Consent Form Info

Once you have expressed interest in participating in a Phase 1 clinical trial, you will receive a lengthy consent form to read and sign. Here are some questions you may want to discuss with the head researcher and your Phase 1 Research Team.

About the Principal Investigator (PI)

It is a governmental requirement that a health care professional, most often a physician, be in charge of a clinical trial at every centre in which that trial is performed. This individual is referred to as the Principal Investigator (PI).

There is always a  Principal Investigator for the overall clinical trial as well, but that individual may not be at the site at which your data is being gathered.

After you know who your Principal Investigator is, here are some questions you might want to ask:

  • Is the PI really a resource for me?
  • Is the PI actually one of the members of my Phase 1 team assigned to oversee the collection of my data?
  • Can I meet with the PI (so you can ascertain directly from that person exactly what your relationship is)?
  • Is that PI someone I can turn to if I do not feel that my concerns are being addressed?

Emergency Contact Numbers

You are not a medical person and are coping with a totally new experience. Therefore, you are not equipped to determine if your situation is an 'emergency' or not.

Tell your Phase 1 team that you are going to define 'emergency' as anything that occurs that is not normal for you.  For instance, the disappearance of edema may seem to you to be an improvement but can in fact be an important indication of dehydration that needs attention.

Question to ask:

Does the person with whom I will be connected when using the 'emergency' number have the authority to respond immediately even if it happens to be 2 o'clock in the morning?

Most Responsible Physician

You will be assigned a physician who is responsible for supervising the care you will receive during the time you are participating in the clinical trial. He or she is referred to as your Most Responsible Physician (MRP). Before the trial begins, you should determine who your Most Responsible Physician will be.

Questions to ask:

  • I am assuming that my MRP is a fully qualified oncologist. Has my MRP undergone training specific to managing clinical trial subjects? Does he/she have accreditation for this research role?
  • Is the focus of my MRP on my personal well-being or on obtaining data to further the progress of the sponsor’s new product?
  • If my MRP is going to be away or if he/she will be assigning another doctor to oversee my care, can I be informed of this prior to the change-over?
  • Is the new MRP a fully qualified oncologist or a student/resident doctor?
  • Will any new MRP be required to be familiar with this Phase 1 trial and have read the sponsor’s/investigator’s brochure?
  • If the MRP is a student, then can I have the name of his/her supervising oncologist and that person’s contact number?
  • If the MRP is a student, will his/her supervising oncologist be fully informed about this specific trial?

Purpose of the Study

Understand that the purpose of the study is to determine the likely toxic dose. Once that has been confirmed, researchers can back-track to establish the maximum tolerated dosage (MTD) – the highest dosage of the drug that can safely be endured by a human being. Though a Phase 1 trial is usually referred to as a safety study, in the interests of promoting full disclosure, a Phase 1 cancer clinical trial should logically be designated a toxicity study.  

Questions to ask:

  • Can you provide me with complete details on the adverse effects (AEs) experienced by each member of the cohort preceding the one I am enrolling in?  
  • What severe adverse effects (SAEs) am I likely to experience should I end up in the cohort that receives the drug dose higher than the MTD?
  • How are these side effects estimation  arrived at if this is the first time this drug has been given to human beings?
  • Are the remedies suggested in this consent form the only ones available or are there additional ways to counteract the possibility of encountering severe adverse events (SAEs)?
  • Will the standard of care that I receive as a Phase 1 clinical trial subject be, at a minimum, equal to the guidelines for medical care given to a normal cancer patient exhibiting similar AEs/SAEs?
  • If I die during my participation in this Phase 1 trial, it would seem logical that an autopsy would need to be performed in order to determine if my death had been caused by my underlying disease or by the test drug. Is an autopsy automatically performed or is permission from my next of kin required?
  • Is this institution responsible for collecting and collating the data from this trial for the sponsor or is another contracted entity involved?
  • This form states that I am likely to get no personal health benefit out of this Phase 1 trial but that my participation might benefit others. What concrete steps have and will be taken to ensure that the data from this trial has and will be made publically available — to the world medical research community, medical personnel and society?

Plan of Treatment

Questions to ask:

  • Exactly how will I be "watched very closely?"
  • Will the research doctors examine me in person or just look at my lab results?
  • Do the many blood tests that I am submitting to constitute the primary monitoring mechanism for determining my well-being?
  • Is there a clinical trial subject diary that I will be required to maintain? How often will the Phase 1 team review it?
  • How often will I actually have a physical, head-to-toe assessment made of my person during this trial?
  • In the normal scheme of things, how often does the MRP plan to meet with me to discuss my situation?
  • Are there any services for emotional, psychological or spiritual support available to me or my personal caregiver?
  • If I do not feel that my concerns are being addressed fully by my Phase 1 team, who can I turn to for a second opinion?
  • I have signed a Do Not Resuscitate (DNR) form. However, it must be important, in the interests of maintaining the integrity of this trial, for researchers to be able to do everything possible to remedy SAEs caused by the test drug. Is my DNR still relevant while I am participating in the trial?
  • Will I be issued a bracelet/card with contact details for this institution and names of the chemical compounds used in this trial and which identifies me as a Phase 1 subject?

Possible Side Effects Estimations

The Consent Form lists possible side effects and their likelihood. How are these percentages arrived at if this is the first time this drug has been given to human beings?

Confidentiality

Questions to ask:

  1. Does Health Canada keep complete records of all Phase 1 clinical trials conducted in Canada? (e.g. the name of each study, where the study occurs, and the outcome for each member of each cohort.)
  2. Is there any legal need for me, as the trial subject, to refrain from communicating my Phase 1 trial experience to others?

Health Canada's Involvement in the Study

Though in this section of the consent form, Health Canada (HC) is mentioned along with the U.S. Food and Drug Administration (FDA), in reality Health Canada is not closely involved.

Most Canadians are well aware of the FDA and its power in the U.S. and we tend to assume that we have a similarly 'hands-on' equivalent in Canada.

However, Health Canada is much less involved with monitoring clinical trials in Canada than the FDA is with trials in the United States. Do not assume that your Phase 1 trial is of great interest to Health Canada. You can contact Health Canada – Therapeutic Products Division – to ascertain the extent of Health Canada's role in governing your particular Phase 1 trial.

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