Using Clinical Trials Activity to Assess Competitor Strategies/media/In... · Clearly, costs and ease of recruitment is a driving force behind the movement of trials to low resource

Using Clinical Trials Activity to Assess Competitor Strategies

CitelinePharma intelligence |

Tracy DeGregorio, Vice PresidentProduct Management, Development & Strategy, Citeline, Inc


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Understanding competitor drug development strategies is critical to maximizing R&D investments. While

looking at competitor pipelines with respect to number of drugs in development is a good starting point,

much more granular analyses are needed to fully understand what is happening broadly in the industry,

and with your competitors, specifically. Here, clinical trial counts are particularly valuable and can uncover

competitor strategies with respect to drug, disease, location, and more.

The value of clinical trial counts is demonstrated in Figure 1. Here you see GlaxoSmithKline leading this

group overall with 227 active R&D products. But when looking at the total number of ongoing clinical trials

with a pipeline drug, Novartis becomes the leader, with 275 trials. [All data for this report are from

Citeline’s Trialtrove® and Pharmaprojects® Pipeline®, accessed July 23, 2012.]

The number of ongoing trials per drug provides a good metric of relative activity, and shows Novartis (at

1.65) much more aggressively developing its R&D products than its peers in this particular group of

companies. When limiting the analysis specifically to oncology, this activity is even more pronounced, with

3.25 trials per drug in oncology for Novartis.

Assessment by trial phase changes the dynamics. Here, Roche/Genentech is more aggressively developing

its late stage drugs (2.80 trials per drug), and not surprisingly, a more pronounced effect is seen when

looking just at late stage oncology.

While this example provides a snapshot of overall activity, with a subset of late stage oncology develop-

ment, similar metrics can be used to create views of competitor development by mechanism of action,

disease, location, etc.

FIGURE 3: Industry-Sponsored Oncology Trials Started 2004-2010, with % change

FIGURE 4: Industry-Sponsored Oncology Trials Started 2006-2010, by Company

FIGURE 5: Industry-Sponsored Oncology Trials Started 2006-2010, by Country

FIGURE 6: Industry-Sponsored Oncology Trials Started 2004-2010, Major Markets

FIGURE 7: Industry-Sponsored Oncology Trials Started 2004-2010, Low Resource Countries

FIGURE 8: Phase II and III Oncology Trials Started with First-line Patients, 2006 - 2010

FIGURE 2: Industry-Sponsored Oncology Trials Started, 2004-2010

FIGURE 1: Number of Drugs in Development and Number of Clinical Trials by Company

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The challenges of clinical development are well known, and ever increasing pressure to do more with less

is not unique to this industry. Couple this pressure with lengthy development timelines and increasingly

complex procedures and protocols, and development costs have soared over the past decade. Above all,

trial recruitment remains the primary reason trials fail to complete on time and skyrocket beyond projected

budgets.

One strategy to shorten enrollment period of a trial is to run a large global development program to

access a larger pool of patients. In this effort to reduce development costs and hasten trial enrollment, the

industry has increasingly been conducting trials in low resource countries. To better understand this

movement, we examine industry-sponsored cancer trials started 2004-2010 as captured in Trialtrove.

Overall, there was a slight increase (7%) in the number of industry-sponsored oncology trials started in

2010 versus 2004, with 1075 and 1007 trials, respectively. This increase is driven solely by increased Phase I

activity, as the number of Phase II and Phase III trials started actually diminished over that time period

(Figure 2).

Breaking down the data by country (Figure 3), we see specific gains and losses by geography. In most

developed markets the overall change from 2004 to 2010 was unremarkable; the notable exception being

Japan, with substantial increases in both the number of trials and percentage gain. A significant percent-

age of this increase is attributed to the rise in the number of Phase I trials started—six Phase I trials started

in 2004; 45 Phase I trials started in 2010 (data not shown).

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Looking at low resources countries, real gain in the number of trials started is seen in Poland, Ukraine,

Romania, Russia, China, and India. However, many countries experienced a decline over this time, with

South Africa, Mexico, Argentina, and Brazil all host to fewer industry-sponsored oncology trials started in

2010 versus 2004.

Of interesting note across many low resource countries is that the number of trials started peaked around

2006-2008, with subsequent decline to 2010; essentially a downward trend over the past five years. There

are many possible explanations for this pattern, many of which can be probed with additional analyses of

trial activity.

One possible explanation is that with the rapid increase in the number of trials started 2004-2006,

investigator and/or site saturation occurred. This hypothesis can be examined by looking at the number of

investigators and sites by country, and the number of associated trials over time. A second explanation is

that sponsors encountered difficulty running trials, and were subsequently hesitant to start additional

trials. Here, we can look to see if the number of terminated trials has increased over time. Alternately,

increasing enrollment periods would suggest an unsuccessful (and thus tempered) strategy to start trials in

low resource countries in order to reduce trial timelines.

With an understanding of what’s happening across the industry with respect to trial locations, the next

step looks at activity at the company level where you can begin to uncover competitors’ geographic areas

of interest for oncology trials.

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Looking cumulatively at the number of trials started for the five-year period, 2006-2010, (Figure 4) you can

see different approaches being taken. AstraZeneca, Eli Lilly, Merck & Co, and Sanofi have taken a fairly

diversified approach with respect to low resource country selection; whereas Novartis, Pfizer, and Roche

clearly have geographic areas of interest, namely China, Poland, and Russia. You can also see differences

by trial phase, with Pfizer starting a good number of Phase II trials in these locations, while Novartis favors

Phase III trials in these same countries.

To understand which companies have the most experience by region, we also looked at the trials activity

by country (Figure 5). This view can unmask a competitor’s strength in a geographic area of interest. For

example, while we can see in Figure 4 that Eli Lilly’s focus among these regions is Poland, when we look at

activity in Poland, you can see that it is Pfizer and Roche/Genentech that have the most experience running

oncology trials in this country over the past five years.

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Clearly, costs and ease of recruitment is a driving force behind the movement of trials to low resource

countries. Clinical trials activity provides a valuable means to assess what is happening, where, and by

whom. But to deduce and understand your competitor’s strategy and likely future moves, it’s important to

understand why. One possible reason why the industry is trending toward trial activity in low resource

countries is that, in oncology specifically, sponsors may be seeking treatment naïve patients. This hypoth-

esis is one that can be vetted by looking at the trials activity and drilling down to patient segment, in this

case first-line patients.

Not surprisingly, as pharmaceutical companies step up their efforts to develop first-line therapies, the

percent increase in the number of trials seeking first-line patients in the major markets significantly

outpaced the overall percent increase in trials started, except for the US (where first-line patients are

extremely difficult to recruit). The UK notably, with a 6% decrease in overall trial activity, saw a 138%

increase in the number of trials started that include first-line patients (Figure 6).

We see this general trend continuing over this time period in the low resource countries as well, where the

percent increase in the number of trials seeking first-line patients also significantly outpaced the overall

percent increase in trials started, but to a much greater degree than in the major markets (Figure 7). There

are also two noteworthy countries. Ukraine, which saw a 41% increase in the overall number of oncology

trials started, saw a 1300% increase in the number of trials started that include first line patients. Romania

saw an explosive 1700% increase; clearly two countries where industry is focusing its efforts to recruit this

patient segment.

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Looking by company specifically at these two countries of interest we see different driving factors behind

the increase (Figure 8). In Romania Lilly, Pfizer, and Roche all contribute heavily toward the increase; while

in Ukraine, we see a big commitment by Pfizer.

Certainly many factors contrib-

ute to country selection, and trial

counts provide an excellent data

set to tease out competitor

strategies. This case study

looked specifically at industry-

sponsored oncology trials by

geography, drilling into patient

segment (first line), finding that

many companies are seeking out

first line patients in specific

countries, namely Romania and

Ukraine.

However similar analyses can be carried across phase, disease, mechanism of action, terminated trials,

investigators, sites, etc. By understanding what is happening in the industry in general, with your competi-

tors specifically, and being able to test hypotheses as to why trends are occurring, you can better deduce

and understand your competitors’ strategies and likely future moves.

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Using Clinical Trials Activity to Assess Competitor Strategies/media/In... · Clearly, costs and ease of recruitment is a driving force behind the movement of trials to low resource