Be Prepared for the Hard QuestionsAnd Earn Sponsors’ Trust
What will the burden on the patients be?See what medical treatment your target patients are used to and compare that to the study procedures. You might decide to simplify your protocol or include decentralised elements to ease the burden on patients and meet enrollment goals.
Where can I find eligible patients?Find out which countries do not reimburse your exclusion criteria drug or do not reimburse it for your sub-population of patients. Alternatively, find out where your ‘must have taken’ drug is reimbursed and part of the Standard of Care.
At which step of their journey do patients become eligible?Will patients in your target countries meet your inclusion and exclusion criteria?
One way to find out: check which drugs are part of their treatment pathway. This also tells you at which step of their journey they might be eligible.
What is the added value of my trial to my target patients?Find out if your trial is an attractive option for your target patients by understanding their standard of care. Patients who enjoy a high standard of care in their countries are less likely to consider clinical trials as an alternative, especially trials with a placebo arm (which is most of the trials).
What is the landscape like for my comparator drug?Set a realistic budget for your trial by finding out the reimbursement status of your comparator drug - if the drug is not reimbursed in your target countries you’ll have to cover the price yourself. Discover investigators with experience and trials that include or have included the drug.