Adaptive Design Scientific Working Group (ADSWG) and Collaboration Opportunities
Experience the innovative vision and mission of ADSWG led by Robert A. Beckman, MD, promoting adaptive designs in drug development for global health initiatives. Meet the diverse membership and engage in educational activities to advance methodologies in clinical trials.
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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 eniac1915@gmail.com
ADSWG Membership: approximately 200+ members from pharma, biotech, academia, and health authorities in the US, Europe, and Japan
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: Creatinga 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) 3
Organizational: 2018 Updates Leadership Bob Beckman, Georgetown, Chair (eniac1915@gmail.com) 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
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
Rui (Sammi ) Tang 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 2016- 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 2015-current
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
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)
ADSWG-BSWG Expedited Approvals Subteam Co-leads: Bob Campbell (ADSWG) and Larry Gould (BSWG) WG initiation Expedited Approvals Team Objectives 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. 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, zantonijevic@mteksciences.com maustin@amgen.com eniac1915@gmail.com carl-fredrik.burman@astrazeneca.com robert_campbell@brown.edu cong_chen@merck.com jennifer.clark@fda.hhs.gov jyotirmoy.dey@abbvie.com vdragali@its.jnj.com larry_gould@merck.com qjiang@amgen.com jwloewy@comcast.net sandeep.m.menon@pfizer.com evamiller425@msn.com david@precisionmethods.guru nitin.patel@cytel.com martin.posch@meduniwien.ac.at rui.tang@shire.com kiichiro.toyoizumi@shionogi.co.jp joeyzhou2012@gmail.com 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 9
Team Charter: ADSWG Adaptive Dose (N-of-1) Individualization Subteam ( ADONIS ) ADONIS initiation 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 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 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. 10
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 11
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
Team Charter: ADSWG Simulation Report (SimRep) Subteam WG initiation SimRep Objectives 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 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 13
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 14
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.
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)
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
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
Team Charter: ADSWG Nature and Extent of Evidence Needed for Rare Diseases (NEED) Subteam WG initiation NEED Objectives 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 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 19
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 20
Subteam: Drugs & Biologics Survey Subteam Chair: Alan Hartford Co Chair: Caroline Morgan Subteam Objectives Participants 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. Alan Hartford Caroline Morgan Li Chen Alun Bedding Lingyun Liu Silke J rgens Mitch Thomann Xiaotian Chen Eva Miller Alan.Hartford@abbvie.com caroline.morgan@cytel.com lic@amgen.com alun.bedding@roche.com lingyun.liu@cytel.com silke.joergens@iconplc.com mitchell.thomann@lilly.com Xiaotian.Chen@abbvie.com evamiller425@msn.com 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 Liaison for survey team working on devices: Fanni Natanegara natanegara_fanni@lilly.com 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 J rgens, 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
Some ADSWG Presentations Numerous; I have only a partial record of the Small Populations Subgroup Presentations: DIA Annual Meeting, 2014.2015, 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!!
ADSWG Book Project Platform trials CRC Press Authors from academia, industry, and government To be published this year
ADSWG Book Project: Participants from ADSWG Authors: Authors/Editors: Zoran Antonijevic Bob Beckman 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
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---2019 TBD---collaboration opportunity---still in planning
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, email Bob or Zoran or Cristiana, and copy Rui (Sammi) (who maintains membership list): eniac1915@gmail.com (Bob) zoranton@yahoo.com cmayer1@its.jnj.com Alsammi@gmail.com
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
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, 2815- 2838 (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: 238-247 (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. 20: 1730-4 (2014).
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: 617-625 (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: 713-729 (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: 293-306 (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: 248-257 (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. 81-90 (2015).
Small Populations: Publications (III) Pathway design (II): Beckman, Robert A. and Cong Chen. Translating Predictive Biomarkers within Oncology Clinical Development Programs. Biomarkers in Medicine, 9:851-862 (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. 155-180 (2014). Beckman, Robert A. Integrating Predictive Biomarkers and Classifiers into Oncology Clinical Development Programs., American Association for Cancer Research Annual Meeting Education Book, pp. 117-121 (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. 179-209 (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, Jobj rnsson, Sebastian, Beckman, Robert A., Burman, Carl-Fredrik, K nig, Franz, Stallard, Nigel, and Posch, Martin. Optimized Adaptive Enrichment Designs. Statistical Methods in Medical Research, first published online December 18, 2017, https://doi.org/10.1177/0962280217747312. Ondra, Thomas, Jobj rnsson, Sebastian, Beckman, Robert A., Burman, Carl-Fredrik, K nig, Franz, Stallard, Nigel, and Posch, Martin. Optimizing Trial Designs for Targeted Therapies. PLoS One 11:e0163726 (2016).
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).
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
