Research translation pathways

Research pathways to impact

Across both commercial and non-commercial pathways, the pathway to impact varies depending on the type of innovation and context and is often an iterative process. Impact is achieved through a series of interconnected stages, including discovery and knowledge generation, development and testing of interventions, evidence generation and validation, adoption and implementation in real‑world settings, and scale‑up and sustained use. Successful translation depends on strong collaboration across these stages, with each pathway shaped by its own regulatory, commercial, and implementation requirements, but all sharing the goal of ensuring that new knowledge leads to tangible benefits for patients, communities, and health systems.

In many cases, research outcomes are translated through non-commercial pathways, including prevention and early intervention, changes to policy and practice, improvements in health service delivery and system performance, and population and public health action. These pathways can deliver substantial health and economic benefits by reducing avoidable illness, improving system efficiency, reducing low-and-no-value care, and enabling better use of public resources.

Commercialisation is also an integral part of research translation where impact depends on scale, sustained supply or long-term viability. Through commercialisation, research outcomes may be translated into health and medical products, services or technologies that can be manufactured, distributed, maintained and adopted at scale. This supports equitable access, system sustainability and improved health outcomes, while contributing economic value through innovation, effective stewardship of intellectual property, employment and reinvestment in the research system.

Clinical trials and other prospective study designs are a core mechanism for research translation across many pathways, supporting informed decisions about adoption, scale‑up and sustained use in real‑world settings. While clinical trials are central to the development and approval of therapeutic products, they are also critical for translating evidence for medical devices, digital health solutions, therapist‑administered and procedural interventions, and public health and health system initiatives. In these contexts, trials can take different forms, including pragmatic approaches that test interventions in real‑world settings, designs that adapt as evidence emerges, and studies embedded in routine care.

NHMRC recognises the diversity of these pathways and the importance of tailoring translation approaches to context, including clinical, community-led, place-based and system-level settings.

Research translation can follow a range of pathways to impact (illustrative examples of common research translation pathways are available on the Case Studies page) that include:

Therapeutic products (drugs, biologics and advanced therapies)

Therapeutic products, including drugs, biologics and advanced therapies, typically progress through a series of research and development stages undertaken in accordance with regulatory and quality standards. These stages commonly include target discovery; preclinical studies to assess safety and biology; manufacturing and scale up; non-clinical development; clinical pharmacology; and phased clinical trials. Together, these steps support regulatory evaluation, approval and ongoing safety monitoring across the product lifecycle.

Clinical trials play a central role by generating evidence on safety, effectiveness and appropriate use. This evidence informs regulatory decision-making, clinical practice and health system adoption at different stages of development.

Clinical research involving therapeutic products serves multiple research translation purposes beyond regulatory approval. While some clinical trials are designed to meet specific quality, governance and regulatory requirements, many others are undertaken to support translation into practice. These include observational studies, trials conducted in routine care settings, implementation research and post‑market evaluations. Together, these approaches generate evidence on real‑world use, safety, effectiveness, equity and value, informing clinical care, health system improvement and public health policy.

In Australia, therapeutic products must be assessed and registered by the Therapeutic Goods Administration (TGA) before they can be supplied, and may also be evaluated by the Pharmaceutical Benefits Advisory Committee to determine public subsidy and public access through the Pharmaceutical Benefits Scheme. These regulatory and advisory bodies also include consumer and community representatives to ensure decisions are informed by lived experience.

Examples:

• Biologic therapies (for example, antibodies developed into new treatments)
• Small‑molecule medicines for chronic disease (for example, tablets to treat chronic conditions)
• RNA therapeutics (for example, mRNA used in some vaccines)
• Cell therapies for cancer (for example, CAR-T cells used to treat certain blood cancers)
• Gene therapies (treatments that aim to correct or replace faulty genes)
• Vaccines (for example, prophylactic vaccines that prevent infectious diseases and therapeutic vaccines to treat cancer)
• Radiopharmaceuticals and theranostics (for example, targeted radioactive medicines to treat cancer)
• Hormone or peptide therapies (for example, insulin or other hormone-based treatments)
• Repurposed drugs (existing medicines used to treat new conditions)
• Combination therapies (for example, two treatments used together for better results)
• Advanced biologics (for example, next-generation antibody treatments or engineered proteins).

Medical devices (including diagnostics and biomarkers)

Medical devices, including diagnostics and biomarkers, generally follow a pathway similar to therapeutics but with additional emphasis on device design and development. This includes iterative prototyping, analytical and technical validation, human‑factors and usability testing, and progressive refinement to ensure safety, performance and suitability for real‑world use. Close engagement with end-users, consumers and community members (especially those with lived experience), clinicians, laboratories and industry partners is essential to ensure devices address clinical needs and can be safely adopted.

In Australia, all medical devices are regulated by the TGA under a risk-based framework. Sponsors must demonstrate that devices meet essential principles for safety and performance, supported by appropriate technical, pre-clinical and, where required, clinical evidence. Manufacturers of all medical devices must operate under a certified quality management system that meets ISO 13485. Diagnostics and biomarkers are a subset of medical devices regulated as in vitro medical devices (IVDs) and must also demonstrate analytical validity, clinical validity and clinical utility prior to approval. Where diagnostic tests are developed, validated or used in laboratories, those laboratories must meet accreditation requirements, including ISO 15189.

Following TGA approval, medical devices must be implemented within health service and, where relevant, laboratory workflows. This includes local governance, workforce training, quality assurance and ongoing performance monitoring to support safe and effective use. Public funding and reimbursement decisions are informed by advisory and assessment processes, including assessment by the Medical Services Advisory Committee for many diagnostic tests and procedures, and advisory input from the Medical Devices and Human Tissue Advisory Committee. Together, these regulatory, advisory and funding processes support the responsible introduction of medical devices into the Australian health system.

Examples:

• Implantable sensors or monitors (for example, devices placed under the skin to track heart rhythm or glucose levels)
• Surgical tools and robotics (for example, advanced instruments or robotic systems that help surgeons perform precise procedures)
• Prosthetics and assistive technologies (for example, artificial limbs, mobility aids or powered exoskeletons)
• Diagnostic devices for rapid testing (for example, point-of-care tests that give quick results for infections or health indicators)
• Imaging devices with improved performance (for example, high-quality ultrasound, MRI or CT scanners that help detect illnesses earlier)
• Genetic tests for disease risk (for example, tests showing inherited risks for certain cancers or conditions)
• Blood tests for early detection (for example, tests identifying early signs of cancer or heart disease)
• Imaging tracers (for example, specialised substances used in scans to highlight diseases)
• Companion diagnostics (for example, tests showing whether a patient is likely to benefit from a targeted treatment)
• Rapid molecular tests for infections (for example, quick PCR-style tests for viruses or bacteria).

Digital health

Digital health is a broad field that includes mobile health applications, health information technologies, wearable devices, telehealth and telemedicine, and personalised and precision medicine. These technologies use computing platforms, connectivity, software and sensors to support health care and related uses, ranging from general wellness applications through to technologies regulated as medical products.¹

Digital and connected health technologies can support research, service delivery and system improvement, and may be used as standalone medical products, embedded within medical products, or as companion diagnostics or decision‑support tools. They may also be used to generate evidence to develop, evaluate or improve medical products and health system practices.¹

Translation of digital and connected health technologies typically requires software, firmware and, in some cases, hardware development and prototyping, alongside analytical and clinical validation. This includes assessing clinical utility using clinical and real‑world evidence, securing regulatory approval where required, and integrating technologies into clinical practice and health system workflows.

Effective translation also requires consideration of human factors, including user experience and interface design, accessibility, quality management systems and relevant standards (such as ISO 13485, ISO 27001 and IEC 62304). Digital health technologies also raise specific regulatory, cybersecurity and data privacy considerations that must be addressed throughout development and implementation.

The rapid expansion of artificial intelligence (AI) and its application through health and medical research, products, services, technologies and processes is likely to drive increased expansion of the applicability of digital health throughout health and care. Where digital and connected health technologies make a medical claim or inform diagnosis/treatment, they may be regulated as a medical device by the TGA as either Software as a Medical Device or Software in a Medical Device.

Examples:

• Connected implantable and ingestible medical devices delivering additional clinical gains through software enabled sensing
• Digital therapeutics deployed to prevent, manage and treat health conditions directly
• Mobile health applications which support clinically relevant behavioural health change
• Remote patient management, monitoring and rehabilitation technologies, with or without hardware (sensors, wearables etc)
• AI driven health and medical technologies, products, services and processes, including advanced diagnostics, precision and personalised medicine, clinical decision support and health system automation and productivity tools
• Digital biomarkers and digital diagnostics
• Telehealth, telemedicine and virtual care platforms
• Precision and personalised medicine applications leveraging advanced algorithms and AI
• AI driven or enhanced drug and device development tools
• Electronic medical record and software enabled prescribing systems
• Clinical administration tools, clinical trial management software and health system predictive analytics.

Clinician-delivered and procedural interventions

Many important healthcare interventions are delivered directly by health professionals and do not fall within product-based regulatory pathways. These interventions are embedded in clinical practice and are often tailored to patient needs and local service contexts.

Translation typically relies on clinical trials, real‑world evidence, workforce capability, professional standards and service‑level adoption rather than formal regulatory approval. Processes for demonstrating safety, effectiveness and value are often less formalised and continue to evolve as practice changes.

Examples:

• Psychological therapies
• Physiotherapy and rehabilitation interventions
• Nutritional and exercise‑based therapies
• Behavioural and lifestyle interventions
• Surgical and procedural innovations

Translation outputs for this pathway may include:

• Clinical practice guidelines and care recommendations that translate evidence into standard clinical practice
• Professional standards and clinical pathways that support consistent, high‑quality care.

Public health and health system‑level interventions

Public health and health system interventions are applied at population or system level rather than to individual patients. These interventions aim to improve health outcomes, equity, safety and efficiency across communities and health services, including through prevention, service design, quality improvement and policy-relevant action informed by health and medical research.

Health and medical research on the social determinants of health informs these interventions by strengthening evidence on how social, economic and environmental factors shape health outcomes and health equity.

Translation pathways focus on policy development, implementation science, system improvement and evaluation in real‑world settings. These interventions are not regulated by the TGA and rely on a broad range of evidence, including real‑world data and ongoing monitoring, to inform decisions about adoption, scale and sustainability.

Examples:

• Preventive public health strategies
• Health system policies and reforms
• Models of care and service redesign
• System‑level innovations and workforce training
• Quality improvement and safety initiatives

Translation outputs for this pathway may include:

• Public health guidelines and environmental health guidelines that translate evidence into population‑level and system‑level policy and practice
• Associated policy frameworks and system‑level recommendations that support adoption and scale.

Community-led and place-based pathways

In priority populations, research translation often follows community-led and place-based pathways that differ from linear models typically used in biomedical or technological innovation. These pathways are guided by local governance, culture and decision-making, and supported through long-term partnerships with community-controlled organisations and representative community groups.

Effective research translation in these settings depends on community capability to engage with and apply research outcomes. Staged or adaptive implementation may be required to ensure approaches reflect community priorities, are culturally safe, and responsive to local needs and can be sustained over time.

Examples:

• Community-designed health programs delivered through Aboriginal Community Controlled Health Organisations (ACCHOs)
• Place based models of care shaped by local priorities, culture and governance
• Co-developed care pathways led by Elders, community councils or local governance groups
• Culturally grounded approaches to social and emotional wellbeing
• Locally adapted implementation of health initiatives based on community needs and context
• Principles of Indigenous Data Sovereignty that ensure Aboriginal and Torres Strait Islander peoples govern the collection, access, use and sharing of data about their communities.

Across all pathways, research translation is informed by cross‑cutting decision‑support processes, including health technology assessment, and evidence synthesis and clinical guideline development, which draw on evidence generated through multiple pathways to inform adoption, funding, scale and use.

References

¹ Food and Drug Administration. What is digital health. https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health (accessed 31 March 2026).