Patient-centric Informed Consent: Weighing in on Product and Process

Patient-centric Informed Consent: Weighing in on Product and Process

Posted by Bonnie A. Brescia

B_Brescia_1_print.jpgAbout this time each year I blog about how much I hate cancer. This year, it’s a bit tougher as my father was diagnosed with advanced head and neck cancer in June. Once again I am reminded about the difference it makes to be knowledgeable about clinical trials when making treatment decisions. We ask more questions. We explore more options. We filter what we hear through experience. And, we know when the informed consent process isn’t being done well – or even in compliance with regulations.

As we explored my dad’s options for providers as well as treatment courses, he was presented with two clinical trials to consider. One was fairly simple and involved collection of blood samples weekly for eight weeks. The other was a much more complex, open-label study involving an active compound, multiple biopsies, and even more blood draws.

Study one was introduced to us this way: “There is a clinical trial that we enroll all of our patients in, so I need you to sign this document now authorizing us to draw your blood. I put the order in for them to come draw the blood and someone will be here in a few minutes.” I let this pass while I reviewed the ICF. It was a very straightforward document – fairly easy to read, not too long, clear about the objectives of the study. In fact, it was what we often hear an ICF should be – patient-friendly, patient-centric. He signed the document and the phlebotomist walked in shortly thereafter. I asked the doctor for a copy of the signed ICF with his signature. “I’m not allowed to sign this,” he said. “But you are the one who consented him,” I countered, “You can’t have someone who didn’t consent the patient sign the document.” “But the investigator isn’t in the building.” “Well, since you cannot start the study procedures without both signatures on the ICF, we’ll wait for him to come back,” I suggested. And even though I know better, when I looked at my father and his stressed, exhausted face, I let them take the blood with the promise of getting the fully executed document to us tomorrow at our next visit.

Study two was introduced to us this way: At our initial visit with the lead oncologist, he mentioned that there was a clinical study underway that might be appropriate. “We’ll revisit it once we have a better handle on what kind of cancer we’re dealing with.” At our visit with the medical oncologist, she referenced the same study and set a date for us to talk in more detail about it after the tumor was typed. She provided us a reference to the study compound and gave us the study ID number in case we wanted to look into it on Clinical At that subsequent visit, after all the histories were updated, the exam performed, questions asked and answered, she turned to the subject of the study. We had a very thorough discussion about mechanics, logistics, fears about a second biopsy, impact on subsequent treatment, risks. When my dad asked about the benefits of the study and the likelihood that it would improve his chances for full recovery, the physician skillfully responded: “Here is why I think this study might be one for you to consider,” and she continued with a review of how the approved compound is used in other cancers, the types of cancers the other patients in the study had and how his subtype would be very helpful in enhancing the analysis. She clearly and thoughtfully talked about his chances for cure without the study participation. I was extremely impressed with her skill in this regard. And then she handed me a 30-page ICF to review.  While I read the document, she continued the discussion with my father, clarifying that he could withdraw from the study at any time, how he would need to coordinate participation with his primary physician and his cardiologist. How she and her team would keep the radiation oncologist in the loop.

After a thorough read, I told my father that he could sign the document if he was ready to commit to the study. Or he could wait and talk it through with my mother again. He decided to do both. He signed the ICF and then told the doctor that if the biopsy couldn’t be done by needle, he’d pass. She took on that assignment, countersigned the ICF, and they had a partnership well established.

At the same institution, within the same week, we had two extremely different experiences with clinical trial participation. Even accounting for the simpler requirements, Study one had the far more patient-focused ICF. Study two – the far more patient-centric process. Although they’re not mutually exclusive, I’d take the better process, well-trained investigator’s approach to study introduction and consent with a thick ICF any day.

Treatment ends this week and we begin the waiting game. I’ll be watching for how post-study communication manifests itself – and will keep you posted.

Topics: Patient Centricity, Clinical Research, Clinical Trials, Informed Consent