This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Bristol-Myers Squibb Expands Access To Clinical Trial Data Through Collaboration With Academic Research Institute

Bristol-Myers Squibb (NYSE:BMY) today announced a collaboration with Duke University through its Duke Clinical Research Institute (DCRI) focused on clinical trial transparency. Bristol-Myers Squibb will expand access to a broader set of clinical trial information from in-scope company-sponsored studies and enable an independent scientific review through DCRI of requests from researchers that meet pre-specified requirements. The collaboration with DCRI is one of a series of initiatives by Bristol-Myers Squibb to support data sharing and enhance the company’s existing policies on transparency and disclosure of clinical trial information. Clinical trial information being made available for scientific research will include protocols, full clinical study reports (CSR) and de-identified patient-level data and study-level data for medicines and indications approved in the U.S. and/or Europe for trials completed after January 2008. Information from terminated programs will be available two years after discontinuation.

“Bristol-Myers Squibb’s collaboration with DCRI reflects our commitment to providing broader, more timely access to important clinical trial information and serves as a catalyst to strengthening public confidence in medicines, advancing science and improving public health,” said  Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb.

“This program is a great leap forward for open science and is highly consistent with the DCRI’s mission to develop and share knowledge that improves the care of patients around the world through innovative clinical research,” said Eric Peterson, M.D. MPH, Executive Director of the DCRI.

Bristol-Myers Squibb will also publish CSR synopses at for studies that support a product’s marketing authorization application to the U.S. Food and Drug Administration or the European Medicines Agency shortly after the regulatory approval of the product has been granted. The company has also committed to provide lay-language summaries of clinical trial results for patients who participated in clinical trials and wish to receive a summary of the aggregate study level results. Bristol-Myers Squibb is working with various industry groups and regulators to evaluate the most effective method to deliver this level of detail to patients.

DCRI is the world's largest academic clinical research organization with more than 40 years of experience conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. DCRI faculty members will serve as an independent scientific review committee to evaluate data requests and their accompanying research proposals from qualified scientific and medical researchers seeking access to clinical trial information from Bristol-Myers Squibb-sponsored trials, and make final decisions on data sharing. These reviews will be conducted by a panel of experts in biostatistics, research ethics and patient privacy, and the clinical specialty of the research. Proposals will be evaluated based on the scientific rationale for the research as well as plans for statistical analyses and publication. The Bristol-Myers Squibb company website will disclose the names of faculty members of the DCRI review board, all proposals and summary statements from the review. Scientific and medical researchers can submit requests for access to data on Bristol-Myers Squibb’s company website at

Bristol-Myers Squibb’s existing policy on disclosure of clinical trial information includes registration of all Phase I, II, III and IV interventional trials where BMS has responsibility, and open and timely reporting of results, regardless of outcome, from sponsored clinical trials involving Bristol-Myers Squibb marketed products through scientific congresses or publication in peer-reviewed journals. In addition, the company submits trial results to be made available on the National Institutes of Health website at, and other similar databases required by other regulatory agencies.

Bristol-Myers Squibb’s policy on data sharing is aligned with the Principles for Responsible Clinical Trial Data Sharing released by the U.S. and European pharmaceutical trade associations, PhRMA and EFPIA, by which biopharmaceutical companies pledge their commitment to enhancing public health through responsible sharing of clinical trial data consistent with safeguarding patient privacy and informed consent, respecting the integrity of national regulatory systems, and maintaining incentives for investment in biomedical research.

Information on Bristol-Myers Squibb’s policy on disclosure of clinical trial information can be found at

Facilitation of this program was enabled through existing legal infrastructure and relationships within the Bristol-Myers Squibb - Duke Translational Medicine Institute Strategic Collaboration. This partnership was announced in March 2012 with the goal of increasing collaboration between the two organizations.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%
YHOO $36.60 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs