White Paper

Mitigating Risk In ALS Clinical Development


The lack of available treatments for ALS has led many ALS patients to view clinical research as the best available care option. That can make it easier for sponsors to attract patients to their trials.

Though, while they may be generally eager to participate, researchers still have to take the time to understand the unique needs of these patients and their families so they can make participation feasible and strengthen engagement. That requires thoughtful upfront planning, and a clear understanding of the obstacles patients face when participating in an ALS trial.

Collaboration across key stakeholders, including patients, sponsors and regulators, is key to driving new research and advancements in ALS treatments. For example, increasing public awareness of ALS brought these groups together to inform new guidance, resulting in the September 2019 update from the U.S. Food and Drug Administration: Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry.2 The guidance integrated feedback from ALS patient advocacy groups (PAGs), and it has largely been viewed as a positive development that is encouraging much-needed innovation in ALS clinical trial design.

access the White Paper!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Clinical Leader