Clinical Trials: Global Overview And Need In India
Among the biggest benefits of worldwide accessibility to clinical trials is the fact that by testing a particular therapy, drug or diagnostic procedure locally across the regions, it becomes possible to reduce the time between approval and availability.
Clinical trials have become a key area of global attention in the wake of the COVID-19 outbreak, as most major countries around the world raced to create a vaccine for the contagion. Clinical trials are essential for developing and understanding the safety and efficacy of any new diagnostic tests, medical treatment procedures and medications. Generally, clinical trials are conducted on willing volunteers to test drugs, cells, biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care practices. In the modern context, it is absolutely important to improve global access to clinical trials by providing unbiased information to patients and volunteers. Too often, patients suffering from diseases such as cancer are told 'there is no cure', meaning no therapy is approved for their indications. In this case, many turn to clinical trials. Though it is usually never known if the patient is receiving a new therapy being tested or just the standard therapy or even placebo, this is the last hope for many.
However, whether due to lack of accessibility, psychological barriers or the pure complexity and bureaucracy associated with clinical trials, many patients do not participate. Research shows over 80 per cent of cancer patients don’t discuss clinical trials with their doctor.
By providing universal and easy-to-understand information to patients about the pros and cons of clinical trial participation, as well as on the clinical trial options themselves, we have the potential to improve accessibility to and recruitment for clinical trials, thereby even accelerating clinical research and bringing therapies to patients, faster.
Conducting clinical trials
A great deal of careful planning, execution and monitoring is required for clinical trials especially for diseases like rare cancers. Depending upon the disease and the number of patients available for the trial, the average timeframe of a cancer trial can vary from 10 to 15 years or even longer in some circumstances. They can be conducted on all age groups including children. A regular biomedical clinical trial has four phases.
Phase I – In phase 1, new drugs are tested for the first time on a small test group to calculate safe dosage range and monitoring of side effects.
Phase II – Phase 2 of clinical trials is expanded testing of the treatments, drugs, and procedures found to be safe in the first phase. This is carried out on a larger user group.
Phase III – Phase III trials are carried out across regions, and larger populations and it is the step preceding the approval.
Phase IV – In the 4th phase, studies are continued over a longer timeframe after the country’s approval has been granted.
Clinical trials global scenario
Traditionally, clinical trials used to take place in North America, Western Europe and Oceania regions. However, in the last decade or so, there is a rapid increase in the trend of global clinical trials (GCTs). With the increase in disease awareness related to ailments like cancer and the spread of various contagions especially the recent COVID-19 outbreak, there is a strong need being felt for accessibility to global clinical trials in areas outside the western hemisphere.
In the last ten years, several pharma companies have opted for GCTs in locations across Asia, Latin America, the Middle East and Africa. These are evolving GCT markets that, despite not having an infrastructure or social awareness at par with the North American and Western European markets, offer plenty of potential and benefits for global healthcare research and development.
For a clinical trial to be more effective, it is ideal to have access to a larger pool of patients from diverse regional and ethnic backgrounds. By conducting the clinical trials on a global scale, this need for diversity is fulfilled with greater ease. In the past, the clinical trials were most accessible to well-informed people who had the option to take time off to work or be driven to different appointments, etc. Thus, the economically and socially underprivileged people outside the west tend to miss out on the opportunity due to lack of access to clinical trials. This is of greater relevance to oncology trials as cancer is one of the biggest killers worldwide.
Among the biggest benefits of worldwide accessibility to clinical trials is the fact that by testing a particular therapy, drug or diagnostic procedure locally across the regions, it becomes possible to reduce the time between approval and availability. We saw the success of this model amply in the wake of the pandemic where most of the major countries including India were able to start mass production of the COVID-19 vaccine within a year of the disease is first reported.
The Indian scenario
India currently hosts only about 1.2 per cent of all clinical trials conducted globally, despite the country having a very high disease burden. This lack of clinical trials and ecosystem conducive for them has been due to unsatisfactory experience with past studies and several occasions where unethical trials were carried out in the country. In 2013, the rules were tightened to prevent such incidents. However, the decline in the number of trials and the need to conduct more clinical trials in the country has made the policymakers take action.
Steps being taken to support clinical trials in India
Firstly, a concerted effort is being made and the Government of India has announced clear and comprehensive rules for clinical trials in the country. This is expected to speed up drug approvals. It is through this fast-track approach that India managed to make its vaccines for COVID-19. India is also set to introduce regulations for universities undertaking human-trial-based research.
Secondly, when it comes to patient recruitment for clinical trials, the crux is in providing patients with accurate and unbiased information. Patients are justified in apprehensions related to clinical trials such as the likelihood of adverse effects, sharing of a patient’s medical data, the concern of a patient of moving to a medical center etc. Greater access to patient-friendly resources which break down the potential benefits, risks involved and the procedural timelines, etc will allow the patients to make better-informed decisions and reduce these apprehensions. This is critical for the establishment of a full-fledged GCT ecosystem in India which would match the existing infrastructure and access in North America and Western Europe.
Finally, it is important to ensure that the best available technologies and care processes are deployed during the clinical trials and throughout the entire clinical research process. Deploying AI to help identify insights for hypothesis generation can reduce the chances of missed insights through manual R&D. In addition, virtual data collection, including real world data, can reduce inefficiencies and even improve patient participation, with reduced need for hospital visits.
What India needs today is a transparent and holistic regulatory framework that doesn’t serve as an obstacle, but as an enabler of clinical trials in India apart from the information and tech support. With clinical trials, information and impactful innovations in med-tech, it is possible to improve drug access.