What are the best practices for patient advocates to improve clinical trial outcomes?

Elevate the impact of advocacy efforts by placing patient perspectives at the forefront. Ensure that advocacy initiatives prioritize the well-being and rights of trial participants.

Knowledge of the trial process assists the patient advocate but is not essential. That is not their area of expertise. Even a new patient advocate can give feedback on participant information materials and consent forms. Could you understand it? Does it explain technical details well enough? Does it use too many TLAs (that’s three letter acronyms!)? Could it use more tables, pictures or bullet points to make it less wordy? Have they forgotten to outline the benefits of joining the clinical trial and just focussed on the risks? Are these risks just a long shopping list, or is it clear which ones are most likely? Does the trial collect and report feedback from participants? Is a plain-language summary of results provided to participants?

#1: Treat the clinical trial patient like a person and not a subject. I've participated in a few clinical trials and I felt like I was just a case number. #2: Address the mental health component because donating your body to science, while still alive, is a mentally exhausting.

This is a very essential discussion and i feel that putting the Patient at first is the most critical step and approaching it with all honesty as pertains to an IP ,including untoward effects and being attentive and a good communicator. Finally observance to the protocol is a must and avoiding deviations at all costs.

While it is imperative to establish trust and rapport with the team, it's equally important to do so in the patient's presence if health permits. Taking this step will not only strengthen connection and trust, but it will eliminate any fear or doubt they may have, which can lead to increased anxiety and fear.

Consent forms should be comprehensive and provided in the patient's native language to prevent any misinterpretations. Offer patients cards with a 24-hour contact number for any inquiries or if they experience any unexpected side effects. A trained medical expert should always be on hand to discuss the study details and address any concerns the participant might have. Lastly the patients should be given ample opportunity to think it through.

Organize collaborative workshops that bring together patient advocates, trial teams, and researchers. These facilitate communications.

In the ICF document, considering lay audience, help patients understand the clinical trial process, ethics and patients rights.

Ensure there are easy read versions of all documents and provide someone to sit and read through the information with prospective participants.

One area we can greatly improve is in committing to have people on the clinical trial staff that look and speak like the patients we are serving. For instance, a non-Spanish speaker struggling to communicate key medical decisions isn’t optimal. A grey-haired, White man explaining key quality of life considerations to a young, Black woman doesn’t feel natural. These are life changing decisions, and we should be intentional about making people feel as seen and heard as they can be by considering who’s giving the information.

To effectively communicate with patients and families, healthcare professionals must be empathetic and understand the unique circumstances of each individual. Building trust and fostering open dialogue can help alleviate fears and anxieties, leading to better patient outcomes. Additionally, involving family members in the care process can strengthen their bond with the patient and improve overall satisfaction. Ultimately, compassionate communication is essential for creating a healing environment that prioritizes the whole person - body, mind, and spirit.

Knowledge is power as I always say. As a Board-Certified Patient Advocate I've seen that it's essential for patients to grasp the trial's details. They need a firm awareness of the pros & cons of doing a trial as well as the potential side effects they may encounter to ensure they can manage health shifts proactively. I also have them keep a detailed journal, where they note better, worse, or unchanged outcomes. That's pivotal and aids in clear communication with healthcare providers, ensuring their feedback enhances the trial's integrity. Through informed decisions and active participation, patients can make clinical trials more ethical and patient-centered.

This is so important because it really takes a village. We all have a role and a part to play and by sharing experiences and best practices and real world information everyone wins. There are constant policy changes and every stakeholder is responsible for being informed, involved and sharing information. This allows once again again for everyone, internal and external stakeholders.

There are several ways strategic collaboration can enhance your effectiveness as a patient advocate. Collaborating with other advocates, organizations, or professionals allows you to aggregate your efforts and amplify your collective voice. Together, you can reach a broader audience, attract more attention, and have a greater impact on policy changes, research directions, and public awareness. Additionally, working with a diverse group brings in a wide range of expertise, skills, and resources. You can tap into the knowledge and experiences of others to enhance your understanding of complex issues, improve your advocacy strategies, and access resources that can bolster your campaigns.

Join Patient Advocacy organizations, they have great resources that make sure to educate and also value the patients needs. They have amazing teams that make sure to always put patients first. They focus on mental health, support groups, educational webinars and meet and greets. They may also have the opportunity to work with companies that create clinical trials and connect patients.

Expand your evaluation beyond traditional metrics and delve into holistic outcome measures. Consider factors like the trial's socio-economic impact, its contribution to healthcare equity, etc.

Based on my nursing exprience. Informed decision making is very important as an advocate for research trials. All the research teams should give all the information the participant needs to make a very good informed decision. Letting them know the benefits, the adverse effect of the research on thier anatomic and physiologic system, the emotional consequencies, financial consequencies will remove the fear that people have about research trials. As health worker this is our pledge not to harm the patients. As a nurse I have used effective advocacy to help my patient achieve thier ultimost health by given effetive and comprehensive infirmation about procedures to improve thier lives.

Evaluating your impact as a patient advocate is crucial to ensure that your efforts are effective and making a positive difference. There are steps and methods to evaluate your impact as a patient advocate: define clear objectives and goals, establish key performance indicators (KPIs), collect baseline data, monitor and track progress, measure public awareness, gather testimonials and feedback, assess policy changes, evaluate partnerships and collaborations, engage in case studies, compare against benchmarks, seek external evaluation and ALWAYS REFLECT AND ADJUST.

I think it is particularly important to recognize what motivates the patient to participate in a clinical trial. A long-standing, trusting relationship with the trial doctor and precise knowledge of the current treatment options and their specific risks increase the patient's reliability and compliance just as much as detailed information about the trial protocol, including the time involved for the participants. Patients who are looking for a high compensation expence or unrealistic chances of a healing are usually inclined to discontinue their participation in a trial.

It is time we start looking at diversity, equity and inclusion in clinical trials for every study. The goal is not just to meet the total accrual recruitment goal in the clinical trial protocol/ study design- it should be about having that diversity in that total number of participants to improve any clinical trial outcome.

Make an intentional effort, supported by operational process, to include diverse populations in the study population while understanding what factors affect specific communities and keep them from participating. 1. Are all your consent forms and educational material only in English? 2 . What efforts are currently in place to make diverse patients feel safe and trust your research interventions? 3. Have you and your study staff been educated to understand cultural differences? It is time to move past best intentions and make actionable changes to include more people in research safely and equitably.

Continuous learning and improvement are vital for enhancing your effectiveness as a patient advocate. Request feedback from peers, stakeholders, and the community you serve to understand the perceived effectiveness of your advocacy efforts. Use constructive feedback to make necessary adjustments and improvements. Be open to adapting your approach, strategies, and goals based on evolving circumstances, feedback, and new learnings. Embrace change as an opportunity for growth and improvement. Value diversity of thought and experiences within the advocacy community. Learn from different perspectives and approaches, embracing inclusivity for a well-rounded understanding of healthcare challenges.

Celebrating achievements are vital to any successful project. I also think it’s vitally important to celebrate working through disagreements, and disproving opinions. Success is not just the end result, but anything that promotes improvement. Another reason this is a must is because of employee satisfaction and retention. Celebrating achievements, involvement, motivation and strong work ethic will make others feel valued. It is also important to celebrate individual and group accomplishments, but not your own. As a leader, we are only as successful as our weakest team member. The ultimate win and celebration for a leader is the end result and the growth both personally and professionally that your team will exhibit.

One thing I would add would be that research consortia/research developers should aim towards patient partnership. Patients should not be regarded as a resource in a clinical trial but an equal partner. As such, patients/patient representatives/patient advocates should be involved from the start (clinical trial design) throughout the entire decision-making process. Their views and perspectives will help shape the medical trial in a patient centered way which would be to everyone's advantage, not only the patients'.

Be prepared to have your beliefs, ideas and plans challenged. Moreover, be open to those challenges, embrace them, explore them and be prepared to learn. The overall outcome may not change your beliefs, ideas and plans dramatically but imagine the possibilities Sue

Always remember that most people have families and it is so important that they are as informed as the person in the clinical trial. First you must assess and evaluate the relationship of the patient and their family. how much information does the patient want them to know? are able to understand? Do you need to speak on a different level? All these questions can be answered by the patient/family. There is nothing worse than feeling like you have been left out of the information about your loved one care or care plan. Holistic care encompasses all the information or details that the patient has given permission to share. Period.

Always remember that most people have families and it is so important that they are as informed as the person in the clinical trial. First you must assess and evaluate the relationship of the patient and their family. how much information does the patient want them to know? are able to understand? Do you need to speak on a different level? All these questions can be answered by the patient/family. There is nothing worse than feeling like you have been left out of the information about your loved one care or care plan. Holistic care encompasses all the information or details that the patient has given permission to share. Period.

Keep them honest and on track with the trial. Stay positive even if the trial turns out to be negative. It’s most likely not their fault. I would hope someone told them that before ever starting it, but did they ask questions or did you ask them for their understanding of what their role in this trial was both positive and negative?