Despite the recent shift to hybrid and decentralised clinical trials (DCT), low enrolment, poor retention, and outdated processes are still holding research back. But it’s not the technology that’s the problem – it is the way we are using it.
From ride-hailing to mobile banking, technology is light years ahead of what it was just a few years ago. Yet many solutions in the clinical sphere have not kept pace with the level of choice, control, and user experience people have come to expect. It all adds up to a clear disparity between the experience in clinical trials and the daily experience of the average consumer.
Recruitment, Retention, Inclusion
Translating discoveries into products has remained a stubborn challenge, with clinical trials facing several well-documented bottlenecks. Chief among them is recruitment, a process that can take up to 30% of development timelines, and commonly delays study start by between one and six months.1 That comes as no surprise when we consider that 11% of clinical research sites fail to enroll a single participant, and 37% under-enroll.1 Even when a study has enough participants to proceed, up to 40% go on to drop out before the completion date,2 draining study power and putting the entire project at risk. There is also a very real need to widen inclusion and increase representation in clinical research. Black/African Americans, who make up more than 13% of the US population, account for just 7% of clinical trial participants, for example.3 Compounding all these well-established challenges is that the advent of precision medicine has shrunk the pool of eligible participants, sometimes to those with a single genetic mutation.
DCTs and hybrid trials, which allow sponsors to cast a wider geographical net and reduce burden on participants, have emerged as a solution to many research challenges. Key to unlocking the benefits of DCTs is making it as easy as possible for people to sign up to, and stick with, a clinical trial. After all, improving recruitment is worthless if sponsors are unable to ensure trial cohorts are more representative at the outset, or if swathes of data are lost to subsequent dropouts. We can take our cue here from the consumer sector, which would never dream of asking users to jump through the hoops some clinical trial technology platforms put up.
Currently, for example, trial participants have to interact with a multitude of solutions or platforms, each with a different log-in system and interfaces. It is burdensome and far from convenient. Many payment and reimbursement systems charge fees, provide a limited choice of payment methods and block participants from raising their own payment requests. In a world where people are used to instant, easy-to-use mobile banking, such restrictions create barriers to trial registration and continuation. Even within the DCT model, people will usually need to visit a site at some point. Yet many sponsors ask their participants to pay the fare and claim the money back, without considering whether the cost could be prohibitive. In addition, they may place the onus for organising travel on their already busy research sites. It is also worth considering that DCTs have the potential to erode the participant/ site relationship. If effective communication is not enabled, patients may feel isolated, and sites can miss drop-out warning signals.