Practically nothing can impact upon the success of a clinical trial like the issue of patient recruitment. Time sensitive and high pressure, patient recruitment issues account for around 80% of trial failures in the US.
On-time patient recruitment is the key to a streamlined road to treatment approval; in this article, we’re going to explore some of the measures you can take to ensure this.
Why Is Patient Recruitment Such A Complicated Issue?
Patient recruitment is a long process and often -particularly when not approached correctly- a complicated one. Between planning and screening, selecting and retaining patients, there are several opportunities for delay. Knowing what causes these delays makes it easier to avoid them. The delays are usually to do with:
Study Protocol & Design
The ‘ideal patient’ for a trial will be dependent on trial design and it’s important to spend some time considering this. However, remember that if criteria are too narrow or you include invasive screening tests/a high number of tests, you may struggle to find enough patients.
The characteristics of not only the site, but the region in general will determine the size of your patient pool. When you are choosing a site, be sure to consider:
- The site profile- their resources, their experience with similar clinical trials and the existing services available for the target population.
- The quality of local medical services and public transport networks.
- The competition from similar clinical trials in the area.
- The expected number of people with the required diagnosis
It is worth taking a little time to find the perfect investigator for your clinical trial. This will be an investigator who has not only extensive experience in clinical trials, but expertise with the condition being treated.
Improving The Patient Recruitment Process:
1. Take a step back
It is helpful to look at patient recruitment holistically, with one person taking ownership of the entire process throughout the study. By disconnecting the different stages of patient recruitment- for example, by assigning screening and recruitment to different teams, you leave more room for error and delay.
2. Keep patient recruitment at the forefront of feasibility studies
A well considered early feasibility study is crucial in planning. By selecting study methods and starting sites, you will be able to understand more clearly the number of patients who are available to you. As well as the patient profile required by your trial, you should address:
- The site where patients will be treated or observed
- Local requirements set by authorities and ethics committees
- The difference between local standards of care and study protocol
- Any advertising or informative materials you will use during recruitment
3. Utilize a “tight funnel” during screening and enrolment
When ensuring that you have enough patients ready before the deadline, it is useful to use the “tight funnel” approach.
Rather than using a “wide funnel” which attempts to enrol as many patients as possible in the hopes that some will stick, the “tight funnel” is a more efficient approach in which only ideal patients are approached.
Of course, each potential participant that you approach to inform about the study will require valuable time and resources. You are likely to waste resources, cause delays and increase staff stress levels if following the “wide funnel” approach.
It’s also important to bear in mind that, if your study protocol requires long or extensive testing, you might accidentally create reporting backlogs and put patients who fail the screening stage off enrolling in future studies.
It’s best to focus your efforts on approaching ideal patients by:
- Training your investigators to identify high quality candidates
- Working with local physicians and health professionals and utilizing useful referrals
- Prescreening candidates using electronic medical records
- Utilizing online recruitment tools, like social media advertising, where possible. Through this, you are able to directly address a specific demographic.
4. Be flexible with your recruitment schedules
Where possible consider adjusting your recruitment schedule so as to reduce the impact from those who drop out of the study.
If you are conducting a large scale pharmacological study, for example, that requires a large number of healthy volunteers, a “batch model” is a good idea. This allows you to have subjects ready for enrolment if needed. This strategy can also be useful in studies with critically ill patients who could deteriorate rapidly.
The adjustments that you make or are able to make will, of course, depend on the exact nature of the study. At Dokumeds, we identify all possibilities during the feasibility and protocol drafting stages to ensure a seamless process.
5. Focus On Patient Experience
People are at the heart of every trial. The better patient experience is, the less likely patients are to drop out. In order to optimize patient experience, try to:
- Prioritize non-invasive tests wherever possible
- Minimize the patient pathway and make enrolling for a trial easy
- Consider family members
- Minimize the inconveniences of commuting and cover expenses
- Schedule appointments and tests at convenient times and use remote visits or online symptom monitoring for patients who are at home
- Make use of video calls to explain the study process
6. Engage Investors
It’s crucial to keep investors in the loop on any issues with patient recruitment and retention. This enables them to feel heard and thus encouraged to maintain engagement. A strong communication system will also aid connection between sites.