Patient involvement in clinical trials

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I have more than 25 years of senior management experience at Fortune 500 companies, including Bristol-Myers Squibb, Immunex, Inc., Amgen and Abbott Labs, where I built and led the company’s Immunology franchise, including the Humira (adalimumab) business, helping to create the foundation for this blockbuster global brand. I was an executive member of the Immunology clinical trial planning committee at Ab responsiblebott Labs that was for strategic planning and approval for clinical trials including Phase 2–4 for new compounds, diseases, indications and REMS (Risk Evaluation and Mitigation Strategy). Additionally, I was involved in the new indication trial planning and protocol design at Amgen as well as strategic planning for Phase 4 trials for Enbrel.

I am now CEO and co-founder of Reverba, a global patient engagement company that has been creating transformative tech-enabled solutions to build a bridge between patients and biopharma companies, from clinical development through commercialisation, for more than 20 years.

The rise of smart technologies such as smartphones with app-enabled health monitors, disease-specific social media forums and virtual healthcare provider platforms have fundamentally changed the role patients play in all aspects of their own healthcare, from how they gather information to how and when they relate to others with their condition and their medical team. Providing what patients need, where they want to access it, in language that is easy to understand, is now more than just a trend—it is an expectation. And this expectation particularly applies to clinical trials. Excluding patients from the clinical trial process can cost both time and budget. According to a Tufts University study, the cost for changes made during a clinical trial can range from $141,000–$500,000+ per change. Clinical trial recruiter Beroe reports that once underway, 85% of clinical trials fail to retain enough patients to reach completion12.

Patients want to play an active role in clinical trials. In a survey we conducted through Reverba’s subsidiary Health Stories Project, we asked 352 patients about their clinical trial knowledge and experience. Among respondents, 88% were familiar with clinical trials, but 65% had not participated in a trial. When asked, 97% of patients said it was important for biopharma to include consumer input when designing trials, and 83% were interested in providing feedback.

It is critical to include patients not only in clinical trial design, but with ongoing input throughout the clinical trial cycle. Before the start, patients can provide feedback to improve protocol design and improve recruitment. Feedback during the trial enables the clinical trial experience to be improved and the trial to be adapted as needed. After the trial, patients can be involved in post-trial results communication to build relationships.

There are many ways to engage with patients to incorporate their input as you plan a clinical trial. Patient advisory boards bring together a small group of patients and caregivers (6–10) either in person or virtually to share perspectives on the trial. One-on-one interviews with patients provide in-depth conversations, which can guide decision making that considers the patient perspective across a range of patients. A patient consultant takes on a more active role and becomes a member of the clinical trial team, participating in multiple meetings and calls during the trial planning process.

With engaged and active patients, their involvement should not end when the trial begins. During the trial, an in-trial insights platform can be used to conduct surveys or interviews with patients currently enrolled for real-time feedback. After the trial, a clinical trial alumni program enables companies to maintain communication with patients to provide information about the study results and whether a product is approved.

Patients provide real-world insight that can help support better trials across a company’s therapeutic areas. Pharma companies can also take a more agile approach, incorporating what they learn from patients to impact how trials are designed in the future—faster, more efficient, more cost-effective and providing a better experience for participants.

Thus, engaging health consumers throughout the clinical trial process has the potential to help get drugs to market faster and truly change healthcare.

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