Poor recruitment is cited as the major contributor to cost and extended timelines in over 80% of clinical trials. While I don’t have all the answers, these are a few simple hints to improve subject recruitment that I have picked up over the years.
Set Realistic Targets
It is much easier to meet recruitment targets when they accurately reflect your site’s patient population. It is very common for sites to overestimate the number of patients attending their practice each year. This is simply because it is human nature to overestimate if we are trying to achieve a particular outcome.
The best way to provide recruitment targets, is to use factual, historical data. Sites who collect data on the numbers and types of patient visits conducted have a strong advantage in estimating recruitment targets. Patient databases that can be searched by diagnosis or presenting problem are also an advantage.
You don’t need to have a searchable database or perform extensive data collection to get accurate reflection of your patient population. It is simple as taking a piece of paper and adding columns for each of the patient subgroups you are interested in reviewing. Tape the paper to the investigator’s desk at the beginning of a set time period (week, fortnight, month). Each time the investigator reviews a patient, he/she places a mark in the correct column. Tally up the marks at the end of the time period and you have some factual, historical data. Easy!
Focus Your Energy
Out of the entire patient pool at a site, only a small subset will be eligible for trials once protocol restrictions are taken into consideration. Looking at each individual patient to see if they meet inclusion/exclusion can waste a lot of time and human resources. In order to know where to focus resources, an in-depth understanding of the inclusion/exclusion criteria is needed in combination with knowledge about how potential patients move through your institution.
The first step is to work out what all eligible patients have in common that is unique from all other patient groups. Will they have a lab result, imaging procedure, billing code or all see the same staff member (eg dietician, clinician, nurse practitioner, etc)? Next is to work out how you are going to access this information. Can you search a database? Will a staff member notify you when a particular diagnosis is detected? Can you have access to a staff member’s appointment list every week? Once you know where to find your patients, it is a simple matter to set up regular screening process.
Communicate, communicate, communicate!
Keeping the trial at the front of everyone’s mind increases the chance of staff identifying and referring potential patients. There are two ways to do this.
The first (and most successful) is to recruit patients. Nothing stirs interest in a trial like being involved in the care of someone on the trial. Unfortunately, this is not very helpful advice if you don’t have any readily available patients.
The second way is to keep the trial at the front of everyone’s mind by talking about the trial frequently and in a meaningful way. If the same approach is used too often, it becomes background noise and looses impact. Some suggestions include tabling the trial at departmental meetings, including a brief blurb at education sessions, handing out study material such as inclusion/exclusion criteria cards or study brochures, circulating recently published papers relevant to research being performed, inhouse competitions (eg a “cup” for the highest referrer of patients each month), circulating newletters and study updates
The early bird catches the worm so they say. Enrolling the first patient within two weeks of site activation greatly increases the site’s chance of achieving a high recruitment target. By putting in processes to identify potential patients in advance of site activation, the site will be ready to recruit straight away. Please note that patients may not be consented prior to site activation but (depending on the study) the study may be discussed with potential patients and their interest in the trial evaluated. Early recruitment has the advantage of raising the knowledge of the trial in site staff and staff are more likely to identify potential patients. It also helps to iron out any logistical issues early on and ensure a smooth trial.
When you are passionate about something, you can’t help talking and thinking about it. If you believe in the study you are conducting, it will be easy to be passionate about it. If you aren’t passionate about the trial, then perhaps you need to reevaluate your involvement.
Do you have any tips to add? I would love to hear in the comment below.