VIRTUAL CLINICAL TRIALS

INTRODUCTION :-

Clinical trials play an important role in the development of every drug , providing scientific information on the safety and efficacy of pharmaceutical compounds and clinical care.

Usually , traditional clinical trials are slow , expensive and inefficient. Additionally, given the requirement to travel to trial sites, these traditional ones can place time and financial burden on research participants. An emerging trend in the clinical trial landscape has been the incorporation of digital health technologies – known as “ Virtual Clinical Trials “.

WHY DO WE NEED VIRTUAL CLINICAL TRIAL?

Virtual Clinical Trials are yet to be implemented methods of conducting clinical research which makes complete use of technologies such as apps, electronic devices and various online social platforms. Such clinical trials can provide digital health technologies for collecting information at each stage of clinical trial, enabling online based, informed consent and keeping a track of adverse events.

BENEFITS OF VCTs :-

* Choice of participating from the convenience of home instead of traveling to a site. This choice can be provided to the trial participants.

* Researches can use information to enhance monitoring and improve understanding of treatment effects and progression of disease.

* VCTs may help save Pharma companies time and money.

* Fast recruitment of patients without any geographical limitations.

* Lower drop-out rates of participants.

* Easily accessible to participants who are reluctant to participate in the usual traditional way.

Although VCTs seems to be beneficial for the society, it also comes along with certain “ RISKS “. Let’s have a glance at a number of them :-

* Patient privacy concerns, such as risk of sharing sensitive health information over the Internet.

* Dealing with populations with very low levels of computer knowledge.

* Lack of in-patient support.

* Operational challenges faced by elderly people.

* Technology cost associated with running virtual trials.

It is important to note that virtual clinical trials aren't a “ one-size-fits-all “ model and only a fraction of clinical trials are fully virtual.

In the near term, digital health technologies may only be accepted in a few sections of the health department.

In recent times, Covid-19 has delivered a great big slap in the face to the on-going planned studies and the future of clinical trials as “virtual” has rapidly become the need of the hour.

HOW HAS COVID-19 CHALLENGED US ? :-

The COVID-19 pandemic has significantly impacted the mind-set around the healthcare provision, with necessary restrictions to face-to-face contact dispelling earlier apprehensions.

The pandemic has hindered companies from enrolling new patients into trial as they faced increased difficulties in continuing visits with existing participants and it might not be ethically appropriate. This might lead to many protocol deviations , locking participants out of trial findings and thus losing a substantial part of the trial’s research data.

We are seeing delays in clinical trials due to sites having been closed due to social distancing measures currently in place.

NEED OF VCTs IN COVID TIMES :-

COVID-19 has created a real sense of urgency to adopt virtual trials, both to help with a vaccine or cure, as well as helping other researches to continue.

The fact that coronavirus is so contagious and has caused various countries around the world to close businesses, schools and implement social distancing which shows increase in the demand for more virtual trials. For COVID-19 trials, virtual approaches can help capture data to assist understand the symptoms and impacts of the virus.

Virtual Clinical Trials can be very fast, can be easily adaptable and safe to use in the assessment of Covid-19 treatments. Virtual trials can be used to determine how safe a particular treatment is for an individual and it can also be used to determine whether the benefit associated with the use of a certain drug in conditions such as COVID-19 is worth the risk.

ARE VCTS THE FUTURE OF CLINICAL TRIALS ?

Virtual trials are the answer for many types of research and we need to see an increase in adoption of such a method. Many trials can adopt virtual elements but most of them are difficult and will always require medical supervision. On increase demand for more virtual trials, we must never forget the important role that human interaction plays in the delivery of healthcare and research.

Best adoption of technology is where it enhances, supports and encourages better human-to-human interactions. Virtual technology should be used wisely and properly to engage more patients in research, to support medical professionals and investigators to deliver better results Hence, the world will be a changed place post COVID-19 and clinical trials will be conducted without any disruption.

Thus, “the way forward for medicine is more digitally controlled, data-driven, personalized and directly deliverable to the patient

By:-

KAROLYN JOSE

Student at Clinosol Research