Project data sphere to make cancer clinical trial data publicly available.

نویسنده

  • Karyn Hede
چکیده

I n the mid-1980s, the emerging semiconductor industry had a problem. Many competing standards and manufacturing practices were a costly drag on progress. U.S. chipmakers realized that solving common problems and developing industry-wide standards would benefit everyone. They created Sematech, a joint venture that helped solve thorny technical challenges and yielded industry-wide efficiencies that no company could have accomplished alone. By the mid-1990s, the group globalized and today represents more than half the worldwide semiconductor manufacturers. Call 2013 the year that large pharmaceutical companies began to share in earnest. It started in 2012 when drug makers joined forces to create Transcelerate Biopharma, an independent entity that many of the world's largest pharmaceutical companies supported, Sanofi. The new organization will cooperate in precompetitive intelligence, such as creating standardized clinical trial formats, to reduce the cost of conducting human trials , the most costly aspect of bringing a new medicine to market. Realizing that data sharing was changing , Charles Hugh-Jones, vice president of medical affairs at Sanofi Oncology, proposed sharing comparator-arm data gleaned from completed cancer clinical trials. He already had the attention of pharmaceutical company CEOs through his involvement in Transcelerate, but what really got the process moving were connections he made with tech company executives involved in the CEO Roundtable on Cancer, a nonprofit organization that George H. W. Bush started to address issues facing cancer research. Hugh-Jones spent several months hashing through technical and proprietary issues that have hampered efforts to share data. He developed Project Data Sphere, which within weeks will go live with cancer trial data from an expected five to seven pharmaceutical companies. The goal, according to Hugh-Jones, is to have Project Data Sphere grow into an interactive platform where investigators can learn from the collective successes and failures of previous trials with the help of powerful analytic tools, which the statistical software giant SAS Institute offered to the project free. " The reality is that we have to do better , " said Hugh-Jones. " You've got to get beyond a 5% success rate in bringing new oncology drugs to market. But it's an economic issue as well. People are realizing there just isn't the money to keep pumping into trials either at a commercial or at a governmental level. " To kick-start the effort, Hugh-Jones persuaded his Sanofi colleagues to contribute the comparator-arm data from three completed trials: the phase III trial for …

برای دانلود رایگان 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

Predicting clinical trial results based on announcements of interim analyses

BACKGROUND Announcements of interim analyses of a clinical trial convey information about the results beyond the trial's Data Safety Monitoring Board (DSMB). The amount of information conveyed may be minimal, but the fact that none of the trial's stopping boundaries has been crossed implies that the experimental therapy is neither extremely effective nor hopeless. Predicting success of the ongo...

متن کامل

I-49: Human Y Chromosome ProteomeProject

The success of the Human Genome Project (HGP) has provided a blueprint for the approximately 20,000 gene-encoded proteins potentially active in all of the hundreds of cell types that make up the human body. Yet we still have limited knowledge about a majority of the gene-encoded proteins which are the “building blocks of life” and “cellular machinery”. It is estimated that for nearly half of th...

متن کامل

Prevalence of High-Burden Medical Conditions Among Young and Middle-Aged Adults With Pediatric-Onset Medical Conditions: Findings From US Private and Public Administrative Claims Data

Adults with pediatric-onset medical conditions (POMCs) are susceptible to early development of high-burden medical conditions. However, research pertaining to this topic is lacking, which is vital information that could assist in health benefit planning and administration. The purpose of this study was to determine the prevalence of high-burden medical conditions among privately and publicly in...

متن کامل

Sharing Detailed Research Data Is Associated with Increased Citation Rate

BACKGROUND Sharing research data provides benefit to the general scientific community, but the benefit is less obvious for the investigator who makes his or her data available. PRINCIPAL FINDINGS We examined the citation history of 85 cancer microarray clinical trial publications with respect to the availability of their data. The 48% of trials with publicly available microarray data received...

متن کامل

BRB-ArrayTools Data Archive for Human Cancer Gene Expression: A Unique and Efficient Data Sharing Resource

The explosion of available microarray data on human cancer increases the urgency for developing methods for effectively sharing this data among clinical cancer investigators. Lack of a smooth interface between the databases and statistical analysis tools limits the potential benefits of sharing the publicly available microarray data. To facilitate the efficient sharing and use of publicly avail...

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

عنوان ژورنال:
  • Journal of the National Cancer Institute

دوره 105 16  شماره 

صفحات  -

تاریخ انتشار 2013