Ira Asherman, John W. Bing, Ed.D., and Lionel Laroche, Ph.D., P.E.
Regulatory professionals work in a complex constellation of relationships. They represent their companies with regulatory agencies, and must work to build strong working relationships with those agencies in order to be effective. In addition, we are all constantly faced with negotiating with co-workers over everything from meetings to individual roles and responsibilities. Critical to all relationships is the degree of trust that exists among the parties.
Research conducted by ITAP International at a major pharmaceutical firm indicates that there is a strong correlation between components of trust (such as communication effectiveness) and productivity. Hence the importance of understanding the nature of trust and the factors that affect it. In this article we will focus primarily on internal staff relationships; we believe that consideration of these factors applies equally to interactions with regulatory agencies personnel.
The Importance of Trust
"The most productive people are the most trusting people. If this seems to be an astonishing statement, it shows how distorted the concept of trust has become. Trust is one of the most essential qualities of human relationships. Without it, all human interaction, all commerce, all society would disappear."1
There is an unspoken assumption in the pharmaceutical industry that all those who work for the same company see and react to the world in the same manner and therefore trust follows easily. As a result, the systematic, conscious building and sustaining of a high trust culture does not regularly occur. However, we believe that a high level of trust is essential to organizational effectiveness, particularly in an industry as culturally diverse as the pharmaceutical industry.
Marsha Sinetar, in an article in Organizational Dynamics, points out:
“Although an organization obviously cannot succeed without high levels of trust between members, most aggressive companies do little to actively build trust. The typical corporation spends huge sums of money training its managers in interpersonal skills, but pays lip service to the critical issue of trust.”
The importance of trust to organizational success was highlighted as early as 1972 in a study conducted by Prof. Dale Zand at NYU, in which he looked at trust and managerial problem solving effectiveness. He reported that:
"Apparently in low trust groups, interpersonal relationships interfere with and distort perceptions of the problem. Energy and creativity are diverted from finding comprehensive, realistic solutions, and members use the problem as an instrument to minimize their vulnerability. In contrast, in high trust groups there is less socially generated uncertainty and problems are solved more effectively."
In a 1977 article in the Harvard Business Review, R. Wayne Boss conducted a study that built on Zand’s work and concluded that:
“Under conditions of high trust, problem solving tends to be creative and productive. Under conditions of low trust, problem solving tends to be degenerative and ineffective.”
A wide variety of studies highlight the importance of trust and a significant number generally support and reinforce the findings of Zand and Boss. One of the most interesting was reported in the November/December 1996 issue of the Harvard Business Review and was called “The Power of Trust in Manufacturer – Retailer Relationships.” The author, Nirmalya Kumar, suggests that trust:
“Creates a reservoir of goodwill that helps preserve the relationship when, as will inevitably happen, one party engages in an act that its partner considers destructive.”
These findings are critical to improving the effectiveness of individual relationships and project teams, and in an industry in which so much happens in teams, it is imperative the findings be considered.(and used.) However, we have found that as new teams are organized, the issue of trust is rarely considered and addressed explicitly.
Trust is critical, not only within project teams, but also in each company’s interactions with regulatory agencies.(and CRO’s.) As with all people, regulatory officials behave differently with companies and individuals that they trust.
Creating trusting relationships is by no means a simple process, particularly in the pharmaceutical industry. Here are some challenges that need to be overcome in order to build trust effectively in this industry:
The Overuse of Technology
Telecommunications technologies such as e-mail, telephone, and fax have become ubiquitous in the workplace. These technologies have helped the pharmaceutical industry become truly global. These technologies have helped overcome distances and enabled the creation of multinational, geographically-dispersed teams, thereby considerably increasing the speed of development and commercialization of new drugs around the world.
However, each form of telecommunications has its own strengths and limitations. For example, telephone conversations carry both verbal messages and tone of voice, but do not convey body language, which may be critical when dealing with people whose gestures account for a significant part of the message (as is the case for many Latin Americans or Latin Europeans). The telephone also requires that people be on the line at the same time, which may be difficult when you are working with counterparts half way around the world (in which case there is no overlap between your work day and theirs).
One common limitation of all telecommunications means is that they fail to reduce psychological distance between people. As a result, the practice of sending e-mail messages to people down the hall can get in the way of establishing authentic, trusting relationships. After all, even people who meet through internet chat rooms and fall in love by e-mail meet face-to-face before making a commitment. It is important for people who work on the same team to meet on a regular basis (three times a year is a minimum). A relationship based on the exchange of e-mail messages is rarely strong enough to get through difficult periods.
Because the technology is so powerful, it is not easy to put aside. There are, however, several steps that you can take to build trust with your co-workers. While these steps require a time investment, this investment often pays off handsomely when difficulties arise.
- When you have time for lunch, have lunch with co-workers with whom you do not usually spend time, but who are important to your success.
- When traveling to other sites, take the time to meet with people you do not usually see.
- Ask yourself when sending an e-mail, “Is it really necessary? Would the issue be addressed more effectively if we meet face to face?”
Language differences are an obvious impediment to effective communication and the building of trust. Many pharmaceutical companies employ people from all over the world and have workforces that look like the United Nations, particularly in the Research and Development functions. While English is usually the common denominator, it may not be the mother tongue of all. Some may speak English well, others do not. Language difficulties can create many misunderstandings in multinational / multicultural teams.
Native English speakers can considerably help overcome the language barrier by following these simple tips:
- Avoid sports English. In the U.S. and in Canada, many phrases come from either baseball (“covering all the bases”, “far out in left field”, “three strikes and you’re out”, “bench strength”, etc.) or football (“fumbling”, “running interference”, “punting”, “one down, three to go”, etc.). These phrases mean virtually nothing to people who do not know these sports – and that is a very large portion of the world’s population.
- Simplify your sentence structure and vocabulary. This is particularly important for English speakers who have been raised in the United Kingdom, where the breadth of one’s vocabulary and the ability to use complex grammatical structures reflects (to some extent) one’s education and position in society. For many non-native English speakers, a simple vocabulary (where one word is consistently used to mean the same thing) and simpler sentences go a long way to increase communication effectiveness. For example, use “big”, which is widely understood, and avoid synonyms (“huge”, “large”, “immense”, etc.).
- Beware of the differences between the various versions of English. British, American and Australian English assign different meanings to phrases, resulting sometimes in significant confusion. For example, stating that a project is a “bomb” is very positive in the UK (where a “bomb” is a spectacular success) and very negative in the USA (where a bomb is a catastrophic failure). Similarly, “tabling an issue” means putting it on the table in the UK and postponing the corresponding discussion in the USA. Keep in mind that, in continental Europe, in Africa and in the Middle East, non-native English speakers study British English.
There are vast cultural differences in the pharmaceutical industry, which are often neither acknowledged nor addressed. Many American companies employ people from a wide variety of countries and backgrounds and, unfortunately, most Americans know very little about them. This complicates dealings, with both co-workers and agency personnel. Cultural differences play a key role in the creation of trust, since trust is built in different ways, and means different things around the world.
How does one build trust?
One issue commonly encountered in multicultural teams is whether trust is built as the team progresses or needs to be established before any progress can take place. In the U.S., trust is “demonstrated performance over time.” Here, one gains the trust of one’s colleagues by “coming through” and delivering on time on one’s commitments.
In many other parts of the world, including China and many Arab or Latin American countries, building relationships is a pre-requisite for professional interactions. Building trust in these countries often involves lengthy discussions on non-professional topics (soccer, family and politics in Mexico, for example) and shared meals in restaurants. In these countries, work-related discussions start only once your counterpart has become comfortable with you as a person. This may take a lot longer than you would consider “normal”; in the case of Arab countries, China, or Mexico, it may take months of repeated interactions to establish trust.
Trust at time zero
The level of trust between strangers also varies from country to country. In the USA, people generally assume that other people can be trusted, until proven otherwise. While there are exceptions to this basic rule (as demonstrated by some of the racial tension observed in large American cities), individuals who do not know one another generally assume that they both have positive intentions.
This assumption is not nearly as common in countries like France or Italy. French people who meet by accident in the street are usually on the defensive: each assumes that the intentions of the other are negative until proven otherwise. One consequence of this initial distrust is that crooks have to resort to far more sophisticated scams in Italy than in the USA to defraud the general public; when transferred to North America, these scams can often run for a much longer period of time before they are detected.
The role of intermediaries in building trust
Intermediaries or go-betweens play a significant role in building trust in some countries. This role is limited in the U.S., where each person is assumed to stand on his or her own merit. In this case, the key role of intermediaries consists in opening doors that may otherwise remain closed. Once the intermediary has introduced the two parties, he or she allows them to decide whether they want to do business together by themselves.
By contrast, intermediaries play a far more significant role in several parts of the world. In many countries, the intermediary in effect “lends” its reputation to the party that asked for the meeting to be arranged. By stating that “you should meet these people”, the intermediary helps turn the initial mistrust into a positive attitude towards the party that asked for the meeting. In some countries, the intermediary participates actively (both behind the scenes and during meetings) in the discussions between the two parties he / she introduced. For example, it is not uncommon for intermediaries between Westerners and Arabs to be part of discussions for the first two years of interaction.
Once trust has been established, it must be maintained. Because Americans move more frequently than people in many other parts of the world, they are accustomed to temporary relationships. They make friends in a new city or a new company and start the process again when they change companies or cities. Americans who have known each other for a while assume that whatever trust they had when they last interacted is still there when they meet again, even when several years elapse between these two events.
In many other countries, such as Japan and Germany, where people are more likely to remain in the same area, relationships between people take a long time to create and need regular reaffirmation to remain effective. In particular, regular visits and communication is needed to keep the relationship alive and trust at a constant level; otherwise, trust spontaneously decays over time, and one needs to reestablish it when the next interaction takes place.
How can trust be developed and maintained on global teams?
There are three linked approaches to the establishment of trust between individuals on global teams:
- Emotional bonding: bonds can be created between members of global teams through informal, “after-hours”, face-to-face meetings in convivial settings. Informal time should be scheduled just as formal time.
- Conceptual understanding: employees should be provided with an intellectual understanding of how cultural similarities and differences influence business transactions.
- Trust: trust can be measured using the appropriate tools. When monitored and reported back to the team and the team leader, problems can be identified and overcome before they endanger team effectiveness.
Building trust is a critical step in the creation and development of multicultural and/or geographically-dispersed teams, which are so common in the pharmaceutical industry. Cultural differences can create misunderstandings between team members before they have had a chance to establish any credibility with each other.p>Managers of such teams need to recognize that building trust between culturally different people is a complex process, since each culture has its own way of building trust and its own interpretation of what trust is. To be effective, this process often requires a significant amount of time and communication.
1 Taylor McConnell in Group Leadership for Self Realization
This article originally appeared in the May 2000 issue of Regulatory Affairs Focus.