Drugmakers, Advocates Share Best Practices for Patient Engagement

Health care advocates and drugmakers are hoping to build patient engagement into an earlier, more integrated and standardized part of clinical trials, amid a torrent of patient-centric efforts taking over the industry.

Those pushing for the changes believe they can reap rewards for efficiency and company bottom lines, but there are engrained barriers to collaboration. The stakes are high: experts say U.S. clinical trials are in crisis as cycle time and financial demands increase but enrollment slows – causing many researchers to pull out of studies altogether “at a time when there is an increasing need for reliable evidence to evaluate new drugs.”

Advocates say what’s needed is a “culture shift.”

Amid this climate, pharmaceutical titan Eli Lilly has given researchers a real-world example of what partnering with patient groups might look like, joining with the Lupus Foundation of America in research efforts to develop new treatments. The debilitating autoimmune condition affects 5 million people globally, costing them an estimated $20,000 to $60,000 out-of-pocket for drugs that have only seen one update in the last half-century.

Michele Oshman, the company’s director of federal advocacy relations, says it’s been important to learn how to stop and listen to patients.

“There’s a difference between how patients feel and act and how the biopharmaceutical enterprise in large part has undertaken research,” she says.

The project included a joint survey that examined the toll lupus takes on lives from diagnosis time – almost six years – to medications, hospitalization, work life, family life and mental health. Lilly developed investigational drug tabalumab in the largest lupus trials to date but abandoned it in Phase 3 last year because of a lack of demonstrated efficacy.

These types of best practices for embedding patient engagement in research were underscored at BIO’s annual summit in Washington where the Clinical Trials Transformation Initiative (CTTI) unveiled new recommendations.

The guidelines say that by building patients into research infrastructure in a measured way, sponsors will develop a “clearer, more focused” vision of unmet needs, clinical goals and potential new drug uses to focus on. Trial design could reap rewards from that, CTTI says, with stronger “selection of optimum subjects, endpoints, and clinical sites; by faster trial recruitment and greater compliance with the protocol; and by alleviating the need for costly and time-consuming adjustments later.”

Industry experts and innovators said sponsors need to listen to patients earlier in the process than current standard practice to make the relationship work for everyone involved — at the beginning of a new research program rather than in its late stages. Too often, patient engagement is an effort to salvage a trial and rustle up enough participants.

Building Relationships

This dialogue should segue into establishing trusting, ongoing relationships. Contacts need to be carefully chosen to avoid overlap and maintain consistency, and all interactions should be documented to ensure obligations are met and trade secrets remain confidential.

Transparency is essential — during both successes and setbacks and also when implementing policies to manage real or perceived conflicts of interests.

But it can’t just mean keeping patients in the loop through a transactional relationship. Integrating a patients-as-partners model means placing patients on steering committees and carrying their input throughout the process not just as “token voices.” Patient advocate groups can help with fundraising, natural history and registries and monitoring.

Communication should include discussions of enrollment rates, presentations, publications, changes and other non-study news. Process should be simplified when possible. This can, in turn, allow sponsors to make trials more understandable and focus on the right priorities that matter most for clinical benefit.

Companies can be hesitant to sign on to changes, with a lack of buy-in the most-often cited barrier to collaboration. To address this, research sponsors should build structured plans around an evaluation of each advocate group’s assets, values, experience and skills and how they fit into the drugmaker’s preexisting goals and development pipelines.

The CTTI guidelines for each sector can be viewed at www.fdanews.com/11-15-Patient-Engagement-Trialspdf.pdf. — Victoria Pelham

$745 $545


Subscribe to Clinical Trials Advisor NOW and save $200 off the regular one-year price of $645 — plus receive a FREE copy of our webinar, Electronic Informed Consent for Clinical Trials: Best Practices – a $347 value!

Key Benefits

LINKS TO KEY DOCUMENTS — Need to read regulatory references, guidances, enforcement actions, and other documents? Simply click on the source documents in your electronic issue.

ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.