DDW’s Reece Armstrong speaks to Scott Gray, President & CEO of Clincierge about its unique approach to improving the clinical trial experience for patients.
For patients participating in a clinical trial, the experience can be one of considerable hardship, both from a perspective on their health and the impact on their everyday lives. Logistically demanding and time consuming, clinical trials can nevertheless offer patients access to therapies that could present a genuine chance at a cure for their condition.
However, for many, the chance to participate in a clinical trial can be rare, and access to potentially life-improving treatments limited to only the lucky enough to be selected. Clincierge has emerged a company in the life sciences industry dedicated to improving clinical trials access to patients, by offering a unique service where logistical demands are met for both patients and sponsors.
Clincierge was born out of its experience in hospitality services, where it had been operating for almost 30 years, offering meetings and events management services for pharma companies.
Gray says the company took this “hospitality foundation” to create the Clincierge services. The goal? “To improve clinical trial performance by enhancing the patient experience as they travel through the rigours of participating in a clinical trial,” Gray explains.
The company does this by offering a fully managed travel journey for patients participating in a clinical trial. For organisations working with Clincierge, every aspect of a patient’s travel is organised – from what transport they’ll be taking, help with Visas, personalised concierge services – the idea being to make the logistical experience as trouble-free as possible, so that the clinical experience is made that little bit easier.
For the clinical research organisations (CROs) and pharmaceutical companies conducting these trials, a better patient experience could ultimately lead to higher retention rates and a smoother operation overall, saving time and cost in the long run.
Retention rates is what Gray says drove a “significant part of the design of the Clincierge service.”
When the company was starting out, Clincierge was seeing a 38% dropout rates for clinical trials, Gray tells me. “Yet no one was attempting to figure out what might help with those retention rates,” he says.
A recent study1 by Clincierge points out some of the problems both patients and caregivers face during clinical trials, including financial concerns, travel and reimbursements. Indeed, the company’s “Voice of the Patient” report states that of patients who participated in a clinical trial, 68% said that travel had been “difficult”, and 95% seriously considered dropping out of the trail due to challenges associated with travel.
By removing barriers to travel through Clincierge, Gray hopes that pharmaceutical companies can expand the “geo and socioeconomic reach of the patients they can get access to.” He offers the example of rare disease patients in India or China being able to access a trial happening elsewhere in the world.
For rare disease patients, this can be significant.
“Many of the trials in rare disease are the only course of treatment available for those patients. So for many it’s life-saving or life-preserving with them,” Gray says.
Our discussion on expanded patient reach puts us onto the issue of diversity within clinical trials and what Gray’s experience of that has been like whilst working closely with the industry.
When asked whether he thinks pharmaceutical companies are focused on diversity, Gray says he believes they are.
“They’re thinking about it because the bodies around the globe that provide approval for drugs are now saying ‘wait a minute you’ve only tested this product on this type of individual, why should we approve it across the population that you say it will be beneficial for?’”.
Indeed, this is something the industry has seen from the FDA this year, with the agency expanding its clinical trial guidance for the enrolment of patients from under-represented backgrounds2.
In the FDA announcement about the expanded draft guidance, the agency mentions how barriers “to participation among racial and ethnic groups may include mistrust of the clinical research system due to historical abuses, aspects of the trial design such as inadequate recruitment and retention efforts,” among other issues.
Gray believes that building trust can help improve diversity throughout clinical trials. Gray says that “providing access and making the playing field more even,” can open up opportunities for communities that have perhaps “resisted medical treatments or participation in clinical trials.” Through this, opportunities to gather better data emerge through different patient cohorts, Gray explains.
Of course, the onus should be placed on both industry and regulators to ensure clinical trials are fairly representative and Gray sees opportunity here as well.
“I believe where the opportunity continues to be is with the pharma sponsors, those that are doing the clinical trial research. They have the budget to produce the information campaigns for the populations that they’re trying to get access to. They have to start there. Many companies have instituted patient diversity officers that oversee the way the company is going about recruiting patients so they can get a more diverse population,” he says.
For Clincierge, the company is aiming to be a service that contributes to the clinical trial landscape in a meaningful way. It’s doing this so far by taking what Gray calls a “human-first approach.”
“There are companies that are trying to replicate what we do. But many have approached it from a technology first perspective where our approach is human first perspective,” Gray tells me.
This is evident in the numerous companies that provide technology solutions or platforms designed to either expedite clinical trials, make gathering data easier or provide a service to enable trials to operate remotely. These are all meaningful endeavours but in the case of decentralised clinical trials, Gray tells me that remote trials are simply not possible a lot of the time.
“I think for certain trials it can have great benefit in reducing the cost of the trial and enabling more rapid collection of the outcomes data needed, keeping patients engaged by lessening the burden of attending the site. But it’s not applicable to many, many diseases. For example in most of the rare disease studies,” he says.
By placing its focus on the people participating in clinical trials, Gray says it’s a “win-win that the investment in our services helps recruit and retain patients.” By improving recruitment and retention throughout trials, Gray says this can help produce faster outcomes data, help contain R&D budgets and benefit the patients by offering them access to treatments that they didn’t think they could afford or access with travel.
Perhaps most importantly “it’s a win for the population who also suffers from the same disease when something is approved and comes to market and can help them with their health,” Gray adds.
References
1: Clincierge Voice of the Patient report
2: https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials