Clinical trial funding: About funding and where to secure it
A clinical trial is conducted when the development of new medications or treatments needs to be tested. These trials inform us if the proposed research or product is a viable way of treating people. Once the feasibility of a clinical trial has been determined, the logistics of running the trial must be considered. This includes developing the trial plan and securing funding.
Funding for clinical trials can come from a wide variety of sources. However, a study by Hakoum et al. (2017) found that most clinical trials are funded by only one source. Most of these sources come from the pharmaceutical industry. Pharmaceutical companies have a large stake in the results of clinical trials. Companies can mass produce and market the product with ownership of the intellectual property.
Securing funding for clinical trials is an important part of the process, as they are often time-consuming and expensive. As trials have such a large financial burden, many trials are underfunded. If a clinical trial is cut short due to lack of funding, it will not generate any advancement in knowledge. This may lead to ethical issues concerning participant involvement, Williams et al (2015).
Clinical trial funding: A quick summary
- funding comes from a wide variety of sources
- it is common for funding to come from one source, but it is not required to
- the vast majority of trials are funded by the pharmaceutical industry.
Read on to learn about clinical trial funding in more detail.
Funding sources for clinical trials
There are many different sources for clinical trial funding in Australia. Most clinical trials are funded by the following sources:
Government grants and programs
The National Health and Medical Research Council (NHMRC) offers several government funding schemes. This includes program grants and fellowships specifically for clinical trials. The NHMRC also has initiatives such as the Clinical Trials and Cohort Studies Grants. This grant supports trials of any size in any health area.
The Medical Research Future Fund (MRFF) also provides funding for medical research. Though they support several initiatives, some are aimed directly at clinical trial funding. One such initiative is the Clinical Trials Activity Initiative. This initiative offers funding for trials dedicated to rare diseases or international collaborations.
However, these are not the only government schemes that support clinical trials. For details on what the MRFF is funding in the next 10 years, take a look at their 10-year Investment Plan.
Pharmaceutical and biotechnology companies
Pharmaceutical and biotechnology companies often fund clinical trials. They most often support trials that test new drugs and medical devices. These can include both investigator-led and industry-sponsored studies.
For the latter, these companies will also fund investigator ‘add-on’ studies. Investigator add-on studies are where an investigator can do a sub-study on that population or part of that population.
Be inventive in how you ask for funding. Collaborative partnerships between industry and research institutions are viewed favourably. These partnerships can co-fund trials and share resources and expertise.
Not-for-profit organisations
Several non-government organisations (NGOs) fund clinical trials. They are generally disease-specific and the research must align with their mission and strategic goals.
Applications are made directly to the NGO. However, for some of these organisations funding applications are made through the NHMRC, such as the Heart Foundation.
The NGO then uses the NHMRC's pool of reviewers to consider applications. The benefit of this is that an applicant can apply to both the NHMRC’s application call and the NGO's with one application.
Academic and research institutions
Universities and research institutions may offer internal funding to support clinical trials. They can also co-fund or partially fund aspects of a trial. This is most common during the early stages of a clinical trial and can be crucial for refining research questions and gaining initial results.
With this support, it can be easier for researchers to build stronger applications. Giving them a better chance at securing outside funding.
Likewise, funders are increasingly requesting to incorporate consumers into the trial design. Universities and some of Australia’s Research Translation Centres offer small amounts of funding to support consumer costs.
Philanthropy
Philanthropic individuals or organisations may provide donations to support clinical trials. Academic institutions and some departments within these organisations employ fundraising teams. These teams often focus on fundraising and philanthropic donations.
While a clinical trial can receive funding this way, it is not as reliable as other methods.
International funding
In some instances, funding is available from international funding agencies. This may or may not require the collaboration of local investigators.
Many global organisations provide funding for trials. The World Health Organisation and the Bill and Melinda Gates Foundation are both organisations that do so. However, to secure international funding clinical trials must usually address global health issues.
Likewise, you can pursue funding from organisations with related goals. For instance, the Michael J. Fox Foundation for Parkinson's Research is likely to support trials that research Parkinson's disease.
Reporting clinical trial funding
When it comes to communicating your research, all funders must be reported in detail when registering your trial in a clinical trial registry.
Likewise, your funding sources must be reported in all other instances of research communication. This includes publications, oral conferences and even poster presentations.
The best way to communicate this involves providing a breakdown of how the money was spent. Furthermore, detailing the role of each funder is important.
Once your clinical trial is complete, it is considered best practice to communicate the outcomes to your funders. Funders can then use these outcomes to inform stakeholders of the impact of their funding and research.
The funding application process
The funding application process can be complex, but it is the best way to secure funding. The first step of the process is researching different grant opportunities. Some organisations may have a different process or preferred format for their applications. Likewise, through this research, you can tailor your application to the program’s goals and improve your chances.
Many funding applications begin with a notice of intent. This is to notify the relevant organisations or faculties that you are preparing an application.
The next step should be drafting your application. Your application should include this information:
- a clear reason for why your product or treatment is necessary. Define the need for your research
- a description of the product or treatment you are researching. Clearly define how it works for funders
- an outline of the clinical trial design and how it will determine answer your research questions
- a feasible plan for recruiting and retaining participants
- a detailed budget that justifies the need for funding
- an overview of how this trial will be conducted ethically
- a plan for how the outcome will be shared with the larger community.
This is the key information that should be included in all funding applications. However, researchers should also include an overview of who their team is and their expertise. This helps funders feel more confident in what they are backing. Likewise, it is necessary to emphasise the potential impact of your trial, as funders highly value outcomes.
Once completed, you can send your application to different organisations for additional guidance. The NHMRC and other research funding consultants offer services to provide application feedback.
Once adjusted, your application is ready to be submitted for application. Your application will be reviewed several times before a decision is reached. Covering each of these points thoroughly will increase your chances of securing funding.
Funding nationally
The NHMRC and MRFF offer health and medical research grants which, nationally, contribute funding for new medical research, clinical trials and researchers.
The majority of NHMRC funding is investigator-initiated and is not directed by NHMRC to any specific disease, health or research topic. Funding decisions are the outcome of a competitive process adjudicated by independent peer reviewers.
The Australian Government funds the MRFF, which is a long-term investment supporting Australian health and medical research. The MRFF aims to transform health and medical research and innovation to improve patient outcomes, stimulate economic growth, and support the sustainability of the healthcare system.
Funding hints and tips
Applying for and sourcing funding can be a difficult and complex process. Here are just a few tips to remember to make the process easier:
- target your application to the funder and their vision and mission. Recycling an application from another source will rarely be funded
- apply to more than one funder. Funding agencies are pleased to receive applications sourced from several funders
- write in simple terms. Application reviewers are unlikely to be in your field of expertise
- include milestones and decision points in your funding application and focus on feasibility. Consider whether recruitment targets are realistic
- before you submit your application, get someone else to review it
- to understand how grant panels work and be privy to what a good application looks like, apply to be on a grant panel
- a description should be simple with no jargon. This description is often used by the grant agency or your own organisation for communication purposes.
