Healthcare Intelligence 2020 Marty Lee Editorial Article Header v1r1

Not every clinical trial is right for every patient.

When you’re seeing patients, you don’t just want to make sure that they’re eligible for a trial. The trial needs to make sense for the patient and what they’re going through in their own personal life.

For someone who’s trying to hold a job or cares for a family at home, a complicated trial requiring many visits will not be a good fit. You have to figure out what’s right for the patient in terms of their overall care and lifestyle.

As we look to make clinical trials more accessible, how do we make it so that all patients can easily participate? This goal has driven me throughout my time in patient care and in the CRO industry.

I was in patient care for 20 years before joining the CRO industry.

I was a research director at a clinic in Minneapolis for several of those years. Working in patient care taught me how to adapt my care to an individual’s situation.

I remember one patient with advanced lymphoma who had to travel 200+ miles for treatment. She came from North Dakota. She had three kids, which made travel even harder. We decided to organize her care in such a way that was as minimally burdensome as possible.

We involved her hometown physician whenever we could. We minimized her visits by doing a lot over the telephone. And we did all of this in the 1990s! We accomplished our goal of making the process easier for her, even without having advanced technology. We didn’t have the ability to video conference back then, but as the Internet became more present in everyone’s lives, we gained the ability to email and communicate with her electronically.

Given the recent advancements in technology, patients have more convenient trial experiences, but unfortunately, not all trials are convenient. Some have become even more complex. There’s definitely some improvement, but over time, the amount of time and effort going into trials has certainly increased. There are more endpoints that sponsors look to measure. There are more exploratory biomarkers. With all of this complexity, it’s challenging to use electronic media to make patients’ lives easier while simultaneously achieving our goals from a research perspective.

I know that trials need to be user-friendly so that patients don’t have undue burdens like frequent visits, but the CRO industry is still trying to figure out how best to do it. I believe the key is keeping patients’ needs in mind when designing the trial. This way the trial can be adaptable with remote visits and testing whenever possible. We should be streamlining protocols to fit into patients’ lives, only measuring what we need to measure, essentially designing clinical trials with patients at the center.

My experience as a research director and site investigator allowed me extensive exposure to the CRO industry before I joined PRA.

What interested me in joining a CRO is the ability to have a wide view of the industry and understand best practices from multiple companies.

A patient-centric trial starts with people who have patient experience. Often, a sponsor company sends a CRO a clinical trial. The protocol feedback the CRO provides often mentions that there are too many assessments, the assessments are too complicated, or the patient burden is too high. But facing these challenges is what I and CROs as a whole do—we make suggestions on how to streamline that. A large portion of a CRO’s work is balancing what the sponsor needs to learn from a clinical trial with what’s realistic to ask of clinical trial participants. That’s where I come in to help translate the patient experience back to the sponsor.

As far back as the 1960s, the pharmaceutical industry employed doctoral-level specialists called Medical Science Liaisons (MSLs) to work with salespeople.

These specialists would travel to sites with sales reps or by themselves to answer the more complicated questions about the company’s products.

For example, these people act as a scientific resource for a physician who’s seeing a patient who isn’t the typical “type” of patient for the drug. The doctor wonders if a medication will work in a special circumstance for an atypical patient, and this is a question that the MSL could help address. Physicians find MSLs very valuable, as they have knowledge beyond what the sales representatives are able to provide.

When I started at PRA, my team and I had an idea based on what we had learned about MSLs. The idea was to take the MSL role, which supports marketed products, and adapt it to support clinical trials, as the information needs by investigators in clinical trials are as high or higher than those of marketed products.

We called this role the Clinical Trial Liaison (CTL). We started our program, which was new to the CRO industry at the time, with two CTLs in 2014. Our team has now grown to over 40 CTLs located on 5 continents. The team supports trials where there is a high degree of complexity, unique training needs, a highly competitive clinical trial market or are difficult to enroll due to restrictive eligibility criteria or small patient populations.

Traditionally, investigators worked with Clinical Research Associates (CRAs) from a CRO or sponsor. The primary role of the CRA is to monitor the integrity of the clinical trial data, ensuring that it accurately reflects what happened in the course of a patients participation in a clinical trial.

In my experience, I’ve seen CRAs discuss the design of the study, whereas investigators often have questions on why a trial is designed the way it is. Much like the MSLs for marketed products, my role in guiding the CTLs is to provide information that answers these more complicated inquiries. As an investigator, if you haven’t had a chance to discuss the trial with a thorough knowledge of the science and clinical landscape, you will not be as effective in translating the benefit of trial participation to patients who may be considering participating.

Beyond this, CTLs work directly with site staff to ensure that the eligibility criteria are fully understood, and that the site is able to effectively look for patients who may be eligible for the trial in their own database or when patients are referred for care from outside their institution. CTLs also assist with implementing training and sharing best practices from other sites that are conducting the same study.

This approach has been highly effective in enrolling difficult trials, as having PRA’s CTLs supporting has increased recruitment rates by 25-30% on average.

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