In recent decades, patients’ interest in participating in traditional on-site clinical trials has diminished and their dissatisfaction has decreased. There are different reasons – the remoteness of clinics and specialists, cumbersome process, financial burden, etc. Although the industry has been discussing a switch to a more remote or virtual way of conducting research studies, this new approach has still not been adopted from the wider network of drug developers.
However, 2020 brought something that the world hadn’t known for a long time – a pandemic causing a lockdown of people and businesses all around the world. The COVID-19 virus completely shaped our lives and turned them upside down. Many of us are now “imprisoned” in our homes, and the need for isolation and social distancing calls for new ways of being and working. Unfortunately, the clinical research industry is not exempt and this situation comes as a reminder that disruption is much needed.
Changing the clinical trial landscape
Even before the coronavirus pandemic statistics were showing negative trends of the trial timelines on a global level. Some of the biggest challenges causing these delays are due to ineffective patient recruitment and retention strategies. Each year drug developers spend approximately $2.28 billion recruiting participants, yet two-thirds of investigator sites still fail to meet the enrollment requirements.
In an effort to address these challenges and improve clinical trial outcomes, more pharmaceutical manufacturers have been exploring virtual services, which includes shifting from a location-depended trial to a patient-centred one. Such an approach allows for a more convenient trial experience for the participant, increased patient diversity and significantly reducing trial timelines and subsequently costs. Studies have shown that over 50% of patients are more likely to participate in a clinical trial if home care is offered. At the same time, such services ensure higher patient retention rates and better patient engagement.
Due to the current COVID-19 pandemic, a large number of trials originally designed for a traditional setting are being forced to adopt virtual elements by enabling remote visits and interaction with the sites or remote data collection. Now more than ever, health care is driving the adoption of telehealth with the help of new technologies and digital advancements. Now it’s the perfect timing for sponsors and investigators to actively explore patient-centric clinical trial models to achieve more accessible, more comfortable and more efficient trials while guaranteeing patients’ safety.
- What value does telehealth bring to clinical trials?
As patients become more comfortable with technology, they are going to demand more of it. We are starting to see this trend in our culture today. We shop and work online, even use our bank online. Healthcare and clinical research have been lagging in this respect, but people no longer want to go to the clinic for a prescription or to take part in a study requiring so much of their time and finances. The more people see the possibilities of telehealth, the more they will demand it.
The technologies required for a virtual clinical trial are now widely available. However, Industry does not have to start with an end-to-end solution but can integrate the technology into specific stages, starting with referral and enrollment systems or data collection and monitoring.
Some of the numerous benefits of this approach are as follows:
- Address difficulties recruiting, screening and enrolling patients
Current clinical trials are inaccessible to many patients. Some of the common barriers include the patient’s severity of disease, age, social circumstances, location, language. If the trial is looking for patients with specific genetic mutations, the recruitment is almost impossible.
The utilization of telehealth (or telemedicine) in clinical research enables patients and investigators to connect and engage with each other more efficiently. Far from creating a sense of remoteness, virtual trials that utilize telemedicine can prevent patients from feeling isolated by creating more timely and personalized touchpoints.
Existing telemedicine providers already support clinical researchers to recruit and meet with participants via digital solutions. Traditionally, potential participants must travel to a research site for an in-person screening visit. With telehealth, patients can complete their personal profile in the app and virtually provide consent. Initial screening is completed through online surveys and voice calls to collect contact and health information. There are options for the medical team to obtain medical records and perform a remote assessment.
A lot of existing mobile apps already rapidly enroll large and diverse patient populations. For example, Stanford’s MyHeart Counts consented 48,968 participants in just six months. Another example is doxy.me – a telemedicine platform developed by Professor Brandon Welch and colleagues at the Medical University of South Carolina connecting doctors with researchers as well as study teams with potential trial participants. Patients are able to express interest in a study, watch an educational video about the study, complete an eConsent form if they wish to move forward, and then answer any necessary questions via a chatbot. The aim is to ensure more human-to-human interactions.
Thus, virtual visits are already enabling remote participation in trials, unlocking the potential for research to be conducted at an unprecedented scale and scope. There is hope that virtual trials can expand the racial, ethnic and age diversity of study populations, allowing for a more complete understanding of how investigational products work in more diverse, real-world settings.
If you are interested in exploring further this landscape, we have compiled lists of existing providers of telemedicine and remote nursing solutions, eConsent providers, and virtual clinical trial providers.
- Facilitate better patient evaluation
While recruiting large populations, investigators need to collect and enter data which often overloads them. What is more, they usually collect this data at the time of the scheduled visits (once or twice a month), not allowing for understanding patients’ health overall. This means endpoints are often subjective and might not provide the real picture during the patient’s participation in the trial.
Mobile health technologies, on the other hand, provide innovative ways of collecting data and measuring endpoints painting a more complete picture of the participant’s health. Sensors such as portables, wearables, and implantable devices can continuously track specific symptoms to make data more objective and frequent. Sensors and app-based algorithms can also detect responses to medications and give researchers better insight into drug effectiveness and dosage.
Remote monitoring devices improve data collection and evaluation so this is why we have selected the top providers in the field for you to consider. (hyperlink the article on remote monitoring solutions once ready).
- Allow patients to balance trial participation and life
Pharmaceutical companies, patient advocacy organizations and technology groups have been collecting patient input from across various disease areas and geographies on whether patients really want to take part in clinical trials from their homes. The results are similar and confirm that patients need an adequate balance between clinical trial participation and life. Travelling to and from physical sites can be difficult because of distance, lack of time or other important daily tasks such as babysitting or working. Telehealth allows study participants to take advantage of the remote interaction and save time and money. This, in turn, leads to increased patient retention and better satisfaction. In a pilot study on virtual visits involving participants with Huntington’s disease, 82% of individuals from 10 states completed the virtual visits with an overall satisfaction of 93%.
- Reduce costs associated with physical trial sites
Virtual clinical trials reduce the number of trial sites needed and the associated costs required for start-up and maintenance. Smaller staff is needed, fewer costs for travel for research teams, better retention rates lead to fewer time costs caused by delays (currently amounting to $8 million for each day of delay). A phase three trial can cost $50 million with larger ones running into hundreds of millions of dollars. Monitoring itself makes up 25 to 30 percent of the overall cost of clinical trials. It is projected that risk-based monitoring, an approach made easier with telehealth, will return a reduction in monitoring expenses by 15 to 20 percent.
- Challenges of implementing telehealth into clinical trials
Some of the challenges of using telemedicine in clinical trials might include:
- The need for education and training in telemedicine techniques and etiquette, as well as training on the digital software and tools being utilized within a trial. All of this would be in addition to standard trial training requirements.
- In the case of the COVID-19 situation, time would be one of the biggest enemies for the industry causing delays and costs until a new solution is found, assessed and implemented.
- Some patient populations may be uncomfortable with the technical aspects of remote clinical trials.
- Therapeutic areas such as endocrinology,, dermatology, respiratory, gastro-intestinal, immunology, cardiovascular, and rare diseases present the best opportunities for a virtual approach. However, more complex indications might require a combination of virtual and on-site elements or might not allow for a remote approach at all (e.g early-phase oncology and first-in-human studies).
- While there is an increasing number of internet-based and electronic tools available for these studies, they might not provide complete solutions. As more researchers move toward the virtual trial model they must be mindful to seek out partners with experience in this research approach.
- Sponsors should keep in mind that virtual trials involve more than technology alone – they remain a complex endeavor that must meet regulatory requirements and demands in-depth clinical understanding.
- Many trials can adopt virtual elements, but lots of trials are complex and will always require patients to see a healthcare professional for their infusion or check-ups. In the drive for more virtual trials we must never forget the vital role that human interaction plays in the delivery of healthcare and research. Our human touch is key and will be even more important following the current crisis.
In the time of pandemic, finding alternative site solutions and utilizing more innovative approaches is critical to keeping trials moving forward to prevent delays in therapies and, ultimately, to reach the patients who can benefit from them. Pharmaceutical companies and clinical research organizations now have the chance to implement the next model of clinical trials and face its benefits and challenges in a real-life situation. There is a pressing need to act on these digital advancements and not ignore the advantages of involving these technologies – we can have a much safer, much more cost-efficient trial design in the future.
- U.S. Department of Health and Human Services. “Examination of Clinical Trial Costs and Barriers for Drug Development.” www.aspe.hhs.gov
- American Academy of Neurology. “Rare Disease Clinical Research: Caregivers’ Perspectives on Barriers and Solutions for Clinical Research Participation.” www.neurology.org
- Sertkaya A, Wong HH, Jessup A, Beleche T. Key cost drivers of pharmaceutical clinical trials in the United States. Clin Trials. 2016;13(2):117-26
Are you planning to incorporate virtual modalities in your trial? We wanted to make the choice of vendors easier on you so we created The Ultimate Guide to Virtual Trial Vendors. You can choose the right partners for your study among the 130 companies in the Guide covering everything from eConsent to remote patient monitoring and health ride services.