As a pharmacist and scientist, Dr. Leen Kawas understands the importance of running high-quality clinical trials. Through that lens, she can see where many studies go wrong: A complete disconnect between all the key stakeholders in the equation. The science and medical sides of the trial, for example, must work in tandem, while patients and researchers do the same. When that happens, the quality of the data and overall patient experience can serve as the main focus of the clinical trial, ensuring the study yields great results.
The Current Disconnect in Running Successful Clinical Trials
When done properly, clinical trials allow medical teams to harness the power of new therapies for their patients. The studies reveal how well the treatments work, the potential for side effects and complications, and other data vital to the care process.
In order to get clear, concise, and wholly accurate data, all the pieces of the puzzle must fall into place, or the study could fail to achieve its key objectives. Unfortunately, in many studies, there's a lack of clear understanding of the key stakeholders' perspectives at every stage of the process. As explained by Dr. Leen Kawas, the disconnect results in a poor patient experience and low-quality data, decreasing the value of the clinical trial results.
Early Feedback is Key in Developing Protocols and Goals
"It is essential to get patients input early and frequently during study protocol development," says Dr. Kawas. Far too many clinical trials run without any feedback from the patients and other stakeholders until late in the study. That's a big mistake because input from all the stakeholders can help guide the development of effective protocols. Then, using that information, researchers can design a study that supports the following areas.
Operations
Efficient studies have practical components guiding their operations, which is only possible with helpful feedback from all stakeholders. Gathering the input must occur at the beginning of the study to guide the creation of the operations and avoid disrupting the trial at later stages.
Conduct
In addition to excellent operations in place, researchers must put their all into rolling out high-quality study conduct. Feedback can help clinical trial teams decide how to go about recruiting patients, overseeing the study, and reporting the data, for example.
Patient Experiences
Without feedback, it's nearly impossible to fine tune the patient experience as they participate in each stage of the clinical trial. Solid outcomes link directly back to patient participation and compliance, after all, so researchers should ask how it's going early and often.
Results
Clinical trials can only generate helpful data if they're designed around clear questions that tie into the health needs of the patients. Only through timely feedback is it possible to ask all the right questions and ensure the study has the right setup from the start.
Feedback also helps researchers make targeted decisions on how to develop the trial, and then make adjustments along the way. As a result, Dr. Leen Kawas points out that it's important to start asking questions early and keep the input flowing all the way through the end of the study.
Successful Studies Demand Excellent Teamwork from Start to Finish
To run a high-quality study that answers all the right questions, every team member must bring their unique perspective and approach to the table. While doing that, they cannot lose focus of the importance of working as a cohesive team.
The clinical scientists have the duty to create the main hypothesis for the trial, then design the study to challenge that idea. While designing the trial, they need to understand how the treatment should work in treating the condition. They must also have a clear understanding of the disease process to fully answer all the right questions.
Everyone on the medical team supports the clinical scientist's efforts by focusing on the disease presentation and patient safety. The clinical operations team members provide support by ensuring the clinical trial always abides by the set protocols. Their efforts ensure the study runs smoothly, so the medical team can keep their focus on the patient experience and data collection process.
As the data comes through the pipeline, the statisticians and other data scientists verify the quality of the information arriving on their desks. They also focus on identifying important trends, overseeing conduct, and generating reports about the data.
Dr. Leen Kawas urges all clinical trial team members to engage in multi-disciplinary discussions, so everyone can stay on the same page throughout the study. By keeping the lines of communication open, stakeholders can ensure that their studies always land at the top of the quality scale and stay on deadline. In addition, the open dialogue helps keep costs predictable by eliminating the need to revise the trial from the ground up.
Patient Population Understanding Opens the Doors for Better Recruitment
With a clear understanding of the patients who can benefit most from the trials, it's much easier to effectively approach the recruitment process and find the right participants. According to Dr. Leen Kawas, gaining that understanding should begin with interviews with multiple parties.
Clinical researchers should have conversations with healthcare professionals, caregivers, and the patients themselves to learn all they can about the target patient population. Only then can they create the inclusion criteria that will open the doors to the right patients and ensure the study generates excellent data.
In addition to designing recruitment strategies around patients' needs, researchers need to open their hearts and minds to the potential challenges ahead. By doing so, they can better adapt as needed to overcome the obstacles that stand in the way of getting great results. They may even need to adjust their inclusion criteria due to changes in the research environment, such as the approval of new medications.
The clinical trial team can only take this measured approach to study development when they have an adequate budget. Without the right level of funding, they may not have the ability to use all their tools and adjust their approach as needed for the success of the trials.
As they use their funding to keep the clinical trials generating quality data, it's important for researchers to always keep the patient experience in mind. If they don't, their hard work in recruiting patients could end up wasted as individuals choose to stop participating.
Researchers should keep in mind that patients simply want to improve the quality of their lives and recover from their ailments by finding helpful therapies and cures. So, trials that require too much time and effort from patients have the risk of ending up with high dropout rates that impact the quality of the study data.
Stakeholders Must Keep Collaborating After Study Begins for Best Results
Clinical trials have the best chance at success when set up correctly from the beginning, but the work does not end there. As Dr. Leen Kawas notes, all key stakeholders must keep collaborating in abiding by the protocols and achieving the study goals to see the trial through to the end.
By working together closely, the clinical trial team can ensure patients have the best possible experience and protect the quality of the data generated every step of the way. Their collaboration can identify potential problems before they arise, making it easy to adjust the approach without losing time and money.
Through that process, researchers can reveal the effectiveness of the drugs and other treatments that help patients most. Then, they can share their data with the world to assist health professionals in helping their patients lead healthy, full lives.
How Successful Studies Support Dr. Leen Kawas in Her Life's Work
Dr. Leen Kawas has a passion for using medical research to help create solutions that benefit patients in incredible ways. She used that passion to launch M3 Biotechnology as a co-founder and promote its growth through the rebranding to Athira Pharma and beyond.
Her leadership prowess helped the company grow and eventually go public, making her the first woman in Washington State to take a technology and biotech company public. Throughout her career, she has earned many exceptional awards, including the Life Science Entrepreneurial Achievement Award from the Life Science Washington Institute in 2020.
While running Athira Pharma, she invented ATH-1017, a potential therapy for neurodegenerative diseases, along with many other drug candidates. Through that process, she was given the chance to see the power of clinical trials in revealing how well certain drugs help patients. She also got to see, firsthand, where trials can fall short, which inspired her to speak up about the importance of collaboration from all key stakeholders in each study.