Patient recruitment – the weak link in clinical trials?

Patient recruitment is the weak link in clinical trials. What is the reason for this and how can patient recruitment be improved?

Clinical trials. A story with many chapters, each with its own challenges and solutions. One of the key chapters is certainly patient recruitment. After all, a clinical trial can’t go ahead without the patients. It’s like having a car without it’s tank full of petrol, or a cell without its mitochondria.

However, a substantial number of trials fail to reach their recruitment targets, with patient recruitment being one of the most common challenges that study managers face. Poor recruitment and retention of the ‘right’ patients necessary to complete a trial can have serious consequences, including the length of the trial being extended, leading to increased costs and resources required.

This inefficient patient recruitment is a barrier in bringing new drugs to the market. More effective patient recruitment processes are needed to deliver timely trial results and help bring drugs to the market more quickly, ultimately resulting in better patient care. This is Ignite Data’s key purpose.

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Reasons for low patient recruitment are vast and various.

One of the main challenges is site engagement, including building good relationships and education.

GP Practices can be a key hub for identifying patients for clinical trials. The great majority of patients’ medical data is stored there. It’s the medical pot of gold for anyone considering recruiting patients.

Awareness about research opportunities is quite low among healthcare professionals, making it difficult for patients to talk to them about potential participation. A patient’s relationship with their doctor is pivotal in influencing their decision in taking part in clinical trials. According to an AMRC white paper, a third of GPs and nurses were not confident talking about research to patients and only 21% of patients felt confident asking their doctor about research opportunities[1].

This may be due to time constraints at a practice. Often, they don’t know that not all studies follow the same traditional methods of clinical trials. A new era has begun where clinical trials have become slick and efficient through the use of technology. Ignite Data uses these polished, tried and tested methods to streamline research at a practice so that protocol-aligned patients may be identified and mailed an invitation to participate in a study at the click of a button.

Due to the general lack of awareness surrounding clinical research, engaging GP practices can be challenging. It takes time and perseverance to ensure the pool of potential patients is maximised. On the other hand, some GP practices are very active in participating in clinical research studies. So, if numerous studies of a similar nature (i.e. diabetes studies) are carried out, the pool of patients can become saturated. As good as this may seem, too much of a good thing can be bad for you! A balance needs to be reached to allow the maximum number of patients to be approached and to allow all patients an equal chance  of participating in research.

Research shows that patients do want to take part in research, they just don’t know how. In the same AMRC white paper, motivations for patient participation in late-stage diabetes research were principally altruism and improving understanding of the disease. Access to new treatment and curiosity about treatment were also mentioned. The key is communication with the patients, tailored to geography and reflecting specific cultural and clinical differences between regions.

At Ignite, we have also found that population demographics play a large role in patient recruitment onto clinical studies. Generally, regions with higher elderly populations from privileged backgrounds are more likely to participate in research. Education, access to further information and more free time may contribute to their decision and view of research.

To overcome these issues; to remove the stigma and misconception surrounding clinical trials and create a more positive view, there needs to be increased education and open discussions about research. It is fundamental that we highlight the need for patient recruitment in facilitating  advanced treatments and higher quality of care within the NHS.

By streamlining research, working closely with healthcare professionals and using Electronic Health Record technology, Ignite Data works to overcome these issues. We have simplified the patient recruitment process to maximise the number of GP practices involved in clinical research. This has allowed us to approach thousands of patients who otherwise may never have considered participating in clinical trials and to raise awareness generally among patients about research opportunities. While our ultimate goal is to enrol patients onto clinical trials, not all patients will choose to go ahead. However, once we have planted the thought of clinical research into both GP practices and patients, this thought will flourish over time.

 

By Tybah Al-Hussainy and Aiysha Rasul

[1] https://www.oneresearch.co.uk/2014/10/12/improving-standards-of-patient-recruitment-and-retention-in-clinical-trials/