Improve Clinical Trial Design By Getting To Know Potential Participants

By Maya Zlatanova, cofounder, FindMeCure

A major part of the drug development process in terms of timelines and budget goes to clinical trials. It’s no secret that a clinical trial’s success is predicated on people — people participating in the clinical trial. From developing the clinical trial design to gathering the patient outcomes, it all requires patients to be fully involved and motivated to work with the clinical trial team.

However, very often patients are the last ones asked for feedback before starting the clinical trial. If you follow all the industry trends and read about the future of patient engagement and patient-centricity, you might think that patients really are the focus now. Yet, ask someone from a clinical development/operations team in a pharma company or a CRO how much time they actually have to consider patient insights when conducting feasibility research. They usually have three to six weeks to come up with the protocol, and there is no extension for bringing in more patients’ data. How are they supposed to better understand patients and their needs while spending the same amount of time on the same feasibility procedure we know from 10 years ago?

At the same time, as was discussed actively during the DIA 2018 event in Boston, patient engagement executives, now a part of almost every organization, are trying to bring the patient’s voice in the fastest and easiest way. Most of these executives come from a clinical development background, hence they know the dilemma from the inside out. Yet, they still lack measurable data to back the statement that if you involve patients early in the process you will have significantly better results during the clinical trial, thus saving both time and money.

In this chicken or egg situation, the only thing we know is that we need to work together and share know-how if we are to change the mentality of the clinical research industry and really shift the focus to the patients.

FindMeCure and HealthUnlocked recently joined forces to research opinions of patients about clinical trials, the different stereotypes, and patients’ reasons and challenges when joining as clinical trial participants. It is a small step to contributing to the industry’s efforts to understand patients better and try to engage with them in every single stage.

You won’t be surprised that out of the 20,000 patients surveyed over 24 hours, only 18 percent have already participated in a study. The main reasons for participation were: 33 percent, desire to help advance medicine and 22 percent, encouragement from a doctor or a nurse. What might surprise you is that 100 percent of these people said they would embark on such a journey again and 50 percent of them described their experience as “very positive.” And, for people coming from the industry, we should not be really surprised, as patients get full attention and monitoring of their health during a study — something that rarely happens in hospitals due to the shortage of doctors and nurses.

The research also reveals disturbing facts. Ninety-three percent of patients who were ineligible during their first screening visit were never offered another option. The communication doesn’t go beyond “I’m afraid you are ineligible,” even when the ineligibility comes from a factor that can change over the course of a few weeks. Only 10 percent of patients said they won’t participate in a clinical trial because of safety or data privacy concerns.

These are all numbers we’ve seen in other surveys, but it shows we still lack a clear strategy for how we can improve the access to information about clinical trials for both patients and their doctors. As a next step, however, the researchers categorized the different types of people on their journey of becoming clinical trial participants. Similar to other aspects of human interaction, before reaching out to your audience, you need to know its needs and drivers. The goal of this categorization is to allow professionals to build better and more meaningful strategies on how to involve patients in the study and when There are six main categories of potential trial participants:

• People who previously participated in a clinical trial
• Patients who would opt in (proactive), but don’t have any information about clinical trials
• Ineligible patients
• Eligible people who refuse to participate (often referred by the doctor or through EHR software)
• Those proactively searching for clinical trials through clinical trial registers/websites
• People interested in clinical trials but passive

Each of them has a very specific way of getting information, willingness to contribute, and expectations on what the clinical trial should look like. Understanding this in combination with their category distribution across therapeutic areas/gender/age/location might be crucial for making your decision of what kind of materials, campaigns, and channels you should use in order to find out more about them and program your study for patient recruitment success from day one.

Another interesting fact from the research is that a majority of people (40 percent) prefer videos as a format for distributing information about a study. Other formats are infographics, blog posts, research papers, etc. Patients expect to have them not only as a way to find out more about a clinical trial but also throughout the study, as they think this will keep them engaged and confident about their decision to participate.

You can download a white paper based on the research here or request it via email at maya@findmecure.com.

About The Author:

Maya Zlatanova is a business development expert with more than 10 years of experience in the clinical research industry. She has done regulations training to some of the biggest pharma companies, as well as to the United Nations and Ministries of Health. She is a cofounder of FindMeCure, a global platform transforming the way people find, understand, and join clinical trials, and is a board member of the Patient Empowerment Initiative Committee at the Alliance for Clinical Research Excellence and Safety (ACRES).