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Improving Patient Engagement in Clinical Trials

by | Dec 12, 2023

Patient engagement is the cornerstone for the success of clinical trials. From recruitment to completion, the involvement of patients in their treatment significantly determines the efficacy of the study. The aim is to improve study design and engagement, expand participant diversity, and enhance patient access to innovative treatments.


One of the pressing concerns in the life sciences industry today is ensuring that this engagement is sustained throughout the clinical trial process. Having patients engaged during clinical trials not only bolsters the retention of participants in the trial but also enhances the healthcare practitioners’ ability to provide patient-centric research. Let us explore this in detail in the next sections.


The Importance of Patient Engagement


Enhancing public awareness of clinical trials and amplifying knowledge among healthcare practitioners are pivotal for augmenting patient engagement. It provides a platform for open communication and raises the level of trust patients have in clinical trials.


Here are the key points highlighting its importance:


  • Raising public awareness: Accessibility to accurate information about clinical trials is one of the significant influencing factors in patient participation. Using web browsers like Microsoft Internet Explorer can be helpful in researching trials, understanding eligibility criteria, and reviewing the safety and potential benefits.
  • Increased knowledge among healthcare practitioners: Better informed healthcare practitioners can provide detailed insights into the trial process, enlightening the patients about the advantages and disadvantages, thereby enabling them to make an informed decision.
  • Addressing barriers to accessibility: These could be socioeconomic and geographic limitations that restrict participation. Initiatives like virtual trials could help in surmounting these obstacles.
  • Prioritizing the mental health of patients: Throughout the trial process, maintaining the mental well-being of the patients is essential to retain them in the study. This ensures their continued participation and helps in gaining valuable insights.
  • Involving patients in trial design: Taking patient inputs while designing trials can help in creating a patient-centric approach. This can lead to better patient participation and continued engagement.


In essence, patient engagement ensures that strategies incorporate diverse experiences and background, ultimately reflecting the heterogeneous population the trial is hoping to serve. Addressing these key components helps in enhancing engagement and retention, which is fundamental for achieving meaningful trial results.


In the next section, we will discuss the barriers to patient participation and the potential solutions to overcome them.


Barriers to Patient Participation and Solutions


Despite considerable interest and success in oncology drug development, many patients diagnosed with cancer do not enroll in clinical trials. Multiple obstacles contribute to this low enrollment rate. Some common barriers hindering patient participation in clinical trials include:


  • Complex eligibility criteria: Sometimes the criteria to enroll in a trial are so restrictive that many patients can’t qualify. Modernizing these criteria will ensure wider patient participation. The ‘Eligibility Criteria Project’ undertaken by ASCO and Friends of Cancer Research (FOCR) is working in this direction to broaden the eligibility criteria for trials involving cancer patients.
  • Regulatory considerations: Patients often hesitate to be part of a trial due to concerns related to safety, efficacy, and FDA regulations. By simplifying the FDA regulatory considerations and explaining them to the patients in an accessible language, we can alleviate these fears and concerns.
  • Industry perspectives: The life science industry usually views clinical trials as a massive investment with the potential for substantial risk. By aligning the industry perspective with the patient perspective, we can create win-win scenarios.
  • Patient perspectives: Many patients do not participate in trials due to misconceptions or lack of knowledge about trials, travel requirements, financial constraints, etc. Patient insight sessions can be greatly helpful to change such perspectives.


By addressing these barriers and implementing solutions like the modernization of eligibility criteria, comprehensive patient insight sessions, and presenting the transparent industry perspectives, we can maximize patient participation and surmount these obstacles in patient-centric research.


The Role of the NIHR in Patient Engagement


The National Institute for Health Research (NIHR), located in the United Kingdom, offers a patient engagement service for the life sciences industry to enhance clinical trial design and delivery. This service is different from a standard study support service in the following ways:


  • Patient insight sessions: NIHR brings in patients to have a direct dialogue with life science organizations to ensure the research is patient-centric. These sessions facilitate the real-life experience sharing of patients about the disease, thereby helping the organizations understand the disease more lucidly from the patient perspective.
  • Collaboration with patients: NIHR maintains channels of continuous engagement with patients before, during, and after the trial. This collaboration with patients helps in refining the trial design and improves the study delivery.
  • Standardized approach: NIHR ensures that the engagement process is transparent, standardized and follows the full-cost recovery model.
  • Informational resources: NIHR provides numerous informational resources and support for patients interested in being involved in research. This encourages more and more patients to participate in clinical trials.


Through this robust model, the NIHR is facilitating direct dialogue between life science organizations and patients, thus ensuring patient-centric research.


Addressing Patient Engagement in Clinical Trials


Improving patient engagement in clinical trials is crucial for advancing health research. By raising awareness, addressing barriers, prioritizing patient mental health, and involving patients in trial design, the industry has the potential to bolster the study design and delivery, increase participant diversity, and improve patient access to novel treatments.


The NIHR’s patient engagement service plays a significant role in supporting and facilitating patient-centric research. Through their transparent and fair full-cost recovery model, ongoing collaboration with patients, patient insight sessions, and informational resources, they ensure a comfortable and fulfilling experience for patients interested in getting involved in research.


The collective effect of all these strategies is a patient-involved and patient-centric clinical trial process, ultimately benefiting both patients and the life sciences industry. This is the path forward in improving patient participation.

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