COVID-19 has had a fundamental effect on every aspect of society, including clinical trials. The search for an effective vaccine or treatment for COVID-19 continues to move at record pace. However, many clinical trials in other therapeutic areas have either been delayed or essentially ground to a halt due to the pandemic.
Such delays place huge limitations on sponsors; yet, also present opportunities that may otherwise not have been possible. If your clinical trial is delayed in getting started, consider maximizing this gift of time in the following ways:
- Get to know your patients
There are many ways to gain insights into your patient population. These can be tailored based on the rarity of the condition, your information needs, and your budget. In addition to general insights about your patient population, targeted research could identify patient and caregiver concerns about participating in a clinical trial following the shadow of COVID-19.
A few approaches to consider include:
- Quantitative online surveys can be a cost-effective way to quickly collect representative data
- Social listening may be appropriate if you are looking to identify trends and topics through analysis of online discussions
- In-depth interviews can be used as a standalone approach, or to delve deeper on initial findings
- Virtual advisory boards create a different dynamic from one-to-one interviews, with the opportunity to immediately verify or build on comments from participants
- Find out what your sites need
Engaging with local affiliates or country study managers is a good way to capture feedback based on previous studies. However, the best information typically comes directly from the source – in this case, site staff. As with patients, this can be achieved through online surveys and similarly, you will obtain richer findings by engaging site staff in a conversation via in-depth interviews and/or virtual advisory boards.
Speaking with your sites has the added benefit of building stronger relationships. These Investigators and Study Coordinators could then be invited to support ongoing initiatives via a national or regional coordinator program as a study ambassador and advisor.
- Ask your audience
Use this time to pressure-test your protocol design, creative concept and patient materials with your target audience. This step is routinely used in mainstream marketing and advertising; but, is often overlooked in clinical trials. Unfortunately, this upfront cost-saving can increase the risk of slow recruitment or high patient discontinuation, requiring additional budget to get a study back on track.
Consider taking this approach one step further by engaging patients and caregivers in co-creation labs to contribute to the development of materials that are directed to them.
- Stretch your horizons
Consider bigger projects that could provide more in-depth insights, such as digital ethnography, to uncover the belief systems of patients and caregivers. This level of patient understanding can have far-reaching benefits. In addition to supporting the current clinical trial program, it can also help with post-launch patient communication and even the design of future clinical research.
Although COVID-19 has placed unprecedented limitations on us, it has also given us the unusual luxury of time to reflect and learn. It is up to us to make the most of this opportunity.
If you would like to discuss your trial’s situation and how AXON Clinical Trial Services could support you in making the most of this time, please contact a member of our team: Daniella McCrorie (firstname.lastname@example.org) or Duncan Shaw (email@example.com).
By Daniella McCrorie and Duncan Shaw