Dr. Leen Kawas, an inventor, leader, and entrepreneur, shared her insights in improving clinical trial and clinical study result applications. She is a pharmacist who has clinical experience, as well as managerial experience. This unique position provides her with insight into just how disconnected the scientific, patient-related, operation, and medical elements of a study really are. She believes that it’s critical to identify and understand all stakeholders in the industry at all stages. In doing so, it may improve the efficacy of any trial.
The goal is to find a way to ensure data quality and patients are the main focus of a clinical study. Kawas says it’s critical to work collaboratively and innovatively to achieve this and makes several recommendations on how to do so.
Get Patient Input Earlier One of Dr. Kawas’ core recommendations is to get input from patients early and often during the study protocol development. It’s beneficial to rely on feedback from stakeholders throughout the process, especially at this stage. That feedback can become useful in various ways and may help with the study’s design and its decisions. This leads to several benefits. First, it allows for the highest possible quality clinical data and study conduct. This data lays the foundation for the best possible outcome. It also helps to improve patients’ experiences, which helps to ensure that the patients’ needs are being met. Using this input creates an opportunity for the study to provide clear and concise questions that are relevant to both the disease outcome and the patients themselves. It also helps to provide feedback on the core operational components of the study. At the core of the process is the patient. To create the study goals and what information the study provides, it is critical to start the process with the patient. That may include not just the individual but also the health care providers and the caregivers. It also means taking into consideration the product and the clinical team. That team includes most of those involved in the process, including clinical operations, clinical sciences, medical and safety, data management, regulatory, and statistics team members. Fine Tune the Study to Address Needs The next area of focus, according to Dr. Kawas, is to create unity between all team members. Each of the team members needs a specific emphasis or focus as well. She breaks this down by each person. For example, the clinical scientist has a specific goal of creating the hypothesis, then designing a trial that supports the drug’s mechanism or action. This person also is responsible for the pathology of the disease. The clinical operations team is responsible for concentrating on the study administration. This helps to ensure there is cohesive focus and a smooth process in place. This team works specifically in accordance with the protocol for the study that has already been created. The medical teams have a different but specific focus. Their focus is on the clinical presentation of the disease. They also help to focus on the safety of all of those participating in the study. In addition to these positions, the statistician and data scientist work to guide assumptions. They help to oversee the quality of the data and report on any trends that occur during the study’s design, operational conduct, and reporting. Each group or person has their own specific tasks but contributes to the shared goal of all parties involved. When there is early and continued communication among these stakeholders, the result is a more favorable study with better information and better results. It can also help create more efficient timelines and eliminate certain study-related expenses. Additionally, gathering patient feedback early may improve patient recruitment and retention, which ultimately reduces the need for amendments to the study protocol. Focus on Improving Recruitment for Patients in the Study The use of patient interviews can significantly improve the outcome when it comes to recruitment for a study. Interviews can help to provide better information and a more current understanding of who the ideal patient is. It can also help to complete more thorough interviews with caregivers and healthcare professionals. By putting more focus on these interviews and insights, it may be possible to better understand the patient population and implement patient-tailored strategies. This can be helpful in addressing operational challenges early on, which ultimately leads to more effective recruitment outcomes. A good starting point is to “develop inclusion criteria,” according to Dr. Kawas. This is critical to ensure that the study is realistic. In doing so, she says that everyone participating in and managing a study needs to be open about the challenges they may face and that when those challenges do arise, they must adapt. Participants need to appreciate that the environment the study is running in will also impact the characteristics of the population. That includes the approval of new drugs. Clinical teams need to anticipate who they need within their study, making a better effort to ensure those in the study are the best possible fit for the outcomes and goals of the study. At the same time, they also have to recognize that there will be mistakes in the process. That is normal and should be expected. As such, they need to be willing to amend the inclusion criteria when needed. When teams take the necessary steps to recognize challenges and then resolve them, it is possible to mitigate the impact these mistakes have on the quality of the study. Another component of this need is to encourage drug developers to create study budgets that meet initial needs and are also tailored to recruitment strategies. To do this, they should use all of their tools to formulate inclusion criteria. This budget may include everything from recruitment platforms and applications to television, radio, and social media. Each of these components contributes to the end result. Patient retention within the study is likely to improve when all participants consider the patient experience early on, Dr. Kawas states. Many times, patients and their families will commit to research if it is going to support finding new therapies and cures for what they are facing. However, dropout rates will increase when the trial itself is simply too demanding and exhausting, or it does not have strategies in place to support caregivers and patients. The importance of mitigating issues that lead to increased dropout rates is obvious, as these rates directly affect the study, the data, and the quality of the results.
The Study Focus Needs to Continue Over Time Strong study initiation is key to any study’s success. However, it does not mean the hard work on the project is over, and that updates and changes can be pushed to the side. Rather, Dr. Kawas says, the work has just begun at this point.
All stakeholders must work together throughout every stage of the study, including overseeing the project’s operations. They also need to consider how the study impacts the patients and the data quality.
There are many tools available to support this process, including numerous technologies, allowing stakeholders to build a more seamless, collaborative platform and process. Dr. Kawas claims that the best protocols and studies focus on “addressing clear and concise hypotheses, are operationally feasible and keep patients at the center of the decision-making.”
The end goal is clear – to create effective drugs that help patients live better, healthier, longer lives. To achieve that, groups need to see how important it is to work within a “united and collaborative framework,” says Dr. Kawas.
About Leen Kawas Dr. Kawas is the co-founder of M3 Biotechnology, now known as Athira Pharma, where she previously served as CEO and President, and a member of the Board of Directors. She invented ATH-1017, a therapeutic candidate for treating various neurodegenerative diseases, and has developed other drug candidates within the company’s pipeline.
Dr. Kawas was the first woman to take a technology and biotech company public in Washington State. As of February 2021, she was also one of only 22 female founders and CEOs to lead their company to an initial public offering. In addition, she has received numerous honors and awards throughout her career.