3 Best Practices for Patient Engagement in Clinical Trials

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research.

Patients offer invaluable perspectives on their own needs, wishes and important concerns. Their input can guide the development of treatments that address their unique challenges, enhancing their overall care experience.

If patients are not engaged effectively during clinical development, the treatment may not reflect real-life needs. As a result, it might not be used properly, or it might not be used by patients at all.

It has been confirmed by independent studies that integrating patient perspectives at the initial stages of clinical development can produce trials with endpoints that are more meaningful. As a consequence, the protocol will be received as more feasible for patients, enabling faster recruitment, a lower dropout rate and fewer protocol amendments which also reduces costs for the sponsor, de-risks clinical development and allows a shorter time to launch.

Alira Health’s Dr. Basadonna, MD, Chief Medical Officer, Head of Global Medical Strategy, and Annabel de Maria, Chief Patient Officer, recently spoke on a webinar where they shared insights on how to increase patient engagement in clinical trials. The webinar was moderated by their colleague Giulia Pierini, Patient Engagement Principal at Alira Health.

Watch the free webinar for expert insights, and read on to learn three best practices to enhance patient engagement in clinical trials.

1) Involve Patients as Early as Possible

Patients who will ultimately use a new drug or device have unique insights into their condition, their needs and their preferences. They can provide valuable feedback on what works and what doesn’t in their daily lives, what side effects might be tolerable and what benefits would be most meaningful.

As such, it is important to consider the complete experience of a patient from the onset of illness through diagnosis, treatment and post-treatment phases, along with the emotional, psychological, social and financial aspects too.

So, when is the best time to incorporate the patient voice in clinical development?

The sooner the patients are involved, the better, ideally starting from the preclinical phase.

The patient journey can impact every stage of treatment discovery, development and delivery. Involving patients from the preclinical phase onwards ensures that future clinical development of therapies and devices can take into account patients’ needs, preferences and experiences.

It is important to include patients in the design and implementation of Phase I clinical trials in drug development. Patient opinions are particularly valuable when it comes to asking patients about the acceptance of certain side effects or potential adverse events of a drug. Patient insights are also equally critical in the initial development stages of medical devices.

Here are several real-life examples demonstrating the importance of involving patients in preclinical and early clinical trial phases in diverse indications, from type 1 diabetes to oncology.

Type 1 Diabetes Treatment

Understanding the patient’s perspective can lead to innovative solutions. In work with type 1 diabetes treatment, it was observed that patients, especially teenagers, disliked pricking their fingers several times a day to check blood sugar levels.

The result of sponsors listening to patients? Companies developed wearable products that provide continuous information on glucose levels without needing a needle. As there must have been many patient consultations to drive the development of these wearable products, this example reflects the importance of integrating patient feedback into medical innovation and care.

Pain Induced by Chemotherapy

A planned study intended to use validated scales to gauge chemotherapy-induced pain in the hands and feet; however, when asked to rate their pain from 1 to 5, all patients claimed to have no pain, surprising both the team and the sponsor. The patients described sensations like needle pricks or numbness, rather than traditional pain.

This example underscored that patients might interpret pain differently from medical professionals and highlighted the importance of aligning understanding between patients and practitioners. It stressed the need to consider patients’ unique perspectives to accurately assess their experiences and ensure safety.

Unique Needs of a Respiratory Disease Population

It is important to involve patients early in the preclinical stage, particularly in the context of respiratory diseases like chronic obstructive pulmonary disease (COPD). But many patients with this condition are often advanced in age and may be reluctant to be treated.

By engaging with patients early in the process, a sponsor was able to anticipate and understand the behavioral aspects of their patient population. This insight allowed them to forecast not only potential problems in treatment but also challenges in recruiting participants for the clinical trial. As a result, they were able to develop a strategic approach to recruitment, leading to a smoother process than if they had not considered the patient perspective.

2) Empower Patients to Share Insights on a Clinical Protocol

The need to include patient feedback in the development of clinical protocols, including the design of endpoints, testing the feasibility of a trial and informed consent, is gaining prominence. Clinical research professionals have been at the forefront of this transformation, advocating for the integration of patient insights into every stage of clinical trials.

When patients participate in the development of treatments, they experience a feeling of empowerment and ownership, leading to increased engagement in their own care.

The importance of starting to involve patients from an early stage can be seen from a specific example involving fertility treatments. Patient interviews revealed that contrary to the researchers’ assumption that pregnancy would be the only successful outcome, women also considered acquiring extra embryos for future attempts to be successful. This is a very practical example of how patient insights can give value to a protocol.

Another example of this is the US Food and Drug Administration (FDA) prioritizing the use of PROs from validated questionnaires about patients’ functionality and quality of life as primary endpoints in clinical trials for permanent implants and for highly symptomatic diseases.

“Patient feedback throughout a clinical trial can help ensure the trial remains patient-centered.” — Dr. Giacomo Basadonna

And the patient voice remains vital as trials progress, allowing for insights and suggestions to modify the protocol based on data or personal experiences. This leads to protocol adaptations that are more aligned with patient needs, maximizing the trial’s impact and chances of success.

The importance of patient input doesn’t stop at protocol development and endpoints. It is also necessary for patients to engage in the informed consent process, a critical ethical requirement in clinical trials. Patients should have the opportunity to read the informed consent well in advance and offer feedback. This is especially valuable because patients can highlight any difficulties in understanding the informed consent, allowing researchers to adjust the format and language of the document to increase its effectiveness.

There is a further ethical dimension to this issue, as it’s about more than just clarity — it’s about respect and patient-centered care. Claiming to prioritize patient-centric care while presenting patients with a hard-to-understand informed consent contradicts that commitment.

The role of patient advisory boards is crucial in giving feedback on clinical protocols, including the feasibility of its schedule for patients. These boards consist of individuals with lived experience of the condition and provide insights on clinical practice, policy development and service delivery. Alongside other methods such as patient surveys and interviews, advisory boards play a crucial role in ensuring that patients’ voices are heard; however, this process should be done through a third party to help bring in an unbiased perspective.

From identifying unexpected endpoints to crafting informed consent documents that respect patient autonomy and diversity, the inclusion of patient feedback is an essential component of modern clinical research.

3) Recognize the Long-Term Impact of Patient Engagement

The competitive landscape of the pharmaceutical industry has magnified the importance of understanding patient needs. Multiple companies are often running parallel journeys against the same diseases.

There is a growing realization that including the patient voice right from the initial phase of product development can enhance the value proposition of a product. Since patients are the ultimate users, seeking their feedback from the outset helps prevent mistakes during commercialization.

Understanding the patient’s perspective on the true value of a product can highlight those products that are more patient-focused and effective. This distinction can offer a competitive advantage, drawing the attention of regulators, health authorities, partners and investors.

The inclusion of patient input takes on an added dimension in the activities that occur after the clinical phases. A recent FDA request for six years of post-market data after trials in specific areas of medicine or surgery is an example of how patient feedback is moving beyond the trial process alone.

Insights from patients’ perspectives, experiences and feedback are vital for enhancing quality, increasing patient satisfaction and fostering patient-centered care practices. These insights extend to areas such as discharge planning, follow-up care and rehabilitation. Patients can assist in recognizing areas that need improvement, enabling sponsors to refine processes, optimize outcomes or even design new trials. And engaging patients in post-market studies is beneficial for the industry because it gathers unique data that can be leveraged for marketing.

Integrating patient perspectives in this next stage of the product lifecycle leads to more effective, patient-centered products. This approach not only differentiates a product’s value proposition in a competitive market but also ultimately contributes to better health outcomes.

A Holistic Approach to Patient Engagement

The evolution of patient engagement, from being an afterthought to becoming a core aspect of the product lifecycle, shows a shift towards a more empathetic and effective healthcare system.

Alira Health has extensive expertise in involving patients during product development and translating their inputs into strategic treatment outcomes. Their comprehensive approach to patient engagement encompasses the entire product development lifecycle, from early-stage exploratory discussions to post-market assessments.

This extends beyond mere consultation, creating an environment where patients feel valued, heard and integral to the decision-making process.

In recognizing patient engagement as both an ethical imperative and a catalyst for innovation, Alira Health emphasizes its commitment to a patient-centered approach.