Abstract Confidentiality Policy Exceptions
ASCO-sponsored and Cosponsored Meetings Guidance for SEC Exception to Data Confidentiality
A research study is not eligible for inclusion in an ASCO sponsored or cosponsored meeting (“ASCO Meeting”) if the data has been released publicly in a manner that does not comply with ASCO’s confidentiality policy. Under this policy, data and other information in a research abstract is confidential from the time the abstract is submitted for the ASCO Meeting until its public release by ASCO in conjunction with the ASCO Meeting.
Occasionally a publicly traded company is advised that it is legally required to disclose certain data or other information from a confidential abstract in advance of the public release date to satisfy requirements of the U.S. Securities and Exchange Commission or a corresponding regulatory body in a country where the company’s stock is traded (collectively, “SEC”). Generally this need arises when there is a substantial likelihood that the information would be considered by a reasonable investor in the company to have significantly altered the total mix of information made available to the investor.
In these cases, the abstract is still eligible for inclusion in the ASCO Meeting provided that the company submits to ASCO, in advance of the release:
1. Written notification of the time and manner of the company’s release, with a copy directed to the lead author of the abstract; and
2. A letter signed by the company’s legal counsel, advising that (a) public disclosure of the information is necessary for the company to comply with applicable securities laws, and (b) the information disclosed is the minimum necessary for such compliance.
This SEC Exception is self-executing and does not require preapproval from ASCO. To the extent that the SEC Exception applies, the abstract will not be rejected or removed from the ASCO Meeting on the basis of the release of data or other information. However, in the interest of effective peer-reviewed presentation of data at the Annual Meeting, ASCO retains the right in its discretion to change the position of the abstract in the ASCO Meeting, e.g., from oral presentation to poster. In addition, the abstract will be ineligible for inclusion in the official press program of the ASCO Meeting.
Partners of the company may, jointly or separately, issue a press release with the same information. The abstract itself may not be released publicly by a company or lead author, as ASCO holds the copyright to the abstract.
If data or other information from the abstract is released publicly in a manner that does not qualify for the SEC Exception, ASCO, in its discretion, retains the right to reject or remove the abstract from the ASCO Meeting in accordance with the ASCO confidentiality policy described in the first paragraph of this Guidance.
ASCO will not review or comment on press releases prepared under the SEC Exception. However, in the interest of effective peer-reviewed presentation of the data at the ASCO Meeting, ASCO would prefer that the company’s press release:
(a) summarize study data cited in the abstract in a qualitative fashion rather than providing specific quantitative information;
(b) avoid interpretations about the implications of the data for practice; and
(c) note that full data has been submitted to the ASCO Meeting.
By way of illustrating these preferences, a statement that a study “met its primary endpoint of increasing survival” is qualitative, while a statement that “survival was increased by 20% with the study drug” might be considered quantitative. A statement that the study “included more than 100 patients” is summary information, while a statement that the study “included 148 patients” might be considered specific quantitative information. A quote such as “We are encouraged by these promising results” would not be viewed as interpretive, while a quote such as “These findings support this drug as first line therapy in lung cancer” could be seen as an interpretation of the data. Any information that was publicly available before the abstract was submitted is also appropriate for a press release.
For companies’ convenience, a sample press release further illustrating these differences is available. A company’s press release may vary from the sample depending on the circumstances.
If the press release includes significantly more information than ASCO’s stated preferences and the sample press release, the abstract’s placement in the ASCO Meeting is subject to change (as described above).
¹For previously published or presented abstracts submitted to the Breast Cancer Symposium, Gastrointestinal Cancers Symposium, Genitourinary Cancers Symposium, and Annual Meeting on Molecular Markers in Cancer, the confidentiality policy applies to new or updated data or information in the study.
²Most abstracts will be publicly available online at www.asco.org approximately two weeks before the Annual Meeting, with plenary and late-breaking abstracts becoming publicly available during the Annual Meeting outside of market hours. Abstracts in the Breast Cancer Symposium, Gastrointestinal Cancers Symposium, Genitourinary Cancers Symposium, and Annual Meeting on Molecular Markers in Cancer will be publicly available online at www.asco.org on or just before the opening day of the symposium. Exact posting dates and times will vary from year to year. Press releases issued at or after ASCO’s public release do not violate ASCO policies.
³In rare circumstances, ASCO may grant an exception based on the requirements of another government agency or on public health grounds.