Technology 2000

As we start the new decade it is a good time once again to review the technology landscape in clinical research with a focus on available solutions and vendors. There has been a rapid turnover in companies, company names, management teams, and financial investments in this area. Sponsor adoption, on the other hand, remains on a more steady course, gratifying in its acceleration, but still cautious and evaluative. There is no question that every player in clinical research biopharma, CRO, SMO, site, lab are all more committed to information technology than ever. Many are seriously seeking how to use technology for competitive advantage.

This pace of adoption is still outflanked by the sweeping changes in technology platforms and application functionality. But the gap is smaller between innovative supplier and innovative adopter. The result enables us to shape a picture of where technology in clinical research is being used in 2000, with whom one can more safely do business, and the expected benefits, at least until the next IT revolution sweeps over us.

EDC

While my company has been preparing the Sixth Edition of The EDC Report, we are struck at the incredible turnover in the companies seeking to deliver electronic data capture solutions. Literally dozens of companies (or at least their names) have come and gone, and at least a dozen new companies have appeared in the last year. The disappearances are due to failed execution (in product vision, in marketing, in management), but particularly due to a poor understanding of your needs and where you need to go. The new companies are driven mostly by the seeming ease of creating applications with Internet technology; it enables one to produce a pretty nice product shell very rapidly, but there is a long way from that demo to a viable clinical trials data partner.

As the Internet is adopted with surprising speed by nearly all business sectors, the inevitability of using it as a platform for conducting clinical trials is becoming more accepted, not the least by the FDA itself. “The Guidance”, i.e. 21 CFR 11 as it now exists and its proposed amendments, has validated the EDC approach and eliminated an important regulatory objection for sponsors and CROs alike.

Two things remain important for readers to consider: a) when do you need to use EDC and how should you prepare yourself to use it effectively?; and b) are your vendors exhibiting the ability to execute, and do you know how to handle it if they don’t? Organizational preparedness for EDC is more important for you to spend time and resources on than staring endlessly at vendor demos.

Some of the current crop of vendors in EDC are demonstrating meaningful leadership in Internet-based solutions, and now even traditional CDM vendors have products which are likley to be quite useful for their customers. Many other new vendors have come out or will soon do so and may be worth a look.

CDM

While most sponsors have made their difficult choice for a third-party CDM already, choosing sides in the Domain vs. Oracle Clinical war primarily, many CROs and SMOs are still catching up, believing they need to move away from simply delivering SAS datasets to having a relational DBMS in-house. This may or may not be true. Sponsor-oriented CDMS’s require a major internalization effort; EDC tools, with their data repositories, libraries of design elements, and coding dictionaries, may obviate the need for a CDMS at the CRO/SMO level.

Meanwhile, the significant development is that all three major vendors are all offering Internet-based EDC tightly integrated with their CDMS’s. As of this writing, these products are all in an early release state, but the significance of having an Internet EDC tool written by and within your CDM vendor’s framework is a powerful option to consider. The question is whether a CDM vendor can learn the site-centric focus and per-trial business model that makes this successful for you and them.

EPD

As long-time advocates of exploiting the use of handheld devices for Patient Diaries, trashing the totally unreliable paper-based method of patient-recorded data, and designing new studies never before possible on real patient experience, we are gratified to see the explosion of new Electronic Patient Diary vendors, driven primarily by the low-cost/high-function platform provided by Palm OS and Windows CE machines. EPDs are a highly significant advance in clinical research, both investigational and post-launch. Several companies are taking a more public stance as EPD companies specifically, while several other new companies, primarily formed for EDC, also tend to mention they have EPDs as well. But patient diary trials are a specialty unto themselves, and it may be best to first talk to those who have experience with them.

ETM (sponsor/CRO/site)

Electronic Trials Management remains the most underserved yet critically important application area in clinical research. Much less progress has been made on this front in the past year. No new sponsor-side tool which would be easier to use, more valuable to individual staff, and well integrated with other sponsor systems has yet been released. There are a couple of solutions on the site side and they are planned for enhancement. Again, EDC vendors come into play, because they usually represent the most recently developed product vision, and several of them offer a modicum of ETM functionality and “intend” to offer more. CROs/SMOs remain the forgotten niche ¡© they are the companies most in need of a comprehensive system that merges sponsor and site project management concerns with tools that help them run their unique business. This niche apparently remains too small for a pajkaged product to be developed for CROs specifically; custom development remains the best option.

How would like to pay for this?

The issue most troubling to vendor and customer alike when it comes to clinical research IT these days, is how would like to pay for this? Both sides are foundering in a sea of alternatives and it is not clear to anyone where we will land. Should we pay for this (be it EDC, CDM, EPD or ETM) per user, per enterprise, per study, per “click”? Presumably one pricing model will not fit all. But I cannot exaggerate the importance of finding an answer to this question. The survival of the vendors that you need to be successful, that you need by your side to handle the throughput in clinical research today, depends on a clear understanding and articulation of how you should reasonably pay for and budget for these systems. For all the good work industry and vendors have been doing cooperatively on data standards, I am certain that answering the pricing question is much more important to the future of clinical IT.