Decentralized Clinical Trials: the next step towards digitalization of clinical research
Decentralized clinical trials are the latest trend in the rapidly increasing digitization of clinical research. Rapidly improving technologies that enable video calls and remote monitoring, along with new telemedicine methods that allow parts of treatments to be done remotely, in turn, have led to decentralized clinical trials (DCT) increasingly being seen as an opportunity by sponsors and sites alike to speed-up and reduce the costs of clinical trials.
As we highlighted in a blog last year, for patients and patient advocates as well DCT’s are seen as a possibility to ultimately make it easier for a larger, more diverse group of patients to participate in clinical trials. By requiring fewer clinic visits and reducing the burden of participation, drop out rates can be improved and thereby accelerate the drug development process.
Yet, decentralized, hybrid or virtual trials also come with a variety of challenges for sponsors and sites, and require a good understanding of what it means for every part of the clinical trial process. In this blog, we answer the following questions:
- What are decentralized clinical trials?
- Why decentralized clinical trials are here to stay
- What are the challenges of Decentralized Clinical Trials?
- How do Decentralized Clinical Trials support patient diversity?
- What patient recruitment strategy is best suited for Decentralized Clinical Trials?
1. What are Decentralized Clinical Trials?
Decentralised Clinical Trials (DCT) are also known as “direct-to-participant trials” or “virtual” studies, and are characterized by less dependence on traditional research facilities and visits, and rather the usage of digital technologies to make possible at home consultation. While DCT’s have been gradually on the rise over the last half decade, it was only during the COVID 19 pandemic that this model really took hold.
DCT’s can either be done in fully decentralized, meaning completely without any study visits apart from the screening visit, to hybrid models that combine elements of both traditional and decentralized approaches. Maybe the biggest advantage of Decentralized Clinical Trials that are done in a hybrid model is that they are flexible. Indeed, different approaches can be tailored within a trial by including mixed patient enrolment, where some patients can still go to a traditional clinical trial site, while others can be enrolled and managed in a remote manner based on their needs.
As we explored in an blog about Decentralized Clinical Trials and Patient Centricity last year, a big reason for the rise of DCT’s was that patients increasingly requested different models of study participation. As sponsors of clinical trials looked at ways to reduce the burden of participation in clinical trials and provide a better experience to participants, they looked at models as Decentralized Studies. This is reflected by a statement of the Association of Clinical Research Organizations that describe the change that DCT’s offers as follows:
“Decentralized Clinical Trials bring trials to patients by using local healthcare providers to optimise digital health technologies and engage the patient voice to accelerate the development of medical products, the delivery of therapies to patients and the efficiency of research processes.“
Surveys in 2022 show that decentralised clinical trials are seen as beneficial by all stakeholders from sponsors to research centres and patients. The most commonly cited benefits for sponsors are that they can achieve greater trial efficiency through innovative technologies, while research centres can greatly simplify their administration and patients have significantly less hassle due to the elimination of travel.
One of the biggest advantages of decentralised studies, besides patient satisfaction, is the improved recruitment options and retention rate. While in clinical trials with face-to-face appointments about 30 percent of recruited participants drop out during the trial for various reasons, the retention rate in decentralised trials is over 95 percent, according to the Medical Research Network.
2. Why digitalization in clinical trials is here to stay
Since the COVID-19 pandemic, digitalization has increased in all aspects of society, including in the health sector and clinical research. What has long stood in the way of a real acceleration of digitalization in clinical research, especially in countries like Germany, has been familiarity and trust in the technology on the part of health professionals, physicians, study doctors and site staff. While studies by the consulting firm McKinsey, for example, showed that even before the COVID 19 pandemic, public and patient trust in digital health technologies was steadily increasing, many providers and pharmaceutical companies and research sites were still lagging behind.
The COVID-19 however, simply forced doctors and research centers to start incorporating technology, just in order to keep functioning. And as a 2021 McKinsey survey with research institutions showed, healthcare professionals and researchers are increasingly convinced and trusting towards technologies in health research.
Moreover, regulatory institutions as the FDA and European Medicine Agency in the past years also explicitly recognized the benefits of technologies in clinical research. This makes experts predict that in the next few years a large proportion of normal doctor visits and consultations will continue to be replaced by remote treatments and that this trend hence will not be reversed or even slowed down.
The digitization of healthcare and clinical research gaining momentum is perhaps best illustrated in Germany, where health authorities and research institutions still rely on fax machines. A recent assessment by the Ministry of Health states:
“Digital technologies can help us to better solve the challenges facing almost all healthcare systems in the Western world – treating more and more elderly and chronically ill people, financing expensive medical innovations, providing medical care to structurally weak rural regions”.
3. What are the challenges of Decentralized Clinical Trials?
The move towards a more decentralised, virtual approach to medical care however is dependent on the development of technologies that support this trend and familiarity of the staff in making optimal use of these options.
Here is a list of the most cited technologies underlying Decentralized Clinical Trials and the challenges.
While patient and physician familiarly with this method has increased rapidly in recent years due to home office and COVID-19 barriers, it is likely that many participants still need an introduction or guided practice on how to properly use video consultations. Especially when health or physical checks are involved.
2. Internet connection
To make DCT’s truly patient-centric, sponsors should make sure they support potential participants by either providing them with a smartphone or tablet if needed, or offer patients options outside of apps or wearable devices. In addition, elderly patients in particular may need assistance from research facility staff in person or through a help desk
3. Wearable medical devices and smartphone-based apps
Both site staff and patients would need training in how to use medical apps or wearables. Some researchers have questioned the quality of health data collected by wearable or remote medical devices, as patients might not follow the instructions exactly as they should. More so, site staff often have busy schedules and limited time to learn new software programs.
4. Coordinating home trial procedures
In theory, it may sound simple: Clinical trial investigators who need samples to test insulin, blood or cortisol levels simply send the devices to patients, who then perform the tests at home and send the data back or use telemedicine options to transmit the data. First and foremost, it requires additional support for patients taking the samples or instruction lessons in person at for example the first screening visit. Secondly, it requires a trained study doctor that knows how to guide the patient to do the test correctly.
5. Digital screening methods
Decentralized clinical trials often still require patients to be screened on-site or, even more costly, through in-person home visits. And that’s not likely to go away completely anytime soon.
This means sponsors must rely on a recruitment campaign that sends only high-quality referrals to the site to save costs and reduce site workload.
At Clariness, in recent years we have invested heavily in our patient-centric pre-screening method, which allows patients to determine if they are eligible for the study by completing a short questionnaire. One example is our method for atopic dermatitis that allows patients to assess the severity of the condition themselves and thereby find out if they can qualify for specific studies or not. In combination with a phone screener, this makes that only high quality referrals are send to the site, reducing workload and frustration for the site staff and disappointment for the patients.
Read more about our recruitment strategy and screening methods for Atopic Dermatitis in our free whitepaper.
4. How do Decentralized Clinical Trials support patient diversity?
In a sense, decentralised clinical trials represent the democratisation of clinical trials at all stages of the process. By reducing the need for patients to travel, the radius within of recruitment can be greatly expanded, making clinical trials accessible to a much wider population, especially minorities, people living in rural areas or from lower socio-economic backgrounds.
Overall, DCTs allow for more patients to consider participating in clinical trials by minimizing disruption to their daily lives. As we concluded elsewhere, DCT’s done right take the trial to the patient, instead of the patient to the site.
Decentralised clinical trials furthermore can be improved over time by direct patient feedback through for example end-of-study surveys and follow-up materials. As patients are already used to example their E-Diary and other questionnaires online, this can easily be used to incorporate direct feedback and adjust future protocols.
Read more about how we employ digital outreach methods to reach minority populations, people from lower social-economic backgrounds or people living in the countryside in our diversity in clinical trials whitepaper.
5. What patient recruitment strategy is best suited for Decentralized Clinical Trials?
A digital recruitment method can be seen as an essential component of any patient-centric Decentralized Clinical Trial. As it removes physical barriers to recruitment and reaches a wider audience of potential participants then traditional methods of recruitment.
A goal of a decentralized strategy is also to remove physical barriers by reducing dependency on site visits and thereby reducing patient and site burden. However, with less physical sites, patients still require regular engagement. Clariness’ Patient Enrolment Managers work closely with sites and support them with patient engagement and retention material but also by regularly communicating with patients, providing materials for patients to read and stay informed, and being available to patients as needed. Sites are also provided with training aids and given assistance with scheduling visits or calls, or sending reminders to patients (e.g., taking medications).
Clariness has over 17+ years of experience with digital approaches to patient recruitment combined with patient understanding through largescale international surveys, a database with tens of thousands of patients and site engagement tools. These are all essential factors to make a DCT’s a success.
This is also highlighted by the fact that we have successfully supported several multiple Decentralized Clinical Trials as well as Hybrid Trials in the past years. Furthermore, we know from experience that digital patient recruitment for DCT’s can improve diversity and representation in clinical trials by utilizing digital recruitment methods that target and attract eligible participants, while also taking into account patient population demographics.
Read our interview with Laura Blauth, the leader of a on Alzheimer DCT that we supported through our ClinLife® Patient Portal.
Want to know how we can support your patient recruitment?
Whether you’re planning, or actively recruiting, we can support your trials to ensure you meet your enrollment targets. Simply get in touch with one of our experts, and we will review your study’s requirements, and develop a strategy to enroll more patients.
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