By Jean McCoy and Pam Garfield
There are so many challenges around designing clinical trials that it can often be difficult to decide where to focus your efforts and resources to improve the process. Based on our recent surveys of clinical trial participants, we see that early engagement with patients can change the course of a study for the better — and research shows it can directly impact the cost of conducting the trial as well.
Over the last two years, we conducted two surveys, one of 100 people and the other of 300 people, asking about their knowledge of and experience with clinical trials and, ultimately, their feelings about participating in them.
We are sharing the survey results in a series of two articles. In the first, Tap Into Patient Experiences To Improve Clinical Trial Enrollment & Engagement, Cheryl Lubbert, CEO of the Health Perspectives Group of companies, examined the role patients can play in assisting other patients who are considering participating in a trial and how to lay the foundation for patient involvement. In this article, we’ll look at how patient input and interaction can help improve clinical trial design, reduce costs, and improve overall retention and clinical trial experience.
In the first clinical participation survey we conducted, patients clearly stated that they want to participate in the development process: An overwhelming 97 percent of patients said that it is somewhat important or very important for pharma companies to include consumer input when designing trials. In addition, 83 percent said they would be somewhat interested or very interested in reviewing details and providing opinions.
What Type Of Input Can Patients Give?
Our second survey showed that simple logistics are top of mind for patients when choosing whether to participate in a clinical trial, with 34 percent of respondents citing some type of transportation, location, or time scheduling conflict as a reason for not participating.
Knowing about these concerns early enables trial planners to adjust specific clinical trial operational factors that have been identified to impact enrollment or retention.
For example, investigators might be planning to require patients to have blood draws two or three times a week to measure biomarkers that are of interest but not required for product approval. Feedback from patients might lead to the decision to reduce or remove those tests, making the trial more “patient friendly” and adjusting the trial to better match real-world patient time restrictions. And, if scheduling or location might be perceived as an obstacle for patients, developing a flexible schedule, clustering required appointments, or something as simple as arranging for a car service to assist with transportation might make all the difference in keeping a patient enrolled. Patient feedback specific to the trial under development before it is finalized can help avoid potentially costly mistakes.
What Impact Can Patient Involvement Have On Trial Design?
The National Cancer Institute gained insight into the potential impact of patients on trial design when planning the NCI-MATCH trial, which sought to recruit people who have tried and failed with traditional cancer treatments by categorizing malignancies based on particular gene mutations. Patient advocate Nancy Roach helped advise the scientists planning this study.
The original plan was to separate participants doing well on the test treatment into two groups: one group would continue the treatment and the other would take a break, called a drug holiday. Roach advised that taking a patient who's responding to treatment off the drug would not be received well by the participants. The organizers agreed and changed the design of the study.1
Dr. Matthew D. Galsky of the Icahn School of Medicine at Mount Sinai in New York, as the principal investigator of a prostate cancer trial, also revised the design of a clinical trial based on patient input. Dr. Galsky’s team wanted to test whether patient input was useful to the trial design process, so they designed the trial on their own and then used an online platform to solicit feedback from patients for six weeks. Dr. Galsky’s team decided they would consider the process useful if the input led to at least one major change in their design, or three minor changes. In the end, the trial design incorporated four major and five minor changes.2
Each change that must be made after a trial is underway can carry a steep price. Kenneth Getz, director of sponsored research programs at Tufts University and emeritus member of the Executive Committee of the Clinical Trials Transformation Initiative, is a pioneer in measuring this impact. His research, published in the journal Therapeutic Innovation & Regulatory Science, shows that the cost for each change made during a clinical trial can range from $100,000 to $500,000+ per change.3
Engaging Patients Before And During The Clinical Process
Bringing in patients early and often is the key to being able to make changes that improve a clinical trial before it starts.
In Lubbert’s article, she discussed how to lay the foundation for working with patients, gathering insights to ensure you fully understand the population you will be working with, and how best to support recruitment. Now we will look at how to specifically use patient feedback programs to improve protocol design and the clinical trial experience.
Before The Clinical Trial
It’s important to get patients involved early in the clinical trial protocol development process to ensure the trial doesn’t have roadblocks built in that will impact recruitment and retention. Early engagement also enables you to request patient feedback during the development of all recruitment materials and channels planned with ample time to make any needed revisions. Some examples of ways to involve patients include:
During And After The Clinical Trial
As the trial protocol is being developed, you can also plan for ways to continue to engage patients during the clinical trial and beyond.
Our survey results show that including patients in a significant and meaningful way before and during the clinical trial process can improve recruitment, keep costs down by eliminating expensive and time-consuming changes, and boost retention by improving the trial experience for patients. Creative and compliant engagement programs built around the patient experience can make these benefits attainable.
About The Authors:
Jean McCoy is senior VP of strategy and innovation at Health Advocacy Strategies, a specialized health communications firm that helps companies include the authentic voice of real patients in all aspects of their business. Jean has 25 years of biopharmaceutical commercialization experience and entrepreneurial business background, including tenure with Amgen (and before its acquisition, Immunex), as well as Zeneca Pharmaceuticals (now AstraZeneca) and McNeil Consumer Products Company. For more info: www.hastrategies.com.
Pam Garfield is senior VP of strategy and innovation at Patient Health Perspectives, a specialized health communications firm that creates intelligent solutions for health consumer participation. She has more than 20 years of professional experience across a range of fields impacting patients. Pam began her career as a lawyer and then transitioned to a career in healthcare with patient education firm Krames and DDB Issues & Advocacy, providing consultation and support services to biopharma advocacy relations teams. For more info: www.phperspectives.com.