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Why Patient Engagement Matters More Than Ever:
Benefits, Impact, Challenges-Solutions, and the Future

Patient Engagement in Clinical trial

In today’s evolving clinical research landscape, patient engagement is no longer optional – it’s essential. As trials become more complex and patient populations more diverse, involving patients meaningfully throughout the research process has proven to enhance everything from study design and enrollment to retention, data quality, and public trust.

In this blog, we’ll explore why patient engagement matters more than ever, the measurable impact it delivers, the barriers that sponsors, sites, and CROs often face, and the solutions and future innovations shaping a more patient-centered research environment.

What is Patient Engagement in Clinical Trials?


Patient engagement in clinical trials refers to involving patients in the research process to ensure their needs and perspectives are taken into account.

This can include activities such as educating patients about the clinical trial process, involving them in the design of the trial, and obtaining their feedback throughout the study.

Patient engagement can help improve clinical trial outcomes by increasing enrollment and retention rates, reducing study dropout rates, and improving patient satisfaction.

Benefits of Patient Engagement in Clinical Research

Sponsors, sites, and CROs increasingly ask: Why is patient engagement important in clinical research? The answer lies in its ability to deliver measurable benefits-improving study relevance, accelerating enrollment, boosting retention, and enhancing data quality across the board.

Let’s take a closer look at these benefits.

  • Enhances relevance of research topics & outcomes:
    With patient input, studies can focus on topics and outcomes that matter most to patients. This also helps ensure trial results get used in real-world care.
  • Improves enrollment rates:
    Patients can help recruit participants by utilizing their networks and sharing their positive study experiences. This expands the reach of trials.
  • Reduces attrition:
    Engaged patients are more likely to stay committed to a trial protocol, leading to lower drop-out rates.
  • Provides real-world perspectives:
    Patients give valuable insights into feasibility of procedures, potential burden, language clarity, etc. This improves study design.
  • Generates greater trust & awareness:
    Patients involved in dissemination raise awareness and build public trust in the research process.
  • Empowers patients:
    Engagement activities give patients an active stake in research and the feeling that their contributions matter.
  • Research That Reflects Patient Priorities:
    Patient engagement leads to research that better represents patient needs, interests, and priorities. This translates into improved clinical trial processes, more meaningful outcomes, and enhanced awareness.
  • Accelerated, High-Quality Trials:
    The evidence continues building – patient engagement pays dividends in the form of accelerated, more robust, and higher quality clinical trials.
  • Improved Study Design:
    Patient engagement allows for a more patient-centered approach to study design. Patient input can help researchers better understand patient needs, preferences, and concerns, which can inform study design and improve the relevance of the research.
  • Increased Recruitment and Retention:
    Patients engaged in the research process are more likely to participate and remain committed to the study over time. This can help to reduce dropout rates and ensure that investigations are completed on time and within budget.
  • Improved Patient Experience:
    Patient engagement can help to improve the patient experience by ensuring that study materials and procedures are understandable and relevant to patients. This can improve patient satisfaction and reduce the burden of study participation.
  • Better Outcomes:
    By incorporating patient perspectives into study design, researchers can develop interventions and treatments that better meet the needs of patients. This can lead to better outcomes and improved quality of life for patients.
  • Increased Trust:
    Patient engagement can help to build trust between researchers and patients. Patients who are engaged in the research process are more likely to feel valued and respected, and they are also more likely to trust the researchers conducting the study.
  • Increased Research Impact:
    Patient engagement can help to improve the relevance and impact of research studies. By involving patients in the research process, researchers can ensure that studies address important patient needs and have a real-world impact on patient care.
Overall, patient engagement is a powerful tool for improving the quality, relevance, and impact of clinical research studies. By actively involving patients in the research process, researchers can gain valuable insights and perspectives that can help improve patient outcomes and advance medicine.

Impact of Patient Engagement on Clinical Trials

What impact does patient engagement have on the concrete results and outcomes of clinical trials? Here are some of the top findings:

Patient Engagement in Clinical Trials
  • Faster enrollment:
    Trials incorporating patient engagement regularly meet enrollment targets 30-50% faster than those that don’t.
  • Better retention:
    Patient advisory boards for some cancer trials helped cut attrition rates by 60-80%, ensuring complete datasets.
  • Reduced protocol amendments:
    Studies show patient input prior to finalizing protocols averts amendments later that cause delays.
  • Improved data relevance:
    With patient input, endpoints/outcomes measures better capture aspects patients care about most.
  • Enhanced usability of interventions:
    Patient feedback leads to designing interventions, diagnostic tests, apps, etc. that are more user-friendly.
  • More participant diversity:
    Patient advocates help recruit populations often underrepresented in trials.
  • Higher quality PRO data:
    Patients help craft patient-reported outcome surveys that yield more meaningful, understandable data.
  • Greater awareness & trust in trials:
    Participants engaged as partners in dissemination increase awareness and credibility of trials.
The evidence continues building – patient engagement pays dividends in the form of accelerated, more robust, and higher quality clinical trials.

Practical Approaches to Improve Patient Engagement in Clinical Trials

There are various technical methods and tools for enabling patient engagement in clinical trials:

  • Patient advisory boards:
    Assembling a board of 4-6 patients to seek input on specific studies or general research topics. Can be done virtually.
  • Focus groups:
    Hosting in-person or online focus groups with 6-10 patients to gather perspectives on study materials, procedures, etc.
  • Patient co-investigators:
    Bringing on board 1-2 patients as co-investigators to join the study team and be involved through all stages.
  • Social media:
    Leveraging digital patient engagement platforms like Facebook or Patients Like Me to recruit participants, provide study updates, disseminate results.
  • Patient panels:
    Partnering with a patient panel company that maintains a large group of diverse patient volunteers who consult on studies.
  • Online patient communities:
    Engaging with established online patient communities relevant to the disease being studied.
  • Patient questionnaires:
    Surveying patients on research topics, unmet needs, clinical trial experiences to inform studies.
  • Wearable devices:
    Supplying participants with wearable devices to easily track endpoints and stay engaged.
  • Online portal:
    Providing a portal for participants to access study information, complete surveys, report outcomes, etc.
  • Virtual studies:
    Conducting decentralized trials enabled by apps, telemedicine, connected devices – improving access.

Challenges to Patient Engagement in Clinical Research & Solutions

Challenges to Patient Engagement in Clinical Research & Solutions
Challenge 1
Recruiting Diverse Patients
Those who volunteer may not represent the wider patient population. Targeted outreach is needed.
Solution:

Implement targeted recruitment strategies using data-driven patient profiling to ensure diverse and representative participation.

Challenge 2
Training Patients
Not all patients have the background to meaningfully contribute.
Solution:

Provide tailored education and support to empower all patients to engage meaningfully in the trial process.

Challenge 3
Unclear Roles & Responsibilities
If roles are vague, patients may feel underutilized or researchers frustrated.
Solution:

Clearly define patient roles and expectations from the outset to ensure meaningful engagement and collaboration.

Challenge 4
Logistical Barriers
Patients have jobs, families, health issues – accommodating availability can be difficult.
Solution:

Implement flexible scheduling, remote participation, and support services to accommodate diverse patient commitments..

Challenge 5

Privacy Concerns
Patients asked to share study experiences publicly may be uncomfortable or have employer concerns

Solution:

Ensure voluntary participation and offer anonymous or private sharing options to protect patient comfort and employment concerns.

Challenge 6
Regulatory Uncertainties
Some researchers worry patient involvement may raise issues around privacy, reporting of adverse events, etc. Clear guidance is needed.
Solution:

Develop clear protocols and training to address privacy, safety reporting, and compliance when involving patients in research.

Challenge 7
Limited Funding
Engagement activities take time/resources. Dedicated funding often doesn’t exist.
Solution:

Advocate for dedicated engagement budgets in research grants and integrate patient involvement into project planning from the start.

With thoughtful strategies and collaboration, these challenges can be addressed to create inclusive, effective, and impactful clinical research.

The Role of Clinvigilant Research’s In-House ‘Engage’ Software in Enhancing Patient Engagement

Engage, the proprietary in-house software developed by Clinvigilant Research, is designed to support clinical trial sponsors and sites in effectively engaging with patients throughout the research process. It offers a range of features and tools aimed at improving patient involvement in clinical trials. Some of these key features include:
  1. Patient education and communication:
    Engage offers a range of tools to help educate patients about the clinical trial process and communicate with them throughout the study. This can include personalized study information, reminders for study visits and medication, and secure messaging with study staff.
  2. Patient feedback and input:
    Engage allows patients to provide feedback on their experience in the clinical trial, including any issues or concerns they may have. This feedback can help improve the quality of the study data and ensure that the trial is designed with the patient in mind.
  1. Patient support and resources:
    Engage offers a range of resources and support for patients participating in clinical trials, including access to study materials and educational resources, as well as support from study staff and patient advocacy organizations.

Exploring the Future of Clinical Research Through Enhanced Patient Engagement

As we look ahead, deeper patient engagement is expected to significantly shape the future of clinical trials. Key emerging trends include:
  • Patient advisory boards and co-investigator models becoming standard practice across clinical trials.
  • Decentralized and virtual trials-enabled by mobile apps, telemedicine, and wearables-expanding access and participation.
  • Direct patient recruitment through social media and online patient communities gaining prominence.
  • Dedicated funding for patient engagement activities increasingly included in grant budgets.
  • Patient participation in innovative trial designs such as n-of-1 trials, pragmatic trials, and registry-based studies.
  • Patient communities providing support and oversight for researcher-led, DIY research initiatives.
  • Rise of fully patient-driven research networks that initiate, design, and conduct their own studies.
  • Improved training and tools for researchers to meaningfully engage diverse patient populations throughout the research lifecycle.
  • Emerging standards and best practices around compensating patients for their engagement and contributions.
  • Greater involvement of patient advocates in regulatory discussions, policy formation, and treatment guideline development.

Frequently Asked Questions

What training is required to prepare patients for engagement roles?
Many options exist, from formal multi-day courses to targeted webinars. Key topics are research and trial methodology basics, ethics, regulations, publicity laws, analyzing/interpreting data, communication approaches, and assessing research priorities.
How much should the clinical trials budget for patient engagement activities?
As a rule of thumb, 3-5% of total study costs should go towards engagement. This covers advisory board and focus group costs, patient partner stipends, training/travel expenses, materials creation, online patient engagement platforms, and staffing.
Are there minimum standards for patient engagement in clinical trials?
Major government/non-profit funders like NIH, PCORI, and FDA have issued policies recommending patient engagement. But no legal mandates exist yet. Groups like CTTI and DIA are developing engagement best practices.

Conclusion

Patient engagement is a vital part of modern clinical trials, improving recruitment, retention, and overall study relevance. Its impact is amplified through technical tools and platforms that make participation easier and more inclusive. Clinvigilant Research’s in-house ‘Engage’ software supports these efforts by simplifying and enhancing patient involvement. As clinical research evolves, deeper patient engagement will be key to driving more effective, patient-centered outcomes.