This quarterly eNewsletter will keep you informed of regulatory news and trends as it relates to the clinical development industry and insights from PRA's Global Regulatory Clinical Services team.

This edition will focus on the impact of COVID-19 on IMP supply and management of trials as well as how PRA is continuing to support clinical development activities with minimal interruptions.

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Edition Highlights:

Country Considerations for Remote Monitoring and Source Data Verification

Whilst COVID-19 is affecting all our day to day lives we need to remember the greatest impact is in hospitals and our health service. All of us have heard about the risk/benefit ratio for a trial, now we need to take that to the next level, based on the current situation. We should not forget that even in the midst of COVID-19, many patients are seeing benefits from clinical trials and their health greatly depend on these trials continuing. On the other hand, logistics of drug supply, investigator/nurse availability and site priorities, in conjunction with country regulations, all play a key part in whether to continue with the clinical trial, suspend new recruitment or close the trial altogether.

All countries are providing individual guidance on the situation and how to proceed in terms of progressing non COVID-19 trials but there is one thing each and every country is agreed on and that is that the safety of the patient is paramount. In line with the EMA guidance issued on March 20, 2020, March 27, 2020, and April 28, 2020, risk assessments should be made for each ongoing clinical trial....

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Direct to Patient Delivery of Investigational Product

As a result of the COVID-19 pandemic travel restrictions of varying degrees have been imposed in most countries, consequently patients are not able to obtain their clinical supplies directly from the sites. In response to this situation, PRA has established a method of delivery of clinical trial supplies direct to the patient.

Before implementing Direct To Patient (DTP) consider the following:

  • Has discussion and approval with sponsor occured?
  • Is DTP allowed per country regulations? If not, are deviations allowed in response to COVID-19?
  • Are there safety concerns with providing IP at home?
  • Does patient agree to receive IP at home?
  • Is CEC/LEC/IRB/RA approval required?
  • Who will contract courier (PRA, Site, Other)? Consider timelines and maintaining patient privacy.
  • Are all protocol deviations documented?
  • Have you ensured no patient personal information is provided to PRA or Sponsor?
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Did You Know?

In Belgium, we have to accommodate up to four languages in our clinical trial applications to both Regulatory Agency and the Ethics Committees - Dutch, English, French and German!

Virtual Trials and the Regulatory Puzzle

Where is that one guideline providing all regulatory considerations for virtual trials? The one document that clearly describes all requirements without much room for interpretation? Unfortunately this Hitchhiker’s Guide to the Galaxy of Virtual Trial does not exist (yet). The regulation of virtual trials is still in its infancy and only just starting to catch up with the development and demands in the field of human research.

However, while there is not one well-established guidance that everyone can adhere to globally, Health Authorities actively support virtual studies and digital tools and there are some existing initiatives, regulations and guidance documents - scattered like puzzle pieces - that can be taken into account, if a study includes virtual aspects. So, let's take a look at the relevant areas and a few of the (missing) pieces.

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Benefits & Challenges of Virtual Trials

Compared to traditional study models, the strength of the virtual trials concept is the ability to make it easier to include patients from diverse regions, rural areas, and different socio-economic backgrounds in clinical trials. By eliminating the need to travel certain distances and reducing the discomfort and cost associated with that, patients from rural areas and those coming from unfavorable socio-economic backgrounds will more likely participate in the trial. Being able to receive treatment in a comfortable space, a patient’s home, can make patient retention rates significantly higher.

We can take rare diseases as an example. These affect 1 person per 2,000, or less, and this can be a big challenge when it comes to clinical trials for many reasons. Reaching the required sample size when the patient population is so low is a huge challenge, and possibly having that population spread across a vast geo-political area just adds to complexity. Also, in certain cases treatment and/or site visits, need to be done abroad which poses a challenge not only from the logistical and financial points of view, but also from the bureaucracy and regulations associated with being treated abroad.

Using virtual channels (e.g. social platforms, targeted e-advertising, etc.) grants greater access to the wider population making it easier to reach out to target populations and can result in faster recruitment. This can be a challenge if the targeted population is elderly, and not that familiar and comfortable with technology. However, in a world that is advancing in this field, this should be less and less of a challenge and concern moving forward.

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The Future is Here

PRA Health Sciences and Janssen have partnered on the CHEF-HF trial, which is the first ever interventional study being conducted in a completely decentralized manner and it wouldn't be possible without mobile health technology. View the video below to see our mobile health platform.

Mobile Health Platform MHP
Mobile Health Platform (MHP)

Now, with the challenges PRA, our Clients, Investigators, sites and patents continue to face because of COVID-19, the case for integrating mobile health technologies into clinical trials grows stronger. PRA's complete Mobile Health Platform (MHP) provides a comprehensive array of products that enable mobile technology integration into our clinical studies. The technology seamlessly integrates into the mobile lifestyles of patients and streamlines experiences for sites and other clinical trial stakeholders.

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Interested in learning more about any of the information mentioned here or want to talk with someone about a specific clinical study?

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