Almost two years after COVID-19 broke out, the notoriously conservative clinical research space has changed significantly. At TrialHub we want to take a look at how individual regions are recovering and what has permanently shifted in how trials are now planned and conducted.
Our partners from Proswell Medical (a mid-size Chinese CRO) shared with us insights about the clinical research landscape in China in 2020 and 2021: how regulatory bodies responded, what happened to ongoing trials in early 2020 and what the future of trial design may hold.
Proswell is part of our Country Advisors Network and an expert in local regulations, sites, patients advocacy and enrollment, clinical trial work flow, project management and startup timelines.
How is Proswell positioned in the clinical research field in China?
Proswell (Proswell Medical Company) is positioned as a medical oriented CRO, which focuses on innovative clinical trials requiring deep knowledge of the field, expertise and bigger number of full time medical professional employees together with abundant resources including hospitals network, healthcare professionals, PI and patient database.
Compared to other mid-size CROs in China Proswell Medical maintains more resources and already has advanced in better developed operation procedures. This is what we are proud of.
How did COVID-19 affect Proswell’s normal workflow?
From the beginning, COVID-19 forced us to move into a virtual space and develop new solutions for our clinical trials. After the quick country recovery we found that overseas Sponsors look for the opportunity to rescue ongoing trials outside their countries and they came to China due to safety issues. To provide a navigation in a new space and guarantee the smooth trial conduct for the foreign partners has become part of our daily work.
In general, what happened to ongoing clinical trials immediately after COVID-19 broke out? What happened to the patients receiving treatments?
Like in other countries the clinical trials were paused at the beginning, but we solved this in a short time. We try to provide the Investigational product directly to patients without their visiting the Site.
On the other hand, we instruct patients to go the hospital near their home to do related inspection to minimize the treatment risk and obtain data to minimize the risk of protocol deviation or patient loss.
After the situation was put under control clinical trials renewed and many more new projects launched. From that time China became a “shelter” for Sponsors having their trials held and who up to now transfered their clinical trials into China to guarantee the smooth flow and successful completion of the trial.
China became a “shelter” for Sponsors having their trials held
Did restrictions towards clinical research in China start to ease up? Was there anything specific that helped new trials begin recruitment?
Generally speaking, there are no restrictions at this moment at all. The industry has totally recovered more than one year ago.
Due to almost absolute COVID-19 clearance China became an option for overseas Sponsors to avoid pandemic-related risks for their projects.
So, we have not only local Sponsors trial recruitment process recovery, but also the obvious increment of foreign-owned company trials conducted in China Mainland.
Did decentralized clinical trials (DCT) become an optional solution? Was the DCT model adopted as a mitigation strategy? Do you know what tools (wearables, software, home nursing/visits, etc) were mainly adopted in DCTs?
Definitely, for some kind of trials it became a unique solution facilitating patient enrollment and simplifying the process at every stage.
It was adapted as a mitigation strategy to communicate with healthy volunteers or patients at the first step to avoid unnecessary visits to medical facilities.
We have used several tools but I would like to mention that the Proswell Medical team is now developing their own solution for decentralized trials. It can be imagined as a simple question list with one question per page with no more than five questions based on inclusion/exclusion criteria and automatically bound to the phone number of the user and integrated into our recruitment system.
Generally speaking, it looks like and works like health codes Chinese people or patients accustomed to scan in daily life in China to enter any public facility.
What is the opinion and experience of Proswell when it comes to DCTs?
DCT is trending now and it is a good solution to retain participants in a trial, and therefore improve patient compliance. In fact, DCT implementation supposes involvement of different categories of professionals and establishing a communication route between all of them, which depends not only on ePRO or Recuritment APP or other digital tool, but also requires each institutional site IT support and nurse resource to perform patient visits.
Currently, we have many choices of ePRO and other digital tools, but it seems to be necessary to improve the institutional site and nurse resources.
In China, hybrid clinical trial (conventional trial and DCT) will be the main model and it will be transformed into DCT along with site and nurse system improvement.
Particularly, we have experience in DCT to use ePRO and recruitment APP.
In your opinion, did clinical trial awareness in China increase due to the publicity around COVID-19 clinical trials?
Definitely yes. Taking into account a lot of talk around COVID-19 and the fact that even regular citizens have begun to pay more attention to science-related topics, we can say that. As we noted, the wiliness to participate in clinical trials among the population has also increased.
Does Proswell have experience with COVID-19 clinical trials?
Sure, like any clinical CRO focused on innovations, Proswell Medical has experience with COVID-19 trials and is not limited by any single service module with one Sponsor. Proswell Medical has provided full clinical service for COVID-19 treatment studies and is involved in the international collaborative network with other small or mid-size CROs to develop COVID-19 vaccines in clinical trials globally.
In your opinion were people eager to volunteer or reluctant about joining a COVID-19 trial?
If you’re asking about China, we can say yes and no doubt. There are two groups: patients who get modern treatment for free or healthy volunteers who feel they are contributing globally, and feel proud to participate in such kinds of activities to improve common health.
What are the trends in clinical research in China in 2021?
Taking a look over all recently launched projects, it is obvious that “innovative medicine trial” is nowadays a trend in China.
Even regulatory agencies created new policies and always upgrade the existing laws to encourage innovators to come to China.
Regulatory environment is warmly welcoming innovative medicines and provides several pathways facilitating clinical trial initiation, which is equally applicable for both local and foreign Sponsors.
Do you have any observations on the diseases or therapeutic areas most affected by the pandemic research-wise? Which TAs took a hit? Which ones increased their research?
When the outbreak happened in early 2020 the oncology, CNS and infectious diseases therapeutic areas were seriously impacted. We can observe the same in many other countries even now and even with promotion of decentralized clinical trials, because above mentioned therapeutic area trials supposes enrolment of severely ill patients requiring clinical observations.
The real cases in China with application of existing and proven clinical trial concepts and models provide the opportunity to conduct these types of trials without any restrictions or unpredictable events to guarantee that innovative medicines surely reach the patients.
Apart from the pandemic topic, the development of new cancer drugs in China accounts for 50% of new drugs.
Are there specific indications, TAs in which Proswell feels most confident based on knowledge, experience and capacity?
Proswell Medical team is experienced in more than 10 therapeutic areas with advance knowledge in oncology, immunology, immunooncology, central neuro system disorders, innovative vaccine trials, infectious diseases, ophthalmology.
How did regulatory bodies respond to the pandemic? What were their recommendations for ongoing and planned clinical trials? Have they changed in 2021?
There are 4 accelerated procedures in China to promote high clinical value drug as follows: Breakthrough therapy, Conditional approval, Priority review and Special review. During the pandemic the Chinese regulatory agencies NMPA and CDE have adopted a special review procedure to promote quick IND and NDA procedure.
We experienced lockdown in early 2020 with severe restrictions for a short time, but then it came back to normal. We cannot say anything about some serious changes in regulations in scope of the COVID-19 pandemic impact.
In 2021 the serious and positive changes came to the innovation medicine clinical trial sector bringing the optimization in the regulatory process that makes conducting a trial faster and easier and guarantees faster approval for IND and NDA for new innovative drugs or urgently needed.
What is one thing that changed in 2020 and won’t soon go back to normal in terms of clinical trials?
To be honest, in contrast to other parts of the world it has already gone back to normal in China.
How did sites respond to the pandemic? And how are they doing now, a year and a half after the outbreak?
That was the challenge.
The total lockdown in early 2020 switched hold on mode for the trials, but very quickly it came back to normal.
Since that time our sites adopted more precautions in their operations and hospital management maintained preventive measures according to policies introduced at the government level. We have never faced any COVID-19 related case emergency in so-called “on-site” trials during our workflow.
Do you have any prognosis for how clinical research will be changed by COVID-19 in China and in the world in general? How it will recover and when? In what ways it won’t be the same again?
We can only guess. We can see the balance was shifted towards telemedicine. This has been already proven to be time and cost-effective. However, decentralized trials cannot be applied to 100% of all trials as we mentioned above.
As we said, the hybrid model (conventional clinical trial and DCT) will be more popular in China.
The post-COVID era trial will be more virtual and more international.
In the future, this approach will be applicable to any trial in regards to its specific goals and requirement process. What happened during COVID-19, except for a digitalization and telecommunication boom?
The regulatory bodies in almost all countries have changed their vision of overseas data acceptance and internationalization of the clinical trial conduct process. It won’t be the same in terms of previous limitations anyway.
What are your hopes for change in clinical trials after COVID-19? Is there any specific work-focus that Proswell follows now?
Proswell is on a mission to introduce a new model into the Chinese research society and balance it with conventional clinical trials or on site mode. At the international level, our mission is to create the China professional CRO image.
We hope that more and more countries and their regulations will be adopted for, ah, let’s say it this way, the “global trial” with minimization of time necessary for interaction with patients around the six continents and initiation. Telemedicine or DCT is a way. This is our hope and vision for our work.
Who said COVID-19 disrupted globalization? No, it has sped it up.