Participants in clinical trials are difficult, expensive, and time consuming to recruit, making it one of the most valuable assets of a study. Yet across the industry, dropout rates are noticeably high.
As drug development becomes more expensive, focused and complex, each topic listed is more important than ever. Investing in patient engagement strategies that make enrollment easier and keep people on board, on track, and on medication might be the answer developers have been looking for.
The recruitment problem
Recruitment for clinical trials is a huge challenge for drug development, contributing to the delay and even failure of the study.
A 2018 review of factors associated with clinical trial failure, by David Fogel, described it as a “long-standing problem.” A study of 114 trials in the UK, he said, found that only 31% met their recruitment targets, and a third of publicly funded trials needed an extension because they did not meet the initial recruitment goals.
Some reports estimate that up to 50% of trials start late because they fail to recruit enough participants in the allotted time. This is a significant figure when delays can result in losses of $ 600,000 to $ 8 million per day.
Lack of awareness, fear or misconceptions about what a clinical trial entails, as well as strict eligibility criteria are all factors that contribute to low recruitment rates and together they serve to create a funnel. increasingly close to willing and suitable candidates.
For all of these reasons and more, recruiting a single patient for a clinical study can cost an average of $ 6,533. This means that recruiting is a substantial part of the estimated $ 314-2.8 billion it can cost to develop and bring a new drug to market.
The problem of retention
As most sponsors and CROs painfully know, recruiting is only half the battle. Even when studies recruit enough people to begin testing, about 30% of participants eventually drop out. And the longer the follow-up, the higher the dropout rate.
The reasons are varied, but they include the financial and logistical implications of participating in site visits and a lack of understanding of the trial protocol. Whatever the reason, the impact cannot be overstated.
When a trial experiences too many dropouts, whether based on planned or actual registrations, the trial can become underfed. There may not be enough data to effectively demonstrate a statistically significant clinical benefit or the safety of the product.
Fogel in his 2018 review said: “Undernourished clinical trials are problematic. The sponsor can adapt to low recruitment by increasing the number of sites (possibly in other countries, with corresponding costly protocol changes and delays in further research), increasing the funds allocated to the study in order to achieve the minimum recruitment.
This burden, he continued, sometimes requires eliminating certain scheduled tests in order to reallocate available funds and, in turn, some parameters may have an insufficient sample size to detect an important result.
For decades, sponsors and CROs have attempted to fill this gap by recruiting replacement participants. But not only is this strategy insanely expensive, the era of personalized medicine is quickly making it unachievable.
With the development of more complex and more targeted drugs, the eligibility criteria for clinical trials are more restricted. Trials of products aimed at smaller patient populations, such as those with a particular genetic mutation, for example, have a smaller pool of potential candidates, making ‘back-to-the-drawing board recruitment’ a profitable approach. decreasing.
Retaining the initial admission of registered participants, then, has never been more important financially or scientifically.
Engage your participants
Focusing on patient engagement can help overcome the long-standing challenge of retaining clinical trial participants by giving people everything they need to become – and stay – invested in the process.
This journey begins at the very beginning of a trial. The patient-centered study design can minimize protocol burden by ensuring that it does not include, for example, an unrealistic number of site visits or invasive procedures.
Prior to registration, teams should work with participants to ensure they understand exactly what is expected of them and what they can expect from the trial. Consent forms, for example, should be written to take into account different levels of health literacy to give people the best chance to start the process with their eyes wide open.
To be successful, however, engagement strategies must span the duration of the study, constantly checking in with participants to make sure they are on the right track and offering support where and when needed.
This may seem difficult, especially as the sector moves more towards the decentralized model and eliminates many face-to-face interactions.
However, by focusing on treatment adherence, teams can constantly monitor participants for signs of waning engagement that may lead to dropouts.
Membership: a barometer of commitment
Adherence to drugs is widely accepted as a marker of commitment to disease management under long-term conditions. The approach has just as much to offer in the field of clinical trials.
Monitoring treatment adherence can provide a wealth of information about participants’ investment in the study. Non-compliance can be a harbinger of abandonment. It offers clues to poor product efficacy, intolerable side effects, or administration issues, all of which can lead to poor retention.
However, measuring drug-taking behavior can be difficult. Traditional validated adherence measures are rare and those that do exist are non-standard and imperfect.
Moreover, even when study teams see non-adherence, then they are faced with the dilemma of what to do about it. There are many reasons for poor adherence and interventions must be personalized for both the drug and the patient.
Digital membership monitoring can help by incorporating smart packaging and powerful analytics to spot when people might need extra support to stay on track.
Digital membership monitoring can improve recruiting, by reducing the load that can discourage people from signing up in the first place, and improve retention, by helping teams keep people engaged in the study.
Smart drug packaging automatically records dose delivery. Connected smart blisters, for example, can collect not only the time and date of pill withdrawal, but also the open pill cavity, number of tablets withdrawn, kit number and expiration date.
This means that dosage histories are compiled without the need for participants to keep a diary or register while taking their medications, for example.
The captured information is then fed to a cloud-based platform, which provides sophisticated analysis of medication-taking behaviors and creates powerful visualization and targeted feedback for study teams and participants. It can even be integrated with third-party apps, such as patient apps designed to build engagement and encourage adherence throughout the study.
Study teams can use this information to identify those whose engagement may be waning and deploy personalized interventions to mitigate issues.
This approach works – the closed feedback loop of active surveillance and targeted actions can increase engagement, resulting in up to a 50% reduction in dropouts.
Ultimately, digital adherence tracking is 97% accurate, compared to 60% for pill count, 50% for healthcare professional assessment and only 27% for self-assessment, and it provides a comprehensive understanding of patient adherence behaviors and risk indicators that matter most to subject engagement and study success.
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