This May, PharmaOut attended the Marcus Evans Evolution Summit in Boston, MA. The summit brings clinical trial executives and solution providers together to discuss challenges and innovation within the industry as well as market development and new strategies to help bring products to patients in need. At PharmaOut, we provide staffing and consulting services for our clients. Our consultants know the ins and outs of the industry and our recruiters are passionate about finding the best fit candidates for our clients. At Marcus Evans we had the privilege of meeting with leaders who are running ground breaking trials and industry experts who shared their knowledge and experience with attendees. Let’s break down some important takeaways from this summit:

Hybrid Clinical Trials due to COVID-19

55% of active ongoing clinical trials have transitioned to remote and virtual execution. While this was done to prevent the spread of COVID-19, many investigators and patients realized there were many more benefits to remote trials than they thought before. 60% of investigative sites reported having had no prior experience with remote processes and solutions before the pandemic. Even with the initial difficulties, investigators found remote trials allowed them to reach more patients and patients found themselves saving time and money by not having to travel to the site as frequently.

Navigating the New Normal from the Research Sites’ Perspective

When asked why a sponsor didn’t move forward with a decentralized trial, not being comfortable or legal/insurance issues wasn’t their main concern. Their answer most often was not having a patient population and patient safety. Researchers predict as more decentralized trials are run; the more patients will be willing to participate. Clinical Trials Arena reports, “a record number of around 1,300 trials with a decentralized and/or virtual component will likely initiate in 2022 representing a 28% increase from 2021.” Taking into account the challenges and benefits, researchers can expect to reduce clinical trial length.

One challenge that the investigators are facing as a result of an increase in decentralized trials is finding on site coordinators due to a lack of funding and lack of experience.  PharmaOut has been working with many sponsors on solutions to identifying study coordinators for their sites.  Please reach out to us if you would like to discuss.

Patient Focused Drug Development

A patient focused directive is a systematic approach ensuring that patient experiences, perspectives and needs are captured during drug development and evaluation. Patient-centric trials recruit the number of patients needed to run the trial in an average of 4 months compared to the average 7 months that it takes non-centric trials and is also able to recruit nearly double the number of patients in half the amount of time. The FDA has created a special initiative titled the Patient-Focused Drug Development Program. This program provides strategic, regulatory, program, and policy assistance within the Center for Drug Evaluation and Research (CDER) to facilitate the incorporation of patient input into decision-making. Informed patients are crucial to the success of a trial.

With the biotech and pharmaceutical industries embracing remote trials and constantly changing, it is crucial to encourage collaboration to develop new ideas and share past experiences. We are thankful to the Marcus Evans team for creating a space for investigators, sponsors and CRO’s to connect and discuss both their challenges and accomplishments.  This exchange of information and an open line of communication enables individuals and companies in the pharma/biotech industries to put their talents together in an effort to bring more drug products and medical devices to market.

If your team is in search of a staffing partner please email info@pharmaout.com to set up a consultation with one of expert recruiters. We look forward to connecting with you.

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