There are many sources of funding available to researchers, but funding clinical trials or research is highly competitive; partly due to the amounts required and the potential risk in terms of the success rate of trials. It is therefore imperative that in order to secure funding, applications should be thought through and written properly.

Some of the sources of funding include charities, patient’s action groups, private industries - pharmaceutical or biotech companies, research councils, state hospitals, independent foundations set up by wealthy Philanthropists, and academic institutions.

Depending on where funding is sought, each institution will have their funding requirements and it is imperative that this is read and understood before applying for funding. For instance, a charity with a bias to a specific disease area may specifically be set up for that purpose and therefore may not entertain applications for research in a completely different therapeutic area.

Private institutions on the other hand will be much more open to a wide range of disease areas but may need the research to be commercial viable or at least have the potential to become viable in future.

Some philanthropists may want to fund research in areas neglected by the academic or commercial institutions such as the AIDS or malaria epidemic. With many institutions, however, there may not be a bias to any disease area but they may just be interested in good research that has the potential of understanding the disease area or furthering the evidence base.

The key with any of these types of funders is to find out if there are any limitations before applying for funding.

Before any funding application is submitted make sure that all potential partners have been consulted and support the application. Often it is necessary to gain institutional approval for a research funding application if the study to be conducted in the institution’s facilities. This can take time as it can involve a committee, so it is important to plan for this relative to any funding submission deadlines.

Funding Proposal/Secure Funding
There is usually an application process (formal or informal) in securing funding for research and in many cases, the requirements for such funding will normally be clearly stated to prospective applicants. It is therefore incumbent on the applicant(s) to ensure that these requirements are met to stand a chance for funding.

Some of these requirements include but are not limited to: the format of the application, the cost of the research, protection of patients enrolled, whether or not the application has been peered review and more importantly, that the research is robust enough for funding.

Costing the trial
Assuming all is well with the application, the next hurdle is the cost of the research.
Each funding institution will have specific funding criteria and this will include the overall or annual funding limits for the research. There may be a requirement to break down cost so that it is transparent to the reviewers where funds will be spent.

Applicants will need to demonstrate that the research can be conducted within the budget stated in their proposal and will be part of the criteria for approving funding. An under or over estimation of cost could give the impression that the applicant is not sure of what they are doing and it is necessary that this is reviewed closely before the application is submitted.

Also, including cost of highly expensive equipment might not be necessary if there are other less expensive alternatives that have proven to deliver similar results. In all, applicants must be able to justify cost and demonstrate value for money.

It is strongly recommended that the process of costing a trial is conducted with the involvement and advice of the institution that will either be sponsoring or hosting the trial. This is typically the PI’s employer, although it may be the case that the trial is being conducted in a separate health facility or institutions. What ever the circumstance the costs need discussing as early as possible with all potential partners and there are often so many forgotten or unplanned costs such as ward fees or overheads perhaps, or activities such as maintaining equipment or transporting patients. Working through the whole study plan in terms of steps and activities can also help identify all possible costs that might arise.

For more help budgeting your research, see the step 'Set budget'.

The WHO ESSENCE ‘Five Keys to Improving Research Costing in LMICs’ has excellent practical advice about developing skills and competencies in this area, including case studies: http://whqlibdoc.who.int/hq/2012/TDR_ESSENCE_1.12_eng.pdf

Peer Review
Peer review or independent scientific review is a process where a research proposal is critiqued by an experienced researcher/clinician with expertise in that subject area, or a group of experiences researchers/clinicians. They will mainly be reviewing and commenting on the research question and will want to ensure the hypothesis is robust and able to reach its end point. Also, having experienced researchers review the proposal will increase the probability of the grant being approved, especially for first time applicants. For some institutions, peer reviewed application is a prerequisite for funding and so applicants will need to show evidence of this prior to submitting their application.
Whoever is nominated to peer review the proposal should ideally be independent of the trial team so as to remove any bias.

They should also have extensive experience in the subject area, as well as in critiquing research proposals. They will help address issues that need to be taken into consideration to ensure a successful application. For clinical trials, the review by an experienced researcher will not only increase the likelihood of the research being approved for funding but it will also improve the chances of approval being granted by the regulatory and Ethics Committees.

Investigator-led studies
As the title suggests investigator led studies refers to studies being run by an individual or group of researchers. This term simply means that the investigator has proposed the idea for the research and therefore led the funding. It could apply to any type of research, and the funding will relate to the type of research being carried out. For example, a hospital may provide funding for one of their clinicians to undertake research which will directly impact the hospital, such as the way staff are trained or how to improve treatment adherence in patients. On the other hand, researchers could propose a review of a specific company’s product (e.g. a medical device or diagnostic test), and the investigators could then approach the company about funding these trials because the company would benefit from the data.

Most industry sponsored trial are initiated within companies and form a strategy element on the product development plan for that specific drug or vaccine.

Commercial institutions, such as biotech companies, may have some involvement in the trials or research they run, but their involvement is usually fairly limited compared to industry run trials. Usually the company will require that all safety data is shared with them. In some circumstances that may also provide the intervention for free and help in kind, by providing elements such as data management or trial monitoring.

A typical example may be that a private company supplies the study medication at no cost to the clinician, whilst the clinicians take responsibility for the cost of running the trials under the auspices of their institutions. In this case, the hospitals or clinics absorb the overhead and monitoring costs.
It is not unusual however for these trials to be taken up by the pharmaceutical/biotech companies partly funding the trials; obviously with the agreement of the clinicians and their institutions. This would be the case if the trial was felt to be of high commercial viability.

One key area in assessing applicants for investigator-led grants is patient recruitment. Applicants have to be careful that the recruitment period is realistic and not over ambitious and that the desired number of patients can be recruited within the time period stated in the funding proposal.

One way of ensuring that the study recruits well, is by conducting extensive site feasibility. If recruitment feasibility is not done properly, the study will need to be extended thus adding to the cost of the trial or if no further funding is available, may have to be closed prematurely.

Nowadays, applicants may need to provide a recruitment plan during funding applications for some studies. This is a valuable exercise for justifying funding for any research and so all investigators might find this helpful whatever type of study they are planning and whatever type of funding they are seeking. A good recruitment plan clearly shows that:

- The patients exists,
- The applicant and his/her team are able to recruit patients within the time frame.
- They are able to maintain patient interest throughout the duration of the trial to avoid too many early withdrawals.

The safety of patients recruited to the trial is also a key responsibility of the applicant and the funding institution. Depending on the novelty of the trial or the risk involved; they may want to know that there is an independent safety committee who will conduct ongoing review of the data to ensure the safety of patients.

They will also want to know that the research/trial will be approved by the Ethics Committee and in many cases funding will be incumbent upon the applicant being able to obtain the necessary regulatory and Ethics approvals.

Again these are both elements that are wise to include in any funding application

Reasons for Lack of funding
Ultimately, not all applicants will receive funding and in many cases this will be communicated to the applicant within the period specified in the application. There are however some reasons why request for funding is not approved. This includes:

- Poor research question and therefore the scientific rationale not established
- Lack of experience of the Investigator and the failure to recruit a collaborator with the relevant experience.
- Proposal involves large amount of work and therefore having an unrealistic project plan.

Conclusion
Whilst the points listed above will not always guarantee funding, they will no doubt put the applicant in a good position to secure funding.
Sometimes, it may well be that the research is sound but the applicant hasn’t been able to put forward their ideas properly; and all it may need is appropriate guidance to ensure that this is done properly. Similarly, funding may be turned down due to overwhelming applications received from prospective applicants. This is where the researcher’s drive and determination is needed to push through their idea especially if there is sufficient evidence and backing to demonstrate that the research proposal is good.

It is advisable to get as much help as possible when writing a funding application and to get others to read it through as if they were members of a review panel in order that they are as rigorous and questioning as possible. Funding is very competitive and so it is worth investing the time in getting solid advice and really reviewing what you are planning to submit.

References

Writing a good proposal - Economic and Social Research Council Shaping Society
http://www.esrc.ac.uk/funding/guidance-for-applicants/how-to-write-a-good-research-grant-proposal/  

National Institute of neurological Disorders and Stroke - National Institute of Health (NIH) : how to write a research project grant application
http://www.ninds.nih.gov/funding/write_grant_doc.htm

Bowman S.J. and Macfarlane G.J. “Successful patient recruitment in investigator-led clinical trials”. Rheumatology (oxford) 2007 46 (7) pg 1207-1208

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