Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. While clinical trials are pivotal to analyze the efficacy of any new therapy or drug, every year, a lot is spent on clinical trials. The cost of patient enrolling, recruitment, and retention come up to cost several billion US dollars worldwide.
With the unprecedented twist in the routine lives due to the ongoing Coronavirus pandemic, the approach to conduct and hold clinical trials seems to be readjusting. The COVID-19 pandemic has massively disrupted thousands of clinical trials globally, putting the patient drug development process at a halt. The conduct of trials was not possible due to the risk of catching coronavirus. At the same time, some pharmaceuticals, due to the priority to develop therapeutics and preventive medicines for COVID-19, had put ongoing trials for other indications at the backfoot. At the same time, the pandemic caused an unusual reorientation kickstarting an effective and convenient way to approach and hold clinical trials – Virtual Clinical Trials (VCT).
What are Virtual Clinical Trials?
Virtual clinical trials (VCT) or Remote clinical trials or Decentralized clinical trials are a way to conduct clinical trials with the help of technology. Although, there is no uniformly accepted definition for Virtual clinical trials, however, there has not been a single trial held yet that can be referred to as completely virtual; but only some of the stages that constitute it. Thus, it will not be wrong to say that the concept of Virtual clinical trials is relatively new to ears despite having known for years that it is bound to be the future of clinical trials.
There exist several ways through which any traditional clinical trial can be transformed into a decentralized clinical trial. For instance, any trial that takes place needs data and if the clinical trials abound with data leveraging the prosperous healthcare technology such as wearable devices, gadgets, healthcare software, smartphones; diagnoses made on the basis of virtual imaging with the help of advanced PACS (picture archiving and communication system); usage of online platforms such as social media, or online communities to reach out to patient groups and so on; are some of the different ways in which the nature of any clinical trial is virtualized.
Why the Need?
The drug development process is a lengthy and time-intensive process that ends up causing fortunes to industries and organizations sponsoring the process. According to a study by the Tufts Centre for the Study of Drug Development, approximately USD 2.6B so far has been shelled out for each FDA-approved drug to get it to the market, constituting its discovery and developmental costs with the complex and extensive trials accounting for a major sum of the expenditure.
To add to it, several studies have demonstrated that approximately 80% of the traditional clinical trials fail to meet the enrolling criteria and targets, therefore, do not see the light of the day. To quote an example, let’s take the case of rare diseases that affect fewer than 1 in 2000 people and the prevalence is very much scattered throughout the world. In such cases, reaching the trial site, regular visits to centers for updates on treatment outcomes becomes challenging for patients. However, when it comes to conducting a decentralized clinical trial, the processing of timelines becomes convenient. Moreover, through virtual clinical trials patients from remote areas, or weak socioeconomic backgrounds can also take part in the trials in a much more seamless, liberated manner.
The current situation of COVID-19 is a live example of how distance and restricted movement can put a full stop to all the ongoing trials delaying results and launches of therapies. However, pharma and biotech companies that were swift enough to upgrade their procedures towards holding a virtual clinical trial were able to minimize the damage.
Besides increased patient access, Virtual clinical trials also promise a faster way to collect and build a robust database by leveraging technology. Medical devices such as tracking wearables, medical kits, mobile applications, and others can help patients and physicians to keep a tab on the patient activities and health, on the other hand, high-end diagnostics devices such as PACS, sensors, imaging devices, and others can facilitate easy monitoring and distributions of patient data in a safer and faster way.
What does FDA have to say about VCTs?
Regulatory agencies such as the USFDA, EMA, PDMA, and others have always worked towards procuring better healthcare services and treatments for people. Transforming the environment of clinical trials from conventional to decentralized, however, requires certain guidelines and strategies that may vary with the disease area, type of drug, trial activities, and others.
Regulatory agencies have always prioritized the well-being of the patients. Keeping in mind the ongoing COVID-19 pandemic, the FDA proactively urged to hold virtual clinical trials ensuring best practices and alternatives for a smooth transition. However, Virtual clinical trials do not fall into the term “one-size-fits-all”, and it requires a standardized approach and strategy to execute a fully functional decantralized clinical trial.
Although the USFDA has always been pushing the idea of Virtual clinical trias, however, in March, 2019, the FDA encouraged sponsors and industries to opt and look out for alternatives stating that VCTs are no more just a way out to cut down on costs, but rather a way to ensure patient-centric trial.
Challenges Lie Ahead
Without a doubt, the massive shift in holding the decentralized clinical trials is going to pose several challenges in the form of availability of technology, training of human resources, internet connectivity, and so on. The availability of collective databases in a single place is of major concern. Despite knowing the importance of maintaining Electronic health records, the execution is far from reality. With a lack of availability of uniform data of patient health, there are risks of misunderstandings and overlapping while opting for a particular treatment regimen. With the training of medical service providers and physicians, it will also require to make patients well-acquainted with the usage of medical equipment and devices, the complete process of trials, treatments via telemedicine, regularly using the removable devices, and so on. However, to overcome these challenges, pharma giants, as well as startups, are partnering with technology providers.
Undoubtedly, Virtual clinical trials are on their way to become the new norm, and to accelerate the pace, several pharmaceutical and biotech companies have tied up with technology and AI-service provider companies to help enable the incorporation of technology into their traditional ways. With the mission to speed up the drug development process and enable operational efficiency in virtual patient enrolling, administration of telemedicine, and seamless use of diagnostics modalities, AI and tech companies including Science 37, Syneos, Flatiron Health, Deep 6 AI, SubjectWell, Tempus, Altos Solutions, Obvio Health USA, Inc., CLINPAL, VIRTRIAL, Lightship, Medable, Science 37, Parexel International Corporation, Medidata, PRA Health, Curavit Clinical Research, and several others are pledging to boost the transition of conduct of clinical trials from conventional means to virtual ones. Although the article gives a cursory look at the advantages, future Virtual clinical trials outlook and key companies engaged in the space, the actual benefits are tremendous that range from boosting the speed of patient enrolling, cutting down on the cost of the physical state of the clinical trials, uniformity in maintaining EHRs, dispensing of telemedicine, and so on, thus, it will not be wrong to say that VCTs are here to stay.