Why is talking to patients innovation?
Clinical trial recruitment is in crisis, with 80% of trials failing to recruit the required number of patients on time. There are few instances in life where we are happy achieving a score of two out of ten, so why are we allowing this to happen in an industry where the end result is a delay in getting life-changing treatments to patients (not to mention billions of dollars of additional costs)?
At the root of this problem is an industry that has been slow to adapt to drastic change over the past 20 years. If we compare the number of trials registered on clinicaltrials.gov there were 13,460%1 more trials registered in 2018 than there were in the year 2000. To put this into perspective, the number of registered trials has increased six times more than Amazon sales over the same period of time. Unfortunately, we haven’t changed our approach at the same pace.
In a time where Google, Apple, Airbnb, Uber etc. have transformed nearly every industry to be completely customer-experience centric we often still take an approach that avoids considering the end customer all together. Instead we focus on the feelings and needs of investigative sites and HCPs missing the fact that the patients are now the ones in control.
A new type of competition
The growth in the number of trials has been coupled with the exponential growth in the use of the internet and smartphones, which has put patients, caregivers, family members and friends in control of their healthcare. There is now an unprecedented amount of noise in the competition for a patient’s attention. With the average person thought to see as many as 3,000 advertising messages a day across all media, the competition for share of voice is no longer just between competing studies, but has expanded across alternative and holistic therapies, as well as powerful consumer brands such as Apple, Facebook, Amazon and Nike.
The competition has shifted, but the way that the industry is speaking to patients has not. It is important to remember that patients are people, and that a unique set of rules does not need to apply when talking to them.
“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 John Lewis saying “Are you 35-55 years old? Do you need some food and consumer goods? You can get some here”, during their annual Christmas campaign. Although the idea sounds amusing, it loses its charm when you think that it is this sort of activity that is keeping medicines from the people who need them and taking budget away from companies planning to re-invest in their pipeline.
This poses the question, what are we missing in patient recruitment?
Patients are being left out; left out of the thoughts of those designing a trial and left out of the discussions during a trial. We need to talk to patients, understand their motivations, their challenges and their requirements. These insights are invaluable, and lead to the creation of patient-centred trials. The current status quo is to create clinical trial protocols based on the insights of industry professionals who often do not have experience as a patient, or healthcare professionals who see each patient once or twice a year. Would you ask a CEO what their staff like to do on the weekends? Although they may be at the top of the game within their respective industries these qualified professionals are often too far removed from the patients to understand their everyday needs.
Patient experience design
At Havas Lynx Faze we believe that a clinical trial protocol should never be written without going through a very simple process – mapping out the entire patient journey from start to finish. This includes highlighting all the hoops a patient will need to jump through in order to successfully make their mark on the future of medicine. This mapping considers all of the visits they will attend, the procedures they will endure, and the data capture forms they will need to complete. But it does not stop there. We must also look at the journeys that they will make, the expenses that they will incur, the things that they will need to remember and the impact on the people around them.
Mapping out the challenges and working out practical solutions which allow a patient to participate in a clinical trial without having to drastically change their daily life is fundamental in the creation of an attractive trial. This can be, and should be, achieved before a protocol has been approved. Working with patients directly, taking their input and feedback, and then feeding it into the design in order to work around the intricate (but often avoidable) challenges. Interrogating the patient journey in this way does not always change a study design; often it simply introduces supportive solutions to prevent the challenges from causing problems and delays. Examples of this include arranging transport for patients through UberHealth or using prepaid study credit cards to cover study expenses so that patients are never out of pocket due to their involvement.
The key is understanding basic human needs. It is easy to overthink the requirements in a world where sophisticated technology appears to be the answer to all our problems, but in reality, it is the simple things that make a study more convenient, less costly and ultimately less of a burden on a patient’s life. Ultimately improving all of these things will increase the overall probability of success.
Work with patients, don’t make them work for you
There is no excuse for a protocol to ever be approved before a patient has been involved. The solution to everything being late is not to rush but to get it right the first time. How often do we hear that taking the time to get something right in the first instance is more efficient and cheaper than rushing and having to fix it in the long term once it has gone wrong? Clinical trials are no different.
When you consider the enormous costs involved in launching a clinical trial, the idea of not talking to those that are going to be involved is ludicrous. This becomes even more absurd when you think about the different countries and markets in which the trials are conducted, and the huge variation in practices, lifestyle and culture between them. It is fundamental to understand that the way you speak to someone in the US healthcare system can be entirely different to how you would speak to someone who is receiving treatment through the NHS in the UK, not to mention the disparity with the Asian markets or in Russia (where culture, media channels and media consumption vary greatly).
Often when people talk about involving patients and patient-centric initiatives, what they really mean is they conducted an exercise where patients are sat down and asked what they would like. This usually consists of asking arbitrary questions like “Do you like apps?”, “Do you want a website?” or “Do you read posters?” While these questions are not bad, per se, we are relying on the patients to validate the expected challenges and solutions that were predetermined without their input. As Henry Ford once said, “If I’d have asked people what they wanted then they would have asked for a faster horse”. We know that patients are experts in their own experience, in their challenges and in their motivations, so we need to talk to them in order to understand every parameter and then use them to create tools and solutions tailored to these specific needs.
How can you be patient-centric without talking to a patient and making them central to your approach? Patients should be involved from the outset, not because it sounds good to say you have spoken to them, but because it is madness not to. Compare this to any consumer market – no consumer brands make their products without thinking of their customers, they design them for their customers and then improve them based on their feedback. Involving customers isn’t seen as a noble thing to do, it just makes business sense. We see no reason why clinical trials should be any different.
Patient focused trials
The magic comes when you unpick the real challenges a patient has, as the solutions to seemingly complex problems are often so logical and simpler than you would imagine. Whether it is help explaining some overly complicated inclusion criteria, making it easy for a patient to get in touch, ensuring someone phones them back, or simply even reminding them of their appointments, often the hard work is done in understanding the real problem (meaning that the associated solutions can be so much simpler).
This is not to say that there aren’t huge innovations coming. There is an array of novel and innovative options aiming to improve the performance and efficiencies of trials as a whole. Looking to the future there is scope for improved trial success through alternative trial designs such as siteless and adaptive trials. These designs will revolutionise the patient experience, eliminating the logistical challenges that we are seeing today, and achieving this simply by flipping the traditional model on its head and moving into a new age where the patient is the focus.
But before we jump ahead to these transformative and technical solutions, we must walk before we can run. We must get it right for patients today by making our approach to trial recruitment a little more human in order to benefit the patients of tomorrow.