With the announcement of the first Vioxx trial verdicts, public attention surrounding drug testing and safety during clinical trials is higher than ever. Along with that heightened attention, the FDA has added new appointees to its Drug Oversight Safety Board. As a result, pharmaceutical companies now face stricter drug safety regulations during the clinical trial and post-marketing surveillance periods. Tighter regulations have led to larger, longer and more complex trials to ensure the proper testing. Therefore, more resources are required to manage and monitor those studies, and staffing requests for both permanent and contract associates are increasing. As a result, there is a shortage of professionals in drug safety monitoring and data collection; thus, pharmaceutical companies will need to become more creative in their staffing plans.

One option is to train professionals with a clinical background in the areas of drug safety monitoring and data collection. As pharmaceutical companies develop such professionals into these roles, the supply will increase and prevent rising costs.

Under the ever-more-watchful eye of the FDA, pharmaceutical companies are dedicating more staff to the review, surveillance and scrutiny of safety data. Late Phase IIIB and Phase IV studies, as well as post-marketing safety studies, are increasing in size to accommodate the FDA’s more stringent requirements for long-term pre-marketing safety data and post-marketing safety surveillance. As a result, there has been an increase in the size of safety departments and data safety monitoring teams.  

The shortage of qualified and trained individuals in the drug safety monitoring and data collection arena could also impact the consumer’s bottom line. As shortages increase, the cost for qualified and trained associates will also increase. Ultimately, the consumer “feels” the overall cost of developing a product. Additional costs associated with maintaining necessary staff in the area of drug safety and surveillance could impact the total development cost and therefore could result in higher drug prices.

Exploring the Options

Currently, pharmaceutical companies use in-source safety monitoring, meaning that companies maintain and grow their resources through additional permanent or contract employees who are co-located at the corporate campus or at an off-site facility. As pharmaceutical companies staff up, their corporate campuses will no longer be able to accommodate their expanding safety teams.

And while companies have begun to build off-site facilities, teams continue to grow at such a rapid pace that those facilities are becoming insufficient well before they are even completed. To address the growing need for space, some pharmaceutical companies have discussed creating “virtual” safety teams – associates who work from home and “telecommute.”  By setting up home satellite offices or having people telecommute, some pharmaceutical companies are seeing not only an increase in quality and efficiency, but also a decrease in costs.

Although outsourcing may be an excellent option for many companies because of the number of benefits it offers, some challenges must be addressed. Obstacles such as technology and information access can present challenges in telecommuting. As pharmaceutical trials involve sensitive and proprietary information, the technology must be able to keep all company information secure. Companies that are not experienced with remote employees or telecommuting will have to invest resources to allow the technology to support remote individuals. Once the technology is in place, companies can build and manage virtual teams and create a flexible resource pool that doesn’t need to be co-located with the client.

Currently, there are no pharmaceutical companies that have fully outsourced safety responsibilities yet, an indication that confidentiality and control needs are high due to the sensitive and proprietary nature of the information.  

Additionally, not all corporate cultures allow companies to adapt to remote workers. A company must have oversight processes and a certain level of trust in remote employees to ensure they are completing projects with the necessary quality level. Some companies’ structures may not be conducive to such an arrangement. On the other hand, for companies that require safety monitoring teams to work onsite, it may be difficult to find people willing to work in such a highly-controlled environment. Another challenge may be identifying experienced individuals within a company’s immediate geographical area or even those who are able and have the desire to relocate.

While regionalization may not work for every company, with the correct technology and fitting corporate culture, it can allow companies to expand their market and increase the talent pool.

Solutions

While pharmaceutical companies are certainly exploring options within their own organizations to combat the staffing shortages in safety monitoring, many are looking at outsourcing options. One outsourcing option to consider is contracting with a staffing firm. Companies should choose a staffing provider that is able to qualify, certify and possibly even train clinical professionals as safety associates. Doing so will allow them to efficiently find the best talent.

With the potential decrease in clinical data management positions due to off-shoring of data management functions, professionals with clinical backgrounds will be in need of additional career options. A staffing firm can not only locate the most talented professionals, but can also assist in cross-training such people in drug safety monitoring and data collection; thus further increasing the talent pool.

Pharmaceutical companies should bring in an outsourcing partner early enough in the process so the client and provider can co-develop success criteria and define strategies for fulfilling the client’s needs. By bringing in the staffing partner early on, the company can develop a proactive, rather than reactive, strategy. A reactive strategy can negatively impact outcomes, and also hinder the relationship-building process.  A partnership that is built early on can benefit from the experiences and knowledge base of both companies. Proactive relationship building increases the opportunities to identify potential obstacles and remedies before they are necessary. Reactive strategies, such as attempting to identify a partner in a time of “performance panic,” involve increased levels of frustration and stress. Such strategies potentially could negatively impact timelines and deliverables. There is no time to adequately co-develop a strategic plan when the focus is on getting the job done as quickly as possible, because the timelines have already been severely compromised. This approach could result in a decrease in quality, efficiencies and will add to the overall financial burden.

What To Look for in a Staffing Partner

One of the most important factors in developing an optimal relationship is to choose a staffing provider with corporate values that match those of the pharmaceutical company. Understanding that both companies conduct business with the same underlying values helps the relationship succeed because both sides enter the arrangement with a level of trust.

Another key success factor is to develop a joint ownership mentality. Rather than “throwing the project over the fence” with the expectation the staffing provider will deliver without sponsor involvement, there should be joint ownership, clearly defined expectations and joint problem-solving and escalation plans. The joint ownership mentality eliminates the “us vs. them” mindset. When problems do occur, the solution will be much easier to identify and implement if the company and provider work together with a team approach and take responsibility jointly.

Providers should also be willing to make their performance highly visible so the pharmaceutical company is always aware of current activities. This can be accomplished through regular face-to-face meetings as well as through such tools as performance metrics, quarterly business reviews and frequent progress reports. The more visible providers can make their current and past performance levels, the more proactive they can be to identify the actual level of performance as compared to the expected level of performance. This kind of visibility and full disclosure enhances the level of trust.

Finally, and most importantly, companies should look for providers with a proven track record of recruiting, hiring, training and retaining the clinical talent needed for the full life of the project.

Keys To Success

When properly implemented, a staffing partnership can expand the pool of quality talent, thus helping to alleviate some of the national staffing shortages in drug safety monitoring. The key to success is the high degree of joint ownership between the vendor and the pharmaceutical company. Management teams must work together to proactively define and design the program, define the alliance management structure and co-create policies and procedures. Finally, by identifying corporate needs and partnering with a company whose values are similar and whose experiences and resources will support all needs, the end result will be a mutually beneficial relationship built on trust.

Kelli Henry is associate director of Clinical Operations for Kforce Clinical Research, a division of Kforce Inc. She can be reached at khenry@kforce.com.