Amended 2013 Conflicts of Interest Policy Expands Requirements for Financial Disclosures

Get Permission

Richard L. Schilsky, MD

We feel this will add a greater level of transparency and will eliminate arbitrary or potentially biased decisions about what is relevant and what is not. Instead, the reader can decide if those relationships are important.

—Richard L. Schilsky, MD

The Society’s 2013 Policy for Relationships with Companies is scheduled to go into effect on April 22, with one large change to its original requirements. The policy will still require the full disclosure of all financial relationships by all authors; however, since announcing the new policy in April 2013, the ASCO Board of Directors made the decision to delay the enforcement of Section V of its policy.

Section V restricted the submission of original research to an ASCO educational program, scientific program, or ASCO journal if a first, last, or corresponding author had participated in the speakers’ bureau, was employed by, or held a significant ownership interest in a company sponsor of that research.

Instead, when the new policy goes into effect, ASCO will require the disclosure of these financial relationships, but will not restrict submission based on the responses. During the next 3 years, ASCO will gather information to learn more about these relationships such as how frequently they occur and whether they occur more frequently in certain research settings.

“Essentially, we are going to move forward with what we were planning to do if the policy had been implemented,” said Richard L. Schilsky, MD, Chief Medical Officer at ASCO. “The information gathered over the next couple of years will be brought to the ASCO Board, and a decision will be reached to go ahead with the full implementation or to modify it in some way based upon what we learn.”

Concerns Raised

After the announcement of the revised 2013 policy, several concerns were raised from medical leaders and scientists working within the pharmaceutical and biotech industry—many of whom were ASCO members—and respected national leaders from public agencies, Dr. Schilsky said.

Among the concerns were that the 2013 policy would restrict credible and innovative scientists working as employees of the pharmaceutical industry from submitting their work to ASCO meetings and publications. Additionally, there is an increasing amount of research of great interest to ASCO members that can only be carried out using proprietary databases and technology that these companies own.

“There were concerns that by limiting the roles of those authors, we would effectively limit the dissemination of their research to our members,” Dr. Schilsky said.

Changing Health-Care Landscape

When reconsidering the policy, the ASCO Board also took into consideration some elements of the changing health-care landscape in the United States. In recent years, there has been a steady decrease in funding from the National Institutes of Health that is changing the structure and support of scientific research.

With fewer funds available, more research is occurring inside pharmaceutical companies or is being conducted through collaborations between the research community and pharmaceutical and biotechnical companies, increasing the likelihood that there may be a relationship between a lead author and a corporate entity.

In addition, since the 2013 Policy was written, the Sunshine Act has been implemented requiring that commercial firms publicly report any payments or transfers of value to physicians.

“All of these things have made the landscape more complex than it has been in the past,” Dr. Schilsky said. “Given the landscape and the points raised about the author restriction policy, the ASCO Board ultimately decided that ASCO should take a step back and collect data before implementing the restrictions.”

Additional 2013 Changes

Authors should also be aware that the 2013 policy has broadened the requirements for financial disclosures for all research authors. The 2005 policy required the disclosure of financial relationships that the authors felt were specifically relevant to the submitted original research.

The updated policy requires a general financial disclosure by all authors of any compensation received for employment, leadership positions, consulting activities, speaking engagements, and expert testimony, as well as ownership interests, research funding, licensing fees, and royalties associated with intellectual property interests. 

“We feel this will add a greater level of transparency and will eliminate arbitrary or potentially biased decisions about what is relevant and what is not,” Dr. Schilsky said. “Instead, the reader can decide if those relationships are important.”

Abstract submissions and author presentations for the 2014 ASCO Annual Meeting will still fall under the 2005 policy. The 2014 Breast Cancer Symposium will be the first ASCO meeting under the 2013 Conflicts of Interest Policy. ■

© 2014. American Society of Clinical Oncology. All rights reserved.