Inclusive of lab services, discovery, preclinical, and clinical, the Contract Research Outsourcing (CRO) market extends from the manufacture of active pharmaceutical intermediates to development and manufacture of dosage forms, clinical research, as well as basic research and packaging. CROs provide specialist services across this drug development continuum. 
 
Amid the COVID-19 crisis, the global market for Contract Research Outsourcing estimated at $49.8 billion in 2022, is projected to reach a revised size of $67.1 billion by 2026, growing at a CAGR of 7% over the analysis period,¹ according to a recent market study published by Global Industry Analysts Inc., titled, “Contract Research Outsourcing – Global Market Trajectory & Analytics”.  Clinical trials, one of the segments analyzed in the report, is projected to grow at a 7.4% CAGR to reach $48.4 billion by the end of the analysis period.¹  
 
According to ClinicalTrials.gov, number of registered clinical trials by August 2021 was 387,363 globally. In general, the research and development (R&D) of new drugs and clinical trials have become more complex in recent years, driving growth in outsourcing R&D and clincial trial services. Also, staying atop of government and regulatory agency guidelines and regulations to predict developments and submissions is of paramount importance.
 
The business and regulatory implications of the pandemic on the CRO market presented both significant challenges and opportunities. Subject matter experts from PPD Clinical Research Services, Thermo Fisher Scientific share insights on these developments. –KB  

Contract Pharma: What are the current challenges and impact of COVID in clinical trials?

 

Andy Burr, Ph.D., Vice President, Infectious and Respiratory Diseases Therapeutic Unit Head, PPD Clinical Research Services, Thermo Fisher Scientific:

 

The key words when discussing the challenges and impacts of COVID-19 on clinical trials have been flexibility, adaptability, teamwork, speed, intel and surveillance. In current trials, flexibility and adaptability have been the real necessities from the outset. The COVID-19 pandemic landscape has changed and continues to change abruptly and substantially. 

 

For example, for a current COVID-19 treatment trial, the initial country and site mix were built while working with the client to establish a flexible approach. This was to ensure the client understood we were going to go through constant changes to the country and site mix; changes that included the regulatory environment itself. Protocol design also has had to adapt to the pandemic with fewer on-site visits, and greater use of telehealth and patient home visits.

 

It was, and remains, very important to establish a process to review epidemiology data for COVID-19. We determined that it was helpful to increase levels of site management, tailored at the country level, in order to obtain local epidemiological data directly from the institutions dealing with the COVID-19 pandemic. 

 

A final point related to COVID-19 challenges in clinical trials has been the availability of supplies. This has driven the implementation of alternative and risk-mitigating solutions, including local sourcing and provisioning of specific materials (e.g., tubes) to sites, replacement of subject visit lab kits with unscheduled visit kits, expediting lab kit supply and shipments, and detailed instructions to support sites with materials replacements and handling workarounds. 

 

One of the challenges that COVID-19 has had on broader clinical research is that the return to pre-pandemic trial participation in non-COVID-19 studies has not manifested as anticipated. It is, therefore, unclear as to what the longer-term impact will be on new therapies’ development timelines. 

 

Finally, the pandemic has essentially overnight created a new indication in the clinical development pathway, not only from a COVID-19 treatment and vaccination perspective, but there is also now the need for development and future research to manage and treat so-called “long-COVID” disease.

 

CP: What are the technology trends and regulatory frameworks for clinical trials today?

 

Ilse-Maria Nolan, Ph.D., Senior Director, Regulatory Affairs, PPD Clinical Research Services, Thermo Fisher Scientific:

 

Regulatory frameworks are evolving to meet changing needs, increasing the importance of regulatory intelligence screening to inform business decisions. In response to the COVID-19 pandemic, regulatory authorities (RAs) worldwide have established flexibilities to ensure trial participant continuity, while accelerating development of COVID-19 vaccines and treatments. Some RAs have established precedents that may lead to permanent change. We already see increasing flexibilities for decentralized clinical trials (DCTs).

The pandemic also brought an additional focus on advanced therapies requiring sophisticated pre-clinical and clinical development. Recent advanced therapy-specific legislation and guidance will support such development. A major recent change in the EU is the long-anticipated application of the EU Clinical Trials Regulation 536/2014 on 31st January 2022. This will simplify and harmonize procedures for the authorization, assessment and supervision of trials over a three-year transition period. The clinical research industry needs to collaborate proactively with the RAs to ensure alignment regarding the use of novel DCT strategies that enable us to move forward with innovation and adoption at the incredible pace that was seen during the pandemic.

Now that we have seen what can be done, we must ensure that progress continues. 

References:
1. https://www.prnewswire.com/news-releases/global-contract-research-outsourcing-market-to-reach-67-1-billion-by-2026–301506515.html