MediciGlobal

According to The Economist magazine’s 2008 conference flyer, “If the pharmaceutical industry were a patient, the prognosis would be grim; revenues are down, capital is hard to come by, and there is not much exciting news in the scientific pipeline.”

But there is a bright side to this tough economic environment. Economic downturns cause companies to become more efficient and productive. They do this, in part, by forcing companies to focus on those areas that use the most resources. And for companies involved in drug development, there is no area more resource intensive than the clinical trials process.

The clinical trial process is the single most expensive and lengthy period in the development of new medical treatments and devices. Fewer than 20% of Life Sciences companies (pharmaceuticals, biotech and medical devices) complete their clinical plans on or ahead of time. As a result, capital burn rate is often higher than expected. This is especially critical for drug development companies where resources are constrained.

The costs associated with bringing a new medicine to market have increased 23 fold in the past three decades. It is now estimated to cost about $1.25 billion to bring a new medicine through the drug development process. Drug development time has increased from almost 12 years in the 1970s to nearly 15 years in 2001. And while clinical trials take between 30 to 50% of the time spent in research and development, a third of this time (in clinical trials) is taken by delays in patient recruitment.

The current economic downturn is having its own impact on the drug development process. Recent press reports show that companies of all sizes are trimming their portfolios, making tough decisions on which compounds in the pipeline receive continued investment, which ones to delay, which ones to spin off, and which therapeutic areas to focus on. Joint ventures and acquisitions are making the headlines of the trade news. And a global recession has every pharmaceutical, biotech and venture capital company considering how to speed the clinical trials process, track progress, control performance and save costs.

These current trends place an even greater emphasis on ensuring that the clinical trials that do survive budget cuts provide the best possible return on investment. One way to do this is to improve patient recruitment. Patient recruitment is considered by the pharmaceutical industry to be one of the biggest hold ups in the clinical-trial process.

Take a look at the patient recruitment process and it’s not hard to understand why. An alarming 75% of clinical trials are delayed due to slow enrolment. This comes at a huge cost to the industry. Delayed trials mean additional research investment. And each day that a drug is not on the market can mean millions in lost sales opportunities.

So what makes recruiting patients so difficult? While there are many clinical trials happening every day, patient volunteers are few. Finding the right patient with the right inclusion criteria for a clinical trial is a highly complex process, and one that experts say often lacks direction and focus. Securing patients for clinical research participation is challenging without the right strategic marketing-communications approach.

Complicating the process of patient recruitment are increasingly complex clinical trial protocols with more procedures and an increasingly competitive environment. But despite these challenges, there are still ways to find opportunity. In the chart below, you’ll learn how. For instance, to cut through the competitive clutter, it’s now more important than ever to ensure you have the right recruitment message from the start. Focus groups are a simple, cost-effective way to accomplish this. And to remain competitive, it’s important to maximize efficiency by eliminating those study sites that fail to recruit patients.

Here are all ten cost-saving strategies for delivering speed, tracking and control over the patient recruitment and retention process:

1. Avoid “watchful waiting.” Be proactive in launching a patient recruitment-retention plan. Companies may not realize, but they will save more money in the long run by proactively implementing patient recruitment-retention programs than by watching and waiting to see what happens. Chancing fate with a high probability of a study falling behind in its timelines will result in sunk costs that cannot be recovered and lost opportunity costs when the drug could get to market faster.
2. Use forecasts and projections to set realistic budgets to achieve accelerated timelines. All too often recruitment is seen as an expense rather than an investment to save money. When recruitment budgets are set arbitrarily and too low, delays are encountered and the costs are even more significant. Don’t be set up to fail from the beginning with an unrealistic timeline and a budget that will not achieve results!
3. When the right advertising recruitment message accounts for about 30% of the response, getting the messages right from the start speeds up the recruitment process and saves costs. Ideally, market research plays an important role of validating assumptions and key decisions before they are made. Online focus groups allow this to be achieved simply, fast and at low cost. Conducting these in the planning stages of a clinical study can result in savings; both opportunity costs and real time costs.
4. Reduce start-up time to maximize time in field with materials. On a global study, shave off 2-4 weeks per country for the development of recruitment materials, getting the recruitment program launched faster. Consider that accelerating the launch of a patient recruitment program by 2-4 weeks per country, means that a study involving 20 countries will result in between 40-80 weeks of additional patient recruitment time in the “field.” MediciGlobal’s proprietary system called ADapt not only customizes recruitment materials on a global basis, but also rapidly deploys them to ethics submission and production, streamlining the process and saving time and money.
5. Weed out non-performing sites quickly using real time tracking data. At least one third of study sites will fail to perform. Weeding out these sites within 4 weeks of program launch will minimize money wasted on non-performing sites. When recruitment budgets are limited and time is of the essence, actively recruiting sites are the ones to be supported.
6. Make study sites accountable for locally placed advertising. While most sponsors include a standard budget for advertising for each study site to spend at their discretion, few sponsors make sites accountable for tracking the response and reporting performance metrics. Companies such as MediciGlobal provide oversight and management of this process, lending their media buying expertise to assist study sites place advertising cost effectively.
7. Use lower cost – high impact communications channels such as the Internet to deliver health information to patients, consumers and health care professionals. When budgets are limited, turn to lower cost media options before using more expensive media such as radio, newspapers and in some countries television. Actively linking with patient groups online can provide additional study exposure.
8. Proactively manage retention—don’t wait for patients to drop from the study before taking action. Look at a retention program like an insurance policy. Initiating a retention program at the start of the study to keep patients interested until study completion, protects the sponsor’s investment and statistical power of the data. Consider the fact that every time a patient drops from the study the value of the remaining participants increase. A sponsor who recently invested in a retention program calculated that the program retained over 650 patients, saving an investment of $7 million that could have been lost.
9. Support study coordinators and put your money where the work is. Burdensome protocols, consenting patients, accurate case report forms, and adhering to timelines are critical tasks that fall to the study coordinator. Increasing study grants to Investigators for ailing studies will not resolve the problem when the workload is carried out by study coordinators, but a program that rewards them for achieving study objectives relating to quality of data and patient care will assuredly be well received.
10. Minimize turn over key staff team at critical project milestones. A change in management can cause study delays; when a clinical team leader leaves the study it can slow down progress by about 8 weeks.
So there you have them. Ten ways that you can improve the efficiency of your clinical trials. Implement them and you’ll be making your company more productive - not just for this economic downturn, but also well into the next economic boom. Liz Moench may be reached at or 484.674.6850