By Joseph Suttner, VP of Clinical Operations, PellePharm Inc.
Clinical development is a delicate balancing act. Our industry works tirelessly to create the perfect union between the right drug, the right target, the right patient, and so on. When it comes to clinical enrollment, a slew of additional factors must be put into consideration. When you throw in a worldwide pandemic, it’s a whole new ball game.
Did you know that over 44 percent of all ongoing clinical trials have been disrupted during COVID-19?
The timely enrollment and progression of clinical trials is critical for a pre-commercial biotech company, as delays can keep treatments from getting to patients and cost an organization significant money and reputation. Even the most experienced companies can face challenges when enrolling patients in their trials. When adversity strikes, it truly requires an all-hands-on-deck approach to stay the course and come out unscathed on the other side.
When we were working to complete enrollment for our Phase 3 study of patidegib in 2019, we faced our share of study challenges. At a certain point, however, we knew it was time to put our foot on the gas and accelerate the effort — our patients deserved it. With a laser sharp-focus on delivering to patients and investigators, and a PellePharm mantra that “disease doesn’t take a day off,” we were able to exceed expectations. Our clinical team drove the study to complete enrollment early — oversubscribed with 174 patients instead of 150 — in just eight months across 50 sites in the U.S. and Europe, no easy feat for a rare disease.
When COVID-19 hit, the strength of our clinical trial was paramount. Since the trial had already exceeded enrollment, we were able to avoid significant timeline delays and provide a significant buffer for dropouts.
What other factors contributed to PellePharm’s clinical success? Well, I can confidently tell you that it has more to do with hands-on involvement than it does with anything else. Here are my top four recommendations for sponsoring a successful clinical trial, especially in a COVID-19 world:
1. Embrace a spirit of collaboration.
As I mentioned before, clinical development requires an all-hands-on-deck approach. When the COVID-19 pandemic first hit, nobody knew exactly what we were up against. As such, it’s beneficial to embrace a collaborative mindset from day one. From patients, to investigators, to advocacy groups — we’re all in this together. In order to be truly collaborative, communication and transparency should be valued and prioritized. With early action that included surveying trial sites to assess frontline impact and needs, we were able to nimbly implement operational strategies such as remote follow up visits and home delivery of study drug. Our clinical team even went the extra mile to personally search for and provide N95 masks when they learned that certain trial sites were running low on personal protective equipment. This was crucial action in keeping sites running, especially in hotspots like Italy and the UK. Of course, we showed the same care for patients — ensuring all received personal care kits of materials like hand sanitizer to stay healthy.
2. It’s all about the relationships.
Building direct, personal relationships with each trial site, and really taking the time to find out what’s needed to move swiftly, should be your biggest priority as a trial sponsor. This becomes even more pertinent during times of uncertainty. Get to know the key stakeholders of your trial. Understand their needs and go the extra mile to ensure those needs are being met. Investing in meaningful relationships and building a foundation of trust will pay you back tenfold. It’s essential that you place value in building strong relationships from the start so that when a crisis such at COVID-19 hits, the foundation has already been set. When various medical centers, such as the Royal Hospital in England, began diverting staff to focus solely on coronavirus patients, we relied on our previously established relationships to keep communication lines open.
3. It’s not all about the investigator.
Yes, it goes without saying that fostering a good relationship with your PI is invaluable, but let’s not forget about the study coordinators. It’s these individuals who are truly in the trenches and doing the lion’s share of the work on a day-to-day basis. Not only do they spend the majority of time with patients, but they take on a slew of tasks that might not be as obvious. They are coordinators, nurses, data managers, and travel agents — assisting patients on every step of their journey as a clinical trial participant. It’s important to be in tune with their needs and offer genuine support. We make sure to foster these coordinator relationships and encourage a direct line of contact with our team. Again, it’s all about relationships.
4. Keep the patient at the center.
At the end of the day, we’re all in this business to make a meaningful difference for patients. We must keep this is mind at every stage of the drug development process, from trial design to commercialization. During a clinical trial, it’s important to remain aware of patient burden. This is even more vital when you’re dealing with a pandemic. In order to reduce patient burden during COVID-19, we reevaluated our processes and reduced the length of patient visits. It is equally as important to keep a close relationship with your patient advocacy group. For us, leveraging our trust and relationships with the patient advocacy groups that represent the Gorlin syndrome community played a significant role in our success.
Now more than ever, it is vital to approach clinical development with strategic thinking, focus, and thoughtful execution. COVID-19 has rocked the boat, but we are an industry that rises to the occasion when adversity comes crashing our way.
About The Author:
Joe Suttner, VP of clinical operations for PellePharm, has over 20 years of drug development experience in both the biotech and pharma industries. Prior to joining PellePharm, he was part of Dermira’s management team involved in project management, alliance management, and NDA/sBLA submission activities. He also participated on acquisition and partnership teams for the company’s first biologic program. Previously, Suttner provided leadership to Allergen Research Corporation (ARC), now Aimmune, as VP of clinical operations. At Aimmune, he helped establish a network of food allergy centers in collaboration with patient advocacy groups. His experience also included roles at Amgen, Allergan, Ipsen, and Peplin. Suttner earned his BA at California State University Long Beach and his MBA at the University of Liverpool.