By Suzanne Elvidge
Patient recruitment is a major challenge for companies setting up and running clinical trials. This is only the beginning, though — there’s no value in recruiting the right people if they drop out before the study is completed. According to a recent CenterWatch analysis, only about 70% of participants completed phase 3 clinical trials.
To improve this rate, it is vital to create patient retention strategies that keep participants informed and engaged, ensuring they stay the course until trial completion. To find out more about patient retention best practices, I spoke with the following experts in the field:
Lars-Olof Eriksson, Ph.D., MSc, VP, Start-up and Accelerated Recruitment Team (START), Clinical Research Services, PAREXEL International
John Benbrook, CEO, MMG
Diana Anderson, Ph.D., president and CEO, D. Anderson & Company
Scott Connor, VP of marketing, Acurian.
How Do Patient-Retention Strategies Differ From Recruitment Strategies?
Connor: The most striking difference is that retention strategies focus on an audience that has already committed to the clinical trial, whereas recruitment strategies must convince a specific group of people to participate. That requires a very different approach.
Benbrook: Both recruitment and retention materials need to evoke an emotional response. The key difference is that recruitment messages should prompt action by provoking the “aha” moment of “that’s exactly how I feel,” whereas retention messages need to reinforce a tie to the study and emphasize the positive step the patients have taken, showing the significance of their commitment, and conveying appreciation for their partnership.
Eriksson: Where patient recruitment and retention strategies differ is in the time scale, with retention activities including interaction on an ongoing basis. Having a good rapport with patients and building a procedure for patient contact are critical.
What Are The Biggest Challenges To Patient- Retention Strategies?
Anderson: There are logistical, educational, emotional, and physical barriers to retention from a patient perspective, and study staff need to identify these barriers and create ways to overcome them.
Eriksson: It is important to understand what motivates patients to remain involved for the full study. These include advancing healthcare, obtaining treatment, or improving quality of life. Taking care of practical logistics as well as providing a comfortable study environment is key. For instance, a specialized call center can handle nonscientific study-related matters from a practical and logistical standpoint. This fosters two-way communication with each patient, which can contribute to positive results and reduce attrition rates.
Benbrook: Sometimes the best thing is simply to show appreciation to patients and/or caregivers. Their participation may involve time off work, disruption of family and childcare schedules, or changes to routines. Some sponsors have restrictive policies that do not allow even small gestures, including those regularly approved by institutional review boards (IRBs) and ethics committees (ECs).
Connor: It can be difficult for study teams to get sufficient funding for retention strategies, even though the impact of losing patients post-enrollment is high. Another significant challenge is to provide metrics to support the investment, because patient retention is often measured by anecdotal evidence rather than hard data, and because retention services are often applied to longer-term studies.
What Are The Types Of Patient- Retention Strategies Currently Available, And What Are The Pros And Cons Of Each?
Anderson: A sound retention strategy includes high standards of patient care, customer service strategies, quality control, educational materials, and IRB-approved patient appreciation items. Maintaining a competitive edge requires a detailed participant retention plan, which evolves from analyses of similar studies and market research. Developing a process to screen out participants who may be noncompliant or drop out also helps.
Benbrook: We group retention strategies into emotion and motivation, education, engagement, and expectations. These tactics don’t have pros and cons as much as they have relative levels of impact, and it’s important to identify the right mix of tactics to maximize retention.
Connor: Traditional strategies include programs that reward patients who achieve specific study milestones. These can be effective, but will receive greater scrutiny from legal and regulatory groups and can be onerous to manage. Other strategies include branded patient kits, therapeutically relevant gifts, such as diabetes cookbooks, and community websites for participants. The downside of online communities is that they can offer clues to whether patients are receiving placebo or investigational drug. Newer strategies focus on automated communication, for example, appointment and compliance reminders. Another approach is a card that provides patients with immediate reimbursement for study-related expenses. This provides positive reinforcement for patients and removes an administrative burden from sites, but could incur increased scrutiny from sponsors’ legal teams. Objections can be overcome with the explanation that these are not additional payments, just a more efficient delivery.
What Types Of Studies Benefit The Most From Patient-Retention Programs? Are There Any That Don’t Require Patient Retention Services?
Benbrook: Most studies can benefit from some level of retention program, but those generally flagged include studies with acute pain that resolves, placebo-controlled studies, studies that require a caregiver, and studies with long timelines. Short studies, open-label studies, and studies with intrinsic benefit have less need for retention programs. It’s important to know the retention goal before determining whether a retention program is required.
Eriksson: Some types of studies are more “at risk” for potential patient dropout, such as those where symptoms tend to disappear with treatment, where the protocol procedures or timing differs substantially from standard of care or where there are many other treatment options available to the patient.
Anderson: Retention plans also have relevance for studies requiring frequent site visits or lengthy appointments, or those with difficult dosing regimens, invasive procedures, or unpleasant side effects.
Connor: Any study over one year is a good target for retention services, especially if visits are spread far apart. This makes it easy to lose contact with patients or for patients to lose interest. Late-stage studies often need more support than early-stage because more investment has been made, and sponsors are more willing to spend because much is at stake. Retention services do not generally have a particular therapeutic leaning, though cancer studies generally do not need retention support.
What Is The Role Of A Site Coordinator In Relation To A Patient-Retention Program?
Benbrook: The site coordinator’s primary responsibility for retention is to build a strong relationship with each study participant and create a partnership that results in a positive trial experience. The study coordinator also needs to champion the retention program and maintain clear communication with the team.
Connor: The most important aspect of the coordinator’s role is education and customer service. Patients want to be involved with something important like medical research, but they also want to be supported and treated with dignity and respect. There may be no long-term therapeutic benefit for them, so the attitude of staff can make all the difference.
How Can A Site Coordinator Track The Effectiveness Of A Patient- Retention Program, And Are There Any Statistics That Can Show Effectiveness?
Benbrook: The effectiveness can be measured by tracking the number of patients who remain compliant and complete the trial, compared with the number who drop out for reasons that the retention program should have mitigated. This requires feedback from the sites and the sponsor, including reasons for discontinuation. It’s interesting to compare this across sites.
Connor: The effectiveness can be compared with previous studies in the same indication or current studies that do not have a retention component. A centralized patient-retention program can track patients across all sites in real time, so the clinical trial manager can monitor patient progress and address attrition immediately.
How Do Both Sites And Patients In Global Regions And/Or Specific Countries Outside The United States Perceive Retention Tactics?
Eriksson: As trials have become more global, the need for recruitment and retention tactics to account for cultural or standard-of-care differences has grown.
Benbrook: Sites outside the United States are sometimes more accepting of retention tactics than they are of recruitment tactics, as long as they meet the requirements for the specific region.
Anderson: Retention tactics vary from “educational” materials to materials increasing patients’ convenience and comfort. There is widespread global acceptance of educational materials, such as study calendars or patient newsletters. There may be reluctance from some regions to accept noneducational materials, such as greetings cards and tote bags for patients’ study medication, which may be perceived as gifts.
Connor: It is less about perception at the site and patient level and more about perception at the regulatory level. The ethics committee stance on patient-retention items varies widely outside the United States. For example, in France, ethics committees are conservative about what patients can receive, often only allowing a reminder card. However, sites are universally receptive to anything that will help retain patients, but the messaging and branding must be appropriate to the country.
What Are Some Best Practices That Study Sponsors Have Used To Navigate Internal Regulatory And Legal Concerns Pertaining To The Use Of Certain Retention Tactics?
Eriksson: Tactics need to be modified by country by knowledgeable experts, taking into account unique medical practices and cultural aspects. Additionally, these experts can advise on patient motivation factors that can impact retention in clinical trials, including providing access to healthcare.
Benbrook: The sponsors that are most successful in implementing retention programs are those who engage in dialogue to establish what is allowable and have a policy that allows for some creativity but provides clear boundaries. Best practices to ensure that concerns are satisfied include providing sponsor policy requirements in advance of making recommendations, reaching internal consensus early in the process, reviewing similar programs, and ensuring that appropriate tracking mechanisms are in place.
Anderson: Because a sponsor’s outsourcing and clinical teams are generally unaware of all the concerns regarding specific retention tactics, best practices include legal and regulatory involvement, after tentative agreement on the initiatives but before contract finalization. In reality, this approach is not always possible because guidelines vary in each country, and legal and regulatory involvement at the contracting stage could yield a separate contract for each country, which would be impractical. If there is no legal or regulatory involvement before contract finalization, specific tactics can be presented to the appropriate bodies for approval within each country before going to investigational sites and/or ethics committees. Knowing that feedback varies per country drives contracts with a degree of flexibility.
Connor: Documentation! The regulatory and legal groups want to see SOPs as they relate to retention support, privacy policies, and patient security. It is also helpful if the retention service provider has a chief privacy officer who can meet with the sponsor’s legal counsel and discuss specific issues that might prevent a study team from gaining internal approvals.