Business as usual isn't good enough

We can no longer shrug our shoulders and say “that’s just how it is”. Too many clinical trials fail to recruit to time or target, or to retain patients. The result? Pharma is haemorrhaging money and patients aren’t seeing the benefits they need. More frustratingly, the solution is staring us in the face.

The problem of eroom

Eroom’s law has quickly become the symbol of the troubled state of pharmaceutical research. Coined in 2012 by industry analyst Jack Scannell, it refers to the fact that the average cost of developing a new drug has doubled every nine years since 1950.

Adjusted for inflation, it now costs 80 times more to develop a new drug than it did in 1950.

The name is an irony-laden reversal of Moore’s law, which shows that transistors become cheaper over time due to lower costs per unit (unlike clinical trials).

This striking contrast with the success of the computer industry’s research and development (R&D) efforts is a source of anxiety for pharma execs everywhere. And with good reason – the average current return on investment from internal R&D in the pharmaceutical industry as a whole is hovering around the 5% mark. Clearly, this exponential decline in the productivity of R&D can’t continue.

Poor patient experience is a billion-dollar problem

Patient recruitment and retention in clinical trials, or lack thereof, are a heartsink for pharmaceutical companies. Take your pick, whichever metric or source you look to, the numbers aren’t pretty. Delays, barriers and discontinuations directly cause a loss of investment. But exactly how much money is leaking from the system?

Across the industry, these figures translate into dollars. These delays affect not just study costs but subsequent sales and ultimately less money to reinvest in finding new medicines. Estimates vary on the cost of a failed clinical trial, but one study calculated that, for every drug programme funded, the manufacturer loses more than $1.1BN in ‘time costs’.

The Food and Drug Administration (FDA) approved 309 new drugs between 2011 and 2018, 38 per year on average. This means that the industry lost roughly $40BN every year during this period, totalling approximately $280BN lost over the entire 7 years.

These money losses are truly exorbitant. And unacceptable.

In our current era of cost-prohibitive prescription, pharma companies face extreme scrutiny for their product pricing – the global scale of continued money wastage means that high product profit margins are increasingly unjustifiable. Not just because of the sheer waste and systematic failure, or because pharma companies report loss of profits, the knock-on effect on our increasingly underfunded and overstretched healthcare systems means that, eventually, it’s patient care that will fall through the cracks.

In 2018, in the UK alone, the NHS faced a budget gap of about £4BN, which could have funded about a year’s worth of cutting-edge cancer treatments for 4,000 patients. Saving money could therefore clearly benefit patients. Avoiding drug development losses of up to £40BN per year could extrapolate to the stretched healthcare systems with reduced pricing released by cost savings, relieving some of this budgetary pressure.

It’s no wonder that things used to be easier – there were fewer trials for sites to run and fewer choices for patients. Today, the number of trials has ballooned: Over 13,000% more trials were registered in 2018 than in the year 2000. The ‘good old days’ (please note the irony) of patients having less control over their own healthcare journey are over.

This huge growth in competition for clinical trials has coincided with the advent of the internet and the digital age, which has forever changed the rules of engagement.

Designing for the right customer

The challenge we face is fundamentally one of perspective. Clinical trial experiences and recruitment are still heavily designed around the wrong customers: the research site, healthcare professional or pharma company. Often the last perspective considered is that of the patient.

Mark Evans of Havas Lynx Faze draws parallels between research sites and Apple stores to describe how we need to change our relationship with research sites. “If you look at an Apple store, they’re a critical part of the Apple experience. They connect with customers and deliver the practical products and support. We also judge the whole brand based on how they treat us in their stores,” he says.

But, crucially, the store and the staff aren’t the end customer for Apple. They are a key stakeholder in delivering the end customer experience, says Evans. “Compare a research site to an Apple store. They are a crucial part of the patient experience and the only real connection a patient has with a study. “Of course, the site and staff need to be well trained and well supported to deliver an excellent experience and care for patients. But they emphatically aren’t the end customer.

“Just because we don’t get to interact with the patient on trials, we should never forget it’s really all about them. They are the only people with choices, without a contract, who can walk away at any point. We need to think of sites not as a customer per se, but as a vehicle for delivering the patient experience,” says Evans.

Take the way clinical trials traditionally communicate with patients as a prime example. Crucial communications such as recruitment adverts are so often couched in impersonal and functional language tailored to the needs of sites and not to the needs of patients. “Do you have asthma? Are you 18-35 years old? You might be eligible for our study.” This is the industry standard for attracting patients to a study. This is the equivalent of Nike saying “Are you male? Are you 18-45? Do you have feet? Our shoes may fit you” in their Times Square billboard ad.

The patient proof

To address the continued failure of clinical trials, things need to change, says Evans. The good news is that things can be different. And there’s proof. ‘Patient-centric’ trials aren’t simply touchy-feely nicer for patients – the evidence shows they work better than more traditional trials. A recent analysis by the Economist Intelligence Unit found that drugs developed using patient-centric designs, which focus on making participation as easy as possible for patients, showed a 10-20% increase in likelihood of launch compared to drugs developed without a patient-centric methodology. And in a world where only 10% of drugs make it to launch, every improvement is critical.

Patient-centric trials took 3 months less time to recruit 100 participants (4 months) than traditional ones (7 months). That 3-month difference takes on major significance when you consider that every month by which the drug development process can be shortened is worth $25M in revenue for the average sponsor. Remember too that the additional costs that are incurred during the clinical research process must be recovered through sales or increased prices – the efficiencies of patient-centric trials could clearly benefit both pharma and its customers.

A holistic picture of experience

An extensive review in The BMJ last year also found that involving people with “lived in experience of a health condition” improves clinical trial enrolment. So the evidence is clear: understanding and improving patient experience makes as much sense for pharma’s bottom line as it does for patients’ wellbeing and satisfaction.

That moves it firmly into the mission critical column of things to do. But optimising something that doesn’t work just makes it not work a little less – in a space where approximately 80% of trials fail to get patients on time, tinkering around the edges isn’t good enough. To truly transform the clinical trial experience, we need to think about every touchpoint of the clinical trial as a point to improve patient experience.

This year’s Havas Lynx Group's white paper campaign explores how bringing the patient experience front and centre in clinical trials could revolutionise trial design, retention and recruitment – ultimately improving outcomes.