By Joseph Suttner, Vice President of Clinical Operations, PellePharm Inc.
Clinical progression is a sensitive balance. Our industry works tirelessly to create the best union between the right drug, the right goal, the right patient, etc. With regard to clinical recruitment, a number of additional points should be taken into account. When you release a global pandemic, it’s an all-new ball game.
Did you know that more than 44% of all ongoing clinical trials were discontinued COVID-19?
Timely recruitment and progression of clinical trials is essential for a pre-commercial biotechnology company, as delays can prevent remedies from reaching patients and charge the organization a lot of money and reputation. Even companies with the utmost experience can face demanding situations when enrolling patients in their trials. When adversity strikes, an off-road technique is needed to stay on course and come out unscathed from the other side.
When we were getting to the full record for our Phase 3 patidegib exam in 2019, we faced our percentage of exam challenges. At one point, however, we knew it was time to step on the accelerator and speed up the effort; our patients deserved it. By focusing on patient and research care, and PellePharm’s mantra that “the disease doesn’t take a day off,” we were able to exceed expectations. Our clinical team took the exam to full early recruitment, with an excess of applications from 174 patients instead of 150, in just 8 months at 50 sites in the United States and Europe, which is no small thing for a rare disease.
When COVID-19 arrived, the strength of our clinical trial was paramount. Since the test had already exceeded the number of records, we were able to avoid significant delays in the schedule and provide significant margin for abandonments.
What other points contributed to the clinical success of PellePharm? Well, I can tell you with confidence that it has more to do with practical participation than anything else. Here are my top 4 recommendations for sponsoring a successful clinical trial, especially in a coVID-19 world:
1. Be collaborative.
As I mentioned earlier, clinical progression requires a practical approach. When the COVID-19 pandemic first occurred, no one knew exactly what we were up against. As such, it is advantageous to adopt a collaborative mindset from day one. From patients to researchers and advocacy groups, we’re all in the same boat. In order to be collaborative, communication and transparency must be valued and prioritized. Through an early action that included an inspection of the verification site to assess the effect and needs of the front line, we were able to quickly implement operational methods such as remote follow-up visits and home delivery of the medicine under study. Our clinical team even went to extra length to conduct non-public studies and supply the N95 mask when they learned that some control sites lacked non-public protective devices. This was a very important action to keep the sites running, especially in hot spots like Italy and the UK. Of course, we’ve shown the same care to patients, making sure that all non-public care kits that contain hand sanitizers are healthy.
2. These are relationships.
Building direct and non-public relationships with each verification site, and really taking the time to locate what it takes to act quickly, deserves to be your top priority as a test sponsor. This becomes even more applicable in times of uncertainty. Meet key stakeholders in your test. Understand your wishes and make additional effort to make sure they are fulfilled. Investing in meaningful relationships and building an acceptance as true based will earn you ten times more. It is imperative that you put a price on building strong relationships from the beginning so that when a crisis like COVID-19 occurs, the foundations are already laid. When various medical centers, such as the Royal Hospital in England, began diverting staff to focus only on coronavirus patients, we rely on our past relationships to keep lines of communication open.
3. It’s just the researcher.
Yes, it needless to say that encouraging a smart appointment with your lead researcher is invaluable, but let’s not examine the coordinators. These are the other people who are actually in the trenches and who do the highest percentage of daily work. Not only do they spend most of their time with patients, but they also have a multitude of responsibilities that would possibly not be so obvious. They are coordinators, nurses, knowledge managers and travel agents, who assist patients at each and every level of their adventure as participants in a clinical trial. It is vital to be aware of your wishes and to offer them genuine support. We are committed to fostering these coordination appointments and fostering a direct contact line with our team. Again, it’s about dating.
4. Keep the center.
In the end, we are all in this business to make a significant difference for patients. We want to keep that in the brain at every level of the drug progression process, from trial design to marketing. During a clinical trial, it is essential to be aware of the patient’s burden. It’s even more critical when it comes to a pandemic. To reduce the burden on patients during COVID-19, we have reassessed our processes and decreased the duration of patient visits. Maintaining a close appointment with your patient advocacy group is equally critical. For us, leveraging our acceptance as true and dating with patient advocacy teams representing the Gorlin syndrome network has played a key role in our success.
Today, more than ever, it is the technique of clinical progression with strategic thinking, concentration and execution considered. COVID-19 has shaken the ship, yet we are an industry that rises to the situation in which adversity stands in our way.
About the Author:
Joe Suttner, vice president of clinical operations at PellePharm, has more than 20 years of experience in drug progression in the pharmaceutical and biotechnology sectors. Prior to joining PellePharm, the component of Dermira’s control team involved in assignment control, alliance control and NDA/sBLA bidding activities. He also participated in component acquisition and ownership groups for the company’s first biological program. Previously, Suttner served as vice president of clinical operations at Allergen Research Corporation (ARC), now Aimmune. At Aimmune, he helped identify a network of food allergy centers in collaboration with patient advocacy groups. His delight has also included roles in Amgen, Allergan, Ipsen and Peplin. Suttner earned his bachelor’s degree from California State University in Long Beach and his MBA from the University of Liverpool.
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