Patient Retention in Clinical Trials: Problems, Costs and Solutions

In clinical trials – throughout all the phases – timely patient recruitment is a constant concern and a key condition for the success of any concrete clinical study. What is overlooked by so many sponsors is patient retention and maintenance of their constant engagement throughout the research. Depending on the trial phase, 15 to 40% of patients enrolled at the beginning of the study drop out later on. This poor retention rate has a negative effect on the research cost for pharma companies and decreases the amount of evaluable data required for regulatory submission. Thus, patient retention throughout all trial phases is crucial from economic as well as scientific considerations.

 

Patient Retention Cost and Methods

Traditionally, about 80% of delays in clinical trial timelines are accounted for patient recruitment and retention, with over 50% of recruitment failing to meet the stipulated timeline. The enrollment process is complicated by such factors as:

  • poor site selection,
  • lack of public awareness,
  • improper recruitment program planning, and
  • non-optimal protocol design.

Patient recruitment costs make over 25% of the overall trial costs, totaling to an average of $805,785 for trial phases 1 to 4, according to a study conducted by the U.S. HHS (Department of Health and Human Services). Whereas spent on patient retention (mainly through patient assistance program) is only about $76,879, or just 9% of the overall clinical trials’ costs. Thus such instruments for control of dropout rate as patient retention and engagement programs remain largely neglected despite their importance to the success of clinical research. Often, implementation of patient support programs (treatment and coordination, identification and prevention, wellness and outcome) is outsourced to relevant service providers.

A closer look at patient retention spendings reveals that only 5 % of the total costs is spent on trial phase 1, 21% on phase 2, and about 74% – on phases 3 (41%) and 4 (33%).

Here are the three major tactics employed by pharma companies for patient retention offered by suppliers within the framework of the patient health (support) program:

Patient understanding, comprising of educating patients so that they have a better understanding of the processes of clinical trials and treatment risks in order to give them the peace of mind that help them make the trial more comfortable.

Incentives and reimbursement, comprising of different combinations of medical treatment and cash compensation for such expenses as telephone usage, travel, lunch, missed work, etc.

Counseling sessions aimed at maintaining the enrolled patients’ motivation by encouraging them at every 5 subsequent visits.

 

Major Trends in Patient Assistance

Support programs growing patient-managed  

With more patients obtaining their coverage through state healthcare exchanges, the balance in the healthcare system of the U.S. shifted from uninsured to underinsured. Due to this change, the services assisting the underinsured are expected to be in greater demand. The number of patient support programs will grow (particularly those targeting underinsured patients) to provide coinsurance and copay assistance. Though the majority of current programs rely heavily on paper applications, manufacturers and CROs make steps towards launching self-service web portals that can be accessed by patients as well as healthcare providers.

Replacement of routine tasks with technology  

Sponsors and CROs make investments in technology solutions to reduce dependence on large call centers for maintaining such activities as application data entry, phone calls, status updates, etc. Currently, the personnel of large contract centers is not sufficiently experienced and they need to be replaced with more qualified specialists like licensed nurses, pharmacy technicians, coders and certified billers to supply high-quality services to patients and health care providers. With the growth of the number of self-administered and oral products gaining approval as investigational new drugs, the demand for clinical call center services will grow too, along with the need for technology that can help patients adhere to their medication.

Digital solutions to educate patients  

The lack of healthcare literacy results annually in additional $100 – $200 billion to healthcare expenses. Pharma is currently considering medical gamification, animations and other digital solutions for educating patients. These solutions allow for gaining the required knowledge virtually and retaining it better throughout the entire trial process.

 

Types of Suppliers and Solutions They Offer

Suppliers are also developing service capabilities and digital solutions to cater to medical clinical studies’ needs in a most time- and cost-efficient way. An increasing number of suppliers become partners with sponsors, supplying them with market access insight and reliable health program support. Some vendors of medical record software develop application programming interfaces together with health program support providers to trim down administration costs incurred by support services. And, of course, the suppliers’ major focus over the next few years is sure to be developing strategies for providing underinsured patients with reliable coinsurance/ copay assistance services.

 

Bottom Line                    

Currently, the industry’s demand for patient engagement programs is high, urged by the need to decrease healthcare costs through improving technological capabilities, increasing patients’ knowledge, compliance, and adherence. Along with this, the principle of the connected patient in clinical studies is developing clearer shapes, as pharma begins to understand that addressing patient-specific barriers through developing patient engagement strategies they are more likely to achieve optimal health outcomes. If listening to patients first and then shaping clinical engagements to address patients’ needs more accurately, pharma companies can create campaigns that advocacy groups will be eager to participate in.