This was as far as "scrambled eggs" would take him. He needed a higher security protocol to get into individual‑case data. Dale either didn't have it or didn't dare give it out.
Well, he thought, at least I've got information on the structure of the clinical trials. I should print that before the system realizes it's been hacked. He clicked on the print icon. Let the games begin.
His real objective was to try to wangle an interview with Karl Van de Vliet, an interview that would have to be approved by Winston Bartlett. Maybe what could be gleaned from this level of the NIH site would be enough to bluff Bartlett into thinking he knew more than he really did. In truth, interviewing discharged patients would have meant anecdotal information, probably not rigorous enough for use in a definitive book. But at the moment, that would have been a start.
He lifted the first printed page and studied it.
Stone Aimes had seen enough clinical trials over the years to know that the data were reported according to an established schedule. Obviously, the schedule was always adapted to fit the nature of the trials under way, but studies that produce the kind of short‑term results Gerex hinted at in their early press releases—before they clammed up—would probably have a tight reporting schedule, possibly even weekly.
He stared at the page for a moment, then lifted out another. He wasn't sure just yet what it all meant, but he might be able to infer something. He was still puzzling over the columns of numbers as the data finished printing.
What was it telling him?
He went back and clicked on study procedures. This section explained how the reporting was structured. He still held out hope that the names of the discharged patients in the clinical trials could be accessed somehow. In the past, when the FDA tested drugs, it often happened that the names of the participants were not revealed to the monitor, or to anybody. The policy was intended to preserve the privacy of study participants. But lately it had been under review. All that secrecy and non‑accountability had permitted some spectacular fabrication of test data.
Surely the NIH had taken this into consideration by now and come up with a system whereby the identities of the participants could be checked and verified. That information had to be stored somewhere.
No such luck. It appeared the NIH had begun using a modified version of the new FDA sunshine policy. NIH clinical trials had a "one week of sunshine" provision, during which the suitability of test subjects could be evaluated by a review procedure. During that time, their real identity was in the database. But after that, the identity information of any patient actually selected for inclusion in the clinical trials was encoded—where thenceforth it could only be accessed through a lengthy legal process.