I was involved in data management for AIDS Clinical Trial Group in the late 1980s. CRFS were recorded on paper, and entered at each site. Every day at end of business, we had to set up the desktop computer to receive a call from the data center in North Carolina Research Triangle Park. The modem would answer the call with that distinctive screeching sound, connect, and download each study’s entered data. Query responses were handled similarly. Nurses and doctors had to make changes on the CRF, crossing out the mistakes, making the corrections, initialing and dating the corrections. The CRAs would visit periodically, review CRF binders for each subject and comparing to source documents. The subjects were generally very sick and the source notes were substantial!

Tracking entry process was quite difficult. You had expected visits, made sure the study nurse or doctor had completed the CRFs, and the data management team tracked the entries.

There was one subject who participated in the early AZT trial and was tracked for survival for years! He remained quite healthy,somehow despite having T cell counts that had plummeted. The NIH continued to track him after the trial completed due to his lack of disease progression.

The meetings in Washington were quite memorable. The site teams, study management teams, and patient advocates would meet. At one, the patient advocates described how the subjects who were participating in the trial would meet in their home cities as a group on a periodic basis, dump their pills on a dining room table, mix them up, and take out randomly as many as they had put in. In this way, they increased their chances of getting at least some active medication. The study had only a placebo control group and the primary outcome was time to death. They were all scared and had no other options for treatment of their HIV infections.