Clinical trials have always fascinated me. The overwhelming questions and learnings clinical trials have raised over the past century have pathed the way in which clinical trials are conducted today and the betterment of human health through new treatment options. We all know it can take approximately 10 years for a drug to go from development to market, but not many people know the sheer number of clinical trials one drug must go through during that time.
I started my career in the clinic of a Phase 1 clinical trials unit in Nottingham, UK, where my day-to-day responsibilities were to perform procedures on clinical trial participants, collect the data outlined in the studies protocol and dose the participants with the experimental drug, eventually working my way up to be a project manager for independent Phase 1 clinical trials. Now at Greenphire, I’m a Project Manager II, and responsible for implementing our technology solutions for industry sponsors conducting global clinical trials. I’ve been able to simultaneously manage projects but also offer insights to my sponsor clients using my own research site experience.
One thing that unites these two experiences is patient engagement, specifically regarding payments. In this short blog, I’d like to discuss my observations regarding payments and how they’ve changed over time.
Clinical Trial Patient Reimbursement
A participant’s involvement in a clinical trial needs to be completely voluntary and with all parties understanding that the participant may withdraw at any time, no questions asked. A sponsor and site have a responsibility to conduct trials ethically, but to do so in a way that makes trial participation not an overwhelming burden on patients.
Participants in all phases of clinical trials are often compensated for their participation, even for things as basic as travel to the clinical trial unit. For a small Phase 1 clinical trial (approximately 20 volunteers) travel is a relatively simple thing to achieve. Usually, the participants live close to the unit and their ability to drive or travel by public transport is assumed as only healthy volunteers can participate in these clinical trials. But if you think about a sick patient in a Phase 4 clinical trial who needs to travel back and forth from a hospital thousands of miles away over a few years, things get a lot more complicated. This type of payment would be commonly referred to as a “reimbursement” as it usually requires the clinical trial participant to pay for the upfront costs with the expectation that the site/Sponsor will reimburse them for it.
While in theory, this is very practical, it’s not quite so in reality. If we were to look at an extreme example, an elderly, poorly participant in a long-term trial requiring them to travel to another country; the expectation is that the participant would pay for the upfront travel costs. This includes flights, food, accommodation, transport within the country for themselves and a companion, as well as the stress associated with arranging all of this. A lot of people would struggle to meet these upfront costs, and while they know they will eventually be reimbursed for it there is an administrative burden on the sites and Sponsor to process this which takes time to process it. Just this aspect of a clinical trial has a negative impact on participant retention and often results in participants removing their consent to participate in a trial, which has a knock-on effect on the trial of often results in delays.
Recognition of Patient Time & Inconvenience through Stipends
The other type of payment you come across is referred to as a “stipend” payment. This is a payment for taking part in a clinical trial, taking into consideration the time and effort of participating through a “substantiated reimbursement”. I have found a difference in mentality between US and UK clients and colleagues because it is commonplace for clinical trial participants to be paid a taxable stipend to take part in a trial in the US, whereas clinical trial participants cannot be ‘paid’ in the UK.
Now as you can imagine, depending on the complexity and phase of a clinical trial, the number, and types of procedures a participant is expected to undergo can vary widely. If the stipend amount is broken down to a procedure-by-procedure basis it creates a huge administrative burden for the Sponsors and the sites. Not only to make sure the payment rates are fair per procedure but to make sure that every participant has been paid what they’re owed within a reasonable timeframe. The longer the timeframe the more negative the impact on participant retention becomes.
The stipend concept is heavily regulated in the UK as it is believed there is a fine line between “encouragement” and “coercion” of a trial participant, and every part of the agreed stipend must be substantiated. So how do we simplify both the terms used to describe how clinical trial participants are compensated for their time and relieve the burden of paying a participant per procedure to avoid being accused of coercion?
To communicate this type of payment more effectively in the UK, a stipend can be referred to as an ‘inconvenience allowance’ which is paid to participants in recognition of their sacrifice and as an appreciation of their contribution to science. The inconvenience allowance is calculated and submitted to the Ethics Committee (EC) for approval prior to patient enrolment and can be updated when changes occur throughout the progression of a clinical trial. The legislation and practice regarding stipends in Europe vary widely from country to country, but the most common practice requires stipends to be reviewed and approved by an EC. It is commonplace for individual sites and CROs to have their own breakdown on how an inconvenience allowance is calculated per trial and is not fully standardised throughout countries.
The Future of Clinical Trial Patient Payments
Given the complex web of different healthcare systems and regulatory environments in which clinical trials operate around the globe, it may seem difficult to imagine the ability to standardise approaches to clinical trial inconvenience allowances, and in an effort to be transparent, I could not suggest where best to start this task. However, because of the intensity in which the clinical trials industry is regulated throughout the world, I think it’s important we start to have these conversations and make changes to standardise these payments to clinical trial participants, to ease the burden on sites, Sponsors, participants and EC’s so that we can focus on the importance and reliability of the data produced in each clinical trial, and get those life-saving medications to market that bit quicker.
In the interim, Greenphire helps clients to navigate the ability to remove patient burden across the globe, providing templates for ethics committees, guidance on global patient payment execution, and modalities that fit the markets each of our clients serve. It’s my pleasure to work with clients to execute on these goals and look forward to doing so this year.
