Why do complex medicines need independent evidence infrastructure?

Lucia

3 days ago

5 min read

Complex and emerging treatments are being delivered faster than the evidence layer beneath them can keep up. They are often new, often delivered remotely or across several providers, and often funded through systems that pay for activity. In that environment, the people being asked to trust the evidence are usually reading records produced by the organisation delivering the care.

That was the question raised by the ABC Four Corners investigation into veteran care, published on 5 October 2026. The ABC reported on providers in complex treatment models where documentation, billing and reporting sat with the same parties, and where a patient's experience and the paper record of their care appeared to diverge for months. The companies involved dispute aspects of the reporting. Whatever the outcome, the structural point stands: if someone asks you to prove what actually happened to the patient, you need something other than your own records to show them.

Why aren't claims and clinical notes enough?

A claim shows what was billed. A clinical note shows what was written. Both are useful, and both are authored by the provider. Neither shows what the patient experienced between appointments, such as how their sleep, mood, symptoms and medication use were changing, in their own words, at the time.

In established care with long track records, that gap is often tolerable. In complex medicines it matters more. Response varies widely, risk can escalate quickly, the evidence base is still forming, and care is increasingly distributed. Relying on a provider's own records to demonstrate outcomes means relying on people to mark their own homework.

What is independent evidence infrastructure?

Independent evidence infrastructure is the layer that sits alongside the delivery of care and independently measures what happens to patients in the real world.

Its purpose is to separate treatment delivery from treatment measurement. The organisation providing the care should not also be the only organisation responsible for determining whether that care is working, whether patients are deteriorating, or whether adverse events are occurring.

For that infrastructure to be meaningful, it needs four characteristics:

Independent: the provider delivering the treatment is not solely responsible for measuring its own performance.
Multi-dimensional: it creates a richer picture of treatment and patient outcomes than any single data source can provide.
Continuous: it captures what happens across the treatment journey, including between scheduled clinical encounters.
Verifiable: the resulting evidence can be examined by researchers, clinicians, funders, regulators or other authorised stakeholders without relying solely on the provider's account of what occurred.

This is the role OnTracka provides. OnTracka is an independent digital evidence infrastructure layer that collects longitudinal patient-level data and transforms it into a structured record of what is happening in the real world.

That record can then support research, monitoring and evidence generation across the treatment journey.

What does this look like in practice? The First Responder Program

The First Responder Program works with OnTracka to collect patient data and evidence alongside treatment. When a patient enrols, efforts are made to bring them into OnTracka's remote monitoring software, recognising that this will not always be possible given the complex challenges some participants face.

The program describes the OnTracka Patient Report as a resource for evaluating how a patient is responding to their treatment plan at key stages. It draws together assessment tools, patient-selected symptom scales and medication use, and the program says the information collected will keep expanding as more assessment tools become available. The program also describes the study and the report as a way of providing reliable and independent evidence.


Program	The First Responder Program
Infrastructure	OnTracka remote monitoring software and Patient Report
What is captured	Mental health, sleep and medication adherence
How it is captured	Directly from patients, with input depending on each person's ability
Output	Patient reports at key stages of treatment

How did this evidence reach the Victorian Parliament?

On 29 July 2026, Rachel Payne, a Member of the Legislative Council for South-Eastern Metropolitan Region, raised the issue in an adjournment matter addressed to the Minister for Medical Research. She asked the minister to consider supporting a government-funded evaluation of medicinal cannabis as a treatment option for first responders with workplace injuries, including post-traumatic stress disorder and chronic pain.

In making the case, she referred to an Australian feasibility study of a first responder program, conducted by OnTracka, which examined whether participants could be safely supported through a structured medicinal program. She cited the mental health, sleep and medication adherence data it generated, and described encouraging signals of reduced nightmares, improved sleep and decreased anxiety.

That is the pathway the infrastructure exists to create. Treatment experience is captured directly from patients, becomes structured research evidence, and begins to inform larger decisions about whether a full evaluation is worth funding.

What can a feasibility study actually show?

A feasibility study tests whether a rigorous evaluation can work in practice: whether participants can be supported and retained, whether the right data can be captured, and whether early signals justify further research. It is not designed to prove that a treatment works. The signals cited in Parliament are self-reported outcomes from a feasibility study, and the request itself was for a government-funded evaluation, which is the step designed to test them properly. OnTracka does not recommend or promote any treatment. Its role is to make the evidence behind complex medicines more reliable.

Is this approach being used elsewhere?

Yes. OnTracka is the technology partner for the Cannabis Use Registry to Improve Overall Understanding of Symptoms (CURIOUS), sponsored by HealthPartners Institute in the United States. According to the registry listing (also available here), the HealthPartners Institute Cancer Research Center worked with OnTracka to create a secure and compliant app-based technology that collects patient-level data on symptoms, cannabis use, real-time response to consumption, and patient-reported changes in supportive care medications. The registry's stated aim is to give patients with cancer and their oncology clinicians reliable, cancer-specific data to inform decisions together. Its primary outcome measure is adherence.

The setting, patient group and country are different, and the approach is the same: capture what happens directly from patients, independently of any single provider, so the evidence can be relied on. People can find out more through the study record.

Frequently asked questions

What is evidence infrastructure for complex medicines?

It is a layer that collects structured, patient-reported data during treatment, independently of the treating organisation, so outcomes can be verified and analysed as research evidence.

Why aren't claims data and clinical notes enough?

Both are produced by the provider, and neither independently records the patient's own experience between appointments. Independent patient-reported data fills that gap.

What is patient-reported evidence?

It is information that patients record directly about their own symptoms, sleep, mood, function and medication use, rather than information recorded about them by someone else.

What did the First Responder feasibility study track?

According to the Hansard record, it generated mental health, sleep and medication adherence data. The program's own page describes assessment tools, patient-selected symptom scales and medication use.

Was OnTracka evidence cited in Parliament?

Yes. On 29 July 2026, a Member of the Legislative Council referred to the study when asking the Minister for Medical Research to consider supporting a government-funded evaluation. See the Hansard record.

Does this prove the treatment works?

No. A feasibility study tests whether a larger evaluation is workable and worthwhile. The signals were encouraging, but they are not proof of effectiveness.

What is the CURIOUS registry?

It is a patient registry sponsored by HealthPartners Institute that uses OnTracka's technology to collect symptom, cannabis use and supportive care medication data from people with cancer. See the registry listing.

Does OnTracka recommend treatments?

No. OnTracka provides independent evidence infrastructure. It does not promote or recommend any medicine.

The question to take away

As complex medicines continue to scale, funders, regulators and the public will keep asking for proof. Sooner or later someone will ask you: what actually happened to the patient, and what do you show them?

Remember, evidence carries more weight when you are not marking your own homework.