GlobalData Conducts Comprehensive Survey of Clinical Professionals

By Sarah Hof

Countless aspects of clinical trial operations have been disrupted in the last 10 months. To explore new pain points and shifts in trial planning across the industry as a result of the pandemic, GlobalData conducted a survey to gather metrics from professionals across the world, as reported by Pharmaceutical Technology.

Overall, GlobalData found that patient recruitment was the most significant challenge to clinical teams across the world. Over 20% of all respondents from each region (North America, Asia Pacific (APAC), Europe and Rest of World (RoW)) reported that patient recruitment due to safety concerns was the biggest challenge they face, with nearly a third (32%) of all APAC participants saying so. 

A significant portion of respondents noted that the pandemic was forcing them to cancel or delay their studies. Nine percent of APAC participants, 16% of European participants, 21% of North American participants, and 22% of the participants from RoW reported as such. 

You can read the full article and see all survey results here

The Future of Decentralized Trials

By Sarah Hof

Decentralized trials are here to stay, and major pharma companies have already bought into their effectiveness, as reported by FierceBiotech. While the operational component of decentralized or remote trials once posed a logistical hindrance, the pandemic has forced rapid advancements in the means to ensure an increasingly smooth experience for both patients and investigators. 

A lesser-known boon to remote trials’ wider adoption was how during the spring of 2020 when the pandemic was nearing its height, the FDA issued an announcement urging sponsors to shift to remote operations wherever possible in trials in order to continue research. 

Paul Kirchgraber, M.D., who is the CEO of Covance was quoted saying that “We anticipate that by the end of 2021, the majority of our new studies will include a decentralized component.”

Read the full article here

A Look Inside Clinical Trials During COVID-19

By: Sarah Hof

It’s no longer surprising to hear that many aspects of the pharmaceutical industry have been disrupted due to the far-reaching effects of COVID-19. Clinical trials are no exception, due to the myriad of moving parts it takes to conduct a clinical trial effectively. Hospital maintenance, doctor availability, and the willingness of patients to participate are areas impacted and if one of these factors is unreliable for whatever reason, a trial can be usurped and critically delayed.

We wanted to get an inside look at how clinical trials are running nowadays, so we invited Dr. Niaz Ausaf, the Principal Investigator of Auzmer Research in Lakeland, Florida to share some of his observations and insights.

Regarding his staff, Dr. Ausaf reported that in the spring everyone had to work remotely, and for a period of two weeks back in March his office was not permitted to see patients in the office. Now, approximately 80% of Dr. Ausaf’s staff are back in the labs resuming work.

Of the current workload in his office, Dr. Ausaf stated that “the flow of clinical trials is at the same ferocity as before.” Also, he notes that patient compliance in terms of completing diaries and attending onsite visits is close to 100%, reflecting the pre-pandemic rate.

A definitive change Dr. Ausaf has seen is the newly necessary budgeting for PPE, or personal protective equipment. He reported that his office now plans for six times the cost of PPE before COVID-19, and nearly all sponsors have been readily accommodating.

Another difference reflects the reluctance of some patients to leave their homes for unnecessary purposes, especially to spend time inside of a medical clinic. To be more accommodating towards patients, Dr. Ausaf sees the potential in new collaborations between sponsors and local pharmacies, allowing study subjects to pick up investigational product in a more convenient manner.

Of these collaborations, they are a new commonality offered for patients in clinical trials. A global survey conducted earlier this year by Medidata found that 45% of clinics and hospitals had transitioned near fully from in-person visits to virtual visits (source). 

As Dr. Ausaf looks to the future of clinical trials, he sees plenty of opportunity for innovation that have been made obvious by the new necessities brought by COVID-19. For example, he believes that the “virtual trial” model is not something that will go away, but rather will take hold in the space. In fact, the same survey found that a third of respondents have amended study protocols to include some degree of telemedicine (source).  

To that end, he sees sponsors potentially partnering with the home healthcare industry to facilitate different aspects of conducting a virtual trial. Sponsors may send nurses to patients’ homes when necessary, and team up with online recording software such as e-diaries, and consumer-facing medical devices such as Bluetooth-enabled stethoscopes. These devices and other home monitoring technologies would enable a patient to monitor and report his or her own vital signs.

Dr. Ausaf has helped forge a viable plan for his clinic, Auzmer Research, should these predictions come to fruition. He noted that his clinic has already been presented with two virtual trial opportunities.

On a macro scale, he believes that hospital networks with the means to do so will start buying independent research sites, which will mitigate the risks of using unknown or unverified sites. Sponsors have seen the negative effects of scrambling for doctors and clinics in the wake of COVID-19, and the experience is not one that sponsors would be willing to repeat.

It is clear that while the world of clinical research is evolving at a rapid pace, we must adopt innovative digital tools and collaborative platforms to be best positioned to meet these challenges and drive the best possible outcomes for patients.

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