The digitisation of information technology used in various industries began in the late last century, but the healthcare industry was not part of it. Somehow, the healthcare industry, including clinical research, has skipped the first wave of information technology. Due to its increasing complexity of regulatory requirements, there has been a lot of buzz in recent years for the use of information technology in healthcare and clinical trials.
These days, paper-based case report forms have been completely replaced by electronic data capture tools. Similarly, the analysis of clinical trials data has gone completely digital with the use of advanced software which is compliant with regulatory requirements. Few operational processes like managing clinical trials at hospitals are still on the verge of being digitised, but very soon, all these processes will be completely governed by the use of advanced information technology.
The race for a vaccine has brought clinical trials to the forefront not only among healthcare specialists but regular populations as well. Governments and regulatory bodies have done their work to support and fund initiatives in this space while expediting timelines and approvals to ensure the drug gets to the market. However, more support is needed for the supply side to ensure a fair and quick distribution of potential vaccines when they roll out.
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To get a better understanding of the Indian clinical testing industry and one of its players, Analytics India Magazine reached out to the Director of Siro Clinpharm, Akshay Daftary. Edited excerpts:
AIM: What are the challenges faced by the Indian clinical trials domain?
Akshay: The clinical trial regulations have evolved primarily to encourage research and fast-tracking of development and approval for new drugs. This trend has worked positively for the clinical research industry. While the regulations will continue to evolve, one of the main drivers for change shall be the situation that we have seen due to COVID-19.
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The pandemic has thrown several challenges to the regulators – one, in terms of fast-tracking a vaccine or a drug for a COVID19 kind of situation, and second, ways and means to overcome the constraints of the lockdown-like situation on the clinical research. We anticipate significant changes in regulations to govern virtual clinical trials and the increased use of technology in their conduct.
In 2016, drug regulatory agencies eased rules for conducting clinical trials in India. Before, it used to take six months to one year to get approval. After 2016, they reduced the entire process timeline by 40-50%. In order to meet the timelines, they have increased the frequency of SEC meetings as well and introduced the SUGAM portal for trial registration.
AIM: What role did AI/ML play in improving clinical trials?
Akshay: AI/ML is the next impending thing for clinical trials. It would impact right from protocol designing to the creation of a report. If we look at simple examples of data cleaning, based on previous errors which one particular hospital has committed, one can focus on these errors rather than going through the entire data.
Secondly, if we look from a safety perspective, using AI/ML, one can find various trends in safety—if a particular drug is causing any specific side effect—SIRO has developed a system to check such trend analysis and intends to run AI/ML on this so that large data can be reviewed at one go and human efforts are reduced with increasing accuracy.
AIM: How does SIRO leverage tech?
Akshay: Mainly in the form of in-house software and programs that we have acquired on a license basis from third party global vendors to run various aspects of our clinical trials. It mainly focuses on departments like clinical operations, programming, and data management. It is used for data entry into structured databases, cleaning of data, and analysis of data. Internally, we have developed tools to review data quality and comply with regulatory requirements.
The clinical operations part, which involves various sequential activities, is also being added to systems so that deviation does not occur. We have created medical calculators for use during clinical trials to have uniform data outputs at hospital ends during the conduct of clinical trials.
AIM: What services do you offer in phases 2 and 4?
Akshay: SIRO specialises in providing solutions to the twin challenges of speed and quality in clinical development. We have experience across business models, including Full Time Equivalent (FTE), Full Service Provider (FSP), as well as individual project outsourcing models. SIRO’s efficient clinical operations team holds the onus of complete project management from onset until study report submission. SIRO’s services focus on clinical operations, clinical monitoring, medical services, feasibility services, clinical project management and planning.
AIM: What are the shortcomings of the Indian clinical trials industry?
Akshay: The clinical trials are very demanding in terms of regulatory compliance. We require more and more GCP (good clinical practices), trained investigators (doctors), and trained staff at the hospital end to conduct the clinical trials as per regulatory requirements. We shall also have more and more awareness of clinical trials so that patients also participate in clinical trials. DCGI has already taken many steps to protect the rights of research subjects; taking it forward in this manner would be very helpful.
SIRO has played its role by participating in studies for alternative treatments for COVID-19 and medical device companies in this space who are working on devices to kill coronavirus particles. The ability to conduct clinical trials has been greatly hampered due to the protective measures that the sites have taken. Social distancing requirements have made the conduct of trials more challenging, along with stringent testing requirements in cities that have a high number of cases.
AIM: Could you walk us through a typical clinical trial?
Akshay: The clinical trial process starts with the preparation of clinical trial protocol. The trial protocol states which population shall be included in the clinical trial, what treatment is to be administered and required tests/examination to check on the efficacy or safety of the drug. There are various factors that govern the trial protocol like comparator product, how common the disease is in the community, etc. After preparing the protocol, allied documents like the informed consent form and case report form are prepared.
The trial sponsor (who conducts/finances the trial) shall reach out to various clinical trial sites (hospitals) to check whether they are interested in conducting a specific clinical trial. Upon confirmation from sites, the application is made to DCGI (Drugs Controller General India) and hospital ethics committees.
The trials are registered on CTRI (Clinical Trials Registry India), and upon approval from both DCGI and ethics committees, the trial can be initiated at the sites, and patients can be recruited. The treatment to recruited patients is provided as per the trial protocol, and examinations/assessments are done as per protocol to get the required data for analysis. Post collection of data, the data cleaning is done, followed by analysis and report writing. Once a clinical study report is prepared, it is submitted to DCGI.
AIM: What does the future look like for the clinical trials domain in 2022?
Akshay: The global research organisation market will grow at an 11.48% CAGR by 2023, led by research and the manufacture of medical devices and therapeutic drugs. With increased investments in R&D, the patent expiration of drugs will support the CRO market growth. The availability of quality health care practitioners lowers the cost of clinical trials across all phases. However, the COVID-19 pandemic certainly broadens the offerings several-fold.
With various economies opening up, travel restrictions have eased up. And most countries plan to advance their access to vaccines, either from other countries or to develop their own. India came out with its own vaccine (COVAXIN) in less than a year through Bharat Biotech. Moreover, with a robust pipeline of vaccines being manufactured in India itself, we are now touted to become the largest producer and supplier of COVID-19 vaccines in the coming months.