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Empowering the ALS Community: The Role of CROs in Research for Patient & Clinical Success

Empowering the ALS Community: The Role of CROs in Research for Patient & Clinical Success

May 23, 2024 In the realm of medical research, few conditions are as complex and devastating as Amyotrophic Lateral Sclerosis (ALS) aka Lou Gehrig's disease. Globally, ALS affects over 200,000 people. This progressive neurodegenerative disorder affects nerve cells in the brain and spinal cord, leading to the gradual loss of voluntary muscle movement and ultimately, paralysis.  While there is currently no cure for ALS, advancements in clinical research offer hope for improved treatments and ultimately, a cure. At Atlantic Research Group (ARG), we specialize in neurological diseases like ALS and are known for our years of success in neurodegenerative disease studies. 

Shaping the Design and Implementation of Clinical Trials

Clinical trials are a fundamental part in the progression of ALS research. Those clinical trials often serve as the heartbeat of progress for neurological diseases. Dr. Ignazio Di Giovanna serves as Atlantic Research Group’s VP of Scientific Affairs for Neurology. ALS is one of many neurological disorders and diseases close to his heart. Because of that passion, he and the ARG team understand the importance of collaboration and personal care when working alongside partners for clinical trials.  “ARG aims to provide a highly collaborative and personal service to research sites,” he said. “We are all too aware of the pressures that clinical trials place on both research sites and the patients, and each patient care, themselves.”

The Role of CROs in ALS Research

Expertise and Specialization

CROs employ experts in various fields of research, including neurology, pharmacology, and biostatistics. This specialized knowledge is crucial in understanding the complex nature of ALS and developing effective clinical trials.  Dr Di Giovanna also noted that sites have a variety of stressors placed upon them and CROs have to also understand these elements in order to create and foster a collaborative environment: “Sites are under more than enough pressure providing their normal clinical services and clinical trials are often a significant additional burden, so we try our very best to make sure we support sites in every way possible.  We feel sites have really appreciated this and we have, in fact, received a number of client approaches following recommendations from sites and key opinion leaders (KOLs).”

Accelerating Drug Development

The process of bringing a new drug to market is lengthy and expensive. CROs streamline this process by providing the necessary infrastructure, from recruiting participants to managing data collection and analysis. This accelerates the timeline from discovery to delivery of new treatments. “ARG has taken part in assisting sites and KOLs to apply for and set up site-initiated research and support them for non-commercially based research, including equipment training and talks on how commercial research-based systems can help academic research,” Di Giovanna noted. “ARG has also been proud to sponsor a number of major academic ALS conferences.”

Regulatory Navigation

Navigating the regulatory landscape is one of the biggest hurdles in clinical research. CROs have the experience and knowledge to manage these challenges, ensuring that studies meet all regulatory requirements and that new therapies are approved in a timely manner.

Patient-Centric Approach

CROs often implement patient-centric approaches in their trials, focusing on improving the quality of life for participants. This means designing studies that are more accessible and less burdensome for patients, which can lead to better recruitment and retention rates. These studies also become passion projects of sorts for those within CROs.  “Having worked in ALS and with a number of ALS KOLs over the last 15 years it’s difficult not to get drawn into this disease area,” Di Giovanna said.  “Not just due to the apparent injustice and indiscriminate nature of how ALS strikes patients, but also due to the dedication and commitment of patients, physicians and researchers to find a cure, or at the very least to make the remainder of each patient’s life as comfortable and independent as possible.  Not forgetting of course the essential role played by each patient’s carer in this process.  This commitment and dedication is infectious and it’s a privilege to contribute to these efforts.”

Empowering Patients and Families

Beyond drug development, CROs like ARG play a crucial role in empowering patients and their families. They do this through multiple ways. First is by simply providing access to potentially life-changing clinical trials. By conducting clinical trials in various locations, CROs help patients access cutting-edge treatments that are not yet widely available. Next is through the educational component. CROs often provide valuable information about ongoing research, trial participation, and new treatments, helping patients make informed decisions about their care. Finally, CROs like ARG should be passionate about creating and celebrating support networks for neurological diseases. Many CROs collaborate with patient advocacy groups to create support networks, offering emotional and practical support to those affected by ALS. For example, Di Giovanna himself just traversed hundreds of kilometers to raise awareness for neurological disorders. Empowering the ALS community involves a multifaceted approach where CROs like Atlantic Research Group play a critical role. From accelerating drug development to providing patient support, CROs are essential in the fight against ALS. Their expertise, resources, and patient-centric focus help translate scientific discoveries into real-world treatments, offering hope and improving the quality of life for those affected by this devastating disease.  At ARG, we are proud to stand alongside patient advocates in the fight against ALS, and we remain committed to working collaboratively to make a meaningful difference in the lives of individuals and families affected by this devastating disease.  
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