IT CAN TAKE 12 YEARS TO BRING A DRUG TO THE MARKET.
Even with fast-tracking, it takes more than six years to get a drug approved, and longer to make it available. This is not acceptable for people with lethal diseases. Every month of delay translates into thousands of life-years lost, and suffering that could have been alleviated. We have proposals that would speed up the process – we need your help to have them heard.
WHEN SAFETY KILLS.
Clinical trials are required for drug approval. However, in the case of emerging treatments for lethal diseases (like gene-targeted agents, immunotherapies, CRISPR-based therapies and others), they can be unnecessarily slowed by inappropriate research designs. Once the trials are complete, complex bureaucratic systems and red tape add years to getting the treatments to people.
The cost is thousands of lives that are lost and unnecessary suffering – and drug prices that are driven up by the lengthy, costly process. A study published in Cancer Medicine looked at 27 different clinical trials. It showed that reducing drug approval time to five years could have saved more than 1,900,000 life-years if only 10% of all relevant patients were treated! Quick safe and rational reform is needed.
RISK HAS A DIFFERENT MEANING IF YOU’RE FACING DEATH.
On 17 June 2016, Bill C-14 legalized assisted dying in Canada. Yet lethally ill patients are routinely denied early access to promising life-extending or curative experimental therapies.
LSTN (Life-Saving Therapies Network) is a patient-led international network of oncologists, researchers, regulators, medical ethicists, health economists and others from North America and the EU. Our mission is to enable patients with lethal diseases to have faster access to better therapies. Our initiatives are evidence-based and supported by a cross section of key players in the healthcare system internationally. Please click here to learn more about our members & advisors.
Our areas of focus include clinical research, regulatory and reimbursement reform.
The need for speed in advanced non-small cell lung cancer: A population kinetics assessment
From the Wiley Online Library: Background Systemic therapy prolongs overall survival (OS) in advanced non-small cell lung cancer (NSCLC), but diagnostic tests, staging and molecular profiling take time, and this can delay therapy initiation. OS approximates first-order kinetics. Methods We [...]
PMPRB: Why lower drug prices may mean less access
From Healthing: "The body responsible for pricing patented drugs in Canada — the Patented Medicine Prices Review Board (PMPRB) — has proposed changes to lower the cost of drugs, which are scheduled to come into effect in January 2022. While [...]
The High Cost of Cheap
From C.A.R.P.: "Like father, like son. In the 1970s, Trudeau senior brought in price controls to combat inflation. They failed miserably. On July 1, Trudeau junior’s government will activate new Patented Medicines Price Review Board (PMPRB) regulations that will bring [...]
Stewart and Bradford: Stiff price controls will hurt Canadians’ access to ground-breaking drugs
From The Ottawa Citizen: "The federal Patented Medicines Price Review Board thinks companies would be happy to sell Canada their new drugs for much less than they get in many other 36 OECD countries. It doesn’t look like they’re right." [...]
A patient's perspective
A physician's perspective
COMPASS FOR CHANGE
Our advocacy landscape is complex and multi-leveled. Our Compass for Change makes each element of our plan clear and helps us navigate our way forward. Please click here to find more detail.
LEAD WITH PATIENT ADVOCACY
Align with patient groups working
on these same nationally and
internationally; use patient-lead
approach for all research and
MAKE THERAPIES ACCESSIBLE
Promote access to new precision
therapies; promote flexible designs
and adaptive trials
Use social determinants of health lens
Follow patients post trial.
Use digital technologies and data
sharing mechanisms to grow
international netoworks, promote
knowledge exchange and
make partnerships more efficient.
BRIDGE DATA SILOS
Real world evidence should
be global. Access to comparators wil
accelerate therapies to patients, cut
costs,engage patients; and boost
assurance data for regulators.
PROMOTE REGULATORY EFFICIENCY
Work with Health Canada to be
the key driver for regulatory change.
Liaise across provincial agencies
to fully support and implement
the Regulatory Review and Drug
Development Initiative (R2D2)
CREATE POLITICAL WILL
Work with partners in government
to represeant therapeutic access as
their issue Present this model as
the "Uniquely Canadian approach
to therapies for lethal diseases.
Please join us. It doesn’t matter if you’re a patient, a caregiver, a physician, a researcher – or simply interested. We need you and so do those with lethal diseases who may already know that the expiration date on their birth certificate is rapidly approaching.
Help us develop an awareness campaign and educate people about this issue. Bring your expertise to our expert conversations. Participate in online support groups. Make connections in the network. Help us refine and broaden the appeal of our message.