What You Need To Know About Volunteering for a Phase 1 Drug Trial

Is Volunteering for a Phase 1 Cancer Clinical Trial Right For Me?

“Entering a phase one trial is a very generous thing to do for others, but it may foreclose other things for you. It may mean that other kinds of treatment are not as readily available to you. You may be passing up some types of palliative care that you need. And you need to think very carefully about your own needs and those of your family and friends. You should ask yourself – If I do this what am I giving up?
-Dr. Michael McDonald, Professor Emeritus of Ethics, UBC.

Only you can make the decision about whether or not to participate in a clinical trial. Before you make your decision, you will want to empower yourself with as much information as possible. Here are some suggestions:

  • Learn as much as possible about your disease.
  • Search the websites of the Primary Public Registries of Clinical Trials listed on the WHO Clinical Trial Platforms website for cancer clinical trials recruiting subjects.
  • Contact cancer information specialists at the various charitable organizations funding research for specific forms of cancer or the various provincial cancer agencies. They can answer many of your questions about cancer and clinical trials, and guide you to further information.
  • Talk about this information and how you feel about it with your health care team, family members, and friends to determine what is right for you.

Points to Consider about Participating in a Phase 1 Clinical Trial

  • Phase 1 cancer clinical trial volunteers are required to relocate to the near vicinity of the research centre for the first while – usually 30 days – to be close to the lab facilities.
  • Volunteers pay all costs incurred for transportation, accommodation, food, parking, etc.
  • Volunteers must agree to present themselves to the research lab many specific times during this initial testing period (Dave, Pat Maddocks’ husband, had 16 blood samples taken in the first five days of his being infused with a Phase 1 test drug).
  • You might be far from the comforts of home and your family and support network at this pivotal time in your life.
  • Volunteers are urged to be careful of exposing themselves to situations that might have flu and cold bugs present. This can leave you feeling isolated in a strange place.
  • In escalating the dose to the toxic level, many volunteers experience very severe side effects and sometimes death.
  • Ask yourself how participating in a trial might impact your quality of life and the life of your loved ones at this point.
  • What kind of treatment and experiences are you giving up by participating?

The incidence of fatal complications with Phase 1 drugs is high. Most people think that the issue is whether the drug ‘might or might not work’ and that the chances of it working are maybe 2%, 3%, or 5%. But the reality is that Phase 1 Clinical Drug Trials are conducted by escalating the dose or undertaking a new procedure until an intolerable toxicity is reached, at which point some patients do die. Often this reality is not really clear to a patient when they start a study.

Questions to ask the clinical trial doctor

If you are interested in participating in a phase 1 trial, you want to be fully informed. Here are some questions to ask the clinical trial doctor about: the Study, Risks and Benefits, Participation and Care, Personal Issues and Costs.

Questions to Ask about The Clinical Trial

  • What new product is being investigated in this trial?
  • Which type of cancer is this new product expected to be a remedy for?
  • How is this new product better than what is currently in use?
  • What is the primary reason for conducting this trial?
  • Is this an ‘escalating dose’ trial?
  • Is the primary goal of this trial to determine the lethal dose of this new product?
  • How exactly is the lethal dose determination arrived at?  
  • Which expert medical bodies have reviewed and approved this trial?
  • How many other volunteers have been involved in this trial?
  • What side effects/benefits have been experienced by them to date?
  • How many volunteers/cohorts are expected to be recruited?
  • Which trial cohort number am I being asked to join?
  • Who is funding/sponsoring this trial?
  • Can I have a copy of the sponsor’s/investigator’s brochure?
  • Is this trial registered on a public registry of clinical trials? Which registry?
  • Is the sponsor guaranteeing to publish the outcome of this Phase 1 trial within 6 months of completion?
  • Will the sponsor guarantee to provide me/my family with a copy of the published outcome?

Risks and Benefits

  • What are my possible short-term benefits?
  • What are my possible long-term benefits?
  • What are my short-term risks, such as side effects?
  • What are my possible long-term risks?

Participation and Care

  • What kinds of therapies, procedures and/or tests will I be required to undergo in order to qualify for this trial?
  • If I am accepted into the trial, how often will the investigational drug be administered to me?
  • What kinds of therapies, procedures and /or tests will I be required to undergo during this trial?
  • Will they hurt, and if so, for how long?
  • Will I receive as much medical care as a clinical trial subject as I would as an average terminally ill cancer patient?
  • Will I be able to take my regular medications while in the clinical trial?
  • Where will I receive medical care?
  • Will a fully qualified oncologist, certified competent in the management of clinical trial subjects, be my personal physician and readily available to me throughout this trial?
  • Will an equally qualified doctor, fully updated on this trial, be readily available to me 24/7 – holidays and weekends?
  • How will I be monitored throughout the trial?  
  • Will I be seen/contacted daily by the Phase 1 team?

Personal Issues

  • How could being in this study affect my daily life?
  • Will I be required to keep current a daily clinical trial subject’s diary?
  • Can I talk to other people enrolled in the study?
  • Will I be connected with local palliative care services?

Costs

  • Will there be any travel, accommodation, parking or child-care costs that I need to cover while I am in the trial?
  • Will I be provided, at no cost to me, over-the-counter remedies for such side effects as constipation, diarrhea, stomach upset, etc.?
  • Will I have to pay for any part of the trial such as tests or the study drug?
  • If so, what will the charges likely be?
  • What is my health insurance likely to cover?

Tips for talking to the research doctor

When you talk with your research doctor or members of the research team:

  • Consider taking a family member or friend along, especially if they have medical expertise, for support and for help in asking questions and recording answers.
  • Plan ahead what to ask—but don't hesitate to ask any new questions you think of while you're there.
  • Write down your questions in advance, to make sure you remember to ask them all.
  • Write down the answers so that you can review them whenever you want.
  • Even if you write down the answers, also use a small, inexpensive digital voice recorder to have an easy to review version of interviews – voice inflections affect the meaning of words and your off-the-cuff questions will be effectively noted.

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