Avoiding Summer Roadblocks to Recruitment
Avoiding Summer Roadblocks to Recruitment
Our Roadmap to Recruitment series will help you navigate the patient recruitment roadblocks often found during the summer months. Click the links at the end of the post to follow the rest of the series.
The summer season is fast approaching and that can only mean one thing – summer holidays. There is one sure thing to cause frustration and delays in reaching your vacation destination – roadblocks. Whilst on holiday, I tend to do all of the driving and I know that in order to reduce the chances of getting caught up in traffic jams, highway repairs, and other unexpected delays, I need to plan my route in advance. The same approach applies to patient recruitment in global clinical trials.
With that in mind, this is the first in a series of posts to help you navigate some of the roadblocks that may impede your ability to enrol patients during the summer months.
3 roadblocks that may impede your ability to enrol
Roadblock #1 – Site & Patient Holidays
I love summer holidays - and so do site staff and study participants! Without careful planning, your study visits could get delayed whilst sites and potential participants work around each other’s availability, especially in July and August. Paediatric studies are particularly at risk as longer family holidays often occur during the summer break. It isn’t unheard of for European sites to put a hold on new enrolments during August with a recruitment freeze between July and September.
With advance planning you can still reach your recruitment goals on time, despite holiday schedules. Front loading recruitment with an accelerated rate of enrolment ahead of the summer - is best. Often, projections of recruitment rates are linear, when in reality there may be “troughs” to reflect downtime in the summer and Christmas holidays. Plan to get ahead and hit your August enrolment in July. Not feasible? Put a plan in place to pick up momentum when sites return to business-as-usual in September.
Map it out
- What can you do to ensure you have enough sites open to support an increased rate of recruitment ahead of the summer slowdown?
- How can you support and motivate your sites to hit recruitment milestones earlier?
Roadblock #2 – Ethics Committees
In Europe, our Ethics Committees (ECs) love long summer holidays too. Typically, many ECs do not meet in August. July is the cut-off point for reviews and decisions. It can take up to 90 days to gain EC approval following initial submission. In some cases, it may take even longer if the EC insists that amendments need to be formally reviewed at a scheduled meeting. Being unable to open sites on time presents one of the most destructive recruitment roadblocks you will encounter during summer and has the potential to derail your journey to LPLV (last patient last visit).
This is a roadblock that needs to be avoided. Having EC approval delayed during the summer months will reduce the number of sites you have enrolling during this period. If your recruitment projections include enrolment activity from European sites planned to open in the months leading up to July, then EC submissions should be made no later than March, depending on the country approval process. Ideally these sites should be initiated by the end of June to enable them to begin enrolment before the summer holiday season starts to restrict their activity.
Map it out!
- Have you set realistic timeframes for the competent authority and EC approvals to be received in time for summer sites to start recruiting by June?
- How can you support sites to begin enrolling quickly after activation?
Roadblock #3 – Lack of Available Site Staff
Summer holidays may not lead to complete shut down for some sites, but it can leave them short-handed as they cover for absent colleagues. If your study relies heavily on sites being proactive in reaching out to people who want to learn more and potentially take part in a study, delays in responding to those enquires can be damaging. The longer the delay, the less likely the respondent is to participate. As a result, some of those respondents will be lost to other studies or simply lose interest. The budget you have used to attract and inform the public about your study will not be used as efficiently as it could.
There is a way around this. For some studies, it’s worth considering utilising a third party to respond to those initial enquiries. Just simply acknowledging receipt of an enquiry, sending study brochures and helping to schedule an initial call or visit with the site will help keep respondents engaged and ease the administrative backlog faced by the site. With careful planning and management of responses, the summer months could be used to generate a pool of suitable and engaged participants who are ready to enrol in September.
Map it out
- Do your sites have adequate capacity to respond to people who want to take part, at the volumes needed to sustain recruitment projections?
- What can you do to support your sites to reduce delayed responses to willing participants?
Now that you’re ready to navigate your way through summer recruitment roadblocks, make sure that you’re using the summer slow-down to your advantage. Read here for three tips that will jumpstart your fall recruitment strategies.