THE PATIENTS VOICE

Written By Liam eves
 

The Power of Patient Voice in Clinical Trials

Over the years we have seen huge transformations in person centred design across many industries such as retail, education, law, technology and even banking. The first step of design thinking is to empathise with the user, so that we can understand their persona’s, motivations and pains. By understanding the person, we can create better products and services. Whilst there have been huge advances in person centred design to improving product or services, the clinical trial continues to struggle. Clinical trials continue to face significant impediments when it comes to patient recruitment and retention, fulfilling deadlines, protocol complexity and managing expenses.


  • A paper published by a group of MIT authors in the Biostatistics journal in 2018 found that the probability of a clinical trial succeeding is only 13.8%[1]

  • 30% of patients who have been successfully recruited withdraw their participation as the trial progresses[2]

  • 85% of clinical trials fail to retain enough patients to continue[2]

Research has demonstrated, that incorporating the patient voice into clinical trial design can eliminate many of these issues and considerably increase the probability of a trial reaching completion and actually succeeding. Patient involvement in clinical research and development may still be suboptimal, but there is a growing body of evidence indicating that patient awareness of clinical trials is steadily increasing:

  • Clinical trial awareness increased from 68% to 74% between 2008 and 2012[3]

  • A survey conducted in 2018 found that 86% of respondents are aware of clinical trials, with 59% of these respondents demonstrating familiarity with the term[4]

  • A paper published within the Therapeutic Innovation & Regulatory Science journal demonstrated that pharmaceutical companies experience a reduction in protocol amendments and administrative burden when they implement patient feedback into protocol design[5]

The importance of understanding the perspectives of patients in research and development cannot be underestimated. Even though patients are critical to the execution of clinical trials, they’re frequently excluded from study design protocols which are written primarily by scientific researchers and medical professionals. As a result of this, numerous studies fail to include or impact their target patient population, which significantly impacts the efficiency, relevance, expenditures and timelines of clinical trials. We are however starting to see change with patients being given voice, which is already generating positive research outcomes, with increased patient involvement vastly improving enrolment and retention[6].

The industry typically looks towards innovations and technologies such as AI, electronic health records and the like to change the dynamic, however to provide meaningful enrolment solutions we first must understand first principles; the motivations and desires of the patients. Adopting a patient-centric approach is becoming increasingly necessary in the design of clinical trials.  Incorporating the patient voice is a critical first step to helping designing better trials and the supporting processes. When patient perspectives are used in parallel with clinical evidence to inform the decisions of policy-makers, there’s considerable opportunity to bring valuable contributions.

Patient Motivations

Historically, patients have been regarded as passive subjects rather than active participants within clinical trials. It is this attitude which has consistently excluded the patient voice from shaping the design of research and development, even though this is a demographic with a direct stake in drug development. It’s essential that researchers recognise that patients will be invested in research which is relevant to them based on their personal circumstances and experiences. Individual patients will have their own motivations and desires which will influence their decision to participate in particular research opportunities.

Patients will opt to participate in clinical trials for a number of reasons. In a 2018 survey, 69% of patients stated that they had participated in clinical research because they hoped to improve their quality of life, whilst 63% responded that they offered their participation in order to receive the best available care. Moreover, 75% reported that they hoped to contribute to meaningful and relevant scientific research that will ultimately improve the quality of life of patients in the future. More than half of patients were also interesting in accessing innovative and cutting-edge therapies without the high expenses typically involved[7].

What Patient’s Consider as Barriers to Trial Participation, Engagement and Retention

It’s important to address barriers to patient participation, because these are also barriers to the clinical trial process. Patients are unlikely to participate in a clinical trial if they feel they’re not being adequately compensated, whether that is through the opportunity to improve their condition or contributing to research that will improve the condition for others.

These issues are further compounded by problems with accessibility since the majority of research facilities are located in urban areas, and travelling to and from these locations on a regular basis incurs high costs and requires significant time commitments. These barriers to patient participation persist because the structure of clinical trials hasn’t adapted to changes in the broader pharmaceutical landscape, especially when it comes to the changing expectations of participants[8].

Moreover, engagement levels suffer when patients feel that they are not being provided access to information that they can access and understand easily, whether that is updates regarding developments within the trial and insights into their condition. This directly impact retention rates, because patients will be more likely to leave if they feel that their opinions are not begin taken into account or reflected in the trial protocol.

Where Patients Access Information About Research

Typically, patients will learn about upcoming or ongoing research via social media, traditional media (such as print, radio and TV), print advertisements, patient advocacy groups, physician referrals, patient networks and direct mail or email. Digital technologies are becoming more and more prominent in patient outreach strategies, and researchers will, for example, create advertisements for online patient communities such as for forums or blogs in order to disseminate information, along with typical outreach to patient organisations and social media platforms such as Facebook or clinical trial registers such as ClinicalTrials.gov.

Patients can also learn about clinical trials via advocacy groups. Advocacy groups may be centred on general patient needs and rights, or alternatively focused on particular conditions or diseases. With information and support from researchers, these groups regularly provide patients with advise and guidance when it comes to identifying relevant research opportunities. These various digital communications channels provide patients with the opportunity to search for and investigate alternative treatment options, which they can then discuss with family and friends, healthcare professionals and researchers.

Patients Decision-Making Process

Whilst patients may have personal motivations for participating in clinical trials, and may adopt the initiative when it comes to learning about research opportunities, family members do play a relatively significant role when it comes to the decision-making process. Family members, alongside healthcare professionals and researchers, comprise an important part of the network surrounding patients prior to their decision to enrol in clinical research. A study investigating the experiences of family members of cancer patients who were searching for clinical trials discovered that the families of patients generally leave the identification of clinical trials to healthcare researchers and professionals and the patients themselves[9].

Families will instead provide ‘cautious family support’ due to their limited understanding of and unfamiliarity with the clinical trial process. Researchers could change this by ensuring that the family members of patients are informed and involved from the outset. This will enable family members to give patients greater assurance and confidence in the clinical trial process, strengthen supportive patient networks and offer relevant guidance and advice that will improve a patient’s experiences in the overall clinical trial process.

Alongside familial influence, a patient’s healthcare professionals also comprise a crucial determining factor within the decision-making process. Generally, the healthcare professional and patient relationship is an important part of clinical research, and whilst families will often refrain from identifying trial opportunities due to lack of medical experience, healthcare professionals will actively recommend and discuss such opportunities with their patients. This is substantiated by evidence, with more than 80% of patients stating that they would consider participating in clinical trials if it was recommended to them by their physician, with a considerably higher percentage (more than 70%) of clinical trial participants throughout the world talking to their physician before deciding to participate[10].

Socio-economic and Ethnic Variables

Gaining a true understanding of the implications of studies exploring patient awareness and participation in clinical trials depends upon assessing the profiles and characteristics of the participant demographics in the study. This is because socio-economic and ethnic factors can potentially impact the outcome of a clinical trial. For example, patients from less affluent socio-economic factors may be more likely to withdraw from a clinical trial because they cannot afford the expenses associated with travelling to and from appointments in medical facilities[11]. Equally, digital technologies are increasingly being used in enrolment efforts but the majority of these resources are available only in English, excluding patients who do not speak English fluently or at all and skewing results towards English-speaking populations[12].

Moreover, numerous studies have demonstrated that patients from ethnic minority backgrounds are less likely to actively reach out for medical advice within a system that has historically marginalised and overlooked them[13]. This is problematic, especially because specific conditions, diseases or symptoms are more likely to present themselves in patients from particular socio-economic or ethnic backgrounds. The purpose of incorporating patient voice is to design trials and develop therapies that contribute to the lives of all patients, including those who have not traditionally had a voice in the pharmaceutical sector.

Conclusion

A patient-centric approach has emerged as one of the key solutions to optimising the clinical trial process. Achieving true patient centrality is dependent upon embedding the patient voice into protocol design and related processes. Researchers have a greater chance of engaging and retaining patients by empowering them with information regarding the purpose, procedures and outcomes of the research, alongside incorporating patient feedback into the trial’s protocols from the onset. By incorporating patient voice into clinical trials, researchers can investigate life-changing therapies and treatments whilst also ensuring feasibility with regards to expenses, duration and applicability.

 
Liam eves
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