Return to Science, Return to Intimacy: Re-Connecting Site & Sponsor

There was a time, before most of us entered this profession, when drug research was done in an atmosphere of great intimacy between physicians — one who happened to work at the pharmaceutical company, and the other who usually was an old friend and colleague at a major teaching hospital. There were many things missing from this style of clinical research, there have been many major improvements since those days, and certainly no one is going back to that simpler, less sophisticated, less controlled and perhaps more dangerous time.

But many of the drugs and therapies we have long since taken for granted were developed in just this manner. And most importantly, several dramatic clinical pharmacology discoveries were made in these times, precisely because the physician researcher was personally seeing the trial patients, and was in close communication with his professional colleague at the sponsor. An observation, a phone call, a return to the lab, a new protocol, and all of sudden a lousy antihistamine becomes the prevention for seasickness.

How can we recapture the best of that atmosphere — the possibilities for scientific interchange that it embraced? I can’t count the number of investigators who have told me, “I miss that dialogue with the sponsor’s physician. Now all I see are young CRA’s who don’t know the disease and every visit there’s a new one who shows up, and we start the education again.” Of course there’s no question that clinical research is a business today, but business and science need not be incompatible. And today’s information technology, applied correctly, can be the answer.

IT Can Transform the Sponsor Site Relationship

Let’s look at some examples of how IT can improve the sponsor-site relationship. One of the most onerous interactions between the parties is the CRA’s site visit. It certainly isn’t intended to be unpleasant, but it often consists of hours of tedious document review and questions for CRA and study coordinator. Electronic Data Capture, a key clinical research technology initiative now increasingly accepted and practical, can reduce this pain by 80%, and turn adversaries into colleagues. While CRA visits may be of a similar frequency using EDC, the CRA can focus more on her scientific role, and have more time to discuss patient experience on the drug and disease management in general.

Electronic trials management (ETM) tools can significantly improve the sponsor-site relationship. By providing automatic and timely reporting of patient recruitment performance to the sponsor, ETM helps eliminate “nagging” the site for information. Through ETM reports on site quality, sponsors can review and reward strong performing sites in an informed manner. ETM and web-based “portals” can also provide a secure and focused channel for electronic interchange of questions and ideas in an appropriate manner. In today’s rapidly changing and highly competitive landscape, site insights need to be benefited from as soon as possible.

Electronic Patient Diaries (EPD) are another example of information technology contributing to the science of clinical research. Their ability to capture real patient experience on a drug enables sponsor and investigator to explore clinical questions never able to be answered before.

Creating Scientific Intimacy

Communication channels enabled by web portals or simple organized email can create sincere scientific exchange outside the trial context. Given sufficient value, physicians are active Internet users, and if a sponsor crafts a communication channel void of commercialization, all kinds of valuable dialogue will ensue. Not only will this help a sponsor’s marketing (the usual way in which a sponsor thinks about web channels), but such an effort also creates an informed community. Sponsors can see who is interested and what they are interested in, who has the patients and who has clinical insight. Sites will get connected to each other and find out who’s thinking about the same questions they are. They can get rapid access to the latest information, and have an opportunity to influence the direction of pharmaceutical research.

This scientific intimacy will be particularly important to the new wave of pharmacogenomic research. Physicians’ clinical insight will be the trigger for companies targeting genes that can lead to tailored or safer drugs. Instant, organized and analyzed communication with these physicians will provide important competitive advantage. Physicians willing to share this insight will demand high value information in return.

There is something of an “odor” around web portals and communities these days, the victim of over-ripe hype. Don’t let the Internet morning-after hangover obscure the value of this basic enabling technology to your research process.

Overcoming Selfishness

The key to any intimacy is overcoming our self interests. It’s OK for sponsors to think about most IT in selfish ways: how it saves them money in running their clinical research factory. But it’s also OK not to be embarassed to say that science is still important. Today’s technology tools can make it easier, faster and cheaper to restore the dialogue, and even perhaps the serendipity, that makes drug research unexpectedly and dramatically beneficial. And that’s a selfishness we can all share.