Patient participation in clinical trials is the only way that new drugs and vaccines can be brought to market, but a lack of patient awareness and access to clinical trials have caused roadblocks to participation for many years.
The Center for Information and Study on Clinical Research Participation (CISCRP) found that only 25% of individuals reported being ‘very confident’ in their ability to find a clinical research study. In a separate report, CISCRP found that many participants (39%) never heard back from anyone after their study was over, despite 71% saying they would be ‘very willing’ to participate in another study.
Last month, Medidata, a Dassault Systèmes company, became the first in the world to offer a completely unified, fully end-to-end solution for decentralised clinical trials (DCTs) – the Medidata DCT Program.
Part of that offering is myMedidata Registries, an all-encompassing platform that allows for active patient participation and seeks to empower patients throughout their clinical trial journey and beyond.
The platform gives patients continuous support in and out of a trial, with access to one portal for all their research needs.
Clinical Trials Arena sat down with Medidata vice president of patient registries and recruitment Kelly McKee, to learn how myMedidata Registries benefits patients and sites and how the platform can boost participation in clinical trials.
Kezia Parkins: Can you introduce myMedidata Registries and describe the patient-user journey?
Kelly McKee: At Medidata, we’ve worked on over 23,000 clinical trials, with 6,000 of them being active right now. That’s over 45 billion patient records from 2 million providers.
myMedidata Registries expands patient engagement into the pre-trial and post-trial space, so that we can move patient interactions in a clinical trial from being transactional and focused only on the data into everlasting engagement throughout their lifetime. This is built on our myMedidata Patient Portal, our unified patient platform where individuals can learn about, be matched to and participate in clinical trials.
With this portal, we can continue that relationship with the patient post-trial with things like patient data return – something really important to patients but only recently being adopted within the industry.
These relationships are really where myMedidata is set apart from others. We put the patients at the centre and really focus on design and experience. I work with some of the most talented people I’ve ever encountered in my life, and we are seeing that through our products and engagement. It really excites me about the future of research.
KP: How will myMedidata Registries work with and support Medidata’s new DCT Program?
KMK: myMedidata Registries is part of myMedidata, our patient platform which enables DCTS. Patients can seamlessly transition from being pre-trial in the registry to undergoing eConsent, myMedidata Live video visits, completing electronic patient reported outcomes (ePROs) and using wearables to collect data. Then, once their participation in a particular study ends, they can go back into the registry in that post-trial engagement and go on to the next trial. It’s seamless and all part of our DCT offering.
KP: How does myMedidata Registries ease the burden on sites?
Our platform is used by more sites than anyone else’s. When sites are using a unified platform, they’re not having to go and remember all their usernames and how to work with every different platform or technology. It really reduces the burden of the day to day.
I spoke to one site worker recently who told me she had 60 different platforms and websites that she had to use to manage her trials, which was very hard on her.
We need to make things easier for sites so that they can identify, engage and take care of patients during a clinical trial, because that’s what they’re here for.
KP: How did the Patient Insights team help with the design of myMedidata Registries?
KMK: NIKE or adidas would not put out a sneaker if they hadn’t put it on people’s feet first and told them to go for a jog. Yet, so many times in our industry, we design solutions for patients without involving them in the process.
I think that that’s one of the super cool things about Medidata – we are a patient-centric company, we don’t just talk about being patient-centric company.
We have a group of 12 patient advocates on our Patient Insights team who are involved not only in the ideation of our solutions but the design, testing and certification of our products. They’re a phenomenal group who have lived and breathed clinical trials in ways that many of us haven’t. We are truly building solutions for patients, with patients.
I decided to participate in one of the Covid-19 clinical trials so now I feel like I’ve got that experience too. Being part of that and seeing it from both sides of the fence was super enlightening.
KP: Can you tell us a little more about your experience being a clinical trial participant?
KMK: I decided that I wanted to be part of the trial because I have been in the industry for 20 years, focusing on patient recruitment and engagement for most of that time.
I saw that people were so hopeful that these Covid-19 vaccines were going to work and I wanted to be part of the solution.
Even knowing what I know about clinical trials and having all the access that I have, it was still hard for me to participate. It was difficult to identify who I needed to talk to at the site once I figured out which site it was. It took time out of my busy days to go down to the hospital and participate. Additionally, some of the technologies used weren’t very patient-centric.
If it’s difficult for me to participate, imagine what it’s like for the average person who doesn’t have my knowledge or access.
Even now that individuals have been unblinded in the trials and vaccinated if they were in the placebo group, there are some states that aren’t giving trial participants the CDC vaccination cards used in the US, so they can’t even show proof that they were vaccinated.
We’re leaving those participants behind when they’re the ones partly responsible for the vaccine existing. It’s those little things that we need to do a better job of across the industry, and we’re only going to be able to do that when we put the patient first.
Kelly Mckee runs through the myMedidata Registries platform.
KP: Why is patient engagement so important before, during and after clinical trials?
Being prepared to participate in a clinical trial is a spectrum and not everybody is ready to participate right away. Participants need to be educated, empowered and engaged. They need time to understand clinical trials and if it’s the right option for them.
That’s when using a pre-trial registry really comes into play. During that pre-trial time, it’s an opportunity to identify, engage and educate individuals, to get them to the point of being able to determine if your particular clinical trial is the right one for them at the right time. It’s also a great way to be able to engage patients in the design of trials.
Through our platform, we’re able to provide sponsors with a way to message potential participants and also gather information and insights from them.
If you are designing a trial with some decentralised aspects, but you’re not exactly sure how you want to write the protocol, you could use myMedidata Registries to survey patients and see if they would be interested in conducting some of those visits at home, for example. You can gather those insights in real time from real patients and use them in the design of your trial.
Post-trial, people who participate in clinical trials generally have really good experiences and they’re willing to participate again, but they’re often not asked. Sometimes they don’t even get a thank you note.
Patient data return is an emerging innovation right now, but even being asked to participate in another trial just isn’t happening. So, in that post-trial engagement, not only are you able to continue to engage with patients through data return, long-term follow up and safety surveillance, you’re also able to provide individuals with opportunities to participate in follow-up studies, or any other studies that may be of interest to them.
KP: You’ve mentioned patient data return a few times – would you be able to talk about that and how it relates to myMedidata’s work?
KMK: In a clinical trial an individual is not only giving of their time, they’re also providing very valuable data that sponsors provide to regulatory agencies to show that their drugs or vaccines are safe and effective. That information never gets back to patients, so sometimes patients don’t even know which arm of a study they participated in. They might not receive any of the data that they provided through questionnaires and surveys, or even see the results of the study.
Through myMedidata registries, we can provide information back to patients to say “hey, your contribution really did make a difference you’re one of the reasons that we were able to provide this information to regulatory agencies and why this new Covid-19 vaccine is available to hundreds of millions of patients,” for example.
KP: How will myMedidata Registries help support patients with rare diseases?
KMK: When you look at any disease or condition, from the perspective of a patient, it’s personal and it’s part of them. That’s even more amplified in the rare disease space, where individuals may not personally know somebody who has that particular disease. Through myMedidata Registries, we’re really breaking down the physical barriers, so that individuals can participate in trials without having to travel hundreds or thousands of miles to be connected to an opportunity.
That’s one of the great benefits of DCTs. It’s allowing for greater participation in clinical trials, which for many rare disease patients is their only option. Through myMedidata Registries, they’re able to learn about these opportunities and then through our DCT offerings are able to participate in clinical trials.
KP: How has the pandemic boosted public knowledge of clinical trials and their participation in them?
KMK: I think that the pandemic really opened people’s eyes to how new drugs, vaccines and devices come to market in ways that they never really thought about.
Every time that you take a medicine or get a vaccine, that’s only possible because people participate in the clinical trials to make that happen. Somebody said, “I want to be part of the solution, I want to raise my hand to be in a clinical trial,” even while not knowing if the drug or vaccine is going to be safe and effective.
Through the pandemic, people started looking at these individuals as heroes, because that’s what they truly are.
At the same time, we still need to continue to bring greater awareness and make it easier for people to participate in clinical trials. We’re able to do that through technology and through DCTs, but only when we really design it for patients. By extending their engagement pre- and post-trial and creating these relationships we’re going to be able to improve awareness of clinical trials and make them a better experience, so that more people want to participate.