Upon submission of an abstract to any ASCO sponsored or ASCO co-sponsored meeting where ASCO is the lead sponsor (each an ASCO Meeting and collectively, ASCO Meetings), the First Author must agree to the following Confidentiality Policy on behalf of all parties involved with the abstract. The First Author is responsible for communicating this policy to all involved parties:
Abstracts submitted to ASCO Meetings are considered final and confidential from the time of submission. The Confidentiality Policy covers all abstracts, including placeholder abstracts and late-breaking data submission abstracts. Compliance with the Confidentiality Policy by all parties related to the abstract is the responsibility of the First Author, and the First Author will be held accountable for any violations of ASCO’s policy.
Prior to the abstract information being publicly released in conjunction with an ASCO Meeting, the author, coauthors, sponsor of the research, journalists, and others may not
- make the information public, or provide it to others who may make it public (such as news media),
- publish or present the information or provide it to others who may publish or present it, or
- use the information for trading in the securities of any issuer, or provide it to others who may use it for securities trading purposes.
For a study to be eligible for acceptance into an ASCO Meeting, information contained in the abstract, as well as additional data and information to be presented about the study at the ASCO Meeting, must not be disclosed before the findings have been publicly released in conjunction with the ASCO Meeting. If information from the abstract or additional study data are disclosed in advance of public release in conjunction with an ASCO Meeting, the abstract may be subject to rejection or removal unless an official Confidentiality Policy Exception applies (see below).
Prior Presentation/Publication Policy
The contents and conclusions of the abstract must not be presented at any scientific, medical or educational meeting of 500 registrants or more or be published in a scientific, medical or educational publication (in any medium), in whole or in part, before the ASCO Meeting. ASCO co-sponsored meetings represent an exception to this restriction on prior presentation and publication. Studies submitted to the Gastrointestinal Cancers Symposium, Genitourinary Cancers Symposium, Breast Cancer Symposium, Quality Care Symposium, or Palliative Care in Oncology Symposium, and other ASCO co-sponsored meetings where ASCO is the lead sponsor are eligible for acceptance even if previously presented or published in the scientific, medical or educational arena. Abstracts presented at these particular ASCO meetings may also be submitted for presentation at any other ASCO meeting. Authors are strongly encouraged to provide updated data in the abstract, as the novelty of the data will be taken into account during the abstract selection process. No new or updated data may be added to an abstract after it has been formally submitted unless it was formally submitted as a placeholder for a late-breaking data submission abstract.
Confidentiality Policy Exceptions
ASCO recognizes that certain federal and international laws require disclosure of certain clinical trial results 1) through federal and international registries within a certain time period of trial completion, or 2) in relation to drug approvals by federal and international regulatory agencies. Should disclosure of confidential information be required in either of these circumstances before ASCO makes the abstract public, the required disclosure will not be viewed as a breach of ASCO’s Confidentiality Policy.
Other than required disclosure for regulatory purposes as outlined above, exceptions to ASCO’s Confidentiality Policy require communication with ASCO in advance of any public release, and a minimum of 48 hours’ notice is requested. Specific inquiries about exceptions to ASCO’s Confidentiality Policy should be emailed. A Securities and Exchange Commission (SEC) Exception applies to the extent necessary to comply with securities laws. Specific information and guidance on the SEC Exception is available on ASCO’s Meeting website under Abstracts>Policies and Exceptions.
Other Exceptions to the Confidentiality Policy may be granted by ASCO in extremely rare circumstances for public health reasons or to meet the requirements of state, national or international government agencies. In these rare cases, requests should be emailed for step-by-step guidance.
Even if a Confidentiality Policy Exception applies or is granted, ASCO retains the right, in its discretion, to accept or not accept any abstract for the meeting on the basis of peer review and, once an abstract is accepted, to place the abstract or change its placement in the ASCO Meeting program depending on the extent of information released. If an exception applies or is granted, the study is unlikely to be included in the official press program for the ASCO Meeting.
ASCO Sponsored and Co-Sponsored Meetings Guidance for Exceptions to ASCO’s Confidentiality Policy
A research study is not eligible for inclusion in an ASCO sponsored or co-sponsored meeting (“ASCO Meeting”) if the data has been released publicly in a manner that does not comply with ASCO’s Confidentiality Policy.1 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.2 The Confidentiality Policy covers all abstracts, including placeholder abstracts for late-breaking data submission abstracts. Compliance with the Confidentiality Policy by all parties related to the abstract is the responsibility of the First Author, and the First Author will be held accountable for any violations of ASCO’s Policy.
There are several types of Exceptions to ASCO’s Confidentiality Policy and all require communication with ASCO in advance of any public release. A minimum of 48 hours’ notice is requested. All exception requests and inquiries should be emailed.
A publicly traded company may determine 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”). This need typically arises when there is a substantial likelihood that the information would be considered by a reasonable investor in the company to significantly alter the total mix of information made available to the investor.
In general, the abstract is still eligible for inclusion in the ASCO Meeting provided that the company submits to ASCO, in advance of the release
- Written notification, with a copy directed to the lead author of the abstract, of the time and manner of the company’s release; and
- 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.
If the submission is in order, the SEC Exception is self-executing and does not require pre-approval from ASCO. If an SEC Exception applies, the abstract is eligible to be peer reviewed and will not be rejected or removed from the meeting on the basis of a Confidentiality Policy violation. However, in the interest of effective peer-reviewed presentation and freshness of data at the Annual Meeting, ASCO retains the right in its discretion to accept or not accept any abstract for the meeting and, once an abstract is accepted, to place or change the placement of the abstract in the ASCO Meeting program depending on the extent of information released. When a press release has been released about an abstract based on an SEC Exception, the abstract is unlikely to be included in the official press program of the ASCO Meeting.
To the extent that the SEC Exception applies, partners of the company may, jointly or separately, issue a press release with the same information at that time. The abstract itself may not be released publicly by the company or lead author, as ASCO holds the copyright to the abstract.
Subject always to the company’s regulatory obligations, ASCO would strongly 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 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 preferences is available on ASCO’s Meeting website.
If the press release or press coverage conveys significantly more information than ASCO’s stated preferences and illustrated by the sample press release, the abstract may or may not be accepted into the meeting on the basis of peer review. If the abstract has already been accepted when the press release is issued, the abstract’s placement in the meeting program may be changed.
The exception will be publicly noted on asco.org once the abstract has been formally accepted to the meeting.
Other Abstract Exceptions to the Confidentiality Policy may be granted by ASCO in extremely rare circumstances for public health reasons or to meet the requirements of state, national or international government agencies (such as the FDA or international equivalents). In these rare cases, requests should be emailed for step by step guidance.
If data or other information from any abstract is released publicly in a manner that does not qualify for an 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.
1For abstracts previously presented at the Breast Cancer Symposium, Gastrointestinal Cancers Symposium, Genitourinary Cancers Symposium, Quality Cancer Care Symposium, Palliative and Supportive Care in Oncology Symposium or any other ASCO sponsored symposium, the Confidentiality Policy applies to new or updated data or information in the study.
2Most abstracts will be publicly available online at 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, etc. will be publicly available online at 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.