__MAIN_TEXT__

Page 47

Therapeutics

5. Find Funding Opportunities Once a consortium is in place, with good plans for clinical development, it will need to look for larger funding opportunities. Some partners may be in a position to fund themselves, but this will probably be unlikely for all, and especially for smaller partners, such as the patient groups and any small-medium enterprises (SMEs). Funding grants are available, but can be very competitive and there are typically fewer grants available for rare diseases than for more common diseases. The main difficulty with funding clinical trials is that they are expensive. Our experience in the UK was that there are few funders able to grant a large enough amount to cover even a fairly simple clinical trial. One possibility is to look at the larger funders, such as the European Commission (EC), which offer grants typically at a greater scale than in individual countries. As may be expected, EC grants are highly competitive and usually have long lead-times. However the time can be well spent, as it will often allow consortia to dedicate more time to planning and evaluation, and the opportunities for peer-review with experts from across the EC can bring in useful suggestions for modifications, both of which can result in a better overall trial. Another alternative would be to look at funding from a pharmaceutical company. However, this would depend on the IP rights connected to the drug in question and the commercial incentive. A company is only likely to get involved with such a consortium if a sound business case can be made. If funding is to come from grants, it can be worthwhile to involve someone who can advise on how to complete the grant application process (which can be onerous for the larger grants) and maximise the chances of success. An additional source of funding is crowd-funding. Although this is unlikely to generate sufficient money to run a clinical trial, www.jforcs.com

it is possible to raise several tens of thousands of dollars from a well-run campaign. 6. Motivate and Manage the Consortium Planning and running clinical trials is a long-term project, which provides plenty of time for consortium partners to question their involvement. Often the most difficult time for consortia is during the previous step, the time spent applying for funding. During this time, the partners are essentially working for free, with no guarantee of eventual funding. Therefore, maintaining the motivation among the consortium is essential. An effective way of keeping momentum is through smaller projects. Gaining funding for a small, distinct project that will generate results useful for a larger application is an effective way to both improve the final application and to keep partners keen. It is the same reason why mobile games become addictive: small and frequent rewards ensures that a consortium’s interest remains focused on the ultimate goal. Once a consortium is established and funding is in place to allow it to work towards its goal of clinical development, the next issue is to ensure that the consortium can handle the project. Typically, the most invested partner is the patient organisation, and so it may make sense to involve them as a management lead. In the AKU consortium, we are obliged to follow EC guidelines, and so have regular 18-month reporting periods. However, we decided to build on that, and agreed on sixmonthly face-to-face meetings, with smaller reports that build to form the 18-month reports. To ensure that our partners in the consortium felt like part of a wider team, we also started weekly teleconferences. With a set time, they neatly fall into people’s routines, and so are not forgotten; and having them so regularly means all partners understand the pressures and successes of each member. Regular news generated by the patient group Journal for Clinical Studies 45

Profile for Pharma Publications

Jcs volume 6 issue 1 (jan feb 2014)  

Journal for Clinical Studies - Your Resource for Multisite Studies & Emerging Markets is a Peer Reviewed Journal, looking into the best prac...

Jcs volume 6 issue 1 (jan feb 2014)  

Journal for Clinical Studies - Your Resource for Multisite Studies & Emerging Markets is a Peer Reviewed Journal, looking into the best prac...

Profile for mark123
Advertisement