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International Clinical Trials

Staying On Course

Recruiting patients for clinical trials is, of course, a vital necessity, but so too is retaining subjects through the duration of a study. However, the retention of trial participants is often overlooked until a study team has a reason to be concerned.

A well-planned and timely retention programme should be implemented as an ‘insurance plan’ against losing participants enrolled in a trial. Whether a study is in the early planning stages, or has started up and a recruitment plan is not yet in place, here are some tips to help prepare for and implement an effective retention strategy.

Bottom Line

Firstly, during the planning phase, it is important to identify and understand how much retention matters to the study. Retention figures vary greatly from one trial to the next. There are many different contributing factors, depending on the complexity of the study, the patient population, the medical condition, study design and duration. Upwards of 40 per cent of subjects can cease their participation in a study after they are recruited (1).

Many teams over-recruit to compensate for this likelihood. However, it costs five times more to recruit than it does to retain, and the impact of lost participants in terms of delays, added costs and the statistical power of the study can be significant (2).

When planning the retention programme, two key questions should be considered. What is the anticipated conversion rate from recruited subjects to randomised subjects? And what level of attrition is acceptable in order to achieve the overall objectives of the study? Put another way, what percentage of subjects can you afford to lose and still achieve success for the study? This is the bottom line, and serves as an overall measure of a programme’s effectiveness.

The retention target will be influenced by variables such as how engaged study subjects are kept through the course of the study, and how proactively and quickly challenges are identified and overcome. Some variables are within your control and some are not, so it is important to address them as part of the initial plan.

Subject Attrition

Delving into the factors that drive subject attrition in the study is essential to devising a retention programme (2,3). Issues to consider include:
  • In earlier studies, did participants tend to stop treatment within three to four months of starting due to onset of certain (non-life threatening) side-effects?
  • Do subjects stop participating due to the impact of the study on daily living?
  • Are transportation issues or challenges getting to the study visits a factor (as is often the case for participants with epilepsy, Ménière's disease and chronic abdominal pain, for example)?
When planning the retention programme, available data points and life impact data should be gathered upfront and used to map out the strategy, with options for addressing each issue (2,3). Gaining insights from participants and study coordinators, in particular, will help answer many questions, and may well identify new issues that have not been considered (2,3).

The following steps are recommended:
  • Ask study coordinators about their experiences on previous similar studies, either through an advisory board, a site survey, or an email or phone call. Find out what pressures and constraints they are facing so these can be addressed through specific components of the programme. The more experienced study coordinators will have success stories to share and examples of what has and has not worked
  • A recruitment survey, which can help to glean important insights about the patient population before they participate in the study, can reveal many of the beliefs, barriers, needs and desires of a particular group of participants (3). Ask them to rank the importance of various features, such as ways to show appreciation for their study participation, input into educational materials, resources, their perspectives on what quality of medical care looks like when involved in a study, and other questions that shed further insights into ways to keep participants engaged
  • Review published papers about the challenges faced by similar studies and gather insights from previous studies that can apply to yours. Compare them to feedback from subjects and study sites involved in your study to see which insights are relevant, which ones are not, and the reasons why
  • Form a focus group to understand the mindset of your patient population and/or carers, including what sources of information they use, what technologies, and their hopes, fears and expectations around the study (2,3)
Shaping the Programme

Once the retention goals and the factors that will influence retention in the study are made clear, it is important to use these criteria to guide the retention programme and decision-making. Here are a few points to consider:

Set Meaningful and Measurable Objectives
Once you have defined what success means and your targets, map out the objectives for achieving these goals. Cost-effectiveness plays a key role as well. Keep in mind the principles of SMART objectives (Simple, Measurable, Achievable, Realistic and Time-based), as well as the principles of return on investment. Break it down into key points along the way of the study – for example, recruit X number of patients and retain Y number of patients at Z point in the study in order to provide meaningful scientific results; finish the study on time; and stay within budget. The tactics employed will naturally flow from these requirements.

Stay in Touch with Study Subjects
In a focus group of 17- and 18-year old students that we recently met with, the leading topic of interest was a request for more information on the study itself. This underscores the message that young study participants want to know how their participation is helping to make a difference in the wider context. In addition, it is recommended that you establish a regular feedback process from study sites about their subjects’ needs and challenges – they are closest to the subjects and this information can be invaluable.

Keep it Personal
One-to-one personal contact is even more important than ever in a technology-driven world. In a recent survey of study coordinators involved in an anaemia study, the leading mechanism for appointment reminders was personal phone calls. Through good management and close monitoring, compliance is more likely to occur. Also, ensure the programme includes ways to show your appreciation, whether it is through a tangible item that meets ethics review and approval, or a simple ‘thank you’ for their time and commitment during the course of the study (4).

Motivation and Involvement of Staff
Responsibility for many of the strategies you employ will be shared across various stakeholders. Study sites play a central role in the informed consent process and are often the main face to the participant. A newsletter and recognition of their efforts can go a long way towards driving patient engagement in the study.

Be Adaptive During Implementation Phase
New trends show that study subjects are using social media now more than ever to connect with others (1,5). Terms like mHealth (mobile health), Twitter and hashtags are household words. So what does this mean for retention programmes? How can we leverage these trends to build meaningful relationships with study subjects throughout the course of their participation? How can we balance this with ethics approvals and regulatory restraints?

Technology now enables us to get real-time results that can help drive our decisions. Use polls and surveys to find out what technology trends subjects are using, what websites they visit, and what information they find key. Bottom line: harnessing the latest technology trends can help us build better relationships. Make sure you are collecting meaningful data points along the way, which will give insights into the decisions you need to make and can serve as indicators for the effectiveness of tactics and the programme.

Does Your Retention Programme Need an Overhaul?
Breathe new life into a faltering programme by revisiting your objectives and re-evaluating the results based on where you are in the study. If something is not working well, change it before it gets worse. For example, change messaging if it is not resonating well for study participants.

Embrace New Technology
Although personal telephone calls as appointment reminders are effective in maintaining human contact, there is also much to be said for automating the process through SMS text messaging, email messaging, and so on (2). In this way, technology can be a useful tool to enhance and reinforce study site interaction with participants, as long as regulations are met with regards to data security and privacy of information. A digital retention programme allows updates, changes and programme additions to be implemented faster and in a less costly manner (1,5).

Use Key Performance Indicators to Ensure the Retention Programme is on Course
These can help serve as a compass to ensure the main objectives are being met throughout the implementation phase. Identify the key intervals at which to measure the programme’s performance.

Lost to Follow-up Programme
When contact with subjects is lost, consider a lost to follow-up programme to regain them. This step is essential to the requisite record-keeping of the study and is often well worth the investment.

The Right Balance

An effective retention plan will have the right balance of factors, including motivation, education, engagement and expectations. It will involve regulatory bodies to ensure the strategies developed are perceived as appropriate in the areas where they will be delivered. Key performance indicators will enable progress to be measured and ensure you are meeting the objectives throughout the course of the programme. The plan should be revisited on a regular basis and modified as necessary.

References
1. Sahoo A, Patient recruitment and retention in clinical trials: Emerging strategies in Europe, the US and Asia, Business Insights Ltd, 2007
2. Raju S, Strengthening patient engagement in clinical trials. Visit: www.ecronacunova.com/pdf/whitepapers/Raju_Sandeep_Patient_ Engagement_v3.pdf
3. Moench L, Putting patients first: Clinical teams need to learn what motivates a patient to become a study subject, Applied Clinical Trials 19(3), S10(3)-2, 2010
4. Burgess LJ and Sulzer NU, Patient retention gifts in clinical trials – undue inducement or justified motivational tools? South African Medical Journal 101(9): pp640-641, 2011
5. Kaplan T, The role of social media in clinical trial recruitment, Applied Clinical Trials, 2010



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Elizabeth Puller has extensive experience developing content and strategy for print and online patient-based support programmes. She is currently Senior Account Director – Europe at MediciGlobal, where she is involved in a range of global corporate communications, recruitment and retention activities. Elizabeth has a BS degree in Scientific and Technical Communication from the University of Washington and an MS in Journalism from Columbia University.

Liz Moench is President and Chief Executive Officer of MediciGlobal. Since founding the company in 1991, she has dedicated her efforts to improving the patient recruitment and retention process in clinical trials worldwide. Prior to this, Liz worked in senior management positions at Rhône-Poulenc Rorer Pharmaceuticals (now Sanofi -Aventis), Ciba-Geigy Pharmaceuticals Division (now Novartis) and Boots Pharmaceuticals.
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