Fielding Clinical Trial Patient Questions for PhDs

Simulation co-authors – Gozde Ulas, PhD and Thi Nguyen, PhD

Simulation vetted by professionals from McKinsey & Company, Genentech, UAB, and UCSF Office of Innovation Ventures

Simulation Objective:

Answer a Potential Enrollee’s Questions About a Study

Associated Simulation Library:

Background

The Clinical Research Coordinator (CRC) is a specialized research professional whose goal is to ensure the smooth and accurate progress of clinical studies. A CRC is involved in all stages of a clinical study from the planning and approval stages to study completion and post-study closure.

One of the main roles of a CRC is to obtain consent from potential study participants. In the first visit, a CRC will go over what it means to be part of a clinical trial, the scientific principles of the study, the organizational details of the trial (drug administration, length of potential hospitalization, etc), and the possible outcomes of the study. During this time, the CRC has to be available to answer all potential participants’ questions. Obtaining the consent is not limited to getting a signature on documents, but is an evolving process according to a patient’s needs and events that may occur throughout the trial. A participant can withdraw his/her involvement in the clinical trial at any time.

The CRC can schedule specific appointments with the participant to answer his/her questions via phone or email. The CRC needs to be able to respond to questions professionally, but with empathy and while ensuring privacy. An important consideration to keep in mind is that patients are likely to come from a wide variety of backgrounds and ages, therefore, the CRC’s language must be easy to understand and respectful.

The Process

  • A patient is introduced to the possibility of taking part in a clinical trial by his/her physician. If the patient shows interest, the physician refers the potential participant to the clinical trial team.

  • Following physician referral, it is the responsibility of the CRC to keep in contact with the patient and to organize the patient’s appointment schedule.

  • The first step after referral is to obtain signed consent from the patient. Without a patient’s consent, no examinations or other medical procedures can occur.

  • Before a patient is officially enrolled in a trial, his/her eligibility need to be assessed according to procedures highlighted in the protocol.

  • For this assessment, the participant must undergo a series of medical examinations specified in the study protocol. Only after it has been confirmed that no exclusion criteria are encountered, and that all eligibility criteria have been met, can the patient officially enter the trial and the administration of the drug(s) can commence.

Resources

The Exercise

Field a patient’s questions related to the study protocol and her experience in the study. Part of a clinical research coordinator’s job is interfacing with current and potential enrollees.

For this exercise, you are the CRC in a team running an active Phase III randomized study that will compare the efficacy of the combination of two immunotherapy drugs to a single therapy in the context of untreated unresectable or metastatic melanoma.

Scientific Background

Nivolumab and Ipilimumab are novel biological drugs called checkpoint inhibitor antibodies. Nivolumab is a human anti-PD-1 antibody, while Ipilimumab specifically recognizes human CTLA-4. Both PD-1 and CTLA-4 are immune-inhibitory receptors that dampen and downregulate the functions of the immune system, particularly of T cells. In the context of cancer, PD-1 and CTLA-4 prevent the proper activation of T cells, hindering T cells from attacking and clearing cancer cells. Nivolumab and Ipilimumab block the interaction of the receptors PD-1 and CTLA-4 with their targets, thus enabling proper T cell activation. Blockade of PD-1 and CTLA-4 allows T cells to fulfill their cytotoxic function against cancer cells.

Additional Information on the study at hand:

Task 1 - Answer Questions

You recently met with Jane Micro, a 63 year old potential new participant for the study on which you are currently staffed. You have discussed the fundamental points during the first interview, but she asked for some time to consider her decision. This morning, you received an email from her with questions regarding the study.

Answer all her questions in the email below in a comprehensive and clear manner, so that she can fully understand the response. Remind her that participation in the trial is voluntary and that she can withdraw her consent at any time.

Please use an abbreviated version of the study protocol to answer the questions. If needed, you can refer to the full, unabbreviated protocol to get more information about ethics requirements and adverse effects..

Email from Patient

August 1, 2022

From: Jane.Micro@abc.om

To: Samantha.Pico@ucsf.edu

Subject: Question on Phase III clinical trials

Hi Dr. Pico,

This is Jane Micro. I wanted to thank you for the time you dedicated me the other day. I have to admit everything was quite overwhelming, and I needed a few days to think about what you said.

While going through this process, I found I have a few additional questions. You already answered many of them during the first consultation, but I would like to make sure I do understand everything before signing my consent and taking part in the trial.

I understand I need to give my consent to be enrolled in the trail before I can take the medication. What are the first steps before I can take the drug?

How does it work in case I don’t want to be part of the study anymore? Can I withdraw my consent? What does that imply?

I also would like to better understand the chances of this drug helping me or curing me. Is that a realistic possibility? If there is a benefit for me from the drug, will I be able to continue taking it after the trial is done?

One aspect I have always been concerned of when taking medication is the possibility of side effects. What kind of side effects could I experience? How bad can they get? If I experience side effects, will you cure me or do I have to rely on my physician?

Also, if I remember correctly, for the administration of the drug, I will need to come to the hospital, am I right? Could you please walk me through these steps once again?

How often will I have to come to the hospital and how long will the whole process last? Will the drug or the delivery be painful? Will the drug impair me somehow? Will I be able to continue my normal life? I would like to make sure that I can still take part in my family’s activities as much as possible.

I was also wondering how high are the chances that I will be given a placebo and not the real drug. I think this is all for now. Thanks again for your time.

Best regards,

Jane

Deliverables

Task 1

Craft an email in response to the patient’s questions. The email needs to touch all the topics raised by the patient. The tone of the email response needs to be professional and empathetic.

After completing the deliverable, review the publication about the results of this clinical trial to gain additional knowledge about the field of immunotherapy, read about the efficacy of this drug trial, and get a sense about how well these types of therapies work. The paper also includes summaries of adverse effects from taking the drug.

Sample Responses

Will the drug or the delivery of the drug be painful?

Based on previous experience, there should not be any discomfort from the infusion of the drug except for the application of the IV. However, if any pain or discomfort arises, the clinical trial nurse on site will be able to assist the participant. Immunotherapy drugs are usually not related to infusion discomfort, unless there is an adverse effect to the drug. In most cases, the pain is related to the cancer, not to the drug itself.

Will this drug cure me?

There’s not any conclusive evidence that the drug would cure your disease, but the data we have collected so far indicate there’s a significant response for participants in previous trials. We’ve observed a X% increase in X indication.

When should I contact the CRC or the physician?

It is essential to the trial that every adverse effect is reported, regardless of the severity of the event (from headache and fatigue to diarrhea). The participant will have the contact information of the CRC, the clinical trial nurse, and the clinical trial physician. Usually, it is recommended to first contact the CRC or the nurse who can then give instructions to the participant and refer the participant to the physician. Adverse reactions may also be reported directly to the physician. If the participant is physically located close-by a clinical site, s/he might be called in to report at the clinical site location. If this is not an option, the physician will give instructions to the participant over the phone (i.e. go to the local ER).

Additional Tasks

  • Collect samples from the patient and deliver them to the research laboratory for analysis

  • Keep track of the status of all the patients and update colleagues and the clinicians involved in the study on the status of the patients

  • Assist in writing and reviewing study protocols

Skills Used to Perform this Task

  • Communicating clearly and professionally via email

  • Communicating to people with diverse backgrounds

  • Simplifying complex information for a lay audience

  • Interpersonal skills – empathy

  • Anticipating patients’ answers by putting yourself in the shoes of the patient and anticipating what they may ask

Skills Used in the Field

  • Excellent organizational skills

  • Excellent communication skills

  • Multitasking

  • Quick problem-solving

Learn about competencies for CRCs from The Association of Clinical Research Professionals

To view detailed lists of skills in job descriptions for policy careers, please see workforce data generated by Boston University’s BEST program.