The COVID-19 pandemic has been a catalyst for change and has forced researchers across industries to implement new technologies and practices in order to survive. The pharmaceutical industry specifically has been tasked with the challenge of developing a vaccine under urgency like never before. While prioritizing research and running trials related to COVID-19, trials for indications across various therapeutic areas were impacted due to a shift in industry focus and supply chain delays. These challenges did not stop our scientists and patients from working against all odds to continue their studies and complete their trials. To prevent the spread of COVID-19 it was absolutely crucial that decentralized trial tactics were adopted in order to keep both researchers and patients safe. Between January and April 2020, the number of trials that started each month declined by 50%, drastically slowing developmental timelines for many researchers. According to McKinsey & Company, patient’s access to trial sites was reduced by 80%. How did the industry combat this?

Fully Decentralized, Hybrid and Fully Centralized Trials

Physicians, patients and researchers had no choice but to implement remote monitoring and trial tactics to continue their trials.  Due to this shift, their comfort with remote trials has increased greatly. Fitness wearables, apps on smartphones and virtual meetings allowed data to be collected regardless of location. Patients have also expressed increased satisfaction and higher retention rates with remote monitoring capabilities especially those involved in rare disease trials that don’t have multiple study sites. The option to complete parts or all of the trials remotely allows patients who previously wouldn’t have been able to participate in trials due to time, resources or accessibility, the opportunity to do so.

Challenges Within the Industry 

With the rapid development and implementation of new technologies it is important to closely monitor potential errors. In any trial, data quality is crucial to the success of a trial and there is no room for error. Implementing technology like real time tracking can help reduce error by detecting signals more frequently. Patients also have varying levels of comfort and knowledge relating to technology. Before initiating a trial, researchers are spending more time on patient-centric trial designs to reduce the room for error; and patient education to help familiarize patients with how to work the technology the trial uses. Especially in a virtual context, maintaining engagement throughout each phase of the trial and providing technical support will help the trial run smoothly.

Combatting Challenges and Changes within the Industry

This change in the industry has also opened up positions for experts in remote trials to join research teams.  Unlike before, clinical trial managers and research specialists can work almost entirely remotely.  Software platforms like Curebase are designed specifically for decentralized research with benefits like increased diversity in patient populations, cost savings and faster enrollment. Digital Clinical Trial platform Medable landed $304 million in series D funding. It is user friendly, highly scalable and extensively vetted, having completed more than 150 studies that included hybrid, remote and onsite trials. The regulatory agencies that are responsible for ensuring safety and enforcing guidelines and protocols like the Danish Medicines Agency are developing frameworks specifically for monitoring decentralized trials.

Each component and agency involved in the clinical trial process has adapted methodologies to accommodate remote trials. Dr. Michelle Longmire, CEO and cofounder of Medable, said “Patients need the life sciences industry to continue innovating at this pace. By working at the intersection of speed, safety and science, we believe we can meaningfully reduce the barriers to drug development – and ultimately, enable more effective therapies for people all over the world.” As we move forward, it is important to address each challenge as it comes and see it as an opportunity for growth rather than a setback. Remote trials are here to stay and have already transformed the way data is collected and patients are monitored. With the implementation and discovery of new technologies the possibilities are endless and we can continue to develop treatment options for patients in need.

The PharmaOut team remains committed to doing our part to fight COVID-19 and help keep our families safe. Our team of expert recruiters and consultants have years of experience to assist our clients in successfully continuing their business with our staffing, consulting, HR and investigator meeting services. Please contact us if you would like to discuss how PharmaOut can be your strategic partner.

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