Can You Keep A Secret?
This is a column that's not all that fun to write. It might even be less fun to read. But, it's important.
Health care providers, at all levels, have to be able to keep secrets. We’re pledged to confidentiality with our patients’ protected health information, of course. But as clinical researchers, we’re also pledged to additional bonds of confidentiality – to our patients, to our research collaborators, even to the journals that publish our results.
Among these obligations, the NCI–Network Group–Industry Relationship Guidelines specify that:
All protocol documents … for studies utilizing investigational agents under a collaborative agreement are also confidential and must not be shared or distributed without the permission of the NCI.
“All protocol documents” is pretty broad, and it covers most materials posted to a trial’s page on the CTSU website. The “Ethical and Regulatory Considerations” section of each SWOG protocol reiterates this expectation of confidentiality:
Please note that the information contained in this protocol is considered confidential and should not be used or shared beyond the purposes of completing protocol requirements until or unless additional permission is obtained.
When it comes to the results of a trial, I think we’re all aware of the need for keeping them confidential until they’re formally published in a journal or presented at a conference.
As a SWOG member, though, there are several ways you may learn something about trial results without necessarily considering that you’re still bound by that expectation of confidentiality:
- via co-authorship on a manuscript or abstract (okay, this one is pretty straightforward)
- via privileged access to information that a manuscript has been accepted for publication or even just submitted
- via discussion in a committee meeting or another group meeting session
- via results-related correspondence, such as a “Dear Investigator” letter, posted to a trial’s page on the CTSU website
I do acknowledge, while we’re pledged to maintain confidentiality, we’re first and foremost pledged to offer the best care possible to our patients. At times, this means making study results available to them and their doctors even before those results have been published, typically via “Dear Patient” and “Dear Investigator” letters.
You should know that even if the results are already being used to provide the best possible care to patients, if those results haven’t been published, they shouldn’t be publicized – via social media or any other public forum (and organizations do patrol these venues for embargo violations).
I know this can seem at times like a minor difference and that it reflects excessive caution, but journals and professional organizations take this obligation of confidentiality very seriously. I have seen – more than once – abstracts that had been accepted for presentation at an ASCO plenary session pulled from the plenary program because of a confidentiality breach. Don’t let this happen to you (or us!).
On SWOG’s end, we’re working to ensure all documents we produce that are confidential are clearly labeled as such. We’ve also strengthened our messaging about expectations of confidentiality in our training materials for investigators, oncology research professionals, and staff.
I encourage you to read through SWOG Policies 21 and 24 for details on our confidentiality expectations related to the release of trial results (21) and to publications generally (24) (now that I mention it, I encourage you to take a look at the full set of SWOG policies – as a member, you are expected to adhere to them).
If you’re not sure whether a document or piece of information should be considered confidential, please reach out and ask: email@example.com. All inquiries will remain confidential.
There! I’m sure we all feel better now. Have a wonderful weekend.
Trial of the Week
S2207: Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients with Relapsed/Refractory Large B-Cell Lymphoma
This week’s trial has just been activated – the S2207 study in patients with relapsed or refractory large B-cell lymphoma (LBCL) who are either ineligible for a stem cell transplant and CAR T-cell therapy or who have relapsed after one of these.
The trial tests adding one of two targeted agents – tazemetostat or zanubrutinib – to a standard therapy combination of tafasitamab plus lenalidomide.
The first 24 patients enrolled will take part in a safety run-in to determine the recommended dose of each targeted agent when given in conjunction with tafasitamab plus lenalidomide. Patients enrolled after the safety run-in will be randomized as part of the phase II portion of the trial to one of three regimens:
- tafasitamab plus lenalidomide only
- tafasitamab plus lenalidomide with tazemetostat
- tafasitamab plus lenalidomide with zanubrutinib
The primary endpoint is progression-free survival, but the trial will also track patient-reported lymphoma symptoms and quality of life measures.
Jennifer Amengual, MD, of Columbia University, is the S2207 study chair.