Intersection of Big Data and Academic Oncology Research – a Reality Check

The MedicRes Congress is a great opportunity to combine different areas of medical research and will give an insight in the big machinery producing the data on which treatment schedules are changing in different therapy areas. 

Big data in medical research and health care comes with big promises and expectations. My talk shall reflect on the some of the current realities of big date-oncology interaction from the perspective of an academically minded sponsor organization. Additionally, I will formulate our expectations of big data and outline development which may shape clinical oncology in the future.

First, I will briefly describe our role as academic sponsor for oncologic trials and our role as a direct and indirect creator of big data; discuss the motivation and the way our data is used. I will then present some select big data sources (e.g cancer registries, drug safety data bases, electronic patient files) describe how they shape and influence our work today and in the near future. I will describe the way we are producing data and how big data can influence or improve the patient treatment by reducing costs for running expensive trials. The last part of the talk will critically reflect on big data initiatives in oncology in general and I shall take the opportunity to comment on our expectations on what big data should achieve. 

I call upon my colleagues to join the discussion on big data in medical research and to take the opportunity to shape the discourse.

October 19th, 15.30-17.00

The Cooper Union, The Great Hall 7 East 7th Street ,New York,  NY 10003

“Big Data in Oncology  Research” , Aysun Karatas , Chief Executive Officer AIO-Studien-
gGmbH (AIO Working Group of Medical Oncology within the German Cancer Society DKG) 
Berlin Area, Germany

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MedicReS 5th World Congress on Good Medical Research

MedicReS 5^th World Congress on Good Medical Research

“The Near Future Perspectives in Medical Research:  Biostatistics, Bioethics &Publication Policy in the Age of Big Data”

5^th World Congress on Good Medical Research

 Chairs:

Arzu Kanık Ph.D. – MedicReS Scientific Director, Mersin University

David B. Resnik J.D., Ph.D. Bioethicist and IRB Chair - National Institute for Environmental Health 

Sciences NIH

3^rd International Good Biostatistical Practice Conference

 Chair:

Arzu Kanık Ph.D. – MedicReS Scientific Director, Professor in Biostatistics,  Mersin University

3^rd International Good Bioethical Practice Conference

 Chair:

Collin O'Neill Ph.D., Department of Population Health, NYU Medical Center

3^rd International Good Publication Practice Conference

Chair :

Zubin Master Ph.D. Assistant Prof. Alden March  Bioethics Institute, Albany Medical College

October 19th-25th

The Cooper Union, The Great Hall 7 East 7th Street ,New York,  NY 10003

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The Ethics of Trials that Offer Less than the Best - Dr. Collin O’Neil

The Ethics of Trials that Offer Less than the Best

Dr. Collin O’Neil - Lehman College, City University of New York.

Good Medical Research is research that has the potential to deliver results that can improve the capabilities and decision-making of clinicians, and that obtains its results via methods that respect the rights of human subjects. Settling questions about what counts as good medical research is an interdisciplinary enterprise, requiring contributions from statisticians, scientists, clinicians, and ethicists, and the MedicReS World Congress will be bringing these experts together. 

My subject is the ethics of withholding care from participants in clinical trials.  These trials are usually conducted overseas in settings where the care is unavailable in the local health care system.  The participants are therefore not deprived of anything they would have had access to outside the trial.  But these trials remain controversial because the researchers could prevent the participants from suffering serious harm, and decline to do so.  It is my hope that attendees will come away with a better understanding of the ethics of these trials.  

There is a growing consensus that clinical researchers are justified in doing less than their best for the subjects in their trials when necessary to obtain results that will help future patients more.  I criticize this view on the grounds that it neglects the moral constraint against allowing harm as a means, and describe several trial designs that intend the harmful consequences of withholding care as a means to various research-related ends. 

I hope you will consider attending the 2015 MedicReS World Congress to hear a variety of presentations on the theme of good medical research, and to participate in the conversations they generate. 

October 19th, 15.30-17.00

The Cooper Union, The Great Hall 7 East 7th Street ,New York,  NY 10003

The Ethics of Trials that Offer Less than the Best Dr. Collin O’Neil - Center for Bioethics, NYU

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The Importance of Teaching Medical Research Methodology - Dr. İrfan Şencan

The Importance of Teaching  Medical Research Methodology in Medical Specialty Education

İrfan Şencan Professor in Infectious Diseases an Clinical Microbiology Department, Deputy Undersecretary of Turkish Ministry of Health

In my opinion, the Congress will present helpful information on series of topics related to the conduct of biomedical research. The speakers will bring up variety of disciplinary perspectives. The audience will be global.

My subject is significant because methodology is important in order to provide evidence based service and research.

I can shortly summarize my subject with these sentences: I’m going to share knowledge regarding Medical education and education of medical specialty in Turkey with this presentation. I will also share summary knowledge on scientific publishing of health in Turkey. I will explain why we need to MedicRes education. Our expectation from this issue is good health care .

My colleagues should join in that an opportunity for generating information from Big Data.

October 20th, Tuesday 15.30-17.00 

The Cooper Union, The Great Hall 7 East 7th Street ,New York,  NY 10003

"The Importance of Teaching  Medical Research Methodology in Medical Specialty Education" ,  İrfan Şencan, MD, Professor in Infectious Diseases and Clinical Microbiology DePartment , Deputy Undersecretary of Turkish Ministry of Health 

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Invited Speakers

Invited Speakers

David B. Resnik, J.D., Ph.D. Bioethicist and NIEHS IRB Chair
E. Arzu Kanık  PhD. Professor in Biostatistics, MedicReS Scientific Director, Mersin University
Adil E. Shamoo Ph.D., Professor University of Maryland School of Medicine
Rebecca E. Cooney, Ph.D., North American Editor, The Lancet
Zubin Master , Ph.D. Assistant Prof. Alden March  Bioethics Institute, Albany Medical College
Collin O'Neil, Ph.D., Assistant Professor, Department of Philosophy, Lehman College, City 
University of New York 
Denise Esserman, Ph.D.,  Associate Professor of Public Health (Biostatistics), School of Public 
Health: Yale Center for Analytical Sciences (YCAS)
Aysun Karatas MD , Chief Executive Officer AIO-Studien-gGmbH (AIO Working Group of 
Medical Oncology within the German Cancer Society DKG) Berlin Area, German
Monica Gaidhane, MD, MPH, Clinical Research Manager at Weill Cornell Medical
İrfan Şencan MD ,Professor in Infectious Diseases and Clinical Microbiology Department , 
Deputy Undersecretary of Turkish Ministry of Health 
Shing Lee, PhD, Assistant Professor, Biostatistics at the Columbia University Medical Center
Han Liu, Assistant Professor, Department of Operations Research and Financial Engineering
Princeton University

The Future of Frequentist Hypothesis Testing - Dr. Denise A. Esserman

The Future of Frequentist Hypothesis Testing

Dr. Denise A. Esserman 

Yale School of Public Health, Yale University 

The Congress will bring together a diverse group of researchers with differing experience and opinions.  This is a great opportunity to get together and brain storm and ponder about the future of collaborative research.  My subject will discuss where analysis, particularly that of big data, is headed.

My subject will discuss where analysis, particularly that of big data, is headed. I will discuss the definition of big data from a biostatistics perspective.  It will review some of the work that has been done and where statistical analyses is headed in the future.  

Please attend the MedicRes World Congress it is a great opportunity to discuss how to advance science using good, ethical practices.

October 20th, Tuesday 9.00-10.30 

The Cooper Union, The Great Hall 7 East 7th Street ,New York,  NY 10003

The Future of Frequentist Hypothesis Testing Dr. Denise A. Esserman  Yale School of Public Health, Yale University 

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Integrity of Authorship in the Age of Collaborative Research - Dr. Adil E. Shamoo

Integrity of Authorship in the Age of Collaborative Research

  Adil E. Shamoo, Ph.D., Professor and Editor- in-Chief, Accountability in Research

University of Maryland School of Medicine

In my opinion, the conference is timely to address the pressing issues in medical research. The intense nature of current progress in medical research necessitates anticipating and dealing with potential ethical and compliance issues. Among the issues of concern are: Integrity of research publications free from falsification, fabrication, and plagiarism.

I find my subject very significant because the integrity of publication free from misconduct is vital to safety of drugs to patients and to the overall process of research.

With the main points, the talk will consist of a short exercise in identifying plagiarism with a fun example. Afterwards, I will discuss examples of plagiarism around the world. I will discuss several safeguards promote integrity of authorship. I will discuss the several models to enhance integrity of authorship among them the contributor model. 

It is certainly worthwhile to attend the conference to participate in the latest issues on enhancing integrity of authorship in medical research.

October 19th Monday
15.30-17.00
The Cooper Union, The Great Hall 7 East 7th Street ,New York,  NY 10003

“Integrity of Authorship in the Age of Collaborative Research”, Adil E. Shamoo Ph.D., Professor University of Maryland School of Medicine

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The Ethical Responsibilities of Academic Research Institutions and Funders to Safeguard the Integrity of Research - Dr. Zubin Master

                                    

                                 Dr. Zubin Master

    Alden March Bioethics Institute, Albany Medical College

I think about Good Medical Research MedicReS World Congress 2015, the goals of medical research are to increase knowledge, and develop products and services for society. Society trusts that medical research is conducted in a manner upholding the highest standards of research integrity. As such, Good Medical Research is of paramount importance in order to uphold this social contract, and to improve human health by developing safe and effective medical treatments. Good Medical Research captures a range of ethical conduct and responsibilities for medical researchers including the collection and analysis of data, ethical authorship and publication practices, good mentoring, and ethical peer review to name a few.

The subject of my talk is important because the current U.S. biomedical and behavioral science environment is unsustainable. Currently, the success rates of obtaining federal grants and seeking jobs is becoming increasingly difficult due to a hypercompetitive environment where there are more scientists than the resources available and the rewards of science. All of the players in the scientific enterprise (researchers, research institutions and funders) need to be involved in order to coordinate a strategy and make the environment more sustainable and attract young scientists into the field.

I will begin by providing data collected by various researchers and organizations on the current biomedical and behavioral science environment. In general, this data will show that many researchers are considering non-tenured, non-faculty and even non-research positions outside academia, longer post-doctoral fellowships, an increased age of first time grant winners, and stress and burnout of biomedical scientists due to publication pressure among several other important facts. This data demonstrates that our current scientific enterprise is hypercompetitive and unsustainable, which has several consequences including the potential for increased research misbehaviors and misconduct, and may dissuade future scientists from entering the field. Near the end of the presentation, I will discuss several strategies that researchers, research institutions, and funders can consider in order to mitigate and create a more sustainable environment.

I hope scientists in a range of medical and scientific practices will attend this year’s MedicReS World Congress and join us for an excellent selection of speakers covering the many aspects of Good Medical Research.

October 19th Monday

13.30-15.00
The Cooper Union, The Great Hall 7 East 7th Street ,New York,  NY 10003

"The Ethical Responsibilities of Academic Research Institutions and Funders to Safeguard the Integrity of Research"  Dr. Zubin Master, Alden March Bioethics Institute, Albany Medical College

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Prevention and Containing Misconduct in Research in the Age of Big Data - Dr. Adil E. Shamoo

Adil E. Shamoo, Ph.D., Professor and Editor- in-Chief, Accountability in Research

University of Maryland School of Medicine

The conference is timely to address the pressing issues in medical research. The intense nature of current progress in medical research necessitates anticipating and dealing with potential ethical and compliance issues. Among the issues of concern are: ethics, misconduct, management of research enterprises, integrity of publications, and the protection of human volunteers in clinical trials.

My subject is very important because It is obvious why the prevention and containment of misconduct in research is of vital importance to research and safety of volunteer subjects. In addition, the safety and integrity of data on safety and efficacy during drug development is of vital importance to the public and industry alike.

My speech  will consist of a short historical information of misconduct. Afterwards, an illustration of misconduct in research occurs worldwide. The talk will address the latest data on prevalence and possible factors of misconduct. The talk will illustrate current means of containing/prevention of misconduct. Reliance on education and training and whistleblowers to prevent misconduct is not sufficient. I will discuss data audit as a method to contain and prevent misconduct in research.

It is certainly worthwhile to attend the conference to participate in the latest issues on ethics and compliance in medical research.

October 19th Monday
09.00-10.30
The Cooper Union, The Great Hall 7 East 7th Street ,New York,  NY 10003

“Prevention and Containing Misconduct in Research in the Age of Big Data”, Adil E. Shamoo Ph.D., Professor University of Maryland School of Medicine

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Research Ethics and Policy in the Age of Big Data - Dr.David B. Resnik

David B. Resnik J.D., Ph.D. 

Bioethicist and NIEHS IRB Chair

The Congress will present valuable information on a variety of topic related to the conduct of biomedical research. The speakers will represent a variety of disciplinary perspectives. The audience will be international in scope.

My speech will discuss ethical and policy issues related to research involving the collection of large amounts of data, including data management,publication, conflict of Interest, informed consent, privacy/confidentiality, and regulations.

Please attend the MedicRes World Congress: you won’t be disappointed.

October 19th Monday

09.00-10.30

The Cooper Union, The Great Hall 7 East 7th Street ,New York,  NY 10003

“Protecting Privacy and Confidentiality in the Age of Big Data”, David B. Resnik, J.D., Ph.D.      Bioethicist and NIEHS IRB Chair

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GMR 2015 Workshop Schedule

WORKSHOPS on Good Biostatistical Practice : E-PICOS

All Workshops will be held on October 21st WEDNESDAY
at 405 Lexington Avenue Chrysler Building  26th Floor 
10174, ​ New York

Please send an email to info@medicres.org about your participation until October 20th

12.00 pm and please select a group according to the your availability

“How to Decide Study Design?  A Practical Guide and A Smart Application Tool: E-PICOS

www.e-picos.org”

Workshop Director: E. Arzu KANIK, Ph.D.

09.00 -  09.45 Group A

09.45 -  10.30 Group B

10.30 -  11.15 Group C

11.15 - 12.00 Group D

Lunch

13.00 - 13.45 Group E

13.45 - 14.30 Group F

14.30 - 15.15 Group G


15.15 - 16.00 Group H

Scientific Program

October 19th Monday

07.00-09.00 Registration

09.00 Opening Remarks MedicReS 5th World Congress on Good Medical Research 

09.00-10.30  3rd International Conference on Good Publishing Practice (Part 1)
Conference & Session Chair:  Zubin Master, Ph.D.
OPENING LECTURES
Speakers:
“Protecting Privacy and Confidentiality in the Age of Big Data”, David B. Resnik, J.D., Ph.D. Bioethicist and NIEHS IRB Chair “Prevention and Containing Misconduct in Research in the Age of Big Data”, Adil E. Shamoo Ph.D., Professor University of Maryland School of Medicine

10.30-11.00 Coffee Break

11.00-12.00  3rd International Conference on Good Publishing Practice (Part 2)
"The Importance of Teaching  Medical Research Methodology in Medical Specialty 
Education" ,  İrfan Şencan, MD, Professor in Infectious Diseases and Clinical Microbiology 
Department , Deputy Undersecretary of Turkish Ministry of Health 
“MedicReS Good Medical Research”,  Burak AKICIER MedicReS General Director
Session Chair:  Aysun Karatas, Ph.D.

12.00-13.30 Lunch

13.30-15.00 3rd International Conference on Good Bioethics Practice  ( Part-1)
Conference and Session Chair:  Collin O’Neill, Ph.D
“Ethical Issues in Artificial Intelligence Applied to Medicine” Cemal H. Guvercin, MD, PhD 
Department of Developmental Medicine, Boston Children’s Hospital, Harvard University, 
Boston, MA, US
“The Ethical Responsibilities of Academic Research Institutions and Funders to Safeguard 
the Integrity of Research”,  Zubin Master , Ph.D. Assistant Prof. Alden March  Bioethics 
Institute, Albany Medical College

15.00-15.30 Coffee Break

15.30-17.00 3rd International Conference on Good Bioethics Practice ( Part-2)
“Integrity of Authorship in the Age of Collaborative Research”, Adil E. Shamoo Ph.D., 
Professor University of Maryland School of Medicine
"The Ethics of Offering Less than the Best.”, Collin O'Neil, Ph.D., Assistant Professor
Department of Philosophy,Lehman College, City University of New York 
Session Chair:  Cemal H. Guvercin, MD, PhD

October 20th, Tuesday

07.00-09.00 Registration

09.00-10.30 3rd International Conference on Good Biostatistical Practice (Part-1)

09.00- 09.45   “Challenges of Big Data Analysis” Han Liu, Assistant Professor, Department of 
Operations Research and Financial Engineering, Princeton University 

09.45- 10.30 “The Future of Frequentist Hypothesis Testing”, Denise Esserman, Ph.D.
Associate Professor of Public Health (Biostatistics), School of Public Health: Yale Center for 
Analytical Sciences (YCAS)
Session Chair:  David B. Resnik, J.D., Ph.D.

10.30-11.00 Coffee Break

11.00 -12.00 3rd International Conference on Good Biostatistical Practice (Part-2)

“Big Data in Oncology  Research” , Aysun Karatas , Chief Executive Officer AIO-Studien-
GmbH (AIO Working Group of Medical Oncology within the German Cancer Society DKG) 
Berlin Area, Germany
Session Chair: Denise Esserman, Ph.D.

12.00-13.30 Lunch

13.30-15.00 3rd International Conference on Good Biostatistical Practice (Part-3)
“The Role and Responsibilities of Statisticians in Clinical trials”, Shing Lee, PhD, Assistant 
Professor, Biostatistics at the Columbia University Medical Center
“Multicenter and Database Protocols Where We Can Accumulate Large Amounts of Data for 
Clinical Research”   Monica Gaidhane, MD, MPH, Clinical Research Manager at Weill Cornell 
Medical
Session Chair:  Rebecca E. Cooney, Ph.D

15.00 - 15.30 Coffee Break

15.30 - 16.30  “The New Role and Responsibilities of the Medical Journal Editors in the Age of Big Data”,  Rebecca E. Cooney, Ph.D., North American Editor, The Lancet Session Chair : Adil Shamoo, Ph.D 

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