Research Article By: Dr. Jorge Estrella MD President & CMO at ESTERN Medical CRO Life Sciences
During the past year 2020 and present 2021 our company has engaged in diverse solutions to catalyzed or accelerate processes in diverse angles in this global pandemic, internally and externally, to our Life Sciences clients.
Our company is currently investing time and management resources in decentralized or virtual-remote clinical research studies that are a potential solution to the current Covid-19 research global restrictions that our company is currently performing in supporting and resolving the challenges of clinical trials.
Virtual or remote clinical trials or more accurately known within the industry as “decentralized” clinical trials are showing promise as a viable, often beneficial, solution to the broad barriers brought on by COVID-19 but it’s not applicable to all clinical trials phases or targeted R&D indications.
A decentralized Clinical Research Trial is one that allows patients to take part in a study within their home environment. This concept was previously trending in certain clinical study types, more commonly in the Biotech’s, Pharmaceutical, Medical Device / MedTech’s & CRO space areas. COVID-19 has only accelerated the trend and its acceptance with international regulators or Ministries of Health (MoH’s) and hospital Ethical Committees (EC’s) / or Institutional Review Boards (IRB’s) within certain parameters.
A decentralized trial differs from a traditional one comparatively, there is greater focus and time spent during the planning and startup phase to ensure the clinical trial runs more accurately or smoothly. This includes more focus on the regulatory trial dossiers, logistics, both from a trial management perspective as well as participant training.
Another option is hybrid trials, which combine in-person and virtual visits. A hybrid model may be required in some trial designs to obtain trial biological patient samples or have specific medial assessments performed. This reduces the burden of the participant to travel locally or abroad to the clinical site for every visit and can result in improved participant retention for longer studies. Decreasing the number of in-person visits helps reduce potential “Covid-19” viral transmission and exposure during the pandemic or other type infections.
Risks are different between Clinical Contract Research Organization (CRO), Pharmaceutical, Biotech’s & MedTech’s / Medical Device companies that our company will need to align to the standards or Standard Operating Procedures of the sponsor, but the standard in-clinics are hybrid, and virtual approaches to clinical research hospitals have taken an alignment to work in overall conjunction ensuring an effective risk management process that will be in place to the key to success of any potential clinical trial. This is a positive outcome not only to our company at ESTERN but also to the sponsors, hospitals, regulatory agencies and most important the patients.
Additional considerations for a decentralized trial pertaining to a study R&D clinical trial product include a greater focus on stability data (to ensure it can withstand longer shipping times, or variable shipping temperatures) as well as adding data loggers for storage at the participant’s home, if the product requires specific storage temperatures.
Overall, the new necessity for decentralized trials has posed great challenges for sponsors with strict traditional studies underway or those in the planning phase. Knowing how to pivot effectively without compromising study quality and integrity has been the biggest hurdle for company. Moving to a decentralized model or using a hybrid approach will force sponsors to change study designs and, in some instances, re-visit their “regulatory process by country and research ethic board approvals process”. Our company is constantly evolving to work with key regulatory authorities and with senior management of Pharma/Biotech’s & Medical Device /MedTech’s to resolve the bottlenecks to expedite any R&D congestions to resolve them and think outside the box with the current Covid-19 Global Pandemic.
Awareness and understanding will be key to using decentralized trials to advance any type of research and all phases.
The potential advantages of decentralized clinical trials that our company has engage including but not limited to are as follows:
- Wider participant recruitment pool for improved recruitment
- Recruitment no longer limited to regional sites
- Maintained trial extreme high quality
- Increased flexibility for conduct
- Flexibility to work around participant’s schedules
- Improved patient retention in studies with long follow-up periods
- Improved long-term follow-up
- Potential for more real-time “data” collection from participants
Given these potential advantages as well as the evolving digital landscape, it is highly likely we will see a shift toward hybrid and virtual models even when in-person trials can resume after the Covid-19 Pandemic.
In conclusion, our expertise and experience have landed our company in stronger position, above all, the most important success factor is that our sponsors have a life sciences clinical research partner that will work with them to design and conduct their clinical trial based in a mutual partner strategy and end goal for potential treatment indications & commercialization.
The “bottom line” is that decentralized trials will be expected to play an increasing role in this present Covid-19 era and future of clinical research. If a Pharma, Biotech and Medical Device / MedTech’s are currently running a study that has been impacted by the pandemic or are planning an upcoming one that has now become unfeasible, to look for the right CRO partner with experience conducting these types of studies in the Covid-19 space, as well as a strong experienced knowledgeable senior management team with specialties in the specific indication or product you are clinically developing.
Contact us to discuss your R&D clinical trial study in the “US or Latin America”.