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Tools & Techniques Clinical trials

Trials on Trial

Clinical trials continue to face a serious problem: patient retention. As it stands, some trial designers are now factoring in dropout rates as high as 30 percent into their plans and budgets (1). The industry has grown to appreciate the important role patient-centric trial design can play in reducing this costly burden, yet only 44 percent of medical professionals believe their companies will adopt patient-centric trial practices in the future (2).

We spoke with Caroline Jackson, mdgroup’s Executive Vice President of Patient Services, to explore the impact of patient-centricity and support on retention rates and to hear her advice on how to put these ideas into practice.

Retention has always been a problem in clinical trials, so why is it such a hot topic now?
 

People’s expectations of clinical trials have changed. Social media, dedicated online forums, and patient advocacy groups (PAGs) mean patients now have access to unprecedented levels of information and support. Their experiences can and will be heard, so it’s time to step away from the one-size-fits-all approaches that leave patients feeling undervalued. Instead, companies should focus on individualized patient support because that’s what it will take to boost retention rates and help clinical studies to succeed.

What is the scale of the problem?
 

The average cost of developing a drug is US$2.6 billion (3). It is estimated that sponsors lose between $600,000 and $8 million for every day a trial is delayed (4). High patient dropout rates can lead to costly delays if new participants must be recruited. A 2018 review found that the typical clinical trial extends recruitment by 71 percent (5), costing sponsors millions. Perhaps it is no surprise that  the average success rate of clinical trials in 2018 was just 14 percent (6).

To resolve the most common issues facing patient retention, we need a shift towards patient-focused protocols. We must use patient feedback and data to improve the overall experience, remove burdens on patients and their caregivers, and ensure the overall success of the clinical trial.

Why do patients drop out of clinical trials?
 

The most common reasons patients give for dropping out fall into four categories – inconvenience and overwhelm, lack of communication, feeling underappreciated, and financial barriers.

Attending a high number of site visits and assessments can be overwhelming for patients, and be a drain on their time, money, and emotions. Timings may conflict with other commitments and negotiating travel logistics and expenses can be stressful – not just for patients, but also their families. Upfront spending on travel and accommodation also compound upon long wait-times for reimbursement, and the intervening loss of conventional wage or salaried income.

When patients feel unclear about their role, confused by jargon, or anxious about what to expect at each stage of the clinical journey, they are far more likely to drop out of the trial.

Patients are integral to the success of a clinical trial, which means they deserve to feel valued and supported. Patients who feel underappreciated or mistreated are highly likely to drop out. The rise of patient advocacy also means they are likely to share their experiences online, negatively impacting recruitment for future trials.

How can sponsors and CROs begin to address the problems?
 

Clinical trials are most successful when the protocol is designed from the perspective of the patient. Here are five points to consider:

i) We can involve patients and patient associations from the start by working with patients and PAGs. Patients are no longer passive recipients of their care. Therefore, we must ensure patients participating in clinical trials feel valued and supported throughout by listening to patient sentiment and acting on it.

ii) The burden of site visits needs to be eliminated. Here, mobile health with visits conducted in the home and technologies such as wearable devices, at-home monitoring via BP machines, and COA questionnaires communicated automatically on smart devices will prove key to supporting patients and professionals across the ecosystem. The option to collect data in the patient’s home or workplace rather than at the site (either with the support of an HCP or the patient on their own can ease this burden, as can provision of support covering travel and expenses.

iii) Assessments and evaluations required by the protocol should be designed with patient convenience in mind. Protocol designers should determine if the inconvenience of procedures is justified by the data being gathered. Simplifying visits and data collection whilst ensuring the endpoints required by regulators are met is key to ensuring patients remain motivated to participate in research.

iv) We must use accessible, easy-to-understand language and tools to effectively communicate with patients.

Why do you place such a strong emphasis on technology?
 

The right technology can enhance the “human touch” in patient servicing. And it can underpin customized patient servicing whilst streamlining operations across the health ecosystem.

Digital platforms can provide patients, caregivers, sponsors, and healthcare providers with a central information hub and a seamless, integrated experience. Platforms like this can connect travel, reimbursement, and mobile health services, allowing the patient to decide how to manage their clinical trial visits. This enables the trial to be taken to a patient or the patient to a trial, delivering a high level of choice at every touch point and ultimately putting the patient first. This is the kind of system we have in place at mdgroup.

A mobile app can help clinical trial patients manage their own expenses, view travel and logistics, study information and visits, and receive personalized support. Here, every individual involved in the clinical journey has one point of contact and can access all of the information they need in real time.

Some patient dropouts are unavoidable, but others are easily preventable.

Does the theory you’ve described translate neatly to work on the ground?
 

Some patient dropouts are unavoidable, but others are easily preventable. A deeper understanding of patients as individuals can help researchers think about strategies to overcome the challenges that are most likely to occur.

PAGs are on the rise, championing better support for patients at every stage of the clinical journey. Sponsors should seize this opportunity to create better relationships with those PAGs, immerse themselves in the world of their patients, and use this understanding to mitigate issues before they arise.

Patient sentiment is not always easy to measure, but using technology to gather relevant data allows us to effectively monitor shifts in sentiment over time which, in turn, helps us act quickly to provide solutions. Monitoring and predicting patient sentiment can also identify where patients are likely to lose motivation or become confused, allowing research teams to work more effectively with them to increase adherence and decrease dropout.

Diversity in clinical trials is another hot topic just now. Do these two issues intersect?
 

Absolutely. The uptake of decentralized clinical trials – which leverage mobile healthcare and available technology like smartphones and wearables to reduce the burden of time, travel, and expenditure for patients – has been transformational. This new approach is helping us recruit a more representative participant population from a wider geographic location and it is more inclusive of a wide variety of races, genders, ages, incomes, and abilities.

You mentioned the need for effective patient communication. How can this be achieved?
 

There are several ways to integrate patient-centered communication into healthcare protocols.

Patients and caregivers should receive dedicated support, with a person or team who can be easily reached via phone or email and are responsible for keeping the patient informed and supported throughout the whole clinical trial. Phone numbers should be local rate or toll-free.

Patients may also be connected with patient associations relevant to the study. Facilitating relevant discussions with patient associations and advocacy groups can broaden patients’ understanding around their participation and make them feel more comfortable. This additional layer of communication and support can have a positive impact on a trial’s success.

What does the future of clinical research look like – and what new challenges do you foresee?
 

I am particularly interested in the growth of the hybrid model, in which patients being treated in clinics and at home are offered the same service and are managed by a single technological platform. At mdgroup we have been tracking the development of our version of this model in an 18-month road map. I’m really looking forward to seeing how it evolves.

Virtual sites are going to become more important as we look to the future, with more treatment provided virtually and more visits taking place in patients’ homes or other preferred locations.

This decentralization means that for some studies, where the assessments can be safely and effectively conducted remotely, hospitals and clinics will no longer need to serve as the site for trials – offering substantial cost savings for the industry. We need to do all we can to help everyone across the ecosystem embrace the transformation driven by decentralization whilst keeping in mind the specific needs of the individual patients and appreciating that a human element in patient care is always going to add value.

Technology and mobile health both have enormous potential to engage underrepresented patient populations and democratize clinical trial participation in an unprecedented way – but we cannot leave anyone behind. We must work hard to ensure patients not only have access to the options, but also understand how to use them. Otherwise, this surge in tech use in particular could alienate people rather than engage them.

Images Credit : Collage collated from Pixaby.com

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  1. W Alexander, “The Uphill Path to Successful Clinical Trials, PT 38(4): 225–227 (2013). Available at: https://bit.ly/uphill-trials
  2. D Stempel, “Understanding Why Patients Drop Out of Clinical Trials”, Patient Centra (2017). Available at: https://bit.ly/pat-drop
  3. JA DiMasi, “Innovation in the pharmaceutical industry: New estimates of R&D costs”, J Health Econ, 47, 20-33 (2016). DOI: 10.1016/j.jhealeco.2016.01.012 
  4. B Hargreaves, “Clinical trials and their patients: The rising costs and how to stem the loss”, Pharmafile (2016). Available at: https://bit.ly/ctrials-cost
  5. DB Fogel, “Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review”, Contemp Clin Trials Commun, 11, 156-164 (2018). DOI: 10.1016/j.conctc.2018.08.001
  6. C Hale, “New MIT Study Puts Clinical Research Success Rate at 14 Percent”, CenterWatch (2018). Available at: https://bit.ly/new-mit-stud
About the Author
Angus Stewart

Angus is Associate Editor of The Medicine Maker

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