All the Challenges in Clinical Research, Are First Such in Healthcare

I was busy lately speaking to people and working on projects to help companies adapt to the “new normal” and find out what this means. It turned out that this time helped me to go outside of my “normal” and see a few mistakes that I have been doing over the last few years. 

Number one mistake: Focusing on the challenge in the clinical research space and not seeing its roots in the healthcare field.

When I first started working in the research field, I was fascinated by the true science happening and the real value for humanity. And I still am, with one caveat. I am also super disappointed by the lack of operational efficiency caused by the complexity of regulations, stakeholders, and their interests. For a lot of years, I have been trying to figure out how can we fix the challenges we see and get better results and I was way not alone. Industry leaders like Craig Lipset, Kai Langel, Jacob LaPorte, Shwen Gwee, and many other innovation frontliners, as well as entrepreneurs, have been trying to solve the puzzle too. And I see huge progress but also know how much extra effort this required because of one simple fact:

All the challenges we see in clinical research, are first such in healthcare.

Let me give you a few examples:

1. Patient Recruitment: We all know the numbers: failing clinical trials, delays, lack of patients, etc. What we have tried to do though to solve it are mainly solutions for the challenges we see on the surface. For example, we have no patients to recruit: Let’s bring patients from social media and the internet

Well, whoever has been in the space knows very well that this approach provides results, yet, it is either too costly or not that effective. Why?

What happens in healthcare as a whole. Patients have no idea of the different alternatives for treatment and procedures they have. They rely on doctors (like to hear about clinical trials). Which is fine, but then if your doctor is not aware of a certain procedure or let’s say clinical trial, this means you don’t have it as an alternative. What we do now is to concentrate our hopes in the hands of the doctors with the big Hubs, yet, not every patient can see them, and let’s not forget these doctors have limited time too. 

The opposite examples are what companies like Elligo Health and Citrus Labs are doing. Elligo is the type of company that helps research-naive practitioners to become part of research which allows for more patients out there to learn about clinical trials as an option and opens up a new pool of potential participants. Citrus Labs on the other side is a company building mobile apps to support patients and their health and by providing extra service and care to patients they kind of become their HCP (or at least trusted source of information) as well and then they can smoothly introduce a clinical trial too and refer them to the closest site. 

2. Decentralized/ Virtual/ Remote clinical trials: It’s a huge burden for patients to comply with all the visits they have to do and especially when they have to travel miles away from their homes. Fair enough, let’s bring the trial online, and let’s support them remotely. Now COVID-19 made it clear it’s not just a wishful thinking but common sense and thankfully, there were already companies out there like Medable, VirTrial, Science 37, Curebase, etc. to help struggling sponsors to maintain their trials and patient support.

During COVID-19 again we saw the problem is not just with clinical trials. Many doctors lost their patients out of fear of going to the hospital. I remember my mum and dad, both with diabetes, asking me for the first time about a telemedicine app that can help them get remote help. But it wasn’t just them. A friend of mine building a telemedicine infrastructure called Healee told me how they saw 200%+ growth in their users and not just patients but now doctors who they had to sell the idea to, were on the platform trying to save their clients and business. 

3. The Patient Journey implemented into clinical trial protocols: A dear to my heart topic. Patient centricity has been a buzz word for a decade. Thankfully, I see more and more governmental, industry, and private efforts to implement the patient’s voice into how clinical trials are being conducted. There are standards and services for patient engagement, yet, the industry is always struggling to keep up with the number of insights they need and how to implement them into their industry KPIs and goals.

Surprise, surprise… Speak to any patient relations/engagement expert and you will see that this is true for clinical trials and also across all activities of each department and company. Insights are important for sales, marketing, reimbursement, market access, drug development, basically everything. The challenge is gathering and analyzing them and “translating” them into workable formats for the rest of the teams. 

A sub-clinical trial a.k.a healthcare problem: It was hard to define who the customer of clinical research/ pharma is. For ages, it was important to “sell” to the investigators/doctors. It still is, they are an essential part of everything. The internet and access to information, as well as different healthcare solutions, made it possible for the patient to be a more active participant in his health decision-making process. Patients also expect more. Knowing the patient journey and the more you own of it and improve it makes you a perfect choice no matter what kind of products and services you are providing.

Disclaimer: I have used a few companies and names as examples, but they are not the only ones. If you want to be listed among them, please let me know.

Disclaimer 2: I have generalized a lot of details around clinical trials and healthcare to demonstrate how challenges are similar and how we need to have a holistic approach towards solving them. I know there are different perspectives and I hope if anyone of you reading has a different than mine to share it and contribute to the discussion. Thanks!

Article originally published on LinkedIn:
https://www.linkedin.com/pulse/all-challenges-we-see-clinical-research-first-maya-zlatanova/?trackingId=4iBFnmxITV2ded%2BjN1ms0w%3D%3D