Clinical Trial Investigator Databank: Andreas Explains

In a bid to speed the clinical trial process, Johnson & Johnson reached out to a pair of rivals – Merck (MRK) and Eli Lilly (LLY) – to form the latest in a string of cooperative undertakings among large drugmakers. The purpose of this latest venture, which is touted as the ‘global cross-pharmaceutical’ Investigator Databank, is to make it easier for drugmakers to locate up-to-date information on clinical trial investigators and sites, and avoid duplicating various efforts, such as training for Good Clinical Practice. We spoke with Andreas Koester, who heads clinical trial innovation at Janssen Research & Development, a unit of the healthcare giant, about the effort and where it may be headed…

Pharmalot: Where did this idea come from? And who initiated the program?
Koester: The spark came at meeting in J&J (JNJ) and we reached out to our competitors. We called a couple of them with the intent to limit initial cooperation to three or a maximum of four… You know, once you start to go into details – there are legal issues, antitrust issues – things become complicated. And we looked at past efforts that were not successful so that we can avoid missteps and bring this to fruition.

Pharmalot: Why do you believe this is necessary?
Koester: We quickly realized that some of the things we impose on investigators as a pharmaceutical community can only be solved or alleviated by working together. We did something we’re not very comfortable with or used to doing – we reached out to other companies… But it’s low hanging fruit - nobody gains an advantage - so let’s pool our resources so we can improve the situation…

Pharmalot: How so, exactly?
Koester: Every company tries to follow obligations and initiates a study with an investigator and trains them in good clinical practice. At Janssen, if we’ve done that in past two years with an investigator, we’re not going to train them again. But if we go into a new disease, a new indication or new investigators, we will do training. But they might ask why when they just did training with Pfizer or Merck or Lilly, and they have to go through it again. But we have to do so, because we don’t’ know exactly what they did (with another drugmaker) because we don’t have a record of their training. Every time we go to a new investigator, we have to ask about infrasturcture, personnel, lab access, ECGs, freezers. Each company has it on file for some investigators and so if we each share information we don’t have to ask these questions each time.

Pharmalot: So how much money do you expect this can save down the road?
Koester: We really did not pay attention to (cost savings). But we’re imposing so much administrative burden on investigators to reconcile clinical reserach with clinical practice that about 70 percent drop out after doing one or two trials… I’m quoting data in the US… There are many bottlenecks, but an important bottleneck is there are not enough investigators where there are good drugs waiting to be tested for safety and efficacy…

You can call the investigator pool a collective resource… And people do mind it if (administrative requirements) drive them away from clinical research. We have to find ways to reduce this burden if we want to have a pool of investigators to partner with us.

So calculating how much it will save is in the background… I was thinking about an analogy and the best I could come up with was getting an electric car and how people make the calculation whether it’s cheaper. But that’s not the point. It’s to make an investment, a long-term investment in the future and, hopefully, by broad adoption, it will pay off…

Pharmalot: What about the role of clinical research organizations. Shouldn’t they able to provide some of this info? And will they be asked to join?
Koester: We did not come out and say ‘let’s build a database.’ That’s difficult and time consuming… And while they work for many sponsors and have investigators and have a database, they don’t own the data. That’s owned by individual sponsors and have to be kept behind a firewall away from each other. A CRO could look at what they have and who can do what in rheumatoid arthritis, for instance, but we wanted granularity of information – data of the last GCP training and dates of the last certification visits - and have it accessible at a centrally located place for everybody. That’s our vision.

We would expect CROs to join and have access once it is operational. As a side note, we asked a CRO to help us and establish the concept, but then we worked it through after we realized they don’t own the data. That would have to be a next step. If one CRO joined tomorrow, that would offer a competitive advantage. We hope to reduce red tape and administrative burdens, not giving competitive advantage to anybody.

Pharmalot: And so what about other drugmakers joining?
Koester: We’ve started discussion with our colleagues in Trancelerate (the recently announced non-profit venture between 10 drugmakers to speed drug development). There’s no limit. In fact, the value will increase with the number of participants. Our vision is to have everybody in there, including every investigator. We don’t know how many are out there, but we want to capture the whole population. Only then can we accomplish our goal of avoiding redundancies.