A Patient-Focused Approach to Clinical Trial Planning Pays Dividends in Better Retention and Compliance

It’s not uncommon for clinical trials of new drugs entering the market to struggle with patient recruitment and retention. This is especially true of trials targeting the treatment of chronic diseases, as the trial can require a one- or two-year commitment for patients. Patient retention cannot be an after-thought in such clinical trials. Instead, trial sponsors and investigators must take a strategic approach to maximize the chances of patient retention, streamlining every aspect of the patient experience.

Patient retention during the clinical trial process is critical for both the trial investigators and patients. Here’s why:

• For sponsors and investigators, if too many patients drop out over the course of the trial, there may not be enough patients left to do an adequate evaluation of the results. Recruiting more patients to replace those who drop out can also increase the cost dramatically.
• For the patients who drop out, they have been subjected to a variety of potential risks by using a new pharmaceutical agent, may have undergone a number of invasive tests which carry risk in and of themselves, and, more importantly, prevented them from participating in a future trial.

Galectin Therapeutics has had great success in recruitment and retention in our NASH-CX Phase 2 clinical trial exploring treatment for non-alcoholic steatohepatitis (NASH), and we continue to leverage the lessons we learned as we are actively recruiting for our NASH-RX Phase 2b/3 study, NAVIGATE, in NASH patients with compensated cirrhosis who have yet to develop esophageal varices.

Taking a strategic approach to patient retention involved two foundational efforts:

Streamline the science

The process began as the team critically reviewed all of the invasive tests planned, challenging the necessity and utility of each test. This resulted in the elimination of several tests, those that might be invasive and riskier, which may have led to interesting experimental findings but would have added unnecessary burden to the patients and did not generally reflect common clinical practice. If patients would not ordinarily have such invasive tests done in the normal course of being treated by their physicians, the test was likely to be excluded from the clinical trial.

Galectin Therapeutics also looked to leverage the efforts made during the clinical diagnosis of NASH, to minimize invasiveness. Patients with NASH cirrhosis may have already had liver biopsies performed by their physician. Where the slides from the biopsy were adequate, Galectin chose to use this data rather than re-perform the biopsy. Two practicing hepatologists worked with Galectin to help ensure that this approach was sound for the purposes of the trial.

The plan was streamlined, paying special attention to the efficiency in the way the tests were carried out. The more tests you subject a patient to, the easier you will extend a short drug infusion to a whole day of testing.

Focus on the patient experience

In the same vein, Galectin Therapeutics considered ways to make the trial process easier and more enjoyable for the patient.

If a patient was traveling a significant distance to the clinical site, it made sense to reimburse their travel expenses. A better experience might involve offering to pay for a hotel stay for the night before, so a patient could have an early morning study visit and ensure they get back home at a reasonable time that day.

Patients frequently volunteer for clinical trials because they want to help advance medical science in treating their condition. It’s important to ensure that each patient feels like an active participant and is furthering the objectives of the trial. Galectin will work to keep patients informed of the progress of the trial and encourage site staff to interact with patients and keep them updated during visits about how the overall trial is progressing.

Patients are giving up a portion of their lives to help themselves and others with their condition. Above all, that commitment should be acknowledged and respected. Furthermore, it should be understood that many patients want to be active participants in the trial and understand the future impact of this research and the hope it might bring to patients with a similar condition.

While the main goal of any clinical trial is to produce solid scientific evidence on the safety and efficacy of a drug candidate, it is equally crucial that we prioritize the most important elements that will make life easier for the patient. This approach will pay dividends both in terms of better retention of patients and better compliance.