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Clinical trials: Current scenario, trends & challenges

Nivedita Doke
Thursday, November 24, 2022, 08:00 Hrs  [IST]

As per estimates by clinicaltrials.gov, India contributes around 1.15 per cent to the global share of clinical trials. The Indian clinical trials market size is anticipated to reach $3.88 billion by 2030 growing at a CAGR of 8.2 per cent from 2022 to 2030. However, the interesting part is that since the inception of the pandemic, India has accounted for an 8.3 per cent share of the global clinical trials activity in 2020, registering an increase when compared with the last 10-year average of a 6.2 per cent share, as per GlobalData.

Industry-sponsored trials accounted for 35.1 per cent share of the entire clinical trials in the country in 2020 when compared with the 10-year average of 41.1 per cent. Non-industry sponsored trials held 64.9 per cent share in 2020 as compared to the average of 58.9 per cent over the last 10 years.

The growing disease variation and prevalence in the country, globalization of clinical trials, adoption of new technology, the introduction of the New Drugs and Clinical Trials Rules in 2019 and increasing research and development are some of the key factors driving the market. Leveraging its experience and expertise, India will continue to play a key role in clinical trials in infectious diseases along with various therapeutic areas like metabolic diseases, oncology, gastroenterology, ophthalmology, rheumatology and respiratory disorders.

Upcoming clinical trials trends in India
Respiratory and Covid-19: Over the last two years, Covid-19 has dominated clinical trials, including vaccines and other therapies. The trend will likely continue in 2023 with new trials for coronavirus vaccine boosters, self-testing kits as well as immunity boosters. RNA therapeutics are also expected to make large strides in the years to come fuelled by the successful use of mRNA vaccines. Vaccines for different infections such as pneumococcal vaccines, seasonal influenza vaccines, RSV
vaccines and Hepatitis are also likely to undergo clinical trials.

Oncology: The top indications for oncology-related clinical trials include lung, breast, ovary, and colorectal carcinomas. Variations in treatment modalities towards targeted anti-cancer drugs because of resistance, refractoriness and survival benefits is the need of the hour, and this has led to a gradual increase in novel therapeutic approaches. Various targeted therapies have been approved but are being further evaluated as mono and combined therapies for the treatment of cancer. Immuno-oncology clinical trials with PD-1 and PD-L1 inhibitors have increasing interest by clinical trial investigators because of their select availability to patients and high costs.

Gene and cell therapy: Personalised medicines are another emerging area of focus, including gene and cell therapies. With different research institutions working on CAR-T cell technology platforms and regulators providing a proper framework for CAGT studies, this is expected to emerge as a potential niche area of growth that will further address unmet medical needs.

Early Clinical Development (ECD): The interest in early clinical development is increasing from industry, academia and regulatory bodies and there has been an increased focus on resources, awareness, training, development of SOPs, infrastructure and qualification of sites for ECD.

Key challenges regarding clinical trials
In a heavily regulated clinical industry, the complexity of the guidelines, the addition of new variations and rules between different regulatory bodies causes constraints and concern among professionals in this field.

  • Conducting clinical trials requires expertise across different domains, including, pharmacology, chemistry, statistics and microbiology. The industry, as well as academia, need to work together to make sure that these gaps are bridged.
  • Tight timelines along with increasing complexity results in high cost of trials and put more pressure on the resources needed to implement and control every step.
  • Awareness of clinical trials in the public is quite low. Quite often, public perceptions about clinical trials are influenced by social media/media that may not be providing a complete view.
Ways to enhance competitive nature of clinical trials
Here are some of the key areas to focus on to make sure that India continues to advance its clinical trial ecosystem and improve overall access to healthcare.

Employ technology: Incorporating the latest technologies like AI, cloud computing, wearables and advanced analytics can accelerate clinical trial outcomes and enhance the opportunities for market success. Technology can help in faster recruitment and better retention, improving patient data capture, improving the patient experience and access to non-traditional data sets. Real-world evidence and real-world data are becoming the keys to clinical trials, and the ability of wearables to collect and store large amounts of patient data is proving to be invaluable for researchers.

Address logistical challenges: Traditional site-based clinical trials are time-consuming, expensive and troublesome for the average person. However, decentralised and hybrid clinical trial models which utilise direct-to-patient drug shipments, telehealth visits, remote sites and data monitoring helps to keep the trials go on at the convenience of the patients while maintaining patient safety.

Enhance clinical research capabilities and quality of trial data: The leadership role that is played by the investigators/institutions during clinical trials is immense. It is important to continue to evolve and augment clinical research capabilities at these institutions so that there is the highest quality of data from the clinical trials.

Final say
A large part of the challenges in the clinical industry is associated with clinical trial design followed by regulatory needs, high costs, patient recruitment and low percentage of trained staff and a deficiency in the adoption of new technology. The patient-centric model with integrated advanced technology platforms and upfront planning can enhance patient engagement and reduce obstacles that can in turn benefit the clinical investigators, sponsors and patients. Training and imparting new skills among experts and specialists like drug developers, clinical investigators, medical advisors, biostatisticians and others can further ensure the success of clinical trials.     

(The author is Executive- Regulatory Affairs & CQA, Entod Pharmaceuticals)


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