Research with Respect Press Room
 Free service supports terminally ill cancer patients
participating in Phase 1 clinical research
Toronto, Ont., Oct. 14, 2008 – Research with Respect, a new program designed to improve the
quality of life of terminally ill cancer patients participating in Phase 1 clinical trials, is being
introduced today. The program was developed by Bayshore Home Health, Canada’s largest
provider of home and community health care services, and ‘Bear Ring “U” ‘n Mind,’ a national
charitable foundation.
Phase 1 clinical trials are the first time that people are used as test subjects in the development of
an experimental cancer treatment. The purpose of a Phase 1 trial is to establish the maximum
dosage that a human body can tolerate so that a safe dose can then be determined.
“Phase 1 participants make a key contribution to the world-wide search for a cure for cancer,”
says Pat Maddocks, founder of the ‘Bear Ring “U” ‘n Mind’ Foundation. “It is only because these
brave people have stepped up and donated their living bodies to medical science that cancer
patients, today and in the future, have a greater chance of beating this terrible disease.”
Volunteers participating in Phase 1 trials are especially vulnerable. They have many unique needs
in coping with their disease and their participation in experimental research. Currently, Phase 1
cancer studies are conducted in only nine major cities in Canada. Clinical trial volunteers are
required to locate themselves close to these centres for a significant period of time. ‘Research
with Respect’ will provide care support to volunteers as they participate in Phase 1 trials during
the time they spend away from home.
Bayshore Home Health developed the clinical guidelines for the ‘Research with Respect’
program. The company drew on its extensive experience in community care and adapted its
protocols to help volunteers in Phase 1 trials. Bayshore Home Health will also provide registered
nurses who will work with trial volunteers to improve their quality of life during their
participation in the trials.
“The vast majority of Phase 1 volunteers will suffer from both physical and emotional symptoms
associated with their primary diagnosis and the Phase 1 trial,” says Holly Quinn, chief nursing
officer for Bayshore Home Health. “Research with Respect will support individuals through
comfort and advocacy in a situation that can often become overwhelming for volunteers and their
immediate families.”
‘Research with Respect’ provides Phase 1 volunteers with daily visits from a registered nurse who
offers the following services:
• Community nurse visit
• Pain and symptom management review
• Client education
• Emotional support
• Liaison with cancer research centres
‘Research with Respect’ will initially be available in Toronto and Vancouver. Volunteers
participating in Phase 1 clinical trials and their caregivers can call 1-866-265-1920 to find out
when the program will be available in their area.
“Research with Respect is a direct result of my husband’s involvement in a Phase 1 cancer
clinical trial,” says Maddocks. “It’s our intention to offer volunteers practical information and
support as they selflessly test new cancer treatments that in the Phase I stage are highly
unpredictable.”
About Bayshore Home Health
Bayshore Home Health has been enhancing the quality of life, dignity and independence of Canadians
in their homes since 1966. Canadian owned and operated, it is the country’s largest provider of home
and community health care services, with more than 40 home care offices, 20 community care clinics
and 8,000 employees. Its core services are in-home nursing, personal care and home support – which
can be purchased directly by individuals and also accessed through government care programs,
personal and group insurance plans and workplace safety insurance. Its caregivers deliver more than
5.2 million hours of home care annually to over 57,000 clients. The company also provides
nurse/caregiver staffing services, health education programs and treatments in its community dialysis
centres. Through its subsidiary, Bayshore Specialty Rx, it offers specialty pharmacy, infusion clinic
and pharmaceutical support services to a variety of health care and pharmaceutical organizations.
Bayshore Home Health has been a winner of Canada’s 50 Best Managed Companies award since
2006.
About ‘Bear Ring “U” ‘n Mind’
‘Bear Ring “U” ‘n Mind’ is a nationally registered charitable foundation dedicated to assisting cancer
patients who volunteer to participate in Phase 1 cancer clinical trials. The Foundation’s primary
program, Research with Respect, is free to the client. The program seeks to improve the monitoring
and care given to Phase 1 cancer patients. The Foundation fully supports the 2005 policy statement of
the International Committee of Medical Journal Editors (ICMJE) and the World Health Organization
(WHO) directive calling for all countries involved in research of experimental products intended for
use on humans to establish a complete public registry of all clinical trials – which, to date, has not
been forth coming in Canada. For more information visit www.researchwithrespect.ca.
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For more information contact:
Holly Quinn
Chief Nursing Officer
Bayshore Home Health
(905) 822-8075
hquinn@bayshore.ca
www.bayshore.ca
Research with Respect, Background Information
Developing a new cancer treatment involves extensive testing on lab animals. Then the experimental
concept must be tried on humans. This initial “people” part of the process is called a Phase 1 clinical trial
for which a group of two to four terminally-ill cancer patients is recruited. The maximum dose that the
animals were able to tolerate is usually the starting amount for Phase 1. If the people being tested
experience only minimal/controllable side effects, another small group or cohort is signed up and a higher
dose is administered to the new recruits. This escalating dose process continues until a cohort experiences
severe side effects, possible injury/death, due to the treatment being tested. The Phase 1 trial is then
stopped. Once that maximum dose is determined then the “safe” dose can be established. Usually, the safe
dose is one or two amounts lower than the maximum administered in a Phase 1 study. Phase 2 could then
commence. This is the point where patients, with the specific cancer that the experimental treatment was
designed to fight, are recruited and studied to see if the new approach is effective. If it is, then a Phase 3
trial might start, during which the now promising treatment is compared to existing products to see if it is
superior. A Phase 1 clinical trial usually needs 18 to 24 months to be completed and approximately 30
human subjects. Each cohort receives the same dose that they started with throughout their association
with the study.
Currently, Phase 1 cancer studies are conducted in only nine major cities across Canada. Because so very
much is unknown about “fresh from the lab” experimental treatments, Phase 1 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 that track a test treatment through the volunteer’s body. This is a significant request as the
comforts of home and community are stripped away at this pivotal time in a terminally-ill cancer patient’s
journey. Phase 1 trials are usually conducted on an “out-patient” basis. The participants pay all costs
incurred for transportation, accommodation, food, parking, etc. As well, Phase 1 subjects must present
themselves to the research lab many specific times during this initial testing period. Dave, Mrs.
Maddocks’ husband, had 16 blood samples taken in the first five days of his being infused with a Phase 1
test drug. Volunteers are urged to be careful of exposing themselves to situations that might have flu and
cold “bugs” present. So “big city isolation” can occur. During the away from home period, ‘Research with
Respect’ provides Phase 1 volunteers with daily visits from a Bayshore Home Health registered nurse
who offers the following services:
• Community nurse visit
• Pain and symptom management review
• Client education
• Emotional support
• Liaison with cancer research centres
Volunteers participating in Phase I clinical trials across Canada who are interested in ‘Research with
Respect’ can call 1-866-265-1920 to find out when the program will be available in their area.
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Greater Love…
“They” are not forgotten; it’s just that most people don’t know about them. “They” are your fellow citizens who “step up to the plate” and allow researchers to test out new treatments in the ongoing battle against cancer.
Today many patients have hope that their cancer can be contained, if not cured. The amazing improvements in cancer survival statistics are due, in great part, to the people who volunteer to participate in Phase 1 Clinical Trials.
Scientists invent treatments; run computer simulations and try out different dosages and methods of delivery on lab animals. But new treatments cannot be incorporated into general use until rigorous investigations are done using live human beings.
Tests need to be done to ascertain if a treatment is effective on humans - a Phase 2 study. Then experiments are done to see if a new treatment is better than those already in use – a Phase 3 study. But the ‘safe’ dosage for use on humans must be determined first – a Phase 1 study.
Only terminally-ill patients, who have exhausted all other avenues of treatment, are eligible to volunteer for a Phase 1 clinical trial. Not all terminally-ill patients are accepted. Only those people with adequately functioning organs can join a cohort – a group of 2 to 4 test subjects.
Phase 1 studies are conducted in major centres so the volunteer must re-locate for a period, usually a month, and then travel back and forth from home to the research facility.
All personal expenses are born by the volunteer. There is no compensation of any kind.
“Research with Respect” is a national, charitable foundation which has taken up the challenge of according recognition and better care to Phase 1 Clinical Trial patients. For more information, from a patient / caregiver perspective, go to www.researchwithrespect.ca
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