The BHF Clinical Studies Committee was set up in 2017 to assess applications for high value cardiovascular clinical trials and observational studies of patient groups. This is the first time the BHF have a grants award process specifically for clinical trials, and that means there is a panel of clinicians and scientists who are directly involved in clinical studies.
Getting the Question Right:
The most important thing to think about when designing a clinical study is to make sure that it is asking an important question and that it is a going to give a reliable answer. The committee want to work with clinical researchers to try to develop some very big and reliable studies that answer the most important questions.
The first part is to get the design right; design cannot be done rapidly, and it often takes many iterations. The design involves things like the sample size, the population that is going to be studied and how you are going to recruit. It is recommended that researchers consult widely with colleagues about the feasibility and consult with a clinical trials unit to make sure all of the technical aspects of the trial are sorted, which will improve the robustness of the study design.
There are many good ideas that are brought to the BHF Clinical Studies Committee but one of the most common reasons funding is not awarded is because applicants have not paid enough attention to the feasibility of recruiting the populations they propose to study. This is an area that applicants need to focus on and provide preliminary data to make the application more powerful in the likelihood of it achieving its aims but also getting funding.
The way the BHF select studies will include assessments of feasibility and feasibility can be demonstrated by doing pilot studies, or perhaps a vanguard phase at the beginning of the study to test the methods and then, subject to a stop-go decision, the BHF will further support the study to go onto its full sample size.
Has your study got the power?
The BHF is not interested in underpowered studies but in studies that are big enough to answer the question. A major factor that brings awards down is they are not properly configured in terms of the scale of the study. Good clinical research is about trying to do studies that change clinical practice so the study needs to be sufficiently large and robust in power to enable the change to take place if the outcome is as positive as is anticipated.
One final but most important point – people get things the wrong way round when it comes to power. Applicants often think how many patients can they recruit and what will that then enable us to detect in terms of effect size. However, it has to be the other way round; applicants should be thinking of what is plausible in terms of an effect size and then calculate how big the study has to be. If this means it can’t be done in the UK alone for example, then the BHF committee will work with you to try to encourage to recruit internationally and to develop the trial that needs to be designed to answer the question.
- Usually applications don’t fail because of cost; they fail because of value for money or deliverability issues
- Clinical question should be important and provide high clinical impact
- Concerns about deliverability: overoptimistic recruitment rates, insufficient feasibility data.
- Concerns about power: overinflated effect size, unrealistic event rates.
- Insufficient pilot data
- Methodological concerns: insufficient input from clinical trialist(s) around methodology and the practicalities of delivering the trial.
An iterative process
The BHF Clinical Studies Committee takes an iterative approach. They may see ideas that are good but the trial design or feasibility may need some work; in this case, the committee enter into an iterative process and the Chair, Vice Chair and members of the committee invite trialists into speak to them about optimising trial design to improve their application so that it is fundable.
Two application rounds per year for clinical study grants. Guidance on preliminary clinical study grant applications can be found here.
Dates and further details on the clinical study grants process can be found on the BHF website