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September 4, 2020

Common clinical trial patient enrollment challenges

Clinical trials are at the center of the life science industry. To ensure success, clinical trial design requires effective patient enrollment.
common clinical trial enrollment challenges

Clinical trials are the lifeblood of the life science industry. Although crucial in the development of new drugs, devices and procedures, clinical trials are also resource-intensive – the average phase I trial can cost in excess of $4 million, while for phase III the figure is closer to $32 million.

To help ensure all that investment is worthwhile, successful clinical trial design requires effective patient enrollment. Let’s explore some of the most common challenges to clinical trial patient enrollment, and how virtual engagement can help overcome them.

The most common clinical trial enrollment challenges

COVID-19

“Clinical trial enrollment halved during the peak months of the pandemic.”
Nature

Patient safety is paramount during the clinical trial process, and the COVID-19 pandemic continues to pose a risk to patients and clinicians alike. Clinical trial teams have had to work even harder to ensure patient safety during the pandemic, but the perceived risk remains a barrier to patient enrolment and a disincentive to trial site visits.

Logistical barriers

“Patients travel an average 25.8 miles for clinical trial visits.”
ClinEdge

Finding the right patients for your clinical trial can be a challenge. Sufferers of rare diseases and certain conditions represent a small percentage of the population, and the patients you need may live a long way from your trial site. Potential participants can be unwilling or unable to travel, or otherwise incapable of committing to your visit schedule. Such logistical issues remain significant barriers to clinical trial enrollment and patient retention. They can also impact how long clinical trials take.

Diversity

“75% of participants in US clinical trials are white.”
FDA

It is the responsibility of clinical trial teams to ensure appropriate representation at clinical trials. But in the US, racial and ethnic minorities remain chronically underrepresented. Without diverse patient enrollment, it’s impossible to ensure that new drugs, devices, and procedures will work consistently across a range of populations. However, language, cultural and financial barriers – as well as a lack of engagement with minority communities – can mean ensuring diversity in clinical trial enrollment remains a challenge. While this persists, there will remain a disparity between trial participants and the patients seen in daily practice.

Dropouts

“The average clinical trial dropout rate is 30%.”
Clinical Leader

Ultimately, successful clinical trial recruitment and patient enrollment are only half the battle. Every clinical trial must expect its share of dropouts, but if your enrollment numbers are only small to start with, then a high dropout rate is likely to impact the efficacy of your clinical study. Clinical Leader reports that a staggering 85% of clinical trials fail to retain enough patients to move forward.

Asynchronous virtual engagement and better trial enrollment

The goal of clinical research is to explore outcomes that reflect real-world scenarios and use cases. However, barriers to clinical trial enrollment continue to result in low clinical trial participation rates and small sample sizes that ultimately do not reflect the reality of everyday practice. All too often, poor clinical trial enrollment can impede the development of potentially promising treatments or compromise the importance of quality assurance in clinical trials.

“55% of clinical trials are terminated due to patient enrollment issues.”
PMC

The last few years of digital transformation – accelerated by the realities of the pandemic – have seen pharmaceutical organizations and research institutions increasingly eager to embrace virtual engagement. And it’s here that the life science industry can begin to address many of the most common clinical trial enrollment challenges and move towards something altogether more efficient.

By pivoting away from the clinic and towards virtual spaces, clinical teams can effectively remove COVID-19 exposure concerns and ensure patient safety. Traveling long distances to fit inflexible visit schedules is no longer an issue when patients can be engaged virtually, and sessions are held asynchronously. When clinical teams can cast a wider net, underserved populations can be engaged effectively and included in treatment and drug trials with the help of tools like online translation. And by making the clinical trial process easier and less disruptive for patients, using insights management and virtual engagement platforms will also help to minimize dropouts and ensure enrollment targets are met.

For more information on troubleshooting common clinical trial challenges, read our Guide to Successful Clinical Trial Design.

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