Today he and the company are actively leading discussions and initiatives that can have a positive impact on patient engagement and overall trial success. OSP took some time to find out his views on successful patient recruitment, what the common problems are and how he suggests solving them.
He has focused his career on building innovative eClinical software companies to address challenges and unmet needs within the global clinical research ecosystem.
Jim earned a Bachelor of Science in Biochemistry and a Master of Science in Molecular Biology from the University of California at Santa Barbara. Jim lives in the Philadelphia area with his wife and three children.
Recruitment
OSP: What are the most important reasons for insufficient recruitment/recruitment problems?
JM: In trials today, we are seeing narrower inclusion criteria and increasingly demanding protocols. This results in a smaller subset of viable candidates who, in turn, face greater burdens - for example traveling further distances and more often for study visits. As such, the time and effort required to participate in a trial is often a deterrent for many prospective participants.
Additionally, awareness continues to be a challenge. Despite recruitment efforts, there is still a lack of knowledge about clinical trials across target populations.
OSP: Can insufficient recruitment be prevented? What could/should be done?
JM: It is difficult to completely prevent insufficient recruitment across the entire landscape as there are a variety of factors – some tied to study design and others a derivative of patient and site burden - but there are steps that can be taken.
For instance, are sponsors validating that a sufficient target patient population exists (e.g., querying medical data)? Are they engaging with sites and patients directly to gain feedback on protocol burden? Are there plans in place to remove those identified barriers to not only enrolling but staying in a trial for its entirety (e.g., implementing flexibility where possible, such as offering at home visits)? Is the site burden being taken into consideration in conjunction with the participant experience? These are some key things for sponsors to think about during study planning and protocol creation to help drive successful recruitment.
OSP: Any changes on a national level that could improve the situation?
LL: The FDA has issued several guidance documents geared towards optimizing the participant experience and reducing associated burdens, including one that reinforces the appropriateness of not only reimbursing participants for trial expenses but paying a stipend in exchange for their time and effort. Another recent guidance is focused on supporting greater flexibility in trial conduct in the context of hybrid or decentralized trials to increase patient convenience.
In addition, there can be a significant financial impact on trial participants, including taxation of trial earnings. We are actively leading discussions around increasing the tax threshold (currently $600) to further reduce the economic burden on participants. These are just a few examples of initiatives that can have a positive impact on recruitment efforts and trial success.
Discontinuation
OSP: Coming from poor recruitment to trial discontinuation – if recruitment to a trial is slow, what can trigger the actual discontinuation of the trial?
JM: According to the NIH, poor recruitment is the top reason for premature discontinuation of randomized clinical trials. There could be many reasons for slow recruitment – small patient population due to narrow eligibility criteria, lack of upfront funding for recruitment, highly burdensome protocol, lack of enthusiasm for the study protocol / study design, etc. Ultimately, you need sufficient data to determine the efficacy and safety of a drug and if for any of the above or other reasons you can’t meet that enrollment target, the trial won’t be feasible.
OSP: What are the major issues with trial discontinuation due to poor recruitment, if any?
JM: A key issue is that the drug or treatment at hand may prove to be effective for some or all participants enrolled in a given trial. However, if the trial is unable to enroll the appropriate quantity / diversity of participants to derive the required data, the trial will be discontinued, and the drug or treatment doesn’t get to market. In the end, a potentially lifesaving or altering medicine doesn’t make it to those who need it, including those who were enrolled in the trial.
Greenphire's approach
OSP: What does Greenphire continue to do to alleviate these problems?
LL: Greenphire’s core focus since inception 15 years ago has been removing barriers to conducting and participating in clinical trials. We do this by eliminating financial and logistical burdens faced by participants while streamlining traditionally time-consuming administrative processes for site staff. Our goal is to keep participants enrolled in the trial and enable operational efficiency so studies can stay on track and treatments can be validated and brought to market in a timely and cost-effective manner. By simplifying the tedious administrative work, sites and participants can focus on what matters – the science.
OSP: What are your most successful platforms?
JM: Greenphire is known for inventing ClinCard, the leading solution for automating and tracking participant reimbursements. ClinCard ensures that participants in trials around the world are promptly and easily reimbursed for expenses and/or time and effort in a study. Over the years we have expanded upon our offerings to further support the participant journey. This includes the addition of travel and accommodation management via our ConneX service to reduce the burden and eliminate out-of-pocket expenses. And most recently, we have developed our GreenSpace participant app, offering centralized access to key information and activities, including financial views, receipts capture & submission for reimbursement, visit and travel details, meaningful insights, trial matching and more powerful engagement tools.
OSP: Once you have established ways to improve, do you then immediately go on to the next idea?
JM: We are constantly innovating and building upon our solutions. We do this through our own experience and learnings as well as continuous market research. This includes gaining feedback from stakeholders across the industry, from sponsors and CROs to sites and participants. Not only have we innovated within the realm of patient engagement, as noted above, but we have also developed solutions to streamline site payments and upstream budgeting processes via our eClinicalGPS and EnvisiX platforms, respectively. As needs arise or evolve in the market that fall within our area of expertise, we seek ways to meet those needs and further remove barriers that stand in the way of conducting research effectively and efficiently.
