View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. Analysis
March 3, 2021updated 12 Jul 2022 11:22am

OCT West Coast: the post-pandemic outlook for clinical trials

At the OCT West Coast conference last week, GlobalData’s global director for databases and analytics Revati Tatake revealed the industry's outlook for the future of clinical trials and the move to more decentralised systems in a post-pandemic environment.

By Kezia Parkins

After a year of disruption, Covid-19 has accelerated the uptake of decentralised clinical trials (DCTs).

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

At last week’s OCT West Coast virtual conference, GlobalData’s global director for databases and analytics Revati Tatake presented the results of a GlobalData survey with 150 respondents holding a variety of industry roles to discover what they thought was in the future for DCTs.

Respondents came from contract research organisations (CROs), contract manufacturing organisations (CMOs), clinical investigators, pharma and biotech companies as well academic and government organisations.

 

The trend towards DCTs

57% of the survey’s respondents predicted that DCTs will be more frequently used in the next two years, while 26% believed it will take three to four years for DCTs to become more commonplace. One third of the survey respondents have already been using DCT methods.

future movement to dcts

The majority of organisations believed that DCTs would be more frequently used in the next two years. Importantly among the most likely respondents to hold this view were government and academic institutions, CROs and other contract service providers.

future move to dct

The graph below shows what respondents who had not used DCTs previously saw as the top perceived benefits.

The top advantage was greater accrual of patients for trials, followed by increased participation of sites. These top two benefits suggest that the future move to DCTs will be due to the need to improve enrolment numbers rather than the specific threat of Covid-19 impacting trials.

 

dct perceived benefits

Challenges of moving to DCT models

Looking at the challenges involved in moving towards DCTs, the number one challenge reported by survey respondents were changes to required procedures and processes, as well as systems integration. Finding and validating technology vendors to start without causing delays to trial initiation may also be a potential challenge.

The next most common concern is unclear regulatory acceptance or guidance. Revati noted that tracking changing regulatory guidance will be key to adapting trials in the post-pandemic environment.

“The regulators are listening now more than ever,” said Tatake. “The FDA in the US is being very flexible, but the policies on new ways to collect data vary by country. In the EU some countries allow centralised monitoring of clinical trials as long as patient confidentiality is maintained.”

DCT biggest challenges

GlobalData analysed responses for the changes needed to pivot to decentralised clinical trials. The top required changes reported by respondents were in system integrations and alignment.

This is followed closely by process changes and alignment, as well as training.

The fact that all of the responses ranked so closely indicates that there are many perceived changes that are need to make a convincing transition to DCTs.

dct biggest changes

 

Emerging tech in clinical trials

Finally, GlobalData analysed the uptake of emerging technologies as a result of Covid-19. As shown in the chart below, most respondents believed that remote patient monitoring (RPM) via telemedicine will become the most common technology even after the pandemic.

“RPM can enable healthcare providers to get data-driven insights, help deliver patient-centric treatment and disease management approaches,” said Tatake. “From a clinical trials perspective it can provide remote monitoring options or outcome measures in DCTs.”

The chart also shows that a shift to DCTs was deemed the second most emerging change post-pandemic by the respondents across multiple regions globally.

emerging tech

Click here to find out more about Covid-19’s impact on clinical trials from Revati Tatake’s presentation at OCT West Coast. 

OCT Westcoast Conference

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

Topics in this article:
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena