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Protocol Amendments Come at a High Cost

 Trending now: New analysis provides insight into the impact of clinical trial amendments and how to anticipate and manage them.

PV0316_KenGetzResearch sponsors implement at least one substantial global amendment for almost 60% of all clinical trial protocols, substantially reducing the number of actual patients screened and enrolled, but leading to significantly longer clinical trial durations and higher costs, a newly completed analysis by the Tufts Center for the Study of Drug Development (CSDD) concludes.

The total median direct cost to implement a substantial amendment for Phase II and Phase III protocols is $141,000 and $535,000, respectively, according to the Tufts CSDD analysis, which defined a substantial amendment as any change to a protocol on a global level requiring internal approval, followed by approval from the institutional or ethical review board or regulatory authority.

In addition, almost half of all substantial amendments — most often undertaken to modify study volunteer demographics, eligibility criteria, and safety assessment activity — are deemed avoidable by sponsor organizations, Tufts CSDD said.

“The positive news is that unplanned delays, disruptions, and costs associated with protocol amendments have spurred the research-based biopharmaceutical industry to identify new approaches to simplify protocol design and reduce the frequency of amendments,” says Ken Getz, associate professor and director of sponsored research at Tufts CSDD.

Other findings include:
Phase II protocols have the highest incidence of substantial amendments (77%), averaging 2.2 amendments per protocol.
Protocols with even one amendment experience a substantially lower actual number of patients screened and enrolled relative to plan, compared with protocols without any amendments.
Study conduct durations for protocols with at least one substantial amendment take on average three months longer, compared with protocols without any amendments.
38% of changes made as a result of substantial protocol amendments are related to safety assessment activity and 21% are related to efficacy assessments.

Market Access Activities Should Be at Least 18 Months Ahead of Launch

A new pharmaceutical industry study found that among surveyed companies, market access teams would prefer to start working on products an average of 4.6 months before they currently start supporting new products. According to research from primary intelligence firm Cutting Edge Information, market access groups would ideally start work on launch sequencing and health economics research at least a year and a half before a product launches.

PV0316_JacobPressonOn average, market access teams would ideally prefer to start conducting products support activities 18.7 months before launch, compared with 14.1 months currently. Payer relationship management is currently only entering market access teams’ purview around 4.4 months before launch, on average. The study’s data show that ideally these activities would begin at least 10 months before launch. Health economics and outcomes research (HEOR) is a particularly important area to begin work well before launch.

“Getting market access teams involved earlier allows them to begin laying the groundwork for a successful launch,” says Jacob Presson, senior analyst at Cutting Edge Information. “Our research has found that allowing more prelaunch time for market access teams to build effective value cases can make the difference in today’s price-sensitive pharmaceutical market.”

Healthcare CRO Market to Grow

The global healthcare CRO market is expected to reach $45.2 billion by 2022, according to a new report by Grand View Research. With the increasing number of patents expiring, increasing number of partnerships to identify biologics and new compounds and growing R&D costs, drug maker and sponsor companies are under pressure to replace the revenue loss specifically due to generics, which has further made drug development more expensive and complex.

In addition, growing pressure on industry players to follow stringent timelines has increased the demand for outsourcing of research activities. Even government organizations are outsourcing their clinical trial activities to CROs so that they can carry out the clinical trials with the required infrastructure, expertise, and minimize cost and timelines.

North America was the largest regional market with revenue share estimated at over 40% because of the presence of global industries, which invest maximum of their revenue in research activities. In addition, many academic institutes receive grants to undertake these activities.

Europe was the second largest market in 2014. This is attributed to the tax benefits offered to the large and small-scale companies to promote more CRO activities.

Asia Pacific is the fastest growing industry due to the reduced cost it offers in comparison to the U.S and other developed economies. China and India are projected to witness tremendous growth in the CRO market owing to their treatment naïve patient pool coupled with disease prevalence rate. Furthermore, genetically diverse population, highly qualified English-speaking investigators, well-equipped hospitals are other opportunities offered by India for global clinical trials.

Drug Companies Outsource Clinical Data Management

Clinical development teams now outsource higher percentages of tactical roles, such as data management and trial monitoring, than strategic ones, such as new product planning or medical communications. A recent study of more than 40 clinical development teams found that 83% of Top 10 and Top 50 pharmaceutical companies outsource responsibility for clinical data management compared to 40%  of medical device companies.

A clinical outsourcing benchmarking study published by Cutting Edge Information also found that 40% of Top 10 and Top 50 drug manufacturers outsource traditional trial monitoring responsibilities. Additionally, 40% of small pharmaceutical and biotechnology companies outsource trial monitoring.

The frequency of activities outsourced and the percentage of the role that external parties actually handle do not always go hand-in-hand. The extent that teams rely on third parties varies depending on multiple factors, but namely company size and activity type. For example, data management ranks among the top activities that surveyed teams prefer to outsource.

“Activity type may shape a clinical team’s willingness to outsource,” says Sarah Ray, senior analyst at Cutting Edge Information. “Surveyed teams prefer to retain much of the strategic responsibility for clinical trials in-house.”

Half of the surveyed companies report outsourcing some aspect of clinical development. However, teams often report outsourcing smaller percentages of clinical development and other strategic elements than execution-driven or tactical responsibilities.

Among the companies that do outsource clinical development, external teams are typically only responsible for 11% of total clinical development duties.
Developing a strong operational foundation for clinical studies is a necessity for pharma and device organizations alike. Working hand-in-hand with knowledgeable third-party groups can help sponsors’ clinical teams fine-tune study protocols and expedite trial timelines.(PV)

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