To keep clinical trials afloat throughout the pandemic, there has been a universal move towards hybridized trials and electronic, remote assessments. With this transition, research sites and sponsors have been able to prioritize safety and simultaneously reduce patient burden.
As we enter the fifth month of the COVID crisis, there has been significant discussion on whether the implemented technological solutions are here to stay and what we should expect to see in upcoming clinical trials?
According to Dr. Mark Opler of WCG Clinical, Dr. Corey Fowler of Otsuka Pharmaceuticals and Dr. Dominique Pichard of the International Rett Syndrome Foundation, we will see the following:
1. Updated Electronic Assessments
While many sponsors have already transitioned from paper based assessments to electronic assessments prior to the pandemic, electronic data capture tools will need to be amended if clinical trials adopt a more hybridized model. With data being collected through devices in the office and at the patient’s home, sponsors will need to make amendments that will allow analysts to distinguish between the two sets of data.
2. Increasingly Advanced Electronic Patient Reported Outcomes (ePROs)
As more and more data is collected electronically, Dr. Mark Opler of WCG explains that the ePRO systems now deployed in clinical trials are looking more like mobile health applications and less like case report forms. In other words, patients are given access to systems that are less technical and much more engaging and fluid. He also advises that if ePROs resemble mobile health applications, patients will be able to access their data throughout the study and be able to track their own progress. Besides increasing transparency with patients, patients will likely be more able to articulate how they are currently doing at different study milestones.
Dr. Opler also predicts that there will be a shift from use of retrospective evaluations (e.g., consider your experience over the last week or month, how would you rate your itch at its worst during the past 24 hours) to questionnaires that ask how the patient is doing now. To that end, sponsors are likely to replace retrospective evaluations with ‘micro-assessments’. Instead of answering one lengthy questionnaire, participants will be asked to answer a question 4-5 times over the course of a day, each time only requiring a couple of seconds. By integrating micro-assessments into trial designs, Dr. Opler explains that studies may be able to produce much more ecologically valid and reliable data.
3. Popularization of “Bring Your Own Device”
Prior to the pandemic, “bring your own device” was only done where feasible. It was considered to be a “nice to have” or “potentially unnecessary” component of trial design. As we continue to navigate through COVID, the ability to have participants bring their own devices could limit exposure to the virus. Additionally, BYOD can mitigate concerns about patients being unable to enter data into sponsor-supplied eDiaries as they are already familiar with their own devices. Not having to carry two smart devices also improves the likelihood that patients will complete assessments as required. Future clinical trials should allow participants to BYOD, but continue to supply research sites with a limited number of sponsor-supplied diaries to ensure that all patients can participate.
Through the hybridization of trial designs and the use of electronic assessments, we have been able to continue clinical research operations throughout the COVID crisis. In closing remarks, Dr. Dominique Pichard reminds us that this movement can benefit the industry by reducing barriers to trial participation (e.g., travel time, travel expenses, unfamiliarity with trial site) and reaching populations that may otherwise not consider trials as a care option.
- Corey Fowler, PhD, Director of Global Clinical Development at Otsuka Pharmaceuticals
- Mark Opler, PhD, MPH, Chief Research Officer at WCG MedAvante-ProPhase
- Dominique Pichard, MD, Chief Science Officer at International Rett Syndrome Foundation
- Lindsay McNair, MD, MPH, MSB, Chief Medical Officer at WCG