Investigator-initiated clinical trials (IITs) are some of the most powerful drivers of real-world medical progress. Putting the spotlight on investigator-initiated clinical trials reveals a gap between their scientific contribution and the resources available to run them. Led by clinicians who see unmet needs firsthand, these studies deliver considerably in scientific impact, shaping treatment pathways, influencing guidelines, and addressing questions that industry-sponsored trials typically do not pursue, as they fall outside their strategic priorities.
But behind the breakthroughs is a tougher reality: limited funding, fragmented infrastructure, and reduced operational support. If we want clinical research to move faster, and smarter, while maintaining compliance, it’s time to put the spotlight where it belongs.
High-impact, minimal support
Large pharmaceutical or biotech companies are the traditional sponsor that comes to mind when considering a clinical trial. They oversee the study’s design, initiation, and management, provide the investigational drugs, fund the trial, and retain full ownership of all resulting data. Such industry-sponsored trials (ISTs) are integral to providing robust safety and efficacy data for novel therapeutics, with a focus on approval of new medicines for commercial use.
However, ISTs are not the only management structure for advancing medical research; IITs, in which non-commercial organisations such as research institutes, charities, hospitals and individual academics act as sponsors, address key challenges in healthcare and the patient experience. Specifically, IITs can focus on research questions not part of strategic priority for industry and explore drug dosing and formulations of registered drugs to increase patient access and reduce costs.
Furthermore, as reported by the ANZ Clinical Trial Registry, in the decade from 2006-2015, while the proportion of funding for IITs was only ~15% of total clinical trial expenditure per annum, these studies still accounted for over half of Australia’s clinical trial activity. This trend has continued into the new decade, with ~60% of clinical trials registered through ANZCTR in 2020 by non-commercial sponsors.
Nonetheless, IITs can face substantial hurdles in conducting research, which must be overcome to ensure a diverse and thriving clinical trial pipeline.
Investigator vs industry sponsored trials: Key differences
Investigator-initiated trials are distinct in focus, management, and funding sources in comparison to industry-sponsored trials:
| Investigator-initiated trials | Industry-sponsored trials | |
| Objective | Clinical need, Policy change | Trialling a pharmaceutical asset |
| Focus | Improve current clinical practice, Provide real-world evidence (RWE), Trialling low-cost strategies, understudied populations or diseases | Commercial development of asset, Gaining regulatory approval. |
| Pharmaceuticals | Approved drugs, May be used off-indication, or in new, understudied populations, Drug manufacturers occasionally donate their product. | Company asset and comparators / standard of care / combination therapies, Specific indication. |
| Size | Smaller, phase II or phase IV RWE (50> patients) trials. | Larger, phase II/III randomised controlled trials, blinded trials (100< patients) |
| Funding | Independent grants, public funds, institutional resources | Commercially funded |
| Publications | Academic journals | Study registries |
Investigator-initiated trials: Key challenges
Industry-sponsored trials: Established infrastructure and resourcing: Industry-sponsored clinical trials are typically supported by substantial and secure budgets across the full trial lifecycle. They benefit from direct access to specialised professionals spanning CMC and supply chain specialists, clinical trial management experts, regulatory affairs, and scientific research. In addition, these trials operate within well-established supply chains and maintain long-standing partnerships with clinical research organisations (CROs) and contract development and manufacturing organisations (CDMOs), ensuring operational continuity and compliance.
Funding uncertainty in investigator-initiated trials: In contrast, IITs are commonly dependent on competitive government grants or limited institutional funding. Researchers may commence studies before securing the full budget, creating financial uncertainty that can lead to delays, postponed data analysis, increased overall study costs, and, in some cases, early trial termination.
Personnel and administrative pressures: Budget limitations are often reflected in staff capacity, with smaller teams managing logistics, regulatory and scientific requirements, without dedicated external support. As sponsors are often physician-researchers or academics, there may be a lack of specialised staff to provide data management or clinical coordination expertise. This leads to further delays in start-up and completion, or multiple amendments to an existing protocol (such as reducing patient numbers or altering pharmaceuticals used), raising costs, administrative burden, and risking losing study power and validity.
Infrastructure and supply chain complexity: Unlike ISTs, IITs do not always have established access to pharmaceutical supply chains, or CDMO relationships for GMP-related activities like placebo manufacture, blinding, and general product labelling. Pharmaceuticals used in clinical trials typically require Annex 13 labelling to ensure traceability, investigational medical product identification, clinical trial information and specific instructions or warnings, and must comply with GMP and GCP standards.
Additionally, permits are required for the purchase of registered pharmaceuticals, requiring organisations to outsource product procurement. Temperature sensitive transport and storage may be required, necessitating specialised infrastructure and higher costs (for further details see ‘Demystifying the Clinical Trial Supply Chain’ article).
Academic institutions and clinical trial networks can provide operational and regulatory support; however, this assistance is not consistently standardised. As a result, the level of available infrastructure and expertise can vary significantly between institutions.
Knock on effects: How can clinical trial supply experts support IITs?
Investigator-initiated trials are particularly vulnerable to supply chain and administrative challenges due to tight budgets and limited staffing. As budgets must be calculated very precisely at grant submission, any unexpected downstream expense can severely impact IIT timelines, and personnel and patient retention, increasing the risk of trial termination.
Early involvement of a clinical trial supply partner can help mitigate some of these risks. By providing real-time market intelligence at the trial design stage, these partners ensure consistent product procurement throughout the trial and can design flexible sourcing strategies that align with lead times, study durations, and budget constraints. Beyond sourcing, services such as labelling, packaging, storage, and distribution can be managed through a single, integrated supply solution, reducing the need to coordinate multiple vendors, saving time, streamlining personnel focus, and minimising waste.
Investigators and supporting clinical trial networks can carefully balance in-house expertise with the benefits of partnering with specialised clinical trial supply providers. Strong collaborations with these partners not only ensure reliable product supply but also provide regulatory and operational guidance, enabling data-driven decisions that enhance trial feasibility and efficiency.
IITs contribute extensively to medical advancements and clinical practice; addressing their unique requirements is a major goal for clinical trial supply companies, aiming to expand and diversify clinical research in the APAC region, an emerging leader for clinical trial activity globally.
Putting the spotlight on investigator-initiated clinical trials — and addressing their unique supply, funding, and operational requirements — is a major goal for clinical trial supply companies, aiming to expand and diversify clinical research in the APAC region.
To learn more about how Akesa supports investigator-initiated and industry-sponsored clinical trials across Australia and the APAC region, visit our clinical trial products and supplies page.
Ready to discuss your trial’s supply needs? Contact the Akesa team today.
