Keeping Patients in Clinical Trials

Keeping Patients in Clinical Trials
Scott H. Connor, Vice President, Marketing, Acurian, Inc.
Drug Discovery & Development - February 07, 2011


The life-blood of advancing medical science often comes in streams of digital bits—the data flowing from high-grade clinical trials. Beyond the goals of enrolling the right patients in large enough numbers into clinical research protocols, lies the increasingly daunting task of keeping them enrolled—to ensure the supply of essential data.  One recent analysis suggested a full 30% drop-out rate in Phase 3 trials.¹ Another offered a more dire estimate.  The report, “Growing Protocol Design Complexity Stresses Investigators, Volunteers”, showed that clinical trial retention rates in 57 Phase 2 and 3 trials between assessments in 1999-2002 and in 2003-2006 fell from 69% to 48%.²
Such high attrition rates can spell disaster for the reliability and validity of conclusions drawn from research. What lies behind high attrition rates? A variety of general factors may be at work, including competing life demands, logistical issues, and general inconvenience.³ But a deeper explanation may be found in evolving patterns in the nature of clinical trials.  One structural factor degrading retention rates shown in the Tufts study is that the overall duration of clinical trials has increased 74%. Between the two sampling periods, average case report forms grew from 55 to 180 pages and consent forms got longer, as well. Over the same period, trial protocols became more complex with higher average numbers of required procedures per protocol.
Intensified communication  and intervention
The standard approach to supporting patient retention has been to reward the patient’s commitment through informational booklets, invitations to join associations, various tchotchkes, thermoses, tote bags and t-shirts, practical health-related aids to exercise or diet (e.g., diabetes recipes and food guides), and other assorted nominal give-aways. The new ethics code of the Pharmaceutical Research and Manufacturers of America (PhRMA) unveiled in July 2008, banning distribution of pens, mugs, pads or other similar items with drug names, while voluntary, however, has reduced distribution of promotional items and other perks throughout the medical community. A survey of more than 700 site coordinators  found the value of such perks for keeping patients motivated toward ongoing clinical trial participation to be modest.⁴  A further survey looking at patients who had participated in and remained in clinical trials found altruistic aspects, the sense of contributing to “the greater good,” as the strongest motivator for patients who stick with the trial to its conclusion.⁵
The site coordinator at the center
Bringing about that “greater good,” especially with the growing complexity of clinical trials and the demands they put on patients, means fulfilling the tasks that eventually lead to the data stream mentioned earlier. Those tasks fall squarely within the responsibility of the site coordinator. It is the site coordinator who ensures that patients make and keep appointments within the stipulated time windows, schedule and submit to lab tests or imaging as required, and stay with the trial throughout the follow-up period. Relentlessly keeping track of patients’ status with regard to all of this is complex and difficult, as is taking appropriate steps when patients miss or fall behind in their appointments.
All too often, the sheer volume of the site manager’s tasks, is simply overwhelming, rendering attempts to foster patient retention less effective than they could be.
Streamlining workflow
A potential solution is to provide a centralized, integrated, and structured approach to workflow, combining effective human services and well-designed software. Software applications should show which active patients are eligible to come in for an appointment, but have not yet made one. It has to provide warnings showing the number of days until appointment windows open and close. It also needs to stipulate whether laboratory testing is needed for a particular visit. In short, a successful program has to coordinate and structure the sequence of tasks to be accomplished.
Many of these tasks can be taken up through sophisticated software and on-site program personnel.  Among these tasks are informing the patient via calls or text messages about the appointment date, sending reminders about dates of upcoming appointments and any requirements (e.g., no eating after midnight for tests), and notifying the site coordinator when an appointment has been confirmed and kept. When there are long intervals between visits, general encouragement notes to maintain patients’ interest in and engagement with the clinical trial can be sent.
Ensuring that a particular patient has an appointment within the visit window and other critical tasks remain the job of the site coordinator. The likelihood that they will be successfully completed is optimized when there is a constant stream of communication within the system and between the patient and the site coordinator so that each knows what the next step is and what steps have already been taken.
When patients drift awayWhat needs to happen when it becomes apparent to the site coordinator that patients have not merely missed an appointment or two, but have lost interest in or are choosing to discontinue participation? Then retention program personnel need to engage in a regimented recovery process. They need to identify the underlying causes of patients’ dissatisfaction. Are they unhappy with their physicians? Investigators can be switched. Are travel expenses excessive? Addition travel reimbursement can be arranged. Every effort has to be made to quickly identify patients’ issues and to ameliorate their concerns and reconnect them with the clinical trial.
The overall effect
The goal of integrating patient retention software and targeted personal communications is to transform what is often a fragmented set of efforts into a simplified, prioritized, and coordinated stream of tasks and events—without adding to anyone’s workload. The aim is make sure that problems appear “on the radar” with sufficient lead-time for effective intervention, while avoiding compromise to data collection and excessive costs.
Given the clearly growing challenges to ensuring patient retention and research data collection, the modest added program cost of building in such strategies may be easily justified. In fact, many clinical operations directors and trial managers regard patient retention services as an affordable insurance policy to protect against the more severe cost implications caused by lost patients and compromised research aims.
About the AuthorScott Connor has more than 20 years of marketing and software experience in the life sciences and technology arenas. He graduated summa cum laude from Syracuse University.
References
1. Elvidge S. Importance of Patient-Retention Strategies. Life Science Leader. April 2010.
2. Kaitin KI. Growing Protocol Design Complexity Stresses Investigators, Volunteers. Impact Report. Tufts Center for the Study of Drug Development. 2008.
3. Janson S, Alioto M, Boushy H. Attrition and retention of ethnically diverse subjects in a multicenter randomized controlled research trial. Controlled Clinical Trials. 2001, 22(6 Suppl): 236S-43S.
4. Patient Retention Services Assessment. MSP Analytics, Inc. December 2009.
5. Clinical Trial Participation Insights. Survey Gizmo. April 2010.