New Study on Time Toxicity Reinforces Value of Home-Based Clinical Trials

As part of the growing focus on patient-centric care, clinical trials need to provide the flexibility and convenience that allows trial participation to work around patient schedules to optimize quality of life. 

By Greg Austin

The May 20 issue of The Journal of Clinical Oncology featured a timely, insightful study (https://ascopubs.org/doi/full/10.1200/JCO.21.02810) entitled “The Time Toxicity of Cancer Treatment.” At the heart of the article was an underlying message that, when diagnosed with an incurable or life-threatening disease, time suddenly becomes more precious.

Faced with the understanding that their lives may be compromised or shortened due to illness, patients must make critical decisions on how they want to spend their remaining time. Do they want to participate in clinical trials that could offer them hope knowing they will need to spend hours regularly traveling to clinical sites? Or, would they prefer to remain in the comfort of their own homes while getting the same potentially life-saving regimens?

Decentralized trials or mobile research have grown in recent years not only because of the complexities and constraints presented by the COVID pandemic, but also because our industry has become more sensitive to the needs of the very patients we are trying to recruit and retain. Patient-centric care has become the norm and that means providing creative and innovative ways to work clinical trial protocols around patient schedules.

How is the time toxicity concept relevant to the clinical trials industry?

As the authors of the recent time toxicity study point out, the medical community historically has not done a good job of acknowledging, quantifying or even discussing the impact of time toxicity. While it has always existed, it is only now that it is being verbalized and formalized.

The authors define time toxicity as the total time spent in coordinating care and in frequent visits to a healthcare facility (including travel and wait times). The amount of time spent in pursuing cancer-related therapy, for example, can be substantial. In some cases, the loss of time incurred receiving treatments and/or participating in clinical trials may offset any possible modest survival gains offered by the treatment.

Depending on the protocols of a trial, there could be significant travel time involved, for example.  That’s because identifying patients that meet a specific profile may require recruiting in remote areas far away from a clinical site. Some trials also require a greater frequency of visits. All this time adds up. And time, especially when it’s short, is not free. It actually comes at a very steep price.

Patients who are tied to a specific schedule that requires them to travel are not able to use that time for the things they enjoy and would rather do. The total required time investment is greater than what is initially perceived, as it includes the time spent on blood draws, infusion visits, picking up meds, clinic visits and waiting room time, among other things.

At PCM Trials, we recognize that time is precious. And we are committed to ensuring that the patients we serve are able to get the most out of their time, doing the things they want to do with the people they want to do them with in the surroundings where they feel the most comfortable. That’s why our Certified Mobile Research Nurses, who we directly recruit, train, certify and manage, make every effort

to accommodate patients’ schedules.  We’ve met people at their vacation hotel rooms, at campsites, at their places of employment and, of course, in their living rooms to handle a specified infusion or blood draw.

The drugs that are made possible from clinical trials help improve and extend patient lives. Our job as a leading mobile research provider is to also make sure that those lives are lived to their fullest.

I applaud the efforts of these study authors who have brought the concept of time toxicity to the forefront. Time toxicity data should be regularly presented to help guide patients in making decisions on clinical trial participation.

Ultimately, as patients become more informed about their various options, they will expect that trial sponsors do a better job of accommodating their needs. And that’s why decentralized trials exist. In the end, it’s all about the patient.

Greg Austin is the president of PCM Trials, which is leading the global shift toward decentralized clinical trials by bringing clinical research to patients, wherever and whenever it is most convenient for them. By reducing the barriers to participation, PCM Trials’ mobile nurses support study recruitment, retention, adherence, and diversity. Learn more at www.pcmtrials.com