PARTICIPANTS
Cancer care has come a long way thanks to research, and we know that the “one-size-fits-all” approach to cancer treatment is almost never the best option. One great option is precision oncology, which takes into account the unique genetic makeup of each participant. Precision oncology allows doctors to make better treatment decisions, thus leading to better participant outcomes, longer lives, and a more efficient healthcare system.
But there’s a problem.
The data required for precision oncology research is often unavailable in Canada or trapped in computer systems that don’t speak to one another. As a result, there isn’t enough data to generate meaningful insights on how to treat the diversity of cancer patients in Canada.
This is where
Exactis comes in.
The Personalize My Treatment (PMT) program created by Exactis, a not-for-profit, and funded by the federal government, accelerates cancer research by making treatment data, blood samples and tissue samples ready for research. The information captured through PMT can then be shared with scientists for the goal of better understanding the full diversity of cancer patients across Canada.
How does PMT advance cancer research?
Clinical trials are still considered the gold standard for studying the safety and efficacy of a new drug. However, clinical trials do not always represent the “real world,” because they take place in a very controlled environment and involve a well-defined population. Because of this, government decision makers, doctors, and drug makers are increasingly turning to real-world data (RWD). This sort of data allows them to analyze a drug’s effectiveness and safety after the drug has been approved and on the market. This real-world data can be found in sources such as medical health records, insurance claims and pharmacy records, and provides additional data that reflects a broader group of participants.
The different ways that real-world data can be used are the following:
- To help doctors make better informed treatment decisions;
- To compare whether one drug works better than another;
- To understand what side effects are occurring in a broader population;
- To help government regulators approve drugs for different cancer types or at different stages of the disease;
- To help government regulators better understand costs and approve reimbursement of a drug.
What are the benefits of taking part in PMT?
As a cancer patient, your tumour tissue, blood samples and clinical data contain information that will help advance cancer research when combined with other cancer patients. Each cancer has unique molecular properties, also called a molecular profile. Some cancer treatments target specific molecular profiles. Your participation in PMT may help accelerate the development of new cancer treatments.
The main goals of PMT are to:
- Increase scientific knowledge of cancer care in Canada;
- Support government regulatory agencies in drug approvals;
- Generate evidence to accelerate drug reimbursement decisions, and as a result facilitate access to more therapeutic options for Canadian cancer patients;
- Attract more cancer clinical trials to Canada, and consequently provide faster access to new therapies for Canadian cancer patients.
What are PMT participants consenting to?
Individuals who wish to participate in PMT must discuss it with their treating oncologist, who will provide them with complete information on the PMT program and collect their informed consent. In a nutshell, PMT participants consent to:
- The collection of relevant data from their medical records (such as cancer type, treatment history, clinical/radiological images, and administrative data). This data will be collected throughout the course of the cancer illness and stored in a secure database;
- Be recontacted to inquire if they would be interested in other research studies or be informed about clinical trials or cancer treatments that match their cancer specifically;
- Provide access to already-collected samples from their tumour, to be asked to provide additional blood during standard of care procedures and to have their biospecimens used for cancer research (this is optional).
It is very important to note that Exactis will:
- Only receive data after it has been anonymized by the treating oncologist, so that no PMT participants will ever be personally identified by Exactis;
- NOT sell PMT participant data to third-parties;
- NOT support research inquiries that are deemed detrimental to participants.
Can a participant withdraw their consent?
Participation in PMT is completely voluntary. A participant can withdraw from PMT at any point by informing their site’s PMT Coordinator. Participants are not required to give any reasons, and withdrawing from PMT will not affect their current or future care.
Are there any risks?
There are no additional physical risks by participating in PMT, because no procedures are performed solely for PMT. If samples are collected for PMT during a routine procedure (such as a biopsy or a blood draw), the risks will be the same as those associated with that particular routine procedure and will be explained to the participant prior to the procedure.
Exactis follows international and Canadian standards and regulations on managing and processing personal health information (PHI). As in any research project, there is a small risk of identification. Exactis takes measures to minimize this risk.
You are encouraged to discuss participating in PMT with your medical team and loved ones.
How is a participant’s privacy protected?
Precautions are taken to protect all participants’ privacy and confidentiality.
Personal identifying information will:
- Only be consulted by authorized personnel at the treating hospital and will not leave the hospital;
- Be replaced by a code before being stored in the PMT databank or shared with researchers.
How can I sign-up for PMT?
We have a network of 16 cancer centres across Canada involved with PMT. At each Exactis Network site, dedicated PMT Coordinators support and assist patients who are interested in taking part in this program. If your centre is not listed, we recommend speaking to your oncologist about PMT and suggesting they contact us for additional information.