While DCTs were all everyone was talking about post-COVID, there seems to have been a shift back to the value of the human touch; why do you think this is?
The 'human touch,' bringing in-person care to the patients in their community (their home, work or school), is critical for comprehensive operational success in addressing all patient populations and all therapeutic areas for clinical trials. Keeping the 'human' element in decentralized clinical trials is how MRN has delivered trials for over 17 years, replicating treatments and medical assessments in the home that would, traditionally, only be available at the research site.
During the COVID-19 pandemic, we had a type of forced adoption of DCT models and technology to keep patients enrolled and engaged in trials. A lot of what was forced onto sites and patients was the remote option of participation, removing many human elements.
Immediately post-pandemic, sponsors and CROs took the opportunity to carefully investigate the operationalization of DCTs and how to effectively introduce DCT elements into their processes and staff roles/titles and responsibilities. This re-engineering process manifested itself through the issuance of Requests for Information (RFIs), mock studies in which technology providers would share solutions/proposals, and then more formal Request for Proposals to established selected vendors for DCT implementation.
This retrenchment is hopefully temporary as the industry takes on more responsibility, pivoting new studies in order to maximize the use of digital technologies and in-home capabilities. I hope!
Why do you think people were so excited about DCTs when they started to take off? (Any similarities to the overwhelming and initial hype around remote working?)
I think people are still very excited about DCTs because we have started to reveal the incredible possibilities and the positive impact that DCTs have had on improving patient recruitment and most importantly patient experience and retention. Providing DCTs to patients, giving them the option to be enrolled and receive medical care for their disease while reducing the burden on their participation, is an important step forward for all.
One major challenge many clinical studies have faced is the delay in achieving the patient enrollment targets defined in the study protocol, and the adoption of DCT initiatives is front and center to advancing enthusiasm in participating in a study while also bringing a major burden reduction to patient participation. The patient no longer needs to travel to the research site for all of their medical assessments and treatments as allowed under the protocol.
The similarity between DCTs and remote working is that now it’s the expectation and more people will demand it. Like remote working, there has been a fundamental shift in the way things are done, and it’s not going anywhere. Remote working offers individuals flexibility and optionality, just like DCTs.
Has there been any solid evidence from patients to say they prefer participating from home/remotely?
We certainly have testimonials from patients and their MRN health care professionals as well as data from patient focus groups we’ve conducted. I wouldn’t say all patients prefer participating remotely, but I will say that patients like having the option to participate when and where they want.
We’ve had patients who are thrilled to be at home, we have patients that like a hybrid approach to their trial, and then we have patients that would rather go to the site. It’s all about building in the option for patients to either participate remotely or at the site, whichever is most convenient for them.
MRN has been around for 17 years this November, and we are approaching 100,000 home visits. We wouldn’t be in business this long if patients didn’t want to have the ability to participate from home.
Will the boom of new job titles that evolved from the new way of working stick around into the future, or do you think those with digital, tech and innovation in their titles will be held more accountable and will need to explain exactly how they have become more qualified in this way of working?
The new job titles, while creating a new level of enthusiasm for what might happen to the design of clinical studies in the future, faces the reality that these individuals did not become technology experts overnight; they did not go out and get their PhD in digital technology or digital software platforms overnight.
The industry and each of us must appreciate that these titles convey responsibilities and not necessarily technical expertise. Therefore, the mandate to those of us who are in the digital technology industries is to be valued consultants and advisors on what is possible to create that new vision of maximizing the use of digital technology, software platforms, digital devices, wearables, and other digital capabilities in the design of studies and what is included and requested in protocols.
The unknown question for each is “What is your job description and what are your job performance success metrics?” to truly understand how we can help them, and our industry be successful.
I would imagine and appreciate the job titles will evolve as the industry evolves.
Do you think companies will cater to both patients who want to be seen and heard in real life and those who are happy to use tech remotely, or do you think a digital/tech approach will eventually be found to accommodate everyone?
Our industry has already, at some level, pivoted, as appropriate, to providing patients with options for how they want to participate in a trial by either going to the research site and/or engaging remotely, as allowed in the study protocol. And you will see the conditional words “as appropriate” and “as allowed” as critical elements.
We know ePRO is a well-accepted tool for assessing the patient journey from their home. The industry has also adopted, to a much lesser degree, the use of telemedicine for patient engagements and has worked with digital/tech solutions for patient payments and reimbursements where needed.
But the broad goal of “accommodate everyone” is a far reach in terms of universal adoption for every level of engagement. There are certainly some studies for specific therapeutic areas, for example some oncology studies, that may mandate the patient come to the research site for their medical assessments and treatments.
Companies like MRN can provide a very valuable DCT-based service, allowing patients to be in their home for medical assessments and treatments, empowered by digital technology for the collection of patient data. This is a valuable bridge between the human element of DCTs and the application of remote technology adoption.
From the conferences I have attended, there seems to have been a solid mix of for and against DCTs – could you explain what the research is starting to show and also what the financial implications/benefits are?
There certainly are different camps of enthusiasm and reticence on the adoption of DCTs for the operationalization of clinical trials. One challenge is successfully integrating the operational expertise of brilliant biologists and chemists who are developing life changing pharmaceutical cures and those who are digital technologists who believe anything can be done using digital technology evidenced by what they do every day on their mobile devices. The post-COVID changes to operational titles with the words 'DCT' and 'Digital Technology' and 'Innovation' and assumed new responsibilities and ownership on how to leverage the benefits of these DCT elements brings great hope for the future.
In the recent paper “Assessing the Financial Value of Decentralized Clinical Trials,” published in March 2023, the following result was shared: “We found substantial value from employing DCT methods in phase II and phase III trials. If we assume that DCT methods are applied to both phase II and phase III trials the increase in value is $20 million per drug that enters phase II, with a seven-fold ROI.”
Additional research concluded that a DCT approach can provide reduction of final protocol to first patient in timelines, reduction of first patient in and last patient in timelines, and reduction of screen failures compared to traditional trial models.2
These are significant benefits in terms of the use of DCTs in accelerating the time to commercialization of a new drug or medical device and the incredible financial impact for the industry.
Could you state your case for telemedicine in trial design and whether you think it is currently a missed opportunity?
Telemedicine in the more general sense is 'the remote diagnosis and treatment of patients by means of telecommunications technology.' The World Health Organization (WHO) refers to telemedicine as 'healing from a distance; it is the use of telecommunications technology and information technologies to provide remote clinical services to patients.'
Thinking of telemedicine in the more current understanding, which has come to mean video conferencing using digital technology, I believe there is a missed opportunity for its use in clinical studies. I think one of the greatest reference points for the enhanced adoption of telemedicine in clinical trial design is what we have seen in the healthcare industry as a whole and our individual engagements with our primary care providers; the immediacy in benefit with engagement, medical assessment, and actionable plans.
With respect to the video conferencing element, there are multiple use cases for adoption that can accelerate the successes of clinical trials, including patient recruitment and screening, face-to-face engagements with patients to support their journey, integration of video conferencing and monitoring compliance with dosing, among others.
An important element to the success of a tool like telemedicine is patient support and training. I will share one experience on the use of telemedicine that also speaks to the challenges of the industry. Earlier this year, I met with a major biopharmaceutical company. They were frustrated with their eClinical provider and their telemedicine platform because as shared: “We had to call the patient and tell them to turn on their mobile phones for the telemedicine call!” This assignment of blame to the eClinical technology vendor was misplaced. As I shared with the attendees 'if your spouse calls you on your mobile phone and you didn’t turn on your phone, is that your fault or the spouse’s?' There was laughter at my question, but the message about training the patients was clear.