How to retain 500 patients to complete 104 site visits over two years

Surprisingly, the number one reason for liver transplants has nothing to do with alcohol. The real cause is liver cirrhosis from NASH, non-alcoholic steatohepatitis, a fatty liver disease without the involvement of alcohol or viral diseases.

For those facing NASH cirrhosis, the most common treatment is a liver transplant. But, with a current Phase III trial underway, Galectin Therapeutics may be on course to change the treatment plan.

Galectin Therapeutics has made notable progress in its clinical trials, in large part due to its impressive patient retention. In its Phase II trial, it had 162 patients complete a full year of dosing, including several invasive measures. At the very start of the trial, all patients were required to complete a liver biopsy, endoscopies and a catheter through their portal vein to measure hepatic venous pressure gradients. Learnings from this Phase II trials are being applied to Galectin’s Phase III trial design.

When the commitment level is high for your clinical trial patients, you have to take a strategic approach to patient retention to maximize the value of your patient data.

Dr. Harold Shlevin, CEO at Galectin Therapeutics is aware that the commitment level is high for their clinical trial patients. For their Phase III study, they will have a two-yeardosing period with every patient having to visit the clinical site every other week for two years.

Dr. Shlevin notes that it’s critical to ensure patient retention during the clinical trial process. As he explains, “if you lose a lot of patients during the course of your trials, you may not have enough to do an adequate evaluation of the results”. He also points out that for the patients you lose, “you have subjected them to a variety of potential risks by using a new pharmaceutical agent, had them undergo a number of invasive tests which carry risk and stopped them from participating in another trial”.

It’s key to implement a study design that is reflective of clinical practice and challenge the utility of every test planned.

Therefore, he believes it is essential to take a strategic approach to patient retention and ensure you retain patients in order to collect critical data required for drug approval. Dr. Shlevin reiterates that “when planning our Phase III trial, it was important to both maximize the value of our data and the retention of our patients by implementing a study design reflecting clinical practice”.

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To achieve this, Dr. Shlevin shared that at the start of the process the team critically reviewed all of the invasive tests planned and challenged the utility of each test. This resulted in the elimination of several tests, which mayhave led to interesting experimental findings but would not have added unnecessary burden to the patients and did not generally reflect common clinical practice.

Galectin also looked into how it could leverage the efforts made during the clinical diagnosis of NASH, with the help of two practicing hepatologists, to minimize invasiveness. For example, many of the patients with NASH cirrhosis have had liver biopsies performed by their physician. Where the slides were adequate, Galectin chose to use this data rather than re-perform the biopsy.

After discussions with key hepatologists, they also realized they needed to be more efficient with the way the tests were carried out. As Dr. Shlevin explained, “the more tests you subject a patient to, the easier you will go from a 30-minute infusion of a drug to a half day-testing experience”.

Consider how you can make the trial process easier and more enjoyable for the patient. Can you refund their travel or offer them an overnight stay? Can you provide information on the progress of the trial?

Galectin aims to be sensitive to its patient’s individual needs to ensure their retention throughout the trial process. For example, if a patient was travelling a significant distance to the clinical site, Galectin would often reimburse their travel. But they would also get them a hotel stay for the night before, so they could have an early morning study visit and get back home at a reasonable time the next day.

Dr. Shlevin also wanted to ensure that each patient felt like an active participant in the trial. Where possible, they kept patients informed of the progress of the trial and encouraged their site staff to interact with patients to keep them updated during visits about how the overall trial is progressing.

A patient focused approach to trial planning will pay dividends in both better retention and compliance.

Galectin realized that for their trials, a lot of the patients with NASH cirrhosis would likely not be able to benefit
from the drug being developed, due to the high rate of disease progression in this population and the time required to gain approval of a new drug. They were also mindful that a third of patients were receiving a placebo
treatment leaving their condition to progress naturally. Dr. Shlevin notes that “patients are giving up a portion of their lives to help themselves and many others with their condition”. That commitment should be respected and it should be  understood that many patients want to be active participants in the trial and understand the future impact of this research, even if they cannot personally benefit.

For Dr. Shlevin, it is crucial that we are flexible to the things that will make life easier for the patient. He truly believes that “this approach will pay dividends both in terms of better retention of patients and far better compliance”. This is clear in the results Galectin have been able to achieve by retaining patients in their Phase II trial. This will be even more critical in the longer dosing duration of their Phase III trial.

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