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Biotherapies/Cellular Therapies and Immunotherapies - Collections/Processing and Storage

(P-BT-29) Successful Advanced Therapies & Clinical Research Registry Initiation & Growth

Sunday, October 26, 2025
12:00 PM - 1:00 PM  PT
Background/Case Studies:
In 2020, a blood bank began partnering with therapeutic developers using leukopaks as starting material, and concurrently assessed the feasibility of creating a Research Registry as a database of individuals interested in participating in research collections.

Following Institutional Review Board (IRB) submission and determination, the Registry was determined not to be human subjects research, because the Registry includes collection of basic contact information without any research interaction or intervention, and no identifiable private information is analyzed for research purposes.

Study

Design/Methods:
Two distinct configurations of the Registry were tested.

In Jun 2021, the initial Registry [Configuration 1; C1] was launched as a 3rd party HIPAA-compliant platform. Participants registered and completed medical and social questionnaires on the external platform. This configuration remained active from June 2021 to Dec 2022. 

In Jan 2022, the blood bank began testing a new configuration of the Registry concurrently with C1. We used a simplified internally managed database with fewer registration requirements, providing contact information and agreeing to be contacted for research opportunities [Configuration 2; C2]. From Jan 2022 to Dec 2022, donors who joined C2 of the Registry (by expressing interest only) were also asked to complete the questionnaires on the external platform described in C1.

When both configurations were active, the blood bank added a question to all blood donors during the blood donation screening process about their interest in joining the Registry. This question was added Jan 2022.

Results/Findings:
C1 (3rd party managed) was tested from Jun 2021 to Dec 2022. The average join rate was 180 new registrants/month.

C2 (internally managed) was tested from Jan 2022 to Mar 2024. The average join rate was 1036 new registrants/month.

When compared, from Jan 2022 to Dec 2022 (when the blood donor research registry question was active for both), average join rate of C1 was 219/month while average join rate of C2 was 1492/month. C2 showed an average of almost 7x more registrations per month than C1. Cumulative registration numbers are shown in Figure A.

Conclusions:
Important conclusions resulting from this study:


  • -A convenient and simple registration process is key.

  • -This is an easy way to ask blood donors about their interest in participating in research with no initial commitment.

  • -Research registries must be submitted to an IRB for determination of human subjects research.




For advanced therapies and clinical research applications, development of a Registry is critical to success, providing important contact information for interested donors. The establishment of a Research Registry allowed for this blood bank to grow advanced therapies starting materials collections and clinical research services, and provided donors with additional donation opportunities.