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Virtual Clinical Trials Gain Momentum as Pandemic Shows no Sign of Slowdown

by Navami Reghunath , Marketing Analyst

4 October 2020

With inputs from Vaishnavi L, Lead Analyst, Clinical Research

virtual-clinical-trials

Clinical research organizations are working relentlessly to develop drugs or an effective vaccine against COVID-19. It takes years of research and testing to bring a vaccine to the market. Biopharma companies, research centers, and universities across the globe are racing against time to find a vaccine against this virus, which has affected industries globally. Clinical trials are a significant phase in drug development and the pandemic has had a substantial impact on ongoing trials.

Impact of COVID-19 on the Clinical Trial Market

COVID-19 related interruptions like lockdowns, travel restrictions, and restricted access to research sites resulted in halting hundreds of ongoing trials. A study conducted by Global Data shows that the number of disrupted trials increased by 1100 in the month of May 2020, the majority of which were in phase II stage. Close to 69.9 percent of trials were affected due to low enrolment rates. Regulatory approvals, ensuring patient safety, and unavailability of sites and investigators are the major reasons for trial disruptions.

Labor Shortage

The clinical trial industry is facing a labor shortage as medical professionals are engaged with COVID-19 trials. Data collection and patient recruitment processes have taken a hit during the lockdown and caused delays to ongoing trials. Personnel shortage had gone up by 8-9 percent during the months of March and April. The unprecedented demand for recruitment of staff for COVID-19 treatment centers and vaccine studies has spiked the cost of temporary labor by more than 80 percent.

The current situation has prompted pharma companies to collaborate with key technology providers to develop tools that can reduce turnaround time and ensure participant safety. Suppliers like PPD, IQVIA, Syneos Health, etc. have expanded their digital clinical trials capabilities to ensure research continuity.

The cost of developing a new drug and bringing it to the market is approximately $2.6 billion in the U.S. (Tuft’s 2014 study). About 60 percent of trial costs are attributed to the overall monitoring budgets, including the number of monitors required for the trial, and their travel overheads. Prolonged delays are causing huge losses to the trial sponsors, and they are looking forward to expand the technology capabilities to complete trials that have been put on hold. FDA’s guidelines from September 2020 lists out factors to consider while continuing clinical trials during the pandemic and guidelines for initiating virtual clinical trials to ensure participant safety.

What are Virtual Trials?

Virtual clinical trials involve the use of software tools to manage various facets of clinical trials and thereby decentralize the trial process. Virtual clinical trials are cost-effective and can bring down the overall trial cost by up to 50 percent per participant when compared to site-based trials. Patient recruitment through software helps to obtain more participants and increases patient retention, which have always been a challenge in the trial process. Better accessibility and the convenience of participating from one’s home makes virtual trials more patient-centric and reduces dropout rates.

The following are the differences between traditional, hybrid, and virtual clinical trials.

	Traditional	Hybrid	Virtual
Study Visits	Visits occur primarily at the principal investigator’s site	Visits can occur at a site, patient’s home, care clinic, or remotely as eVisits	Visits occur at patient’s home, care clinic, or remotely as eVisits
Data Collection	Data is mainly captured via the site’s medical records and transcribed to EDC (Electronic Data Capture) at study site	Data is captured by study sites as part of traditional or eVisits, by field-based staff from patients, caregivers, etc.	Data is captured by study sites as part of eVisits, by field-based staff from patients, caregivers, etc.
Monitoring	Monitoring by field based staff at study sites, remote monitoring can be used as appropriate	Monitoring by field based staff at study sites (reduced as fewer visits and more eSource) remote monitoring can be used as appropriate	Field based staff to monitor only one central study site onsite or remotely
Drug shipments	Completed in bulk to study sites	Distributed at study sites or delivered to patient’s home (shipped directly or by field based nurses)	Delivered to patient’s home (shipped directly or by field based nurses)
Site Management	Sites maintained individually by CRAs (Clinical Research Associates)	Fewer sites can be used along with remote elements and home health nurses (due to less travel/onsite visits for patients)	One centralized site is used with remote elements along with home health nurses
Regulatory Documents	Informed consent obtained through site or eConsent system	Informed consent obtained through site or eConsent system	Informed consent obtained through eConsent system/Patient platform
Site Costs	High due to sites performing “high-touch” administration	Lowered due to fewer sites being activated and fewer site visits	Minimal due to central sites being activated

Technologies that support virtual clinical trials include the following

Artificial intelligence
Big data/Data analytics
Clinical trial payments
Electronic data capture
Mobile health
Patient engagement solutions
Wearables

Though the above technologies had been introduced in the clinical trial market earlier, the adoption rate was relatively low. The pandemic has accelerated the adoption of digital technologies in clinical trials in order to expedite the trial procedure and cut down on costs.

Virtual Clinical Trial Suppliers and Their Solutions

PPD

PPD has invested in innovations to mitigate the challenges of completing trials during the pandemic. This includes mobile apps that enable patients to call investigators and complete assessments without the need to visit study sites. Accelerated Enrollment Solutions (AES), jointly developed by PPD and Science 37 enables patients to participate in trials virtually.

Curavit

Curavit is a clinical trial enterprise, which partners with healthcare entities by providing telehealth and clinical trial platforms through which patients can be reached at their homes directly.

IQVIA

IQVIA launched their first technology-enabled COVID-19 trial matching solution within the U.S. to accelerate treatment and vaccine development. Their study hub offers telemedicine for a maximum of five participants, patient eDiaries and questionnaires, and securely tracks IMP/lab kits shipped to patients.

Medidata

Medidata Virtual Trials consists of a web-based platform, which acts as a patient-facing interface for trials and hybrid studies.

Paraxel

Paraxel conducts decentralized trials by using their telemedicine capabilities, home trial support, and direct-to-patient drug shipments.

Halo Health Systems

Halo Health uses IoT, AI, and mobile technologies for various solutions like remote monitoring of patient vitals, automated drug delivery and drug adherence, patient engagement for drug adherence, etc.

ICON

ICON’s patient engagement platform goes directly to patient support, helps them track the progress of ongoing trials, and has the provision to opt-in for any studies at the nearest research site. Their evidence platform helps to gather and collate observational data to be used at various stages of research.

Sourcing Practices for Selecting Virtual Clinical Trial Suppliers

Procurement is a versatile function so much so that the function can even scout for suppliers who offer virtual clinical trial services. This shows how diverse this job role can get.

If you are a procurement or sourcing manager responsible for picking the right-fit, virtual clinical trial supplier, the ready reckoner below gives an indication of sourcing practices.

Strategy	Expanding with current clinical trial supplier	Engaging with a new supplier
Supplier Type	CRO and/or Clinical IT provider	Established CRO and/or Clinical IT provider	Specialized player
Engagement Model	Strategic partnership with Master Services Agreement (MSA)	Functional service provider
Pricing model	Volume-based pricing	Fee for service
Discount Structure	Volume-based reduction schemes, based on overall global spend with the vendor and discount rate, based on prior experience	Volume-based discount
Contract Duration	3-5 Years	2-3 Years

Pharmaceutical research companies were on the path towards patient-centric clinical trials over the years but the disruption caused by COVID-19 has made the pharmaceutical companies rethink the future of clinical trials. The trend will continue in the coming years with the clinical trial market seeing more partnerships between pharma companies and technology players. While there are numerous technology service providers in the market, procurement teams should focus on identifying the best-fit supplier to collaborate with.

References:

https://digital.hbs.edu/innovation-disruption/software-enabled-clinical-trials/

https://leoinnovationlab.com/2020/04/02/virtual-clinical-trials-create-new-possibilities-for-patients-pharma/

http://www.pmlive.com/pharma_intelligence/The_impact_of_COVID-19_on_clinical_trials_1343258

https://csdd.tufts.edu/research-milestones/

https://www.who.int/research-observatory/monitoring/processes/clinical_trials_1/en/

https://www.fda.gov/media/136238/download

https://investors.ppd.com/news-releases/news-release-details/accelerated-enrollment-solutions-and-science-37-collaborate