STRATEGIC INSIGHTS Clinical Trials
Low adoption rates of e-clinical trial technology can't be blamed on external market dynamics alone. Biopharmas must face four inhibitors within their own organizations
By Kenneth Getz
March 17, 2004 | First, the good news: The past 12 months have seen a notable shift in the biopharmaceutical industry's stance toward adopting electronic clinical trial (ECT) technologies. The majority of large and mid-sized biopharma companies have redirected their focus from tactical to strategic technology adoption; from piloting point solutions to enterprisewide implementation.
Most major biopharmas, for example, have now established internal functions and working groups supported by dedicated junior- and mid-level clinical research personnel to integrate technologies into appropriate development projects.
According to a recent Clinical Data Interchange Standards Consortium (CDISC)-Thomson CenterWatch report, nearly 20 percent of all clinical trials initiated in 2003 utilized ECT technologies, up from 12 percent of clinical trials in 2000. And biopharmaceutical companies project that within the next 18 months, technology solutions will be used in four out of 10 Phase I through Phase IV clinical projects.
Meanwhile, the electronic data capture (EDC) market rapidly consolidates. Market leader Phase Forward, with an estimated $75 million in annual revenue and reported financial health, is likely to make an initial public offering in 2004. Competition from Oracle Clinical, as well as trial sponsors' own proprietary systems, is increasing. Adoption of e-diaries to collect data from study volunteers has been the fastest-growing technology area due to its lower relative cost, flexibility, ease of integration, and regulatory support.
The use of CDISC standards has also accelerated. One in seven sponsor companies is expected to make submissions to regulatory agencies using CDISC models, as well as use the consortium's interchange standards when collecting data for clinical projects. HIPAA regulations, CDISC's alliance with HL7, and new FDA guidance are all expected to significantly boost CDISC standards usage in 2004.
Now, the bad news: ECT technology adoption, overall, remains slower than anyone anticipated. A variety of external market dynamics — from a lack of regulatory direction, to a historical absence of data-interchange standards, to an overcrowded vendor market operating in a tough economy — have all helped retard adoption rates.
Equally to blame, however, though rarely discussed, is the biopharmaceutical industry's own deeply rooted inhibitors. The culture and organizational mindset of trial sponsors has raised nearly insurmountable barriers, making the 20-percent adoption rate of ECT technology and standards all the more remarkable. These internal barriers fall into four broad areas:
· High corporate aversion to risk
· A traditionally proprietary mindset
· High personal aversion to risk
· A highly fragmented and heterogeneous organizational structure
For these dynamics to be changed, they must first be understood and anticipated. Let's look at each in detail.
High corporate aversion to risk. We all know drug development is risky. Companies now spend an estimated $900 million to $1.7 billion to carry a single successful drug from bench to bedside. This massive investment assumes a 17- to 20-year time horizon, as well as the shared cost of other drugs that fail along the way. Needless to say, clinical research personnel are obsessed with controlling development cycle times and costs.
But operating structures designed to create explicit and tightly managed practices and expectations create problems. Companies rely heavily on standard operating procedures (SOPs), on good clinical practice (GCP) guidelines, and on well-defined development planning, implementation, and corporate reporting mechanisms.
This, in turn, creates a high aversion to risk, preventing organizations from broadly adopting innovations that may change long-established SOPs and potentially derail development projects already on a tight timeline. Ultimately, this cultural condition prolongs the pilot-testing phase, entices companies to contain adoption in order to carefully study its impact, and results in lower levels of vendor loyalty.
Proprietary predisposition. Historically, biopharmas have viewed their clinical development processes as competitive advantage. Most companies report that they are using "proprietary," internally developed data-interchange standards, for example. Yet these are not really standards at all.
A proprietary mindset prevents biopharmas from openly collaborating to establish a foundation from which innovation can flourish. In other research-intensive industries, such as telecommunications, consortia have successfully established standards that benefit the whole industry. The very existence of CDISC, and the fact that it's now becoming more widely used, is a monumental achievement given the cultural predisposition of biopharmas.
Yet trial sponsors continue to roll out proprietary and disparate data-collection systems to their investigative sites. These systems are incompatible with others installed at a given site location, and they require unique training and technical support. Although sites are interested in embracing ECT solutions, a large percentage report that their workload has increased when data-collection technologies are introduced.
And, anticipating technical failures, the majority of sites reported last year that they still used paper backup for ECT-based trials.
High personal aversion to risk. Clinical researchers have traditionally been concerned about endorsing novel approaches for fear that they may damage their reputation — or worse, lose their jobs. Almost all clinical research personnel know a risk-taker who quickly fell out of corporate favor.
In addition, clinical staff must carry the burden of rigid regulatory, operating, and budgetary controls along with high demands on their schedules and performance. Most staffs have very little time to interview technology vendors, and they typically lack management support to embrace and promote serious technology innovation.
Technology pioneers within a biopharma's drug-development units are rare. When present, they're often found at more senior levels where vision fails to translate to corporatewide acceptance. Again, this cultural predisposition prolongs the pilot-testing phase and reduces vendor loyalty.
Fragmented organizations. Big biopharmas — and even midsize companies — are so much more diverse today. This operating environment can be predisposed to squelching innovation. Project teams within the same therapeutic area, and even working with the same investigative sites, rarely if ever compare notes and share information.
In many large companies, procurement and outsourcing are the first line to receive and then suppress innovative ideas before clinical staff has even considered them. Initiatives embraced by one department's staff often fail to carry across departments. In the absence of empowered centralized operating structures, innovations adopted within one therapeutic area face difficulty translating over to project teams in other therapeutic areas.
For ECT vendors, highly fragmented structures and inconsistent functional responsibilities across their client base make it challenging to target companies effectively. To make matters worse, similarly named functions across individual companies often have very different roles and responsibilities.
Combined with other cultural conditions described earlier, vendors with limited resources must call on multiple individuals within the same sponsor company, thereby extending already costly sales cycles. This not only drives consolidation and divestiture within the vendor market, but also contributes to sponsor perceptions that innovations may be unstable and risky.
Mother of Re-Invention
The clinical research enterprise now faces what is surely one of its most tumultuous periods. Drug companies are grappling with depressed rates of innovation, anemic pipelines of drug candidates in later stages of development, and a dramatic drop in funding from blockbuster candidates.
This tumultuous period demands that the biopharmaceutical industry re-evaluate how ECT technology can be more effectively and more rapidly adopted. If necessity is the mother of invention, never have drug companies more badly needed to re-invent their internal cultural dynamics, which have so far quietly, but dramatically, stifled innovation.
Kenneth Getz is the founder, president, and publisher of CenterWatch, a research, consulting, and publishing firm focusing on all aspects of the clinical research enterprise. E-mail: kenneth.getz@centerwatch.com.
PHOTO BY MARK A. GABRENYA