We are here to work with Canadian skin patients to promote skin health and to improve quality of life. We hope that you find some useful resources on our site and we welcome your feedback.
During this uncertain time we will be sharing news and information relevant to risks and impacts of COVID-19. Be sure to stay up to date and take care of yourself.
We have launched an update to our 2017 report Scarred for Life. Through this report, the CSPA has identified 11 recommendations to healthcare providers and policy makers to improve awareness about Hidradenitis Suppurativa and care and management of the disease and the lives of HS patients.
We are very proud to release the first ever charter specifically for patients living with conditions, diseases or traumas that affect the skin.
Skin conditions are a leading cause of overall disability and death in Canada. Canadian researchers have made substantial contributions to address the heavy burden of skin disease, but much of the work is conducted in relative isolation by a dispersed community of scientists and clinicians. The creation of the Skin Investigation Network of Canada (SkIN Canada) plans to expand the critical mass of skin research expertise, create new collaborations, and enhance skin health through innovation. We have brought together patients and an interdisciplinary team of leading researchers and clinicians across the country who are tackling the mechanistic, clinical, health systems, and population health questions for a broad range of skin conditions.
The vision of SkIN Canada is to promote novel and high quality research that is guided by advice from patients and that improves the skin health of Canadians. The Network’s mission is to advance skin research in Canada by creating a national forum, guided by patients, to strengthen collaborations and capacity in the skin research community. The Network will be managed through a formal governance structure that includes patients, researchers, and healthcare providers.
SkIN Canada Strategic Aims
Strategic Aim 1: To develop and strengthen national infrastructure that will empower research teams to operate with greater scale and efficiency;
Strategic Aim 2: To identify priority research questions and create novel, multidisciplinary collaborations involving new teams of researchers, patients, and knowledge users;
Strategic Aim 3: To grow the community of successful skin researchers by developing talent across academic ranks and training levels.
SkIN Canada Disease Areas of Focus
There are three disease areas that the network will focus on. However, we expect that connections made among patients and researchers through SkIN Canada may also lead to interesting research questions and additional projects outside of these three disease areas of focus.
SkIN Canada is excited to welcome patient research partners to shape how research on skin diseases will be fostered across Canada. This is different from being a research subject. A research subject participates in research by agreeing to be part of an experiment whereas a Patient Research Partner works with researchers to help them understand patient perspectives as they:
Patient research partners will be asked to:
Expectations of Patient Research Partners
Should you wish to receive an honorarium, SkIN Canada will provide one based on the hours you have participated, according to the patient research partner compensation and reimbursement policy.
The CSPA will support Patient Research Partners to expand their knowledge about research. You don’t have to know everything about how research works in order to make a valuable contribution! The CSPA will provide updates and training to patient research partners as part of PAC meetings and at the annual conference & patient engagement workshop.
If you are interested in participating, please fill out this questionnaire by June 21, 2020.
Are you interested in how research questions are chosen, how research is done and how patients can contribute to research? There are several opportunities to be a patient research partner with SkIN Canada. The CSPA is looking for 14 Patient Research Partners to help shape skin disease research in Canada.
The CSPA is providing this information as general guidance in the evolving and uncertain circumstances of COVID-19. We encourage you to contact your dermatologists or other physicians for information about your specific circumstances as these professionals are best placed to consider all relevant factors and provide you with the best advice for you.
|BC Lymphedema Association||https://bclymph.org/|
|Canadian Alopecia Areata Foundation||https://www.canaaf.org/interested-in-canaaf-virtual-support-meetings/|
|Canadian Burn Survivors Community||https://www.canadianburnsurvivors.ca/|
|Canadian Association of Scarring Alopecias||http://casafiredup.com/meeting.php|
|Canadian Psoriasis Network||https://www.canadianpsoriasisnetwork.com/|
|Eczema Society of Canada||https://eczemahelp.ca/blog/eczema-and-covid-19/|
|Melanoma Network of Canada||https://www.melanomanetwork.ca/|
|Neurofibromatosis Society of Ontario||http://www.nfon.ca/|
|Save Your Skin Foundation||https://saveyourskin.ca/new-covid-19-information-hub/|
|SCLERODERMA ASSOCIATION OF B.C.||https://www.youtube.com/watch?v=RoEPF-u5phs&feature=youtu.be
|Scleroderma Society of Ontario||https://www.sclerodermaontario.ca/|
Clinical trials—and the treatment of participants in those trials—are highly regulated. In addition to being subject to a series of independent reviews and measures, Canadian clinical trials are regulated by Health Canada (the federal government), which in addition to Canadian specific requirements bases its regulations on a set of international standards called Good Clinical Practices (GCP) which were developed and agreed by global authorities at the International Conference on Harmonisation (ICH).
Those regulations entitle participants to a number of important rights.
Confidentiality and privacy
Once you are deemed eligible for the trial and have given your consent, your personal health information will be collected during the trial, including items such as physical examination details, test results, imaging results, blood tests, and tissue samples. Trial staff also will have access to your original medical record.
Activities related to your personal information are regulated by the Personal Information Protection and Electronics Documents Act (PIPEDA), which is part of the Canadian Privacy Law. PIPEDA requires participant consent for collecting personal and identifiable information. It also requires trial staff to inform participants of their privacy rights and to provide them with the opportunity to learn about what information is being collected and why.
Information from the trial will be submitted to the trial sponsor (see below), Health Canada and possibly government agencies from other countries (such as the US Food and Drug Administration, FDA), but that data remains anonymous. Even if results are published in scientific journals, no personal information is released: the data is valuable because it represents results accumulated from many participants in aggregate, and not specific individuals.
Overall, your information will be kept in a secure location and only viewed by select members of the clinical trial (such as the trial doctor, staff helping the trial doctor, representatives from the sponsor, and the Ethics Committee).
Access to your own data
As a clinical trial participant, you have the right to see your trial records. Depending on the trial, however, you may not be able to review or make a copy of your records until the study has concluded: sharing trial data with anyone outside of the study before it is complete might compromise the confidentiality and integrity of the trial.
Withdrawal at any time
Clinical trial participants have the right to leave a trial at any time. Data collected from participants prior to their withdrawal will still be used by the researchers.
If you do stop your participation, you should inform the research team know about it and tell them your reasons for leaving. They may want you to return for a final evaluation or tests.
Best possible care
Clinical trial doctors are responsible for providing you with the best possible medical care throughout the study. Depending on the protocol (a document that describes the design and methodology of the trial), they also will provide the same level of medical care and follow-up for an appropriate period once the study is complete.
Even if you withdraw from the trial early, you will continue to receive care for an adequate period.
It is important to note that clinical trial doctors do not replace your everyday health care professionals. In fact, if you give them permission, trial doctors and your health care team may collaborate to share information and avoid repeating tests.
Informed consent is a crucial part of the clinical trial process. Mandated by law (see “Confidentiality and privacy,” above), informed consent is an ongoing process that ensures anyone who wishes to participate in a trial fully understands the study and its objectives.
It is important to remember that the informed consent document is not a contract: it is to protect your rights at all times. You can still withdraw from the trial at any time (see “Withdrawal at any time,” above).
As a participant in a clinical trial, you have several responsibilities, which will be outlined in greater detail in the informed consent form.
Perhaps your greatest responsibility is to read and understand the informed consent form and to remain an active participant in the trial.
Clinical trials not only involve a team of health professionals, but also a collection of other people and organizations that oversee its operation and management. The following are a few of the important parties that you may encounter during your participation in a clinical trial.
The sponsor is the group or organization that initiates the trial. It can be a pharmaceutical or medical device company, a university, a health-care institution, a voluntary group, a government body, or an individual physician or care provider.
An Ethics Committee is comprised of physicians, researchers and community members. Its role is to review, approve, and monitor a trial: before any clinical trial can begin in Canada, its principal investigator must present a detailed request to the Ethics Committee that has been tasked with reviewing the trial. Ethics Committees also periodically review trials to protect the rights of participants.
Ethics Committees also can be called an Ethical Review Board, an Independent Ethics Committee, an Institutional Review Board (IRB), or a Research Ethics Board (REB).
Clinical research coordinator
The clinical research coordinator (or study coordinator) handles the day-to-day logistics and reporting of the trial. Often a certified nurse, the study coordinator frequently is involved in the informed consent process and ensuring compliance with the trial protocol. The coordinator also makes sure that the trial visits, tests and procedures are scheduled on time, and that patients understand how to take the study drug and complete the trial questionnaires or diaries.
The investigator or principal investigator (often called the “trial doctor”) is the highly trained doctor who carries out the research and interacts with the patients. Investigators have completed additional training on conducting clinical trials and research, with particular emphasis on trial patients.
The principal investigator is in charge of how the trial is conducted, and he or she supervises the team of trial professionals who contribute to patient safety
Any treatment received as part of most clinical trials is provided free of charge. The only exception is in Phase IV observational trials, when the drug has already been approved by Health Canada. In those instances, the cost of medication is the responsibility of the patient, although there are insurance and other support programs that may provide reimbursement.
There are some indirect expenses that clinical trial participants may need to pay on their own:
The trial coordinator can help you determine your costs over the full trial period and whether or not any will be reimbursed.
Before you decide to participate in a clinical trial, you should discuss it with your doctor. He or she will tell you if there are any medical reasons for you not to participate in the trial.
It also is important for you to do your own research. This includes asking the members of the clinical trial team some questions.
In general, you should consider asking the following:
You can find a helpful printable and mobile-friendly list of potential questions here.
You should also discuss the trial with family and close friends. Ask them to help you with the research and decision-making process: this will help them to provide better support for you should you decide to join the trial. A friend or family member also can attend your meeting with clinical trial staff to discuss your potential participation.
It is up to you to decide who you tell about your involvement in a clinical trial. You are not legally required, however, to inform your employer: if you need to take time off for the trial, you can decide to use vacation days to cover that time.
If you do decide to tell your colleagues about your involvement in a trial, there is no need to go into great or personal detail. You can simply tell them you are participating in research and provide a brief overview of why you have decided to do so. Again, the decision of whether or not to tell them—and how much—is up to you.
It can be a challenge to find a clinical trial that is relevant for you. Your doctor may direct you to a promising trial, but you also can search databases and websites dedicated to clinical trials. You can find some of these websites under “Additional resources” (below). In particular, you will want to visit the Patients at Heart, Clinicaltrials.gov and Canadatrials.com sites, all of which provide some clinical trial listings (as well as other resources).
Make sure that the sources you search are reputable ones! If you find a trial on a site that is not listed below, be sure to research it thoroughly to ensure that the trial is a legitimate one. If you have any doubts at all, be sure to check with your doctor and ensure that it is registered on the Clinicaltrials.gov website.
Canada Trials (canadatrials.com)
CanadaTrials.com contains a searchable database of clinical research trials that are actively enrolling patients in Canada. It also provides general health information and links to patient support programs.
The Center for Information & Study on Clinical Research Participation (CISCRP)(ciscrp.org)
CISCRP is a nonprofit organization in the United States that works to educate and inform the public, patients, lawmakers and medical community about clinical research. Their site is an excellent source of information about clinical trials for patients, although some of the resources are specific to the medical system in the United States.
CenterWatch is an unbiased source of information on clinical trials. It also includes a database of clinical trials that can be searched by condition, therapeutic area or location.
Part of the U.S. National Institutes of Health (NIH), ClinicalTrials.gov provides a registry and database of clinical trials from around the world. It is the gold standard when it comes to listings of clinical trials: most legitimate trials are registered on its database. It is worth noting that the database here is quite complex and not always user-friendly. The site does provide a selection of resources for patients and their families, however, including instructions on how to use the database.
Health Canada (hc-sc.gc.ca) http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/clinical_trials-essais_cliniques-eng.php#a2
Health Canada is the government department responsible for “helping Canadians maintain and improve their health.” Their homepage contains the latest health updates and health-related information.
International Conference on Harmonisation (ICH)(ichgcp.net)
The ICH is the international body that outlines Good Clinical Practice, which is the “standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials…”.
Network of Networks (N2)(n2canada.ca)
N2 is “not-for-profit…alliance of Canadian research networks and organizations working to enhance national clinical research capability and capacity.” Their “Resources” page contains a selection of resources about clinical trials.
Patients at Heart (patientsatheart.com)
A support program created and run by the pharmaceutical company AbbVie, Patients at Heart contains a wealth of information about clinical trials. It also serves as a database of AbbVie trials and an online portal for participants in ongoing AbbVie trials.
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