COVID-19 has forced an industry-wide adoption of decentralized clinical trials and increased public awareness of clinical research, and the need for patient participation. This combination has created a unique opportunity to increase patient involvement in the design of clinical trials and then implement these patient-centric trials with the widely adopted methods we now have in place.
The lean startup methodology brings a scientific approach to starting a business, testing a hypothesis by measuring and analysing outcomes – build, measure, learn. Companies release a minimum viable product, the most basic version of their product, then continuously test and analyse their assumptions to improve their product tailored to what customers want. They test assumptions by randomly assigning customers to two different groups then measure the outcomes. They call this split testing – sound familiar?
Just as the entrepreneurial world has adopted methodologies from science, we can from the lean startup by viewing patients for clinical trials as customers for a new venture and test our assumptions in advance of finalizing a protocol and initiating a clinical trial.
Our minimum viable product is our draft protocol, draft welcome brochures and visit guides. By creating material in layperson’s terms we can effectively engage with patients who are not clinical trial literate. These patients tend to be more representative of those who enrol onto clinical trials.
We build, measure, learn through focus groups and interactions with patients and advocacy groups to receive qualitative and quantitative feedback. Analyse the information and evaluate how study designs can improve. This information is then implemented back into our draft protocol and further tested where necessary.
Implementing this feedback loop and engaging with patients can gain insightful information to improve patient recruitment, retention, and compliance before starting a clinical trial. Here are examples of valuable insights:
· Possible effect of reducing the number of follow up visits on dropout rates
· Possible effect of decreasing the time, intensity, and invasiveness of hospital visits on dropout rates
· Preference for in-hospital visits, home nursing, and/or telemedicine.