Clinical Trials in the New Normal

Clinical Trials in the New Normal

The accelerated use of technology in clinical trials and the shift towards virtual trials is here to stay

  • By Gaurav Kaushik | March 24, 2022

Technology is transforming the healthcare landscape worldwide, with the conduct of clinical trials also undergoing drastic changes. Covid-19 caused huge chaos to the social and economic activities globally and seriously challenged the existing model and systems. This has led us to only one option to adapt or innovate and such circumstances have paved the way for virtual clinical trials worldwide altering the traditional approach to clinical trials forever. Technology has reshaped nearly every industry, including healthcare, in lasting ways. As we struggled to dodge the spread of the virus, site closures, social distancing, travel limitations, and quarantine procedures led to significant disruptions. The accelerated use of technology in clinical trials and the shift towards virtual trials is here to stay.

Digital Moves 

Virtual clinical trials, also known as decentralized clinical trials (DCTs), can be described as studies conducted using digital technologies and processes that are different from traditional clinical trial models. A virtual clinical trial efficiently harnesses the power of digital technology with improved patient recruitments, patient sample retention, collection of data, and analysis. Consumers and patients have access to a wide range of information with the dissemination of digital information, this has initiated rethinking of clinical trials towards embracing the advantage of data analysis and forge clinical trials that cater to the current demand. Also termed remote, hybrid, digital, or site-less trials, DCTs help bring research closer to a patient’s residence, making it more convenient, transparent, and patient-centric. Telemedicine, remote patient monitoring (RPM), mobile health, eConsent, electronic clinical outcome assessment (eCOA) etc., are some of the ways virtual trials are conducted. 

Virtual trials, however, is not a novel concept. In 2001, Eli Lilly became the first pharma company to initiate a hybrid virtual trial to test its erectile dysfunction drug, Tadafil, through online surveys with patients. Ten years later, Pfizer conducted its first entirely virtual clinical trial, Research On Electronic Monitoring of Overactive Bladder Treatment Experience (REMOTE), a study on the hyperactive bladder, but it failed as the drugmaker was unable to enlist enough patients. Coming back to 2022, with the worst of the pandemic hopefully behind us, many companies are putting their learnings to practice. Although companies had initially implemented virtual trial capabilities out of necessity to ensure business continuity, many intend to continue to use DCTs even after the pandemic. With an increasing demand for these services, there has been a spurt in clinical research organizations, eClinical software vendors, and specialist virtual trial service providers in recent times.

Regulatory Purview

The virtual clinical trial is a combination of traditional patient selection and digital recruitment. Patients are targeted with technology to ensure maximum participation & retention. Remote electronic monitoring, digital health data, safety monitoring, data security and analysis & optimizing trial procedures are the key essence of a well-regulated clinical trial. The regulatory landscape in India has been evolving over the recent years to pave the way for research, development, and approval of new drugs. Intending to boost innovation, the government eased the norms for conducting clinical research and trials in 2016. It also made it easier and faster to process and get regulatory approvals for clinical trials. On the other hand, regulations were tightened on the quality parameters to ensure that contract research organizations (CROs) adhered to stringent quality and compliance checks. Other measures introduced included increasing the frequency of meetings of the Subject Expert Committees (SECs), which is tasked with granting approvals and waivers. The government also introduced an online portal for the registration/approval of trials.  In 2019, the New Drugs & Clinical Trials Rules were notified, another step towards promoting global clinical research in the country while ensuring patient safety. Despite these initiatives, experts believe the country needs more reforms in regulatory support and flexibility to facilitate innovative approaches and interventions to disease management.

In the backdrop of the pandemic, fast-tracking a vaccine/drug for the virus and overcoming the effects of lockdown restrictions on clinical research was of prime concern. Moreover, at the pandemic's peak, the regulators had given their nod for emergency use of a variety of drugs against coronavirus. However, no defined regulatory framework exists for the emergency approval of drugs. Besides, remote patient monitoring and devices pose security threats and confidentiality issues.  Going forward, significant reforms are expected, especially in the area of patient consent, Investigational Medicinal Product (IMP) management, data security and use of digital technology, 

Indian regulators should promote and encourage the initiation and conduct of virtual clinical trials in an ethical manner with strategic processes and policies. We hope that this will continue beyond the pandemics to sustain the momentum and fast track the clinical trial application and its review processes.

Positive Outlook

The investment opportunity has been noticed in trial infrastructure, this development coupled with the introduction of the new drug and clinical trial rules, 2019 which was a significant milestone to encourage more global clinical studies to be connected in India, thus improving the access to patients, population, and growing disease burden. The Healthcare industry in India is at the cusp of a digital revolution. The digital healthcare industry is expected to touch Rs 485.43 bn by 2024 from Rs 116.61 in 2018. Increased internet and mobile penetration, access to e-commerce, and a growing shift towards decreased physical interaction and mobility have further precipitated the demand for digital healthcare in India. Meanwhile, automation, artificial intelligence (AI), and machine learning (ML) have the potential to improve clinical trial processes, starting from protocol design to report creation. AI/ML and data analysis tools can also help ensure patient safety and check for side effects due to drug usage. Unique solutions using IoT-driven technologies have evolved for remote monitoring and home care of patients, while medical calculators can help streamline data outputs during clinical trials. On the flip side, however, regulatory ambiguity and lack of infrastructure and skilled human resources can be major roadblocks. 

It is imperative for a successful virtual trials industry to build a tech-savvy workforce with strong clinical and medical expertise. Moreover, data security, privacy, and protection are other core issues that need to be addressed. Being in the nascent stage, the ecosystem supporting DCTs is still evolving. Over time, we hope to see standardization, greater maturity, and improved regulatory checks within the industry. With the right blend of health management systems and digital capabilities, virtual clinical trials can help develop life-saving drugs while ensuring patient centricity.

(The writer is MD & CEO, Meteoric Biopharmaceuticals)

Disclaimer: The opinions expressed within this article are the personal opinions of the author. The facts and opinions appearing in the article do not reflect the views of IPP and IPP does not assume any responsibility or liability for the same

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