Since the COVID-19 outbreak, the world of clinical research has permanently changed. The need to lessen the burden on patients and introduce more agile and remote processes became more pressing. All the discussions even prior to having the first virtual trial conducted by Pfizer in 2011 became real actions. Now, a few months after the first lockdowns, every protocol either gets revised or is being planned with the mindset: How can I keep my operations going even when people cannot go to the site?
“COVID-19 is the ultimate accelerator of virtual trials.”
This is what everyone from my last 3 panel discussions with top clinical leaders from Novartis, Janssen, Takeda, and Boehringer Ingelheim about virtual/hybrid/decentralized trials agreed about. To my surprise, they all had solid previous experience and were prepared to put their know-how in the space in action when the time came.
But when did the right time come? With COVID-19?
It came with the first FDA recommendations to use digital health technologies and solutions to keep patients safe and ensure the integrity of the trials.
Was that so significant?
FDA has been accepting these “remote” support methods for quite some time. In general, if you look at the information on previous clinical trials you will see many of the virtual components (e-Consent, wearables, ePROs, mobile apps) there. Yet, at the same time, it was significant, because for the first time they said: Please go virtual!
Is this the ‘happily ever after’ ending?
No, it’s just the beginning.
Yes, FDA and all the other regulatory agencies are a lot more open towards supporting patients remotely in clinical trials, but this was not the only obstacle to conducting such trials and we are just starting to work and understand the landscape better. Here are some of the most common questions, clinical operations leaders are asking themselves and struggling with when planning their virtual trial setup:
Patients Convenience VS Real impact on Patient Recruitment & Retention
“It’s one thing to ask patients: “What do you need and expect in a trial?”, it’s another thing how much this contributes to lowering the patients’ burden when in a trial, resulting in better patient recruitment and retention.”
This was one of the most discussed topics during Patients and Pharma. Experts were sharing their experience that when they ask patients whether they want mobile applications and remote nurses, it’s almost always – YES. But in the business world, there is one very relevant definition for this kind of response. It’s called yes for “nice-to-have” not “must-have”. This means you can bring a lot of enhancements to the trial (causing more complex trial design and higher budget) but not contribute to patients really wanting to participate at the end of the day. So the question is:
How can I ensure that I am adding only the elements that are essential to my targeted patient population and will really make my trial more attractive and accessible?
There are three ways you can answer that:
- Give patients the “Mom test”. Anyone that is interested in this method, just ping me. This ensures you are not asking questions that are leading you to nice-to-have requirements but only things that are essential.
- Learn from previous studies. Find out why they were successful/unsuccessful with a given virtual trial setup or if this setup had any impact on patients/site/month. This was one of the reasons why we created the first global database of virtual clinical trials. Ping me if you want to learn more.
- Speak to a professional (investigator) who has already worked in the indication and has introduced virtual trial elements to his/her patients. He/she would know if the patients used it, liked it, and what it was like compared to without it. For finding such an investigator, you can use our global database of virtual clinical trials.
“I want to have ePRO and eConsent, but what if the local ethic committees or regulatory institutions would not accept it?”
This is absolutely possible, as “ethical” and “safe” can be understood and defined differently. There is no silver bullet to overcome this. Yet, one way to maximize your chances to go to the right country that will approve your virtual/hybrid trial protocol is by looking at which countries have already approved such in the indication.
Well, no matter what we speak, the budget is the king as clinical research is a huge investment for all companies. Being able to support patients remotely and on the site means you need to introduce even more solutions and vendors to your operations contributing to increased cost. I personally believe that only time can solve this. If we know better what works and what doesn’t (previous points discussed) and we get to the point where we are sure of getting on more patients on board quicker, then cost will be naturally reduced.
As you can see if we want to be more successful with virtual/ decentralized/ hybrid clinical trials, it all comes to having more experience (which usually comes from trying, failing, and then improving). My team and I believe that it will be so much quicker if we don’t only learn from our own mistakes, but can see what other people are doing and learn from their trial-and-errors too. This is why we’ve built the first global database of clinical trials which is a part of TrialHub 2.0. If we want to have next-generation trials, we need to have next-generation feasibility – and that’s what we are working on.
Are you planning to incorporate virtual modalities in your trial? Finding vendors can be a real challenge. Check out The Ultimate Guide to Virtual Trial Vendors.