Industry tends not to consult patients in the protocol development process. Many will look at what regulators have previously accepted into a trial, or translate lessons learnt from animal models into human trials. However, even at this phase, industry is starting to make decisions that will affect who will take part in the study - without consulting them. Trials would never be designed without consulting a statistician, but many don't know how to involve patients and wonder why clinical trial recruitment is hard or why drop out is high. We will support that process by taking clinical trial protocols and boil them down to what a patient might worry about. There are clearly parts in clinical trials that are inconvienient, not fun; every clinical trial will have a deal breaker. It could be lumbar punctures, you have to drive to Phoenix, stay over in hospital, no money is provided to pay for a caregiver's hotel, you will be reimbursed 90 days later, we will cut a piece out of you, you need to come off all meds a month before. These might be medicines that must be delivered carefully to a strict schedule. You have 100% control in pre-clinical animal research work, but it's a different matter when you come to human trials and people don't always behave as intended. The number of procedures in clinical trials has gone up 6% year on year. We take aspects of the trial design – feed them into a system and turn them into a concise series of questions to get quantitative and qualitative fields. We will show these to patients to determine which are the deal breakers to participating in the trial and to whom – which subsets of people are ruled out. We look at statistically meaningful set of patients. We also use conjoint analysis and pick out parts that are salient. Using a mathmatical model and simulator we can determine, this is the percentage change in interest that this protocol would have. We can try to help pharma to make better decisions. In terms of ROI, we are looking at whether our feedback matches what the regulators come back and say on current projects. Protocol deviation can have, conservatively, half a million dollars in direct costs. Having that information earlier, or anything that can be done to increase recruitment, decrease attrition or provide missing data - can only be good.
To reduce burden on patients, increase clinical trial retention, reduce attrition, avoid protocol amends, increase the likelihood of regulatory approval and improve the reputation of companies that seek to incorporate patient input.
Problems addressed by Initiative
Taking part in a clinical trial is burdensome. There can be missing data, low retention and recruitment. To make the process less burdensome, more relevant and reflect what is important to patients.
Involving patients in the lifecycle of medicine development