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Although the entire clinical trial process has historically been handled completely by pharmaceutical companies themselves, the drive to gain efficiencies in the process has led to outsourcing of much

By Editor on Jun 7, 2004

Although the entire clinical trial process has historically been handled completely by pharmaceutical companies themselves, the drive to gain efficiencies in the process has led to outsourcing of much of the setup and management of trials. The clinical trial support industry has burgeoned and includes contract research organizations (CROs), academic research organizations (AROs), site management organizations (SMOs) and patient recruitment firms.

According to a new report from Cutting Edge Information, Accelerating Clinical Trials: Budgets, Patient Recruitment and Productivity (available online at www.AccleratedClinicalTrials.com ), study sponsors that use CROs dedicate 29% of their clinical affairs budgets to that purpose. Those that use patient recruiters allocate 10% of their budgets and those that use contract SMOs earmark 8% of their clinical budgets for such contracts.

With more parties involved, communication has become critical to the success of trials. And although the move to outsourcing has come with some improvements, trials are lasting longer than pharmas anticipate they should at their outset. Phase I trials are exceeding initial expectations by 42% on average. Phase II trials last 31% longer than originally scheduled and 30% of Phase III trials extend beyond initial deadlines.

These findings, according to Jon Hess, lead analyst for Cutting Edge Information on the study, indicate companies must plan better to navigate the unforeseen challenges that almost always arise during the course of conducting clinical trials.

The study, based on primary interviews and quantitative surveys with clinical affairs directors and clinical project managers at 32 pharmaceutical and biotech companies, as well as executives at CROs, SMOs, AROs, and patient recruiters, reveals that in addition to the fact that much of the clinical expertise now resides outside study sponsors's direct control, a variety of other obstacles is compromising the efficiency of clinical trials.

According to McKinsey & Company, the number of patients required to receive FDA approval has nearly doubled since the early 1990s. More trials are required per compound, including cardiac safety studies on all drugs and additional Phase III effectiveness and safety tests.

The increase in required trials has companies competing fiercely for available patient populations. This adds to longer trial timelines and drives clinical costs up.

Cutting Edge Information ( www.CuttingEdgeInfo.com ), in a survey of 25 biopharmaceutical companies, found the average cost of Phase I trials is $5,500 per patient. Sponsors spend about $6,500 per patient in Phase II trials and more than $7,600 per patient for Phase III studies. And considering that each additional day a drug spends in clinical development is estimated to cost from $600,000 for niche drugs up to $8 million for a blockbuster, the additional time spent in trials results in staggering losses for pharmaceutical companies.

It's no wonder the clinical development industry is taking a renewed look at ways to accelerate clinical trials. Three main approaches to improving the process have emerged.

Many companies are commissioning internal performance improvement task forces to study each step in the process, looking for ways to streamline everything from study development to report writing. Second, Cutting Edge Information's research shows that as two of the leading causes of rising clinical costs, patient and site recruitment offer the greatest opportunity for clinical trial acceleration. Lastly, companies are struggling to raise awareness among patient populations about their eligibility for trial participation.

The report focuses on three main areas of the clinical development landscape: patient recruitment, budgeting and performance assessments, and clinical operations structure and workflow.

According to Hess, patient recruitment consumes 30% of the overall clinical trial process, while investigator recruitment eats up another 11% on average. So, it's no surprise executives rank patient recruitment as the primary area where the industry could make strides to accelerate clinical trials.

Difficulty in patient recruitment is the leading cause of delays in clinical trials, Hess said. Given these conditions, drug companies must continue to support clinical operations and, most importantly, patient recruitment, with substantial funding in order to accelerate trials and meet deadlines, he said.

Cutting Edge Information's research shows companies spend 60% of their average clinical affairs budgets on internally run and outsourced trial operations. However, on average, sponsors spend only 8% of their budgets on internal patient recruitment efforts and just 6% on outsourced patient recruitment.

Hess said if companies want to complete clinical trials on time or accelerate trials to bring drugs to market faster, they must invest more intelligently and heavily in patient recruitment.

Smarter budgeting involves allocating funds to the highest-ROI patient recruitment channels and remaining flexible enough to adjust recruitment plans mid-stream, he said. Only then will companies overcome increasing competition for patients, rising FDA requirements and the need for more tests of each compound in development.

Another trend, Hess said, is to look beyond the United States, Western Europe and Japan to places like Eastern and Central Europe, India, China and Brazil to find the patients to complete clinical trials faster. Overseas trials can offer cost benefits and diverse patient populations, however, stumbling blocks such as GCP standards and travel and shipping costs for supplies must be factored into such an approach.

According to Cutting Edge Information, an important key to improving clinical trials will be the establishment of standard performance measurement scorecards for recording and analyzing the time and money spent on each stage of trials, including patient recruitment. The most commonly used metrics are time-based and track trial duration from milestone to milestone.

Companies must integrate performance tracking into new clinical trials management systems and convince internal and external users all to track the same set of measures to ensure comparability from trial to trial, Hess said. Performance metrics and accurate measurement enable companies to identify improvement opportunities, cut costs and accelerate overall trial timelines.

Survey respondents ranked time to completion of a trial and time to enroll a target number of patients as the measures with the greatest ability to affect organizational change and clinical trial strategic and operational decision-making.

Cutting Edge Information's survey of 28 industry executives shows that training site staff and coordinators ranks as the most effective patient recruitment referral tools. Investigator physician referrals are the second-most effective tool and the investigator meeting ranks third.

According to Hess, however, a number of companies interviewed during the survey identified investigator meetings as burdensome bottlenecks in their clinical trials processes. Meetings were often unmanageable and turned into free-for-all discussions, becoming time consuming and unproductive.

Companies are solving the problem, Hess said, by removing investigator meetings from the clinical trial critical decision path. Companies chose to forego investigator input in protocol design at the investigator meeting in favor of earlier recruitment planning and smoother investigator meetings, he said.

To eliminate delays, pharmaceutical firms and CROs must improve how they attract site investigators and recruit patients, Hess said. Then, they must lower study participant dropout rates or risk negating trial findings. These are complex problems and the company that solves them stands to break away from the rest of the industry.

To learn more about the report, visit www.AcceleratedClinicalTrials.com.