Demystifying the Clinical Trial Experience: A Conversation with Sandy Gilbert

March 25, 2015Sandy Gilbert recently joined CAF as our Patient Outreach Director. Below, we speak to Sandy about a special aspect of her job: acting as a resource for patients who are curious about clinical trials. Sandy can be reached at 212-279-8090 X 207.

CAF: You are working with patients to help them learn more about clinical trials. What kind of information are you providing to patients in this area?

Sandy Gilbert

Sandy Gilbert

Sandy: I’ve updated the clinical trial listings on the CAF website so that patients can easily browse a complete list of all thalassemia trials in the U.S. The trials are organized by topic area to help patients locate the trials of greatest interest to them. For example, there are clinical trials in progress which are investigating curative approaches to thalassemia such as gene therapy. Other trials are designed to assess the safety and effectiveness of experimental iron chelators, or of combination chelator therapy. There are also observational studies in which patients’ outcomes are simply monitored over time, without making any changes to their treatment plan. The trial listings on our website include links to more detailed descriptions of each study. This is a good starting point to obtain basic information about a wide variety of thalassemia trials.

In addition, when a new clinical trial opens up, I try to notify our patient community by posting the information on the CAF website and Facebook page, and by emailing patients on our mailing list. Even for those patients who cannot enroll for one reason or another, it may give them a great sense of hope that new treatment options may be available sometime in the future. When preliminary results from ongoing clinical trials become available (which usually happens during presentations at major medical congresses), we discuss them with our Medical Advisory Board and inform our patient community of the findings.

You are helping patients formulate questions to ask site investigators about possible clinical trials. Why do you think this is important? What kind of questions might a patient want to ask?

SandyPraiseParticipating in a clinical trial is a serious decision which may involve some risks. Patients who are thinking about participating in a clinical trial have the right to ask the study doctors and nurses any questions they have about that trial. Patients should continue asking questions of the medical team until they feel that they understand any risks to which they might be subjected while participating in the trial.

I recommend that patients make a full list of all questions they have about clinical trial participation before they visit the doctor conducting the study. This may include financial questions in addition to health-related questions. Some key questions a patient might want to ask include: (1) Do I qualify to participate in this study? (2) What will I be asked to do if I participate in this study? (3) How long will the study last? (4) Will some patients be receiving a placebo or alternative treatment? (5) What has been learned about the study treatment so far? (6) What are the potential benefits of participating in the trial? (7) What are the side effects and potential risks? (8) If I were to experience medical complications during the trial, what kind of medical treatment would be offered to me? (9) What other options, besides this study, are available to me? How do these options compare to this clinical trial? (10) Will I be able to keep seeing my own doctor? (11) What would happen if I decided to leave the trial for some reason? (12) Do I have to pay for any part of this treatment? If so, will my insurance cover these costs? (13) Is there any reimbursement for the travel costs involved in getting to the clinical trial site? (14) If the treatment works for me, will I be able to continue using it after the study has been completed?

What can you say to a patient who might be hesitant to ask questions of a site investigator?

Research studies are very complicated, so it is important that patients learn as much as possible about a study before consenting to participate in it. The medical team is obligated to discuss all relevant information about the study – such as its purpose, its potential risks and benefits, and the procedures that will be performed – with potential participants. However, it is the responsibility of the patient to ask questions about anything he/she does not understand. The medical team may simply assume that a patient has understood everything if he/she doesn’t ask many questions. In case English is not a patient’s first language, the patient should request that study documents be provided in his/her preferred language. The patient can also ask to have an interpreter present to translate conversations with the medical team.

StagesofClinicalDevelopmentIf patients would like some additional background information and preparation before meeting with the doctor conducting the study, they may want to speak to their regular physician first. Thalassemia patients are always welcome to call me, also, to have a “starter conversation” about clinical trial participation (212-279-8090 X 207). We might begin with a general discussion of the clinical trial process, since that is not familiar to most people. Then we can review some of the specifics of the particular trial they are interested in, such as the inclusion and exclusion criteria (which determine whether a patient does or does not qualify for the trial). We can also review the location of the clinical trial sites to see whether or not they suit the patient. This might help patients to feel more knowledgeable and more prepared when they do have that important conversation with the study doctor. I can also help patients to start making a list of some key questions to ask the study doctor when they meet with him/her.

Briefly, can you talk about what informed consent is?

Informed consent is a voluntary agreement by the patient to participate in medical research. By signing an Informed Consent Form, a patient acknowledges that he/she understands and accepts all aspects of the clinical trial – including any risks or benefits. Patients should not sign the Informed Consent Form until all of their questions and concerns have been addressed. Adult subjects providing informed consent must be 18 years of age and competent to make the decision to participate. When children/minors are included in studies, the parent/guardian must sign a parental permission consent document.

Patients do not need to sign the Informed Consent Form during their initial meeting with the doctor who is conducting the study. Instead, patients are welcome to take a copy of the Informed Consent Form home to review when they are not under time pressure. After discussing the trial with family/friends/other medical professionals, they may find that they have other questions or concerns that did not arise during their initial visit. Patients should take as much time as they need and continue asking questions until they are ready to make an informed decision whether or not to participate in the trial. If trial participation still seems like the right choice after careful consideration, then the patient can sign the Informed Consent Form and enroll in the trial. Importantly – even after a patient has consented to participate in a trial – he/she still has the right to withdraw at any time. Clinical trial participation is always voluntary.

What else would you like to say about how you are working with patients considering a clinical trial or about the clinical trial process?

There is always uncertainty in deciding whether or not to participate in a clinical trial. The doctors in charge of running the study do not know how it will turn out in the end (which is why they are conducting the study in the first place). For that reason, they don’t have a simple answer to a patient’s question: “Should I take part in this clinical trial?” There isn’t a right or wrong choice in deciding whether or not to participate in a clinical trial. The decision is a very personal one, and depends upon many factors such as perceived benefits versus risks, as well as a patient’s goals for the future. The decision also depends on individual values, preferences and priorities. Knowing as much as possible about a particular clinical trial can help patients feel better about their decisions. And for patients who do decide to take part in a trial, this knowledge can help them know what to expect and what to look out for once they have enrolled.

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