CRCA Clinical Research Editorial: Eu Apellis Study Coordinator Meeting
The Appelis Study: Coordinator Meeting Recap
Article by: Rachael Sawaya, Clinical Research Coordinator at Colorado Retina Associates
Last month I had the opportunity to travel to Barcelona, Spain to represent Colorado Retina Associates (CRA) at the EU Apellis Study Coordinator Meeting. I was asked to speak on a panel of high-enrolling sites to guide expecting and newly activated EU sites on ground breaking clinical research. Our panel focused on effective recruitment strategies, limiting screen failures, and our big takeaways from the trial. For effective recruitment strategies, I explained how important it is to chart mine and identify patients early even if your site is not activated yet. If you have the inclusion and exclusion criteria you can identify patients early and can quickly meet enrollment. Limiting screen failures is essential for both the study and the site. With this study having a screen fail rate around 50 percent our site came up with a few ways to limit screen failures. We measure the Geographic Atrophy (GA) size before we even contact the patient since this study has very specific GA requirements. I also have Colorado Retina physician, Nancy Christmas, M.D., who is the Principle Investigator (PI) of the study to review images to share her valuable input and provide guidance to designate strong clinical study candidates. With these strategies, we have a below average screen fail rate and dedicated trial participates. My big message to the EU study coordinators was to voice their needs and to not hesitate to reach out to Colorado Retina or study team contacts. These individuals are here to support sites and in the end we all want the same thing, a successful trial.
It was an incredible honor for Colorado Retina's research program to be recognized as a high-enrolling site by the sponsor. The CRA team has put long and many hours of hard work to make this study successful at our site. To be recognized as a leader in ophthalmological clinical trials at an international level is a goal that we have worked for and I am thankful to have had the opportunity to representColorado Retina Associates on that scale. Barcelona is a beautiful and historical city. Even though I only had one day to be a tourist, I was able to visit some of its spectacular landmarks such as: the Picasso museum, La Sagrada Familia, Park Güell, Casa Batlló, and I even caught a Spanish Flamenco show. I would like to thank the Apellis study team for giving me this amazing opportunity, photos coming soon...
CRA Research Director: Frank Garcia