Alpha allocation:
Shentu, Yue, Cong Chen, Lei Pang, and Beckman, Robert A.  Auto-adaptive Alpha Allocation: A Strategy to Mitigate Risk on Study Assumptions. Statistics in Biosciences, 1-15 (2017).
Chen, Cong, Deng, Qiqi, He, Linchen, Mehrotra, Devan V, Rubin, Eric H, and Beckman, Robert A. How Many Tumor Indications Should Be Initially Studied in Clinical Development of Next Generation Immunotherapies? Contemporary Clinical Trials, in press (2017).
Beckman, Robert A., and He, Linchen. Maximizing the Efficiency of Proof of Concept Studies and of Arrays of Proof of Concept Studies for Multiple Drugs or Indications. Proceedings of the Joint Statistical Meetings of the American Statistical Association, Proceedings of the Joint Statistical Meetings of the American Statistical Association, Biopharmaceutical Section, (2016).
Chen, Cong and Robert A. Beckman. Informational Design of Confirmatory Phase III Trials. Biopharmaceutical Report. 23: 1-16 (2016).
Chen, Cong, Li, Nicole, Shentu, Yue, Pang, Lei, and Robert A. Beckman. Adaptive Informational Design of Confirmatory Phase III Trials with an Uncertain Biomarker Effect to Improve the Probability of Success. Statistics in Biopharmaceutical Research, 8: (2016).
Chen, Cong and Beckman, Robert A. Maximizing Return on Socioeconomic Investment in Phase II Proof-of-Concept Trials, Clinical Cancer Research, Published online before print, February 13, : (2014).

30. Small Populations: Publications (II)
Pathway design:
Chen, Cong, Li, Xiaoyun (Nicole), Li, Wen, and Beckman, Robert A. Adaptive Expansions of Biomarker Populations in Phase 3 Clinical Trials. Contemporary Clinical Trials, in press (2018).
Guinn, Daphne, Madhavan, Subha, and Beckman, Robert A. Harnessing Real World Data to Inform Platform Trial Design, in Platform Trials: Umbrella Trials and Basket Trials, Zoran Antonijevic and Robert A. Beckman, eds., in press (2018).
Chen, Cong, and Beckman, Robert A. Control of Type I Error for Confirmatory Basket Trials, in Platform Trials: Umbrella Trials and Basket Trials, Zoran Antonijevic and Robert A. Beckman, eds., in press (2018).
Beckman, Robert A., and Chen, Cong. Basket Trials at the Confirmator y Stage in Platform Trials: Umbrella Trials and Basket Trials, Zoran Antonijevic and Robert A. Beckman, eds., in press (2018).
Li, Wen, Chen, Cong, Li, Xiaojun, and Beckman, Robert A. Estimation of treatment effect in two-stage confirmatory oncology trials of personalized medicines. Statistics in Medicine, in press (2017).
Beckman, Robert A., Antonijevic, Zoran, Kalamegham, Rasika, and Cong Chen. Adaptive Design for a Confirmatory Basket Trial in Multiple Tumor Types Based on a Putative Predictive Biomarker. Clinical Pharmacology and Therapeutics, 100: (2016).
Trusheim, Mark, Shrier, Alice A., Antonijevic, Zoran, Beckman, Robert A., Campbell, Robert, Chen, Cong, Flaherty, Keith, Loewy, John, Lacombe, Denis, Madhavan, Subha, Selker, Harry, and Laura Esserman. PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms. Clinical Pharmacology and Therapeutics, 100: (2016).
Yuan, Shuai S, Chen, Aiying, He, Li, Chen, Cong, Gause, Christine K, and Robert A. Beckman. On Group Sequential Enrichment Design for Basket Trial. Statistics in Biopharmaceutical Research, 8: (2016).
Chen, Cong, Li, Nicole, Yuan, Shuai, Antonijevic, Zoran, Kalamegham, Rasika, and Robert A. Beckman. Statistical Design and Considerations of a Phase 3 Basket Trial for Simultaneous Investigation of Multiple Tumor Types in One Study. Statistics in Biopharmaceutical Research, 8: (2016).
Beckman, Robert A. and Cong Chen. Efficient, Adaptive Clinical Validation of Predictive Biomarkers in Cancer Therapeutic Development. In Advances in Cancer Biomarkers (Advances in Experimental Medicine and Biology Series, #867), R. Scatena, ed., Springer Netherlands, pp (2015).

31. Small Populations: Publications (III)
Pathway design (II):
Beckman, Robert A. and Cong Chen. Translating Predictive Biomarkers within Oncology Clinical Development Programs. Biomarkers in Medicine, 9: (2015).
Beckman, Robert A., and Chen, Cong, Portfolio Optimization of Therapies and Their Predictive Biomarkers. In Optimization of Pharmaceutical R & D Programs and Portfolios, Z. Antonijevic, ed., Springer, Heidelberg, pp (2014).
Beckman, Robert A. Integrating Predictive Biomarkers and Classifiers into Oncology Clinical Development Programs., American Association for Cancer Research Annual Meeting Education Book, pp (2014).
Chen, Cong and Beckman, Robert A., Evidence-Based Adaptive Decision and Design Strategies for Maximizing the Efficiency of Clinical Oncology Development Programs with Predictive Biomarkers. In Clinical and Statistical Considerations in Personalized Medicine, C. Carini, S.M. Menon, M. Chang, eds., CRC Press, Boca Raton, Florida, pp (2014).
Predictive subgroup methodologies:
Beckman, Robert A., Carl-Fredrik Burman, Chen, Cong, Sebastian Jobjornsson. Franz Koenig, Nigel Stallard, Martin Posch. Decision Analysis from the Perspectives of Single and Multiple Stakeholders, in Platform Trials: Umbrella Trials and Basket Trials, Zoran Antonijevic and Robert A. Beckman, eds., in press (2018).
Beckman, Robert A., Chen, Cong, Posch, Martin, and Zohar, Sarah. Trial Designs for Rare Diseases and Small Samples. In Oncology. In “Textbook of Clinical Trials in Oncology”, S. Michiels, ed., in press (2018)..
Ondra, Thomas, Jobjörnsson, Sebastian, Beckman, Robert A., Burman, Carl-Fredrik, König, Franz, Stallard, Nigel, and Posch, Martin. Optimized Adaptive Enrichment Designs. Statistical Methods in Medical Research, first published online December 18, 2017,
Ondra, Thomas, Jobjörnsson, Sebastian, Beckman, Robert A., Burman, Carl-Fredrik, König, Franz, Stallard, Nigel, and Posch, Martin. Optimizing Trial Designs for Targeted Therapies. PLoS One 11:e (2016).

32. Small Populations (IV)
Master Protocols:
Roychoudhury, Satrajit, and Amit, Ohad. Efficiencies of Platform Trials. in Platform Trials: Umbrella Trials and Basket Trials, Zoran Antonijevic and Robert A. Beckman, eds., in press (2018).
Li, Janet, Yuan, Shuai, and Robert A. Beckman. Effect of Randomization Schemes in Umbrella Trials Where There are Unknown Interactions between Biomarkers. in Platform Trials: Umbrella Trials and Basket Trials, Zoran Antonijevic and Robert A. Beckman, eds., in press (2018).

33. Adaptive Designs in Medical Devices Survey Subgroup (Thomann, LaLonde, BSWG)
Survey Creation:
Updated and revised previous adaptive design device survey
Link to final version
Targeted Population:
Identify priority companies from a list of Advanced Medical Technology Association (AdvaMed) member companies
Action item – gather contacts to fill out the survey on behalf of their company
Ideal respondent: a biostatistician with visibility across therapeutic areas and various phases of development
Projected Timeline:
Sept 2018 – Send out survey
Jan 2019 – Analyze data
April 2019 – Submit manuscript