Best Practices in Pre-Screening Includes Use of Technology
Pre-screening potential participants for a clinical study is common practice at most research sites. It can save time by quickly identifying those who may qualify for a study prior to having them move on to the informed consent process. Pre-screens can be done in person, over the phone, or in some cases, even online. The role technology can play in this process is important not to overlook. Regardless of the collection method, the questions and any accompanying script must first be reviewed by the IRB to ensure the materials presented are not beyond the scope of the inclusion/exclusion criteria.
Often, low accrual or delays in clinical trials stem from an undersized pipeline of potential participants. When site staff must manually find participants for trials, or even when automated recruitment solutions don’t deliver as promised, it puts the trial’s viability at stake, with sites and sponsors in the hot seat.
If more trials made pre-screening a fixed part of the study lifecycle in a way that optimized both personnel and technology, many of these problems might be avoided. But too often, comprehensive pre-screening is overlooked in favor of more familiar, but also more outdated, manual tactics. Here’s why that’s a mistake — and why pre-screening is the great missed opportunity for modern day trial enrollment.
What is Pre-Screening in Clinical Research?
Pre-screening activities take place at the outset of a trial, before informed consent. In this critical time, sites review the inclusion and exclusion criteria to determine a potential patient pool for the study. This information then gets reported to the sponsor so they can assess enrollment feasibility.
Ultimately, sponsors and sites aim to start with as many pre-screened patients as possible to maximize the participant pipeline. However, there are several different approaches to pre-screening and no true standard.
“Typically, sites conduct pre-screening manually through paper-based logs or printed spreadsheets that get emailed to sponsors,” said Gillian Barron, Senior Project Manager at Advarra. “This outdated method leaves ample room for incomplete information, typos and other human errors that delay reporting and inevitably, delay enrollment.”
As Barron adds, such manual workflows place too much expectation on overworked site staff with minimal optics for sponsors. But on the other hand, automated solutions place too much expectation on technology — without considering human capacity and strengths.
Who is Responsible for Pre-Screening?
When time is a precious commodity at a research site, it can be advantageous to delegate the pre-screening process to a non-clinical team member. Since the pre-screen itself cannot include any research procedures, it’s quite practical for anyone at the research site to conduct the pre-screen. It is important, however, to ensure the script used is well written and followed as closely as possible. A good script should:
- Identify the staff member conducting the research and inform the subject of the type of the questions asked – that they are to determine eligibility only, and some may be sensitive in nature. If the staff member is not on the clinical team, it is best to disclose this so as not to give the subject the false impression they are speaking with a medical professional directly related to the study.
- Tell the patient how long the call is expected to take, and offer the option of completing the pre-screen in person or at another time that might be more convenient.
- Let the subject know they can stop the interview at any time if they don’t feel comfortable continuing.
- When possible, a closing statement should inform the subject of what the next steps will include with a timeline. It should also indicate what will be done with the information collected (destroyed or stored, and for how long and where).
- Concisely disclose applicable information to minimize future dropout rates.
As pre-screen questionnaires are completed, either manually or electronically, it is equally important to have an action plan to ensure eligible subjects don’t slip through the cracks and the information from those who didn’t meet the criteria are handled appropriately. Who will follow up with those who are eligible and when? Who will be responsible for managing the information collected? If the initial collection was done on paper, consider the advantages of maintaining this information electronically:
- Easy information retrieval
- Quick updates to answers or ability to complete unanswered questions at a later time
- Analyze ineligible forms to modify questions if enrollment has slowed to a stop
- If storing for a period of time, eliminate excess paper around the clinic
- If using a clinical trial management system (CTMS), easily transition the subject from pre-screen to enrolled
The Role of Staff and Technology in Pre-screening
Given the coexisting barriers and opportunities of pre-screening, the optimal approach is to engage a platform designed to gives sites the tools they need for a more efficient process while also providing more transparency to sponsors.
Solutions like the pre-screen navigator within Advarra’s Longboat Platform is one example of a solution doing so with a cloud-based, multi-device platform. Built to standardize the complexities of pre-screening questionnaires, the Longboat Platform provides easy yes/no toggles for the most important eligibility criteria.
The completed form then gets presented in real-time to sponsors, who can see pre-screening activity on a global, regional, and site basis. Study teams can see where the patients are located across each country and gain early insights into which of the inclusion or exclusion criteria are causing most prospective patients to fall out of the funnel. This removes the delays inherent in paper-based logs.
“It’s so important for sponsors and study teams to have this information available to them in real time,” Barron said. “With that insight, they can more quickly identify trends, discover pre-screening failures, monitor site performance and consider amendments to expand the participant pipeline — all at the very beginning of a study.”
Already, the Longboat Platform’s pre-screen navigator has been deployed in more than 80 studies, effectively pre-screening thousands of participants, many of whom go on to enroll and stay in the studies. In one case study exploring its application across four trials of a top-10 pharma company, the solution’s efforts accounted for 94 percent of trial participants who eventually enrolled.
Learn why the 64% of sites using the Longboat Platform’s Pre-screen Navigator accounted for an average 94% of patients enrolled.
Boosting Trial Success with Pre-screening
As sponsors look to expand their participant pipeline, pre-screening is an essential part of the clinical trial ecosystem. However, not all pre-screening methods are effective. Failure to optimize this critical process can impact study timelines and ultimately, delay commercialization plans and treatment to patients.
Pre-screening is a common strategy to add to any patient recruitment campaign. Fortunately, there’s a better way to do pre-screening. To maximize your pre-screen activities, make sure you have a well-written script, ask the right questions, and have a follow up plan in place.
Additionally, using technology to help manage your pre-screen paperwork and records can serve many purposes. With streamlined technology like the Longboat Platform’s pre-screen navigator, site staff can more easily do their jobs while getting back to what matters: their patients. In turn, sponsors can have the real-time insights they need to make decisions that affect the success of current and future research.
This blog was originally published Jun 21, 2013 and has been updated.