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Clinical Trials Q&A: Examining clinical trial design

Jocelyn Ulrich   |     April 12, 2016   |   SHARE THIS

Clinical_Trials-1.jpgConversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest discussions, including patients, stakeholders, innovators and others, to share their perspectives and point of view. Views represented here may not be those of PhRMA, though they are no less key to a healthy dialogue on issues in health care today.

With Clinical Trials Awareness Week coming up May 2-6, we spoke with Abbe Steel from HealthiVibe, an organization dedicated to helping patients and caregivers.


Abbe_Steel_head_shot.jpgJOCELYN ULRICH: What is patient-focused clinical trial design?

ABBE STEEL: Patient-focused trial design involves working closely with patients who may qualify to be in the clinical trial. This happens through a variety of techniques including qualitative and quantitative methods, such as mock trial simulations, in-depth interviews, advisory boards, global online surveys and participant satisfaction surveys like HealthiPerspectives™, to gain deeper insight and understanding into what they think about the study and perceive as barriers to participation. Working together with patients, sponsors can uncover the issues that matter most from the patient perspective, which might have otherwise gone unrecognized, resulting in faster studies with better recruitment and retention.

Patient insights can and should feed directly into protocol design, and those insights can be leveraged to support many operational aspects of the trial, as well as shaping the clinical endpoints for the study. This will help sponsors better understand patient perceptions and treatment preferences related to their illness, its treatments and management.

JOCELYN ULRICH: What is a clinical trial protocol, and why is it important to test prior to putting it into practice?

ABBE STEEL: A clinical trial protocol is the blueprint for a study and describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and structure of a clinical trial). It ensures the safety of the trial participants and quality of the data that will be collected and analyzed. Whether it will be to test a new drug, device or procedure, or is only observational in nature, every study begins with the protocol. And, as is the case with all types of design, what looks good on paper may not be practical or effective when implemented.

Testing the protocol with patients who resemble the profile of the trial participant allows sponsors to gather valuable feedback about everything from perceived risks to number of visits or types of procedures. Understanding what patients think about the study allows sponsors insight into why someone might not join a study or might be inclined to drop out before completion.

Study designers don’t typically consider the patient experience as a part of protocol development. Instead, the focus is on efficacy, safety and tolerability of the drug. Feedback is sought from a stakeholder group that might include the clinical and operations teams, a steering committee of key opinion leaders, or partners such as a clinical research organization (CRO) or technology provider. Rarely are patients included in that group of stakeholders, and yet the patient is the key customer for a clinical trial.

JOCELYN ULRICH: What are some of the types of feedback you’ve received after testing a protocol?

ABBE STEEL: If we can involve the patient in the study’s operational and clinical considerations, then ultimately improved recruitment and retention will be a natural positive outcome, as well as reduced protocol amendments.

To accomplish this, we ask patients questions like “What trial requirements would hinder your participation?” and “What would enhance your participation?” We have heard responses like:

  • “I can’t drive so transportation support would be great.”
  • “Mixing the drug formulation myself would be a problem from a time commitment and confidence standpoint. Can a local pharmacy do it instead?”
  • “I don’t understand the instructions on the blister packs.”
  • “The packaging is too hard to open with my rheumatoid arthritis.”

If we listen to the patients’ responses and modify our approaches accordingly, timelines will be improved, costs will be reduced and overall study objectives will be met.

Clinical trial sponsors need actionable, meaningful feedback before they start a trial. This allows sponsors to focus on areas of risk and modify things before finalizing the protocol. Based on patient feedback, sponsors might consider things like hiring a patient recruitment vendor, reducing or combining study visits, including specific patient outcomes instruments, or utilizing new technology such as wireless glucometers. The goal is to reduce patient burden and stress, identify specific drop-out risk areas, increase patient retention and, ultimately, improve trial recruitment rates.

Ms. Steel has 25 years of experience in the life sciences industry, leading clinical development and post-marketing programs. She is an advisor to pharma sponsors in the design and implementation of patient-directed global programs that leverage data, insights and mobile/digital technology to satisfy patient/caregiver, provider, payer and regulator needs. She has extensive experience designing and managing large-scale clinical development programs, as well as successful patient adherence, clinical trial patient recruitment & retention and drug safety initiatives.

Ms. Steel previously worked as vice president of patient & physician services at UBC-Express Scripts; worked at Sanofi on global marketing programs; was senior director, patient programs at PAREXEL; and was vice president at a health IT start up. Ms. Steel received her Master of Science in Health Communications from Boston University and her BA from The George Washington University.

clinical_trials_q.jpgAdditionally, Ms. Steel serves as a member of the AWARE for All D.C. planning committee. The event, being held April 20, 5 - 8 p.m. at Howard University, is designed to educate the community about clinical research—what it is, what it’s like to participate, what researchers learn from studies and why it’s important for many different people to get involved.

Topics: Clinical Trials

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