Applied Clinical Trials
In this article, Moe Alsumidaie will identify several bottlenecks that study sites experience from the subject recruitment to the enrollment phase.
Subject recruitment has always been a pain point in clinical trials. However, with new recruitment technologies and methodologies, biopharmaceutical enterprises are capable of reaching patients through a variety of channels including targeted social media and internet ads, and leads are subsequently referred to the site. In my experience with running studies at sites, recruitment does not end with patient referrals, as site staff becomes overburdened with an overwhelming amount of leads. In this article, we will identify challenges with processing these leads, and recommend strategies on how sites can successfully transform leads into enrolled patients.
Set up a Pre-Screener Questionnaire
Sponsors prefer that study coordinators conduct as much prescreening activities as possible to reduce the screen fail ratio. To support these requirements, it is recommended that sites create a pre-screener questionnaire that they can conduct over the phone with prospective subjects. Questions that exhibit the highest likelihood of screen failure should be asked first to disqualify candidates sooner and avoid wasting time over the phone with the candidate. Once you draft the prescreening questionnaire, you’ll be ready to launch your lead collection initiative. Naturally, the prescreening questionnaire will need to be submitted and approved by the IRB.
Organize Your Leads
You should expect subject recruitment vendors to refer prospective subjects to you, and as a research coordinator, you will need to prescreen, engage, and schedule appointments with those subjects. One challenge is volume; a little bit of money goes a long way with online recruitment campaigns, so expect to receive a lot of patients that you will have to pre-qualify. Another major challenge involves the fact that patients referred from online recruitment campaigns exhibit deficient engagement levels; they will not likely pick up their phones, and you will leave countless voicemails and emails.
Nonetheless, the way around this requires a strong foundation in lead engagement tactics. This means developing a lead tracking system that automatically sends the patient information and follows up with the patient to the point where they become aware that you’re reaching them about your study. You will have to be able to quickly and immediately pull up a contact and have all their information (i.e., notes about the patient and all communications made) available to you.
Engage Your Leads
When you input your lead into your lead tracking system, it is a good idea to send them an automated email sequence that contains study information (typically three automated emails sent in three days), so that when you speak to the patient, they are aware of the study and why you are contacting them. It is advisable to initiate lead engagement activities within 24 hours of receiving the lead from subject recruitment vendors; otherwise, the leads grow stale and do not respond. It is also advisable to make at least three phone calls to the lead and leave voicemails if you do not reach them. If you are fortunate to speak to the lead over the phone and prequalify them, as a coordinator, it is important to avoid coercing the patient into study participation and stick to an IRB approved script.
Technology tools, such as Monday, can help you organize your leads and maintain all notes related to that lead in one place, and allows for some communications automation. If you are unsuccessful at reaching the lead (i.e., three text messages, emails, and voicemails), it is probably a good idea to stop contacting the lead because at that point it is unlikely that they will respond.
Schedule a Prescreening visit
Once you have prequalified the lead, you will need to schedule them for a prescreening visit. Planning a screening visit is not an appropriate option during this phase, as, assuming you’ve never seen this patient before, you will need to collect their medical records, and generate source to review prequalification criteria against, such as medication history, treatment history, and other inclusion/exclusion criteria. A big challenge in this phase is that many patients do not show up to the prescreening visit. Hence, it is essential to continue engagement before the visit occurs (i.e., confirming that the patient is coming to the visit). If the patient shows up to the prescreening visit and passes prequalification criteria, it would be appropriate to present the study to the patient and consent them during this visit. Moreover, introducing the patient to the study team and the PI enhances the relationship between the patient and the site, which means that the patient will feel a sense of commitment and will be less likely to not show up to future visits.
Continue Engagement Before the Screening Visit
Continuing to engage the patient (i.e., sending several automated text message visit reminders, and calling the patient to verbally remind them) before the screening visit also helps to improve retention. If the patient shows up to the screening visit, it is likely that you have succeeded at connecting with the patient and making them understand the commitment required to participate as a clinical trial volunteer.
Engagement by Site Staff is Critical to Successful Enrollment
In this article, we have identified several bottlenecks that study sites experience from the subject recruitment to the enrollment phase. By implementing engagement technologies, automation, and active effort into fostering relationships with patients, study sites can improve the chances of successfully enrolling patients into clinical trials.
Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.