The coronavirus pandemic has highlighted and revolutionised the conventional ways of drug discovery and development. Despite challenges like lockdowns and uncertainties of the new virus, the clinical trial industry accelerated the pace of moving some of its services from clinics to the cloud or even the patient’s couch so that important research could continue remotely.
According to industry experts, the move toward decentralized clinical trials has many benefits including patient-centricity, which ensures greater engagement, access, and the possibility of shortening timelines for important drug and vaccine development.
In 2021, APAC has more widely seen trial activity trending upwards over the last decade – the region contributed almost half of the entire global clinical trial activity.
According to reports, India accounted for an 8.3% share of the global clinical trials activity in 2020, an increase when compared with the last ten-year average of a 6.2% share.
After coming to a halt in 2013, clinical trials are once again showing an upward trend in India, and new study sites are reemerging.
Parexel is one of the largest clinical research organizations, supporting the development of innovative new medicines to improve the health of patients. The company provide services to help life sciences and biopharmaceutical customers everywhere transform scientific discoveries into new treatments.
Financial Express.com reached out to Sanjay Vyas, EVP, Global SBU Head – Safety & Logistics Services & Managing Director, Parexel India, and he highlighted misunderstood aspects of clinical trials, the regulatory landscape for clinical trials in India, and evolution safety parameters for participating patients among others. Exerpts:
So, when we talk about clinical trials, there is a lot of skepticism among people. Would you like to debunk some myths?
Before the pandemic hit us, people were not aware much of clinical trials. Currently, it is unfortunate that only 5 percent of the global population participates in clinical trials. This is ironic as at the end of the day we are trying to get new therapies to the market but if you don’t have patients’ participation how will you be able to get those therapies into the market? I believe that it’s a matter of education that is what lacks in the industry at this time. I personally believe that its a job that needs to be done jointly by the regulators, the industry, and the academia put together. People tend to think that those who participate in this trial are guinea pigs.
The clinical trial industry is so highly regulated in terms of compliance…as at the end of the day we are dealing with patients’ lives. There are proper processes in place, and proper regulations, so at the end of the day I think these myths need to be discussed and debunked…we have also created a patient advocacy group and the whole idea behind it is not only just to hear what’s happening but to get understand what the patient wants and they go through when they are participating in a clinical trial. Since COVID-19 a lot of this discussion is already happening. People now understand what is placebo or other aspects of a clinical trial are. However, there is still a lot that needs to be done.
According to you, where does India stands in clinical trial and research?
There was a time when more than 320 studies were happening in India around 10-12 years ago. Of course, there were some local challenges that took place in terms of compliance and then there was a big curb by the government and then we had to wait till 2019 for the clinical trial regulations to come in. If you see, since then…the trajectory of the clinical trial has been on an upward trend. During COVID-19 itself the number of clinical trial applications that we had seen being approved for therapies as well as for vaccines we saw it was enormous…it was mind-boggling. India was a huge contributor in many of the therapies testing at this point of time both from supporting the vaccine trial as well as therapies. I believe India has a great ecosystem at this point of time…India is also becoming a healthcare destination from a health tourism perspective. So, I think those are some of the factors that are contributing positively. If you take a step back, and look at the 2019 clinical trial new policies that are put in place…there was a time when it used to take 3-6 months for a clinical trial application to get approved. It happens around 30-60 days time now.
The regulators have done a fantastic job. The ethics committee setup across India which has a mandate now that within 50km radius there has to be ethics committee which has to present out their report that validates this process. The clinical trial regulations are also supporting the patients perspective. From an investigator’s perspective, there are very stringent regulations that they now have to adhere from a standards’ perspective. The application fee is also now at par with USFDA. I think they are created positive barriers and at the same time they have broken from old barriers which is providing a conducive environment to grow. But is it at the same level as it was 10 years back? Probably not. But now the environment is conducive. Now, Multinational companies are looking at India as a potential site for doing their global studies. I think there is more to happen and more patients from India will be benefitted.
As you mentioned that there is an upward trend after 2019. According to you, how has the pandemic affected the clinical trial status in India? In a post-pandemic world, what are the key takeaways from the pandemic that we can use to strengthen clinical research in the country?
Due to the pandemic, the alternative strategies of innovations became a mitigation strategy. So, when the sites shut down for the clinical patients and the focus shifted towards COVID-19, there was panic as there were still patients suffering from other diseases who needed to continue the medications for the study. So the industry pivoted to Direct-to-Patient. So, instead of the patients coming to the site, we took the clinical trial setup to the patients’ homes and this approach was pushed heavily. There were a lot of deviations that happened at that point in time and remote monitoring became more positive and regulators also supported this approach…the focus on immunomodulated therapies suddenly increased…The pharmaceutical companies are now talking and focusing on “What’s Next?” According to me, now that we have adopted these measures and technology, let’s not look back. We are now exploring ways to enhance the Direct-to-Patient approach…how can we use telemedicine more…how can we make e-consents easier for the patients? How can we use real-world data and evidence for a clinical trial? I think these are some of the takeaways that we really need to start implementing and make sure that we don’t fall back to the old ways.
To combat COVID-19 the whole united together. There is still n number of diseases that are still incurable and hard to diagnose. Do you think, the same approach can be implemented for diseases like Alzheimer’s or Parkinson’s also?
I believe that the industry is definitely passionate. There are a lot of studies and research underway on Alzheimer’s and Parkinson’s currently. But most of this research takes time which… Cell & Gene Therapy is a great example and it is becoming very prominent at this point in time. Cell&Gene has come forward with some cures on the oncology side which probably did not exist in the past. Now, there are concepts like taking cells from the body and taking them to the vector, modifying the cell and genome, and putting it back into your body. The whole idea of using CRISPR technology which has great potential for Parkinson’s disease. There are now talks about mRNA. A particular pharmaceutical company told me two weeks that we used mRNA technology for vaccines how can we use this for other rare diseases? I think a lot of discussions is happening, zeal is there…and I think at the end of the day…fortunately or unfortunately the industry is also driven by how much amount of money is there in terms of research vs how much money is there for the finished products. The other challenge to this is also poor patient participation.
Could you please share some insights about the regulatory landscape of clinical trials in India and the business impact?
Since 2019, the new regulatory policies have definitely opened new doors. I believe that ex-DCGI Somani did a fantastic job we now have our new DCGI, Dr. Raghuvanshi. I think the regulators are pretty open to any kind of suggestions. But there is still a lot to do. Currently, in India, if there is an early-phase molecule and it’s not a molecule that is invented in India…there is a little bit of skepticism…they are okay with bridging studies…but if you have a good business case at the table the DCGI is now also approving those early phase trials too. So, those are some of the changes that we are seeing…the vaccination was so successful in India because of ASHA workers. I think we can also use these ASHA workers to educate patients across India about clinical trials.
Currently, in which area is the clinical research increasing, and in which area more attention is needed?
The biggest focus at this time…post-pandemic…one of the biggest areas of investment for pharmaceutical companies is immunomodulated therapies…anything to do with respiratory diseases…because after Spanish Flu and COVID-19, people pondering what’s next? Oncology and hematology is also a big area for investment as there are a lot of patients suffering from these diseases. Rare diseases and Cell&Gene therapy are also coming up very strongly. Cell&Gene therapy has a lot of potentials as it has the ability to target the genome sequence and the cells which are technically leading to those kinds of challenges. I have personally seen that in the last 12 months, we have more than 25 studies in Cell&Gene. Our biggest challenge is patient recruitment.
There are now a lot of talks about public-private partnerships in the healthcare sector. Do you think a similar partnership is also possible or much-needed in the clinical research industry?
Absolutely. India is becoming the mecca for start-ups. The number of unicorns that have come into the country in the last 2 years has been mind-boggling…I think a lot more of that public-private partnerships have to come into play. The government is also giving a lot of incentives for innovations. If you look at the new budget, it is really impressive. There is a fund allocation for research on new molecules in rare diseases. The Health ID initiative is also fantastic. I think there are a lot more opportunities in this arena.
According to you, what are the regulatory challenges that companies tend to face while conducting clinical trials in the country?
…The early phase is one area in which I think the regulators can definitely look. So, most of the time all the early phase trials…they come in Asia…they either go to Australia or to China. The reason is both China and Australia have created a conducive environment. Who is benefiting? The patients. If these early-phase molecules come into India, a lot of patients can benefit. Another recommendation that I tend to give the regulators is that they should start taking into consideration the data that are being accepted EU and FDA. Shouldn’t we use that as a baseline and make it much simpler? If they have approved certain molecules, then is it really necessary to go through those checks again or shouldn’t we just make it simple?
According to you, how the safety parameters of participants have changed over the years?
Just three months back, I took over an additional role as a head of Pharmacovigilance and Safety Services. There is a very stringent pharmacovigilance process in place, whether the product is going through a clinical study conduct or once the product is in the market. There are two aspects to it: One the product gets released into the market, and there is a regulatory mandate in most countries that its the responsibility of the pharma company to continue to monitor the patient’s adverse event. The pharma companies come to us and our safety scientists…we have more than 300 physicians sitting on board right now who medically monitor these drugs and they have to submit reports and these reports are supposed to be submitted back to regulators. This same procedure is followed during the clinical study conduct too. Patient safety is the topmost priority for investigators…we are doing more than 6000 studies globally currently.
What has been Paraxel’s role in the clinical trial industry? What are your upcoming plans?
In India, we are one of the largest CROs. We have over 6000 people now and the reason being the talent is fantastic. These talents are helping in conducting global studies as well as local studies. We have a very strong presence in Chandigarh, Mohali, Hyderabad and Bangalore, and Mumbai but with the pandemic, we are now recruiting people across the country. We are giving constant inputs to regulators, we are working with academia as well…we are the first CRO to launch a patient advocacy group. So, these are the investments we are doing in India. Our upcoming plan is to continue to enhance what we are doing and it also includes how do we put India on the global map for clinical research.
There is a persistent challenge with respect to rare diseases, especially with the availability of orphan drugs. According to you, what are the challenges that often come with clinical research for drugs for rare diseases?
Today what happens is that many patients…even though they are going through treatment, they are going to multiple hospitals. The biggest requirement for orphan drugs or therapies to into the market faster…you cannot put these patients on a placebo. It is unethical. The only way to then conduct orphan drug trials is to create a synthetic arm…and it can be created using real-world data on what these patients are going through in current therapies. Another aspect is, in most cases the molecules of these rare drugs are being innovated in Europe or America. With this budget, there will be fund allocation for R&D for new molecules. I think a lot more can be done by our Indian biotech firms. There are already two companies in India who are discussing how Cell&Gene could be developed in India as well. I think the growth of Cell&Gene can also help in the development of orphan drugs.