Sites and Investigators Are Still Number One, or Are They Really?

It’s been a long weekend and I had more time to think about the things in LIFE. I have been thinking lately about how balance in nature is the only thing which is certain. Everything around us (including political craziness around the Globe these days) can be explained with the world trying to find a better balance spot.

I am not so big on Politics but one thing I truly care about is Life Sciences. And so I focused my thoughts on one imbalance that I see increasing in the last few years:

Patient Centricity vs Site Engagement

Traditionally, the clinical research industry has been focusing on making sure that KOLs and in general the investigators are well covered in order for them to be a part of clinical trials. If we look at the history of clinical trials and the first achievements and technological enhancements, you will see that all done is in directions: (of course, first is SAFETY) and then better data management, data entry automation, reducing paperwork and helping sites run trials as a separate business. This is great because (especially in Europe) most sites are also active hospitals and so doctors are treating physicians as well as investigators – which means more work for them.

Sites and investigators are still number ONE, or are they really?

Sites and Investigators are super important for any clinical trial. Selecting the right ones, motivating, and engaging them is what many CROs and sponsors are trying to optimize all the time. Yet, somehow Patient Centricity took away the focus from that.

In the last few years, the Industry realized that there is a huge gap between what patients expect and what the industry gives. It’s been believed that if the investigator is engaged with the trial, she will make sure the eligible patients they work with will join the trial. But…

50% of sites recruit one or no patients during clinical trials (CenterWatch)

On top of that, it’s a public secret that investigators would overestimate the number of patients they believe they will recruit. Why is that? There are many reasons:

  • They really want to get this new business (a clinical trial is exactly that for most investigators);
  • They know how many patients they have but have no clue how many of them will actually agree on the terms of the protocol. Not just eligibility criteria, but also motivated to join as participants. Here we can argue a lot why this happens. My 50 cents here is that when you are the doctor of a patient, you care about his medical well-being. You don’t necessarily understand “irrational” decision-making because you don’t have time for small talk (in the UK doctors spend less than 10 mins per patient). Nurses and study coordinators have more experience with patients and how they feel about protocols, yet, they are rarely asked for any estimations. (We should definitely change that!)
  • They have no idea how many clinical trials will start at the same time asking for the same type of patients (Yes, this happens too – competition is an especially important factor with the more renown investigators)

Why do we tip the scales towards Patient Centricity?

Simple answer – Patient Recruitment and Retention. As mentioned above, sites don’t always perform the way we need them to. I am not saying they are to blame, I am just saying that these are the results. The industry tried with rescue sites, rescue countries, patient referrals – nothing really moved the needle and all came with increased budgets – something that pharma and biotech can not afford anymore as prices of clinical trials have been increasing mainly due to the demand of more patients per study:

“Most new drugs are only incremental advances,” says Dr. Joel Lexchin, a professor at York University’s School of Health Policy and Management, in Toronto, Ontario. “You need larger numbers of patients to demonstrate those very small new benefits.”

This together with the logistics around protocol amendments led the industry to trying to get closer to the patients and their expectations. In the last decade we’ve been trying to answer questions like:

  • How to engage with patients?
  • How to make more patient-friendly protocols?
  • How to relieve the burden on patients?

All leading to improvements in these directions. Patient advocates on the board of new study protocols, patient engagement-related – SOPs (at least big pharma), now the COVID-19 -accelerated virtual clinical trial wave. They are all presenting a better future for clinical trials allowing more patients to agree on the terms and be a part of studies.

Is that the right thing to do?

Of course, it is. I believe patient-centricity will bring us to the next stage of research success. It’s the right thing to do in terms of ethics too. But what’s wrong? – the BALANCE

Example: Now that we’re speaking about virtual clinical trials that allow for participating in a trial without having to change your schedule to fit all the procedures at the site, we are forgetting how this will impact sites. Have you thought about it?

Well, imagine you as an investigator or a coordinator working on 3 clinical trials at the same time and they all use their technology for supporting patients remotely. Would you have to deal with 3 different platforms? At the moment, yes. Would that help you or just bring complexity to your already busy schedule?

A few years ago, we had the same situation when digital patient recruitment started to become a trend and some of the first companies tried to build their own tools for tracking the patients’ referral process. It turned out sites are not happy to use yet another tool and so they refused to either get referrals or just didn’t use the platforms as expected.

There is one really great article by the Society of Clinical Research Sites that explains the overheads a site usually has when deciding to conduct a clinical trial, which is normally not paid additionally.

This is what caused a lot of sites to be worried during the COVID-19 first wave earlier this year. I am afraid that if we stop innovating on our relationship with sites while improving our connection with patients, this will lead to a lack of long-term results.

We need to embrace the fact we are working in a complex industry with many stakeholders and agree that only when we have a balance and alignment between their interests, only then we can achieve our goals and have the next generation of clinical research.

I am super proud that my team at TrialHub has been working to bring together the first global database of investigators with experience in virtual clinical trials. We believe they are super important stakeholders in the next decision about virtual and decentralized clinical trials and helping them understand how they need to adapt and why they become even more important is essential.

First posted on LinkedIn:

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