Pandemic COVID-19

Pandemic COVID-19 impact on Clinical Trials and the Way Forward: Virtual clinical trials

History was inked with first clinical trial by Dr. lind.

In 1747 first clinical trial in the world by Dr. James Lind into the causes of scurvy on board the HMS Salisbury. His trial consisted of just 12 men and grouped into pairs and given a variety of dietary supplements from cider to oranges and lemons. The trial was for six days but, within that time, there was a noticeable improvement in the group eating the fruit, providing Lind with the evidence required of the link between citrus fruits and scurvy. he published a book with his findings, "A Treatise of the Scurvy,". Amazingly, Lind had found a cure for scurvy.

virtual trials will be inked in the coming history with correct planning, coordination, integration, trainings, technology with confidence in the coming time. Inspiration from Dr. James lind for all clinical researches and he is behind the visionary of modern clinical trials which can be the solution for pandemic covid-19 effect on clinical trials.

Restrictions on movements and stay-at-home social distance lockdown orders are helping to mitigate the spread of COVID-19. But this solution and chain breaking strategies against this virus of selfish are creating threats of another kind – obstacles to clinical trials essential to finding effective treatments and cures for more diseases.

Healthcare communities in entire world is busy with doing together in efforts develop therapeutics, understanding the virus life cycle and vaccines for covid-19, one thing we should not forget the other trials which are ongoing and those in the R&D that will also help conquer other diseases. There is an urgent need to use advanced and innovative approaches to ensure the continuity of existing trials and the start of new studies: Here the importance of virtual trials.

The virtualization of trials:

Virtual or “site less” clinical trials allow trial investigators and subjects to conduct clinical study visits through online video calls. In this corona time concentrating and adopting this type of visits will be beneficial to continue the trials. Collection of data via handheld or wearable technology and wearable devices like Fitbit for diagnosing sleep apne, Garmin watches to detect atrial fibrillation, wearable device to improve arm movement in people who is having stroke, automated bionic pancreas system that delivers both insulin and glucagon to young children with diabetes.

Furthermore size and diversity of the patient pool by virtual trials and accelerate recruiting, generate more informative, clinically-relevant data that is accepted by regulatory agencies.

Virtual clinical trials are a more recent trend for clinical research and are based in the idea that the study is conducted at a single site, rather than multiple sites. Because of this, virtual clinical trials have primarily been limited to studies that do not require specimen collections from study participants. However, with access to a flexible and broad-reaching network of mobile phlebotomists and exam centers, trials with specimen requirements don’t need to be limited to traditional program designs.

Successful drug development depends on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. what we are using the current model for clinical trials is outdated, inefficient and costly. Traditional trials are limited to sample sizes and that variations among patients in the real world is not reflected, financial burdens on participants, slow processes and these factors leads to the disconnection between research and clinical practice.

Moving from traditional to virtual trials welcome the challenges as clinical trial sponsors learn how to design, execute, and complete effective virtual trials. To assure success, trial sponsors need to better understand the digital tools and platforms used in virtual trials, how to manage the data collection they enable, and the valley deaths to avoid.

This concept, which allows patients to participate in trials without having regular visits to a clinic and engaging patients by eliminating trial burdens. Although the concept has been around for years, it is still met with skepticism. In fact, many technologically advanced pharma companies have yet to enter into this arena.

Challenge: virtual trials make our studies easier for subjects by not requiring them to travel to sites. But another problem may arise.

In clinical trials Receiving accurate data from subjects is of utmost importance, as is protecting the data and privacy of those patients.

Major challenge is not all patients are tech savvy, some training may be required and this can be a big concern when recruiting elderly subjects or those who live in rural areas where there may be limited access to technology or the internet. More over in the case of home nursing, some patients may feel their home is not tidy enough, or they have limited space for a home nurse to perform their duties. So need of recognizing that even virtual trials can create unique burdens for subjects.

Data integration: There is a fear that too much data coming from too many technologies and devices can’t be aggregated in ways that allow for effective analysis that will pass regulatory review.

Patient safety: If patients don’t have direct personal contact with sites or study physicians, there are concerns that there may not be enough recognition of serious adverse events or assurances that patients will get the relevant care.

Regulatory acceptance: well known, one of the reasons for slow technology adoption in the pharma industry is regulatory concerns.

Several researches stated that for large Phase 3 trials regulators are not ready to accept digital endpoints. The prospect of dealing with multiple technologies was also a concern, with participants noting some hybrid trials may require dozens of different technologies, each with a separate portal and login credentials for sites. This can slow the trial process as site will need to be trained on each technology. These new tools may create a burden for technology-averse patients or those not possessing the latest technology.

Participants believe that a move from traditional trials to virtual decentralized trials should be gradual, moving into Phase 3 trials only after successful use in a Phase 2 study.

Virtual trials will necessitate changes in SOPs and a change in mindset of clinical trial internal teams, including therapeutic areas, clinical operations, quality, and legal.

CONCLUSION:

Of course, performing virtual trials requires technology solutions. Bringing a company with technology and an integrated platform is one way to fulfill that requirement.

                                                                                               

   -Pravallika Racherla