During the 2025 San Antonio Breast Cancer Symposium (SABCS), I had the privilege of participating in a panel discussion that was a collaboration between the Alamo Breast Cancer Foundation, the Metastatic Breast Cancer Alliance (MBCA), the American Association of Clinical Research (AACR) and the Advanced Breast Cancer Global Alliance (ABCGA). Dr Fatima Cordoso and Teri Pollastro were the moderators, Dr. Mariana Chavez MacGregor from MD Anderson was the keynote speaker, and in addition to myself, Kirstin Spencer from METUPUK was a panelist. The title of our discussion was, in part, Demystifying Clinical Trials.
This post is the second of two and you can access the first post addressing finding clinical trials here: Finding Clinical Trials. If you haven’t had a chance to read/watch it, I’d highly recommend it, especially if you are a patient interested in finding clinical trials to participate in. I’ve not been able to locate the full recording online of the panel, but will keep an eye out for it. I do have some snippets from our discussion that are particularly important to me.
Here’s the snippet on what every patient needs to know about informed consents:
Here’s a little more about what I think patients need to look at in informed consents in the few minutes I had to speak:
- Every informed consent for medical care (for clinical trials or otherwise) is an important legal document and needs to be treated as such. The title itself assumes that you are informed (i.e., you understand what you are agreeing to), so be sure you know what you are agreeing to. One practical suggestion is to ask for a copy of the informed consent document in advance of the meeting where you are expected to sign it so that you have time to review it carefully and with anyone you want to know about it. I highly recommend you have at least one other person look it over — two pairs of eyes are always better than one and your caregiver should be on the same page as you are in agreeing to participate in a clinical trial.
- Do not take on the responsibility for negotiating or changing the informed consent (unless you want to and have the bandwidth to do so), but know what you are signing because you and your family may be bound to legal implications beyond just your current treatment.
- If you are enrolling in a clinical trial, from my perspective both as a legal professional since 2002, although I’ve had to officially retire, and a patient participant myself, it is important to know the following (and yes, in the video above I forgot how to count to 5, I’m blaming chemo brain for that):
- Know how many and how long each appointment is anticipated to last. Hopefully you will be able to participate in the trial for a long time and it is important to know if participation is sustainable. Be realistic and consider all of the other things you have to handle as a human being. Some organizations purchase sufficient access to Epic that allow the patient to see in your patient portal how long each appointment is contemplated to last, but if your trial location didn’t, then you may have to ask. I also try to get an idea about how long as a patient I’d be expected to wait but have been surprised at times when I wasn’t told all of the elements that could cause delays — now, I always ask the timeline that the pharmacy has to prepare medication after my arrival, which has been up to 2 full hours after the time of my appointment at various locations making my appointment last much later than I expected.
- Know what you as an individual will be reimbursed for and what expenses you will likely incur in order to participate. Don’t forget travel expenses, parking, food, overnight stays, etc. Don’t forget to factor in the cost of you being gone will have on your family — i.e., who takes care of children or pets or other responsibilities when you are at an appointment. All of these things cost you something and are not always reimbursed by the sponsor. There are some other organizations that will help with these out of pocket costs, but you need to know what you are incurring to be able to ask for reimbursement.
- Know what your insurance company will be responsible for and what the sponsor will pay for — often the sponsor will only pay for the experimental medication and your insurance company will be billed for anything considered Standard of Care (SOC). SOC usually includes bloodwork, scans, exams, etc. You will still be responsible for your deductible, co-pays and co-insurance when your health insurance company is billed for SOC items. Watch carefully for whether the blood work or scans or other surveillance in the trial is the same or different from your current norm so you know how to compare.
- Know what happens to your access to the experimental medication if the trial moves to a new phase and/or the sponsor applies for FDA approval while you are still in the clinical trial. If the medication is working for you, you won’t want to endure a lapse in treatment and the informed consent is supposed to address this situation.
- Know if there are legal rights you are waiving in order to participate in the clinical trial — for instance, you and/or your legal representatives may be unable to file a malpractice or wrongful death lawsuit under certain circumstances.
I didn’t capture in the video included above how Dr. Chavez chimed in after I spoke about how an informed consent for a clinical trial may include other elements outside of the specific clinical trial at the end, so to be sure you know if you are agreeing for your data or tissue or blood to be used in different ways. This is not to say that there would be an issue with this request, just know what you are agreeing to.
The bottom line overall is that an informed consent will often be utilized to cover access to information or data or pictures or something outside of actual medical care. A medical system’s ability to utilize pictures of me (or my children) is a hot button issue for me, but maybe that’s not an issue for you. Whatever it is, just be aware of what you are agreeing to, what you are signing, and ensure that your family/caregiver is aware of what you’ve agreed to.
The resources I discussed at the end of the video above are truly close to my heart. The first is Triage Cancer, which is a national non-profit providing legal direction and information to cancer patients of all kind (we call this “pan-cancer”). I mentioned during the video that they have a legal and financial navigation program, both of which give cancer patient’s access to a staff attorney’s guidance, among many other resources. The second are the monthly Legal Clinics at Project Life, which I oversee, for Stage IV Metastatic Breast Cancer (MBC) patients and their caregivers.
I do realize that the financial toxicity of cancer treatment often renders us unable to access resources and if there are other legal resources you have found helpful, please feel free to comment!
Next up — hard won information on ports from the perspective of someone who has her third (3rd) port, dubbed Portia the Equalizer.
No Half Measures 