This month we’re sharing some answers to common questions about clinical trials. Stay tuned for more answers from our experts!
Question: We’re considering using a homehealth care agency to complete some of the monitoring in our upcoming clinical trial. Do you have any suggestions?
Answer: Using a home health care agency can be a great solution for some studies, but there are many things to consider before choosing between traditional site visits and home visits. As a Sponsor, you will want to weigh the potential benefits with the overall cost and effort. Below are a few questions to get you started.
How complex is the study and how many monitoring visits will need to be completed? Can all of the study visit procedures be completed in the subject’s home?
Not all procedures can be completed safely or accurately outside of a medical facility. Visits that require special equipment or complicated procedures may be better suited for a traditional study facility.
Will the use of home visits positively or negatively affect study enrollment and subject completion?
The use of a home health care agency can be great for studies enrolling frail or home-bound subjects. Giving subjects the ability to participate in a clinical trial without adding the burden of traveling to and from the study site can help increase subject enrollment, compliance, and completion.
How will home health care providers be chosen and trained?
You’ll want to carefully assess the qualifications and capabilities of a home health care agency. You should also consider the time it may take to train employees on the study protocol and company Standard Operating Procedures. All training, re-training, and corrective actions will need to be carefully documented.
Who will provide oversight and ensure compliance with the protocol and applicable regulations?
By adding another layer to the study monitoring process, you will need to decide who will take responsibility for managing the home health care agency. Communication between all parties is key in any clinical trial, so be sure to include representatives from the home health care agencies utilized in team meetings, as appropriate.
What reporting and communication systems will need to be setup? How will access to EDC systems, IVRS, or CTMS be handled?
Think of all the reporting tools you have at your study site – you’ll need to give the home health care agent the same tools. Training should be provided on all available systems to ensure accurate and complete data recording.
How will lab kits and drug shipments be shipped and tracked? Who will be responsible for dispensing and destroying the study drug?
If your study drug requires special handling or storage, you’ll want to choose a home health care agency that has these capabilities. Before your trial begins you should decide on a drug handling policy that outlines the responsibilities of everyone involved.
By answering these questions – and more – you can decide if using a home health care agency would be beneficial for your study. Our experienced clinical team can help get your study off the ground and running smoothly. Contact us for more information on clinical project management, study monitoring, and consulting.
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