Prior Presentation/Publication and Confidentiality Policies Governing Abstracts for ASCO Sponsored/Co-Sponsored Meetings
When submitting an abstract or late-breaking placeholder to any ASCO sponsored or 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 Prior Presentation/Publication Policy and Confidentiality Policy on behalf of all parties involved with the study. The First Author is responsible for communicating the policies to all involved parties.
Trials in Progress (TPS) abstracts are excluded from these policies.
Prior Presentation/Publication Abstract Submission Policy
Prior to the ASCO Meeting, the contents and conclusions of the abstract must not be presented at or published in conjunction with any scientific, medical, or educational meeting with the following exceptions:
- Studies previously submitted to ASCO-led meetings and ASCO co-sponsored meetings (ASCO Meetings)i are eligible for acceptance even if previously presented or published in the scientific, medical, or educational arena. Abstracts presented at these ASCO Meetingsi 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.)
- Study results may be presented at closed (non-public) meetings, such as investigator or cooperative group meetings, so long as no meeting materials are publicly disseminated.
In addition, contents and conclusions of the abstract must not be published in a scientific, medical, or educational publication (in any medium), in whole or in part, before the ASCO Meeting. Pre-prints (non-peer-reviewed online comment drafts) are permitted before the abstract is submitted.
The Prior Presentation/Publication Policy remains in effect according to the following schedule:
- Publication Only Abstracts (e) – Until the time the abstract is publicly released by ASCO.
- Late-Breaking Abstracts (LBA), including Plenary – Until a time specified by ASCO in conjunction with the ASCO Meeting.
- All other abstracts – Until presentation at the ASCO Meeting; however, publication in a medical journal may occur any time on the day of presentation in the ASCO Meeting or thereafter.
Any abstract in violation of this policy may be subject to rejection or removal from the ASCO Meeting.
- Gastrointestinal Cancers Symposium
- Genitourinary Cancers Symposium
- ASCO Quality Care Symposium
- ASCO Breakthrough: A Global Summit for Oncology Innovators
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.
Once an abstract is submitted to an ASCO Meeting, the abstract and any study data to be presented at the ASCO Meeting are confidential. For late-breaking placeholders, the Confidentiality Policy does not apply until the study data is submitted to ASCO.
After the abstract is submitted to and prior to the abstract information being publicly released in conjunction with an ASCO Meeting, the author, coauthors, sponsor of the research, journalists, and others must not:
- make the information public, or provide it to others who may make it public (such as news media), 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.
Confidentiality lifts once ASCO publicly releases the abstracts in conjunction with the ASCO Meeting.ii Once the abstract is publicly released by ASCO, the Confidentiality Policy is no longer in effect, and authors are free to discuss their study findings publicly, although ASCO expects the formal presentation (including slides and/or poster) of the study data to be made at the ASCO Meeting.
If information from the abstract or additional study data are disclosed after abstract submission and 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).
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 advance communication with ASCO prior to any public release. Communication should be directed to CPexceptions@asco.org with at least 48 hours’ notice where feasible.
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 are detailed further below in the “Guidance for Exceptions to ASCO’s Confidentiality Policy” section.
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 directed to CPexceptions@asco.org for step-by-step guidance.
Even When a Policy Exception is Granted
Even when an Exception applies or is granted, ASCO retains the right, in its discretion, to accept or not accept any abstract for the ASCO 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.
Specific inquiries about exceptions to ASCO’s Confidentiality Policy should be emailed to CPexceptions@asco.org.
Guidance for Exceptions to ASCO’s Confidentiality Policy
A research study is not eligible for inclusion in an ASCO Meeting if the data has been released publicly in a manner that does not comply with ASCO’s Confidentiality Policy.iii
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 sent to CPexceptions@asco.org.
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, a letter signed by the company’s legal counsel that contains the abstract title, indicates the format/nature of the public disclosure, and advises 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. ASCO also requires that the lead author be copied on the request.
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 ASCO 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:
- summarize study data cited in the abstract in a qualitative fashion rather than providing specific quantitative information;
- avoid interpretations about the implications of the data for practice; and
- 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. Information that is also appropriate for a press release includes that which is already publicly available.
For companies’ convenience, a sample press release is available further illustrating these preferences.
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 ASCO 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 directed to CPexceptions@asco.org for step-by-step guidance.
ASCO does not grant Exceptions for preprint publications (non-peer-reviewed online comment drafts) occurring after abstract submission. Once an abstract has been submitted to the ASCO Meeting, preprint publications will be considered violations of ASCO’s Confidentiality Policy.
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.
ii Most abstracts will be publicly available online at ASCO.org approximately two weeks before the Annual Meeting, with Late-Breaking Abstracts (LBAs), including Plenary, becoming publicly available in conjunction with the Annual Meeting. Abstracts in the symposia listed above 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.
iii For abstracts previously presented at the following ASCO Meetings, the Confidentiality Policy applies only to new or updated data or information in the study:
- Gastrointestinal Cancers Symposium
- Genitourinary Cancers Symposium
- ASCO Quality Care Symposium
- Breakthrough: A Global Summit for Oncology Innovators