Currently, most Clinical Research Organizations list recruitment targets as one of the most challenging aspects of setting up a trial. According to a recent U.S. survey, issues with patient recruitment were identified as a major reason in 80% of cases where a trial was canceled or delayed. Meanwhile, clinical research managers now list patient recruitment as both a major cost driver for clinical trials, as well as an important factor shaping protocol design and site selection
Why Are There Not Enough Patients?
Undeniably, it is becoming increasingly harder to motivate people to enlist in a clinical trial. There are many factors behind this trend: from the lack of eligible patients with certain rare diseases to a general lack of interest or even fear of what participating in a clinical trial may entail.
Other factors that may be at play include:
- As specific hospitals see the prestige of their researchers rise, they may start too many concurrent trials and saturate the local patient population.
- The wider availability of effective treatments for some diseases makes clinical trials seem less attractive for sick patients.
- Patients often feel that participating in a trial would include more frequent invasive or painful testing.
- The current pandemic has caused the general population to be warier of hospital visits in general.
Following talks with a series of industry insiders, we received feedback on many different types of strategies that have been used to boost recruitment numbers. Although many seemed efficient for specific niche specialties, we identified 5 strategies that could be widely applied for a large number of clinical studies.
5 Strategies To Make the Patient Recruitment Process More Efficient
Designate a Head of Patient Recruitment
Often, clinicians and managers think of patient recruitment service as a specific task that needs to be checked off before the trial can truly start. In reality, the process of patient recruitment truly begins while the initial protocol is being drafted, and continues until the last patient has undergone its complete intervention.
This is because patient recruitment will depend on the study design and the eligibility criteria that best suits it. After the trial has already started, patients still retain the right to drop out – and if enough of them do, completion of the trial may also be jeopardized.
Because of this, many managers may accidentally make decisions that will indirectly impact patient recruitment and retention. To prevent this, it is important to assign one manager that will be in charge of drafting and supervising this process from start to finish.
Devote a feasibility study to it
The patient recruitment process can be significantly eased by tweaking two specific variables in the trial: the inclusion or exclusion criteria, and the sites selected for the trial. This is because both will directly impact the total amount of eligible patients available for a trial.
Both issues can be addressed during the initial feasibility studies, at the early stages of the planning process. The results of the feasibility study will help identify the key strengths and weaknesses of each potential site, such as the difference between the local standard of care, the physician networks that may be available to collaborate, or the tactics used to inform possible patients about the trial.
Focus the site selection process around recruitment
Each selected site or country in which the trial will take place must be thought of in terms of its facilities, available professionals, and the patient population it contributes to the overall patient pool.
For the latter point, it is key to study the local city or town where the site is located, as well as its complete “catchment area”. This will require in-depth knowledge of:
- The area’s total population and demographic characteristics
- The quality of medical services available in the area
- The quality of the transport infrastructure in the region
- The presence of similar trials at the same site or city
Aim to retain patients, not just recruit them
The patient recruitment process goes through several filters between the initial approach and actual participation. Each eligible patient will have to be initially screened, enrolled, and retained – and through each step of this process, it is expected that some patients will be lost along the way,
This phenomenon has led to many industry jokes, such as Muench’s Third Law (the number of patients you need is ten times the number of patients that you think you need). Consequently, many site managers often place their strongest efforts on approaching as many patients as possible, with the hope that enough will stay.
This is a wasteful approach that costs extra money, as all these “less-than-ideal” patients will need to be screened and briefed. These resources would be better utilized retaining a smaller number of patients.
Protect the patient’s experience
Finally, it is important to ensure that the patient has the resources available to enrol and continue participating in the trial. The more positive their overall experience with the trial is, the more likely he or she will be to continue participating in the trial.
At the simplest level, small tokens such as travel reimbursements or taxi rides to the site can go a long way. When possible, the least-invasive tests possible should be preferred during screening or monitoring.
For interventional studies with very ill patients, investigators may also need to consider the needs of the caretakers or other family members. Psychosocial support for terminally ill patients should also be considered.
In the clinical research industry, patients are one of the scarcest resources. Patient recruitment needs to be seen as a holistic “live” process. This should acknowledge both the needs of the sturdy and the comfort of the patients.