Site Business Trends: How to Remain Competitive in 2021
Throughout the course of 2020, we have seen a lot evolve in the clinical trial space. With the inception of virtual trials and hybrid trials, it has been possible to bring the trial right to the patient’s home, virtually. It is important to remember that with this type of evolution will come changes to procedures, budgetary items, patient engagement and participation, and more.
Managing Your Trial Budget:
Virtual and hybrid studies have been a huge part of the success of clinical trials during the 2020 year due to the COVID-19 pandemic, but it has also introduced changes in how you will need to manage your trial budget moving forward. Some things to consider is the amount of remote study items and protocols that will be expected including patient safety calls, monitoring visits, source data verification, SIVs, initiation visits and close-out visits, this doesn’t even include the items you will have to budget for due to COVID-19 – PPE, testing kits, cleaning supplies, etc.
You may not have a sponsor or CRO coming on site for things such as your initiation or close-out visits, or even your source data verification, this does not mean that your team isn’t spending time on these items, and ultimately, you need to make sure that this time is accounted for so that you can maximize what you’re getting from a budgeting standpoint.
What these costs might look like:
Remote Studies:
- Initiation Visit: $1,000, typically a one time fee
- Close-out Visit: $1,500, typically a one time fee
- Patient Safety Calls: $50 per call
- Monitoring Visits: $500 per occurrence
- Source Verification: $75 per occurrence
COVID-19 Expenses:
- Testing Kits: Up to $100 per test
- PPE: $500-$600 per month per study
- Cleaning Supplies: A pass through cost
Handling Patient Engagement & Participation:
But what about patient engagement and participation? We hear you. With the evolution of hybrid trials we have seen both some pros and cons when it comes to the patient.
Pros:
- Patient participation may be easier due to reduced on-site time
- More diverse patients based on reduced travel for those who live further from site for hybrid trials
- Patients can set their own schedules, within study parameters
Cons:
- Less opportunity to establish strong patient relationships due to less “face time”
- Technology and system limitations
Based on the design of a hybrid study, it is crucial to communicate what is expected and required from the patients, this includes outlining which visits are on-site and which are at home, proactive phone and text reminders for upcoming visits, reminders after each visit, as well as PROs. These few things will have a large impact on patient compliance.
These are the current high level pros and cons that we have seen since the inception to virtual and hybrid studies. This does not mean that your site will experience these cons and it doesn’t mean that there won’t be a way to address them to resolve them before they happen. These are simply pros and cons to keep in mind if you are to plan a virtual or hybrid study in 2021.
Therapeutic Trends & Activity:
Driven by the response to COVID-19, in 2020 there was a large increase in trial volume for vaccines to infectious diseases. On top of the large increase for infectious disease trials there was also a point in Spring and Summer of 2020 that we saw declines in other therapeutic areas. This is not only due to Sponsor focus being largely on COVID-19 treatments and preventions, but also due to the impact of trials that had to go on hold.
While we are expecting to see continued COVID-19 trial focus for 2021, we are also expecting to see a return of “normal “ levels for other areas and growth in hybrid trials. It is necessary that sites continue to evolve for hybrid studies as well as ensure the correct procedures for budget negotiation and patient engagement to be successful. Therapeutic areas and indications that lend themselves to easier adaptation of remote visits will see the quickest return.
Be Prepared:
As you are working toward being awarded new studies, make sure you are making the changes to adapt to the hybrid model of clinical trials. Success in 2021 will largely be impacted by who is prepared to run hybrid trials. Use the information learned above to help you manage your budget, prepare for expenses you may not have expected, and communicate with patients to run a successful hybrid trial in 2021.