Retention planning should start at the very beginning 

Think of subjects as customers

Recruitment is expensive and increasingly difficult, so it’s vitally important to improve the retention rate of those who are enrolled in a clinical trial. Experts say a retention plan should be developed before the study gets under way.

At the very beginning of planning a clinical trial, site administrators should plan for subject retention through a thorough discussion of protocol challenges, study implementation barriers, and issues related to patient compliance, says Beth D. Harper, MBA, senior vice president of global operations for Dallas-based D. Anderson & Co.

Treating subjects like customers is the key to better trial retention, notes Tom Sturgis, president of Integrated Clinical Trial Services of Cary, NC.

Harper and Sturgis offer the following suggestions for improving subject retention.

1. Anticipate retention burdens.

Some of the retention barriers to consider are these, Harper notes:

  • What is a burden to a patient and family caused by getting into a study?
  • How long and frequent are visits, and can anything be done to shorten waiting time before procedures?
  • How cumbersome are the procedures?
  • What are the needs and expectations of the patient population entering the study?
  • What can be done to ease the burden on patients?

For example, some retention issues involve the lack of support of family members or primary care physicians, causing patients to lose interest in the study, Harper says. Or, if patients have jobs, they might find it difficult to make it to every clinical trial appointment during regular business hours, so one solution might be to provide extended visit hours on evenings or weekends, Harper suggests.

"If patients are elderly and dependent on a caregiver or child to bring them to the visits, what can be done to not interfere with the caregiver’s work or family life?" Harper says. "They’re making a significant effort to get to the center, so can study staff provide a stipend for travel, child care, things to make it easier and less financially burdensome for the patient to participate?"

Of course, any strategies that involve some monetary value have to be considered from the ethical and IRB standpoint as well, she notes.

Often, it’s the little things a clinical trial site can do that will make the difference in patient retention, Harper says.

For instance, perhaps all that is needed is a parking pass for subjects, which is a minor expense that might make things easier for them, Harper says. Or perhaps you could offer transportation reimbursement or a coupon for lunch, both of which would need IRB approval, Sturgis notes.

2. Provide subjects with service, information, and support.

Research and clinical staff who work with patients volunteering for research studies should adopt basic good customer service skills, including using the patient’s name when addressing him or her, maintaining eye contact, smiling, having a welcoming voice when answering the telephone, and avoiding the practice of keeping callers on hold, Harper advises.

"Make the patient feel valuable," Sturgis says. "That’s so simple for any business, retail or otherwise."

It helps retention when study coordinators and other clinical trial site staff have the interpersonal skills to maintain a personal contact with participants and are able to sell the value of the research without being coercive, Sturgis says.

Clinical trial staff should inquire about participants’ families and interests, showing they care about them as individuals and not just as research subjects, Harper says.

The idea is to make the patient’s research participation as convenient as possible, Sturgis suggests.

For example, one clinical trial site that worked with subjects between the ages of 5 and 14 years old put together a catalog of inexpensive items, similar to the old S&H Green Stamps program, Sturgis says. When the children showed up for their study appointment, they were entitled to pick out an item from the catalog, he says.

For adult subjects, a clinical trial site could provide refrigerator calendars that include dates marked for all study appointments, making it easier for them to remember, Sturgis says.

Clinical trial sites also could send out reminder postcards to subjects, and if the study lasts long enough, they could send out birthday cards to participants, Sturgis and Harper add.

"Most sites don’t consider sufficiently the condition of their facilities," Sturgis notes. "Is the waiting room a happy place, or is it a disaster with chairs that are old?"

Some research sites will provide family members with pagers so they can leave the waiting room during the appointment and be paged when it’s time to come back and pick up the patient, Harper notes.

Also, consideration should be given to how much information a site will provide to participants, Harper says. The literature supports the notion that patients expect information as they participate in clinical trials, so investigators should consider how much information can be provided beyond the informed consent, she says.

For instance, D. Anderson & Co. has sent participants monthly newsletters that provided education about the disease that’s being studied, as well as tips about managing symptoms and updates about the study, the research process, and the drug development process, Harper says.

A key to good customer service is to treat subjects as customers, making encounters positive and responding readily to questions, Harper says.

"This will go a long way to overcoming problems with patients who become skeptical or concerned or weary of their participation," she says.

3. Watch for red flags that a subject might drop out.

One red flag is tardiness or missed appointments. "If patients miss an appointment or two or don’t show up on schedule, then maybe something is going on," Harper says. "Maybe the patient has had a life change, lost a job, moved, or has lost interest in the study."

If anything changes in the subject’s typical pattern, such as a patient who used to be scrupulous about showing up on time now missing appointments or calling in, then this is an indicator that something is amiss, she adds.

Another red flag is when a subject increasingly complains about the clinical trial experience or is feeling frustrated, Harper says. It’s important to find out what has changed in the patient’s life or experience and to address this problem, she says.

For instance, perhaps the subject is being influenced by a family member or primary care physician who advises against participating in the study, or perhaps something has happened in the person’s life that has nothing to do with the study, Harper says.

If a patient has moved out of town, then a solution could be to transfer the care to another investigator who is doing the study at a site closer to where the subject has moved, Harper suggests.

If a subject’s financial burden has increased because of a job loss, the feasibility of paying for transportation should be considered, she says.

Or if the subject is being influenced by views of a family member, then maybe that family member could be brought in to speak with the clinical trial coordinator and to have questions answered, Harper says.

Don’t forget ethical guidelines

Although clinical trial sites should work as hard as they can at retaining subjects, it’s important to make certain that all actions meet all ethical and safety guidelines and do not appear coercive, Harper and Sturgis note.

"If someone is experiencing an adverse event and is not comfortable with the trial, then the appropriate thing to do is to help them discontinue," Sturgis says. "The data they’ve reported still will be good, valuable data, and it helps with the process."