Opening clinical trial data: are the voluntary data-sharing portals enough?

نویسندگان

  • Nophar Geifman
  • Jennifer Bollyky
  • Sanchita Bhattacharya
  • Atul J. Butte
چکیده

Data generated by the numerous clinical trials conducted annually worldwide have the potential to be extremely beneficial to the scientific and patient communities. This potential is well recognized and efforts are being made to encourage the release of raw patient-level data from these trials to the public. The issue of sharing clinical trial data has recently gained attention, with many agreeing that this type of data should be made available for research in a timely manner. The availability of clinical trial data is most important for study reproducibility, meta-analyses, and improvement of study design. There is much discussion in the community over key data sharing issues, including the risks this practice holds. However, one aspect that remains to be adequately addressed is that of the accessibility, quality, and usability of the data being shared. Herein, experiences with the two current major platforms used to store and disseminate clinical trial data are described, discussing the issues encountered and suggesting possible solutions.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity

INTRODUCTION The opening of research data is emerging thanks to the increasing possibilities of digital technology. The opening of clinical trial (CT) data is a part of this process, expected to have positive scientific, ethical, health, and economic impacts thus contributing to research integrity. The January 2016 proposal by the International Council of Medical Journal Editors triggered ample...

متن کامل

A Global, Neutral Platform for Sharing Trial Data.

icine (IOM) report argues that availability of deidentified (anonymized) patient-level data from clinical trials can permit verification of original results, enhancing public trust and accountability; facilitate other critical research (e.g., evaluation of adverse event rates according to compound class or subpopulation or identification of surrogate end points); and avert duplicate trials, shi...

متن کامل

چالش‌های اشتراک‌گذاری داده‌های پژوهشی از دیدگاه پژوهشگران حوزه پزشکی ایران

Introduction: Data sharing accelerates research activities and production of science. It has numerous benefits for the stakeholders. However, researchers withhold it for different reasons. Accordingly, the present study examined the challenges refusing data sharing among Iranian researchers of medical sciences. Method: The present survey study sought to identify data sharing challenges from th...

متن کامل

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project

BACKGROUND Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges ...

متن کامل

Identifying the technical requirements for designing health portals

Aim: Considering technical requirements in the design of health portals increases the validity of information. This study identified the technical and content structure required to create these portals. Methods: This was a qualitative study which was conducted in 2020. A combination of comprehensive review and interview was used. The search was performed in Elsevier, EBSCO, Scopus, Web of Scie...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره 13  شماره 

صفحات  -

تاریخ انتشار 2015