Welcome back to the second part of streamlining clinical your trials for 2024. In this last segment, we’ll uncover additional key tactics that leaders like you can employ to not only navigate the complexities of trial management but more importantly drive your projects towards envy-inducing success. 

5. Learning From the Best, Don’t Reinvent the Wheel

The power in collaboration and networking is nothing that you haven’t heard, but how do you do it effectively? Growing your connections on LinkedIn or expanding the list of names in your department is not going to move the needle.  Creating synergies with other industry leaders, academic institutions, and research organizations is something that requires reaching out and connecting authentically.  With minimal effort, you can create a united front, combining different strengths and perspectives to achieve common goals. Think of it as assembling a dream team of experts, each bringing their unique superpowers to tackle healthcare challenges. 

A great example of this is the collaboration between Gilead Sciences and Galapagos NV. This high-stake partnership hoped to leverage the different strengths of both companies by combining Gilead’s expertise in drug development and commercialization with the innovative discovery platform of Galapagos with the shared  goal of increasing the speed at which new and transformative treatments can get to patients without sacrificing quality or safety.  It wonderfully demonstrates how strategic partnerships can be beneficial for all involved. 

The collaboration between Pfizer and BioNTech in developing the COVID-19 vaccine is an example that everyone can relate to. During that unprecedented global health crisis, that not many will soon forget, these two companies joined forces to use Pfizer’s vaccine development capabilities with BioNTech’s mRNA technology. The result was one of the world’s first and most effective COVID-19 vaccines, developed at an unprecedented speed. This partnership not only shows us the power of collaboration in addressing urgent global health needs but also set a new standard for rapid vaccine development. 

Pooling knowledge, resources, and expertise can help companies achieve what might be impossible alone.  Innovation has led to amazing breakthroughs that we all enjoy living in the 21st Century, but innovation is the byproduct of collaboration and strong partnerships. For leaders in the industry, fostering these connections is key to staying at the forefront of medical innovation and guiding what medicine will look like for patients tomorrow. 

6. Streamlined Protocols: The Blueprint for Success

Crafting a clear, concise, and well-structured protocol is just like when a pilot inputs clear and concise coordinates into the onboard GPS to fly from San Diego to Hawaii, so that when they are over the open ocean there is a path that is easy to follow with no risk of straying off course.  If it works EVERY single time to ferry people across the pacific, it will work in your trials.  

Let’s look at an example of streamlined protocols in action. Genentech has a relatively rigorous approach to their clinical trial design and focuses on advanced software tools for protocol development.  Their approach ensures that each aspect of the trial, from patient selection criteria to data collection methods, is meticulously planned. “We need to be strategic in designing these trials to ensure they can answer the right questions. That’s the only path to determine the relative efficacy and safety of different medicines, or combinations of medicines, in specific patient populations,” says Nancy Valente, M.D., Vice President of Global Product Development for Hematology and Oncology. This attention to detail streamlines the trial process while it also enhances the quality and reliability of their findings. 

Regeneron Pharmaceuticals has also set a high standard for protocol efficiency. By adopting adaptive trial designs, Regeneron makes sure that their protocols are flexible and can be modified based on interim results.  Because of this, they can make decisions more quickly and reduce the number of unnecessary delays.  Adaptive designs can also help you accelerate your trials more swiftly from early-phase I to pivotal phase 3 trials based on the analysis of data in real-time. 

The key takeaway here is the value of investing time and effort into your protocol development. Like the airliner headed to Hawaii on GPS guidance, a streamlined protocol acts as a compass, guiding the trial team through each phase of the study. It makes sure that everyone involved, from researchers to participants, understands their roles and the objectives of the trial clearly.  Moreover, a well-crafted protocol ensures that patient safety is always the top priority, and that the trial’s scientific integrity is upheld. 

7. Patient-Centric Approach: The Heart of Clinical Trials

Placing patients at the forefront of every decision and action is paramount and adopting a patient-centric approach is fundamental. Prioritizing their safety, comfort, and overall experience does more than making the study ethically sound, but it also significantly impacts the success of the trial because happy patients stay.  Patients who feel valued and cared for are more likely to stay engaged and more importantly COMPLY with the trial requirements. 

An example of patient-first thinking is the Pfizer, Novartis, and Eli Lilly initiative to set aside competition to form the consortium called “Patients to Trials“. This initiative focused on understanding and addressing patient needs, ranging from providing clear information about the trials to ensuring patient comfort during the process. “If we can compress the time it takes to enroll a trial, we can get medicines to patients much faster,” says Jeff Kasher, formerly vice president of Clinical Innovation and Implementation at Eli Lilly, and president of Patients Can’t Wait. The results?  Not only did patient retention rates improve, but the new approach gathered richer, more reliable data, enhancing the quality of their clinical trials. 

Another stand example of putting patients first is Amgen’s focus on patient engagement, especially in their oncology trials. They have included strategies such as patient advisory boards and feedback loops to make sure that patient perspectives are included into their trial designs. This approach has helped trials sponsored by Amgen report higher patient satisfaction and retention, which has contributed to the successful completion of many of their studies. 

8. Continuous Monitoring and Adaptation: The Agile Edge in Trials 

The final key component in modern clinical trials is continuous monitoring and adaptation. Being agile allows for quick adjustments in response to changing dynamics of a trial such as interim findings, challenges, or the changes that may occur in the regulatory landscape.  

For instance, Roche adopted the approach to utilize real-time data analytics to continuously monitor trial progress and identify areas needing adjustments more quickly. According to a Roche report, this proactive approach has allowed them to make timely decisions, ensuring their trials remain on track and relevant. 

Merck has incorporated flexibility into their protocols through their adaptive trial designs, they can modify aspects of their trials based on interim results without compromising the integrity of the study. “Adaptive designs appear to hold promise for more efficient drug development by allowing sponsors to adjust the trial as results become known. “Adaptive trials are one way of helping to push critical decisions earlier in the drug-development process,” says Jerald Schindler, Dr. P.H., VP of biostatistics and research decision sciences at Merck Research Laboratories. This flexibility has been crucial in accelerating the development timelines of their new therapies. 

Continuously monitoring and quickly adapting is more of a forward-thinking mindset than a methodological way to conduct trials.  Embracing this agility means staying prepared for change, and ready to adjust as new challenges present themselves, and adopting this strategy as a leader, will help your trials remain strong, innovative, and most importantly… complete.

From smart budgeting to embracing the latest tech, and from patient-focused strategies to staying agile with continuous monitoring, we’ve covered a lot of ground. We’ve seen how collaboration can amplify our efforts and why having a clear protocol is like having a secret roadmap. Each point is a piece of the puzzle, and when put together, they create a picture of efficiency, innovation, and success. So, as we close 2023, remember that staying ahead means you must set the pace.  Here’s to making your clinical trials in 2024 not just successful, but a benchmark in innovation!