At Lilly COI we spend plenty of time exploring the future of clinical trials. We continue to explore clinical trial matching, Internet-based studies, mobile health in trials, and other possibilities. Though we are excited by these possibilities, we also know that it will take some time for possibilities to fully morph into practicalities. Technologies need to improve, regulatory questions need to be answered, and clinical trial models need to evolve. Meanwhile, patients are in great need of an improved clinical trial experience today. We can’t ask patients to wait on a convergence of ideal conditions, especially when there are feasible improvements that we can make now.
Improving Patient Access to Clinical Trial Information
We believe that one area ripe for immediate improvement is in how we inform patients about clinical trials. According to the Center for Information and Study on Clinical Research Participation (CISCRP), the Internet is the top way that people find out about clinical research. But we haven’t been treating it as such. Sponsor websites, clinicaltrials.gov, and private third-party websites provide patients with limited information. Our discussions with patients and caregivers have taught us that these sources do not answer the questions that truly matter to them. Such questions might include:
- How much time will I need to take off of work or school to participate?
- Will I need to fast before my visits?
- What can I expect to happen at these visits?
- Will this study interfere with my upcoming travels?
Patients don’t get the answers to these important questions until they contact a research site and begin the formal informed consent process. Patients should have access to needed information before the formal informed consent process takes place. In other words, informed needs to be separated from consent. Given patient interest in accessing clinical trial information online, sponsor websites are an excellent opportunity to do just that.
As a result, we’ve revisited what many would consider to be a study basic – the study website. And we found some areas where we and other sponsors could do better. We’ve incorporated these ideas for improvement into a pilot project, which is a study website for our Duchenne muscular dystrophy trial. The LVJJstudy.com website is designed for parents of boys with Duchenne’s to richly explore and simulate what participation in the LVJJ trial would be like. Using the website, parents can begin to answer the questions that matter most to them -- before initiating contact with a research site.
The LVJJ website incorporates a variety of improved features and details. And since the website is mobile responsive, all of these features and details render beautifully regardless of the visitor’s device. On the homepage, key study information is displayed graphically to facilitate efficient comprehension and assessment by caregivers. Using the interior pages, which include “Study Details,” “Get Connected,” and “Resources,” parents can delve deeper into the study information.
The “Study Details” section, for instance, provides both general and specific study visit information. General visit information includes average study visit duration, study length, and the total number of visits. The specific visit information provides details for individual study visits, including visit length, visit before and after instructions, and a visit assessment list. In addition, the “Get Connected” section allows caregivers to select a potential study start date and view a tentative schedule of visits for the entire study.
The LVJJ website is the product of contributions from a few important perspectives. The prototype was built in our lab, where we imagined what a study website with no restrictions might look like. Then we brought in an external vendor, who incidentally was a winner of the patient engagement app challenge that LCOI had previously sponsored. This vendor is relatively new to clinical trials, but they had a wealth of experience building user interfaces and brought a needed fresh set of eyes. Along the way, we also worked with an advocacy group and incorporated their feedback.
I’m proud of our team to move this concept from our labs to a final public product. Innovation realization is hard work, especially in our regulated industry. It takes courage, perseverance and an unfailing commitment to patients to see these ideas through to completion. But we are not done nor satisfied.
Building on the LVJJstudy.com Pilot
The launch of LVJJstudy.com is merely one milestone on our long-term commitment to improve the patient experience. We will continue to improve the patient experience for ongoing and upcoming trials, while working on a vision for future trials. Our intention is to use the LVJJ website as a model for future study websites, improving upon that model as we learn. In fact, we’ve already identified some areas we’d like to enhance. For example, we’d like to improve the website visitor’s ability to view site locations and other information.
We plan to build on this launch by:
- Streamlining our internal processes for sharing clinical trial information externally
- Gaining feedback from internal and external stakeholders, including IRBs, advocates, patient groups, research sites, and patients
- Defining a template that can be scaled to other Lilly trials
This second bullet is where we need your help! What do you think about the LVJJ website? How can we improve upon it for future trials?