Adverse Trends Affect Finding Experienced Investigators

Trend 1: Declining numbers of investigators

The 2005 Impact Report from Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) shows a 6% annual decline in number of clinical investigators since 2001.

Trend 2: Increased drop out rate for first time investigators

CenterWatch reported 8,616 first time investigators were used between 2001 and 2004 and 50% of them dropped out of research after their first study. Astoundingly, the number of investigators who choose never to conduct a second study has increased from 27% in 1990 to 50% in 2004 (CenterWatch Monthly Nov. 2006).

Why is the percentage of first time investigator drop out increasing? It could be because sponsors have been forced to try new investigator when they cannot identify enough experienced investigators. Using inexperienced investigators for today’s increasingly complicated protocols is a recipe for disaster. Failed trials at new sites result in increased new investigator dissatisfaction in doing clinical trials and dramatically contributes to prolong study completion, negatively affecting drug development timelines.

Trend 3: Investigator demand increasing

BCC Research reported in Aug. 2006, the annual number of U.S. clinical trials continues to increase at an average of 6%. 8,386 trials were conducted in 2005 and 10,000 were projected for 2006.

Trends 1, 2 & 3 = Increased Competition for Investigators

These three trends, a decline in experienced investigators, the high drop out of first time investigators and the increasing demand for investigators, mean that competition for experienced U.S. investigators is increasing, dramatically.

New Rate Limiting Step

Rapidly finding unused investigator capacity becomes an essential and critical task for clinical trial management with pharmaceutical, biotech, medical device, diagnostic and CRO companies. This is a challenging task in a declining, fragmented investigator population. Investigator recruiting has now become a rate limiting step that occurs before reaching the long recognized, rate limiting patient recruiting process.

The Reality

Often, sponsors and CROs have relatively short lists of investigators previously worked with and find that these investigators are already committed to competing sponsors when contacted. This increases the delay in study launch, negatively affecting the drug development timetable. For smaller companies, funded by VCs and investors, such delays can be financially devastating as prolonged timelines increase cash burn. For larger companies, such delays compromise their competitive positions in product approval and launch. For all sponsors, the patent clock keeps ticking.

Can industry rely on posting studies online to recruit investigators?

No. According to WOCP (2005), few physicians have the free time to proactively access online information to find clinical trials.

What tools are needed to accelerate Investigator recruiting?

Ideally what is needed is an up to date database of experienced investigators coupled with an instant ability to contact and screen investigator interest in a new protocol. Since the number of clinical trials continues to increase, experienced investigators routinely receive multiple study opportunities. The key is approaching enough experienced investigators for a given study to find current unused capacity for the new study.

Innovative Solutions

Specialized investigator recruiting services, such as those provided by Investigator Location Services, Inc. (ILS), offer efficient processes to rapidly find unused investigator capacity.

ILS has become the largest investigator recruiting service with a database of 20,000+ experienced U.S. and Canadian investigators across all medical specialties. Proprietary technology allows instant access to targeted investigators in the database to satisfy client needs across all therapeutic areas.

Since the company's launch in July, 2001, over 220 sponsor and CRO companies have used ILS to recruit 4,800+ investigators on more than 420 protocols including difficult to place projects. ILS investigator recruiting services are free to sponsors and CROs as investigators pay ILS fees. ILS can literally reach hundreds of investigators in many specialties in seconds and solicit their interest in a clinical trial.

The following Table indicates examples of ILS recruiting activities across several therapeutic areas:

Motivated & Experienced Investigators

The key to ILS’s success and repeat business from sponsors and CROs is that investigators who sign up through ILS are extra motivated to perform and experienced. Motivated; since they agree to pay ILS a fee when the study launches, ILS studies get a higher priority at the investigator’s site. Experienced; ILS investigators typically have ten or more years of clinical research experience. From the investigators perspective, ILS helps them maximize their research operation to full capacity.

Summary

Increased competition for a shrinking pool of experienced investigators is a challenging reality that sponsors and CROs must meet to rapidly launch new clinical trials. Rapidly identifying unused capacity with experienced investigators can be accelerated efficiently by using innovative service companies with proprietary databases and integrated communication mechanisms to screen investigator interest in new protocols.

About Investigator Location Services, Inc.

ILS is a privately held company with a seasoned management team with over 30 years of clinical research experience.
Joe Bollert, Ph.D.
President
Investigator Location Services
1280 Bison St.
Newport Beach, ca 92660
949-417-0437x179
jbollert@invlocate.com
www.invlocate.com