The Role of Diplomacy in Clinical Research Leadership
Anatoly Gorkun, Fiona Kearney
PPD, a Company of Thermo Fisher Scientific
The application of diplomatic principles was crucial to the success of the project in the following case study.
A

project team was not meeting their deliverables and milestones for a project, and the stakeholders were concerned. The situation kept increasing the pressure on this project team, which was working hard but without any visible improvement. A newly appointed project leader re-analyzed the situation and found two major challenges: inefficiency and poor client relationships. The leader decided to implement additional measures in the existing project plan, nearly all of which appeared to be connected to diplomacy. These real-life examples (below) demonstrate how applying diplomatic principles in the day-to-day work of clinical researchers led to better control of the situation, significant improvement in the project, and a much-improved CRO-client relationship. Applying diplomatic principles also led to a significantly more motivated and satisfied CRO (Clinical Research Organization) team.

Relevance and Application of Diplomacy in Clinical Research

Successful management of any situation, whether in clinical research or any other endeavor, requires diplomacy. Diplomacy is about influencing decisions and behavior through dialogue and negotiation and maintaining friendly relationships between individuals or groups. Diplomacy is a framework for controlling a difficult situation without causing resentment, with the ultimate goal of strengthening the project or organization. Leaders use diplomacy to guide their people and projects through complex situations and fragile relationships to success.

Table 1 summarizes and explains The Main Functions of Diplomacy in Clinical Research. The functions of negotiation and promoting friendly relationships are further illustrated below.

In negotiation, finding common ground—a point, topic, opinion, or interest upon which both sides agree—can make it easier to bring people together and move the negotiation forward. Focus on similarities instead of differences.

Example: At the 1985 Geneva Summit, US President Ronald Reagan and Soviet leader Mikhail Gorbachev took a break to take a walk. During this walk, Reagan asked Gorbachev if they could set aside their differences to help each other in case the world was invaded by aliens. Gorbachev and Reagan both agreed to help each other. Historians consider this famous “pool house conversation” to be a diplomatic example of finding common ground.

Friendly relationships lead to increased knowledge sharing, team spirit, and morale, and can even positively impact team members’ work environment and mental health by reducing stress.

Example: A project leader was asked to attend a business development meeting with a new client soon after joining a new organization. This new client was a prior client of the project leader’s former company, and its representatives were very happy to meet the project leader again because they had built a strong, friendly relationship based on trust and transparency. Each side knew what to expect from working with each other. This relationship was key in the client’s decision to award their project to the project leader’s new organization.

The Main Principles of Diplomacy

The following real-life examples reflect the successful application of the Principles of Diplomacy (see Table 2) to clinical research.

Clarity brings freedom from nondifferentiation or ambiguity. It ensures that neither party has reason to speculate or have unnecessary concerns, which could lead to incorrect assumptions about what the other side is saying.

Example: An open-label study was a part of a three-study program. The central laboratory supply process for this program was complex, and coordination with the laboratory was challenging: The central lab had limited capacity for studies of this size, the kit build time was long and its expiration period was short, and the importation procedure in some countries was difficult.

The project leader noted that a communication being prepared stated that there was a green light for shipping lab supplies to the new clinical research sites in one of the countries. The new sites in this country, however, were not expecting to receive these supplies or start the study for several months. Upon reviewing the situation, the project leader realized that the green light only meant that the shipping documents were ready, not that the supplies needed to be shipped. The project leader edited this communication, using different wording to avoid this confusion and premature shipping.

The project leader was also concerned that the ambiguous communication may lead the laboratory to discontinue building laboratory kits for all clinical research sites in this country, not only the new ones. The project leader asked the clinical supplies department to ensure and confirm overall understanding of the issue. Thanks to this discussion, agreement was reached that the laboratory would stop building kits only for the new sites in this country.

Credibility means being trusted and believed. Keys to achieving credibility include good communication skills and taking the right actions. Knowledge and expertise, teamwork and collaboration, logical thinking and common sense, and confidence also play a major role in promoting and ensuring credibility.

Example: A CRO was awarded a phase 3b study with the goal of generating an extension of the marketing authorization of a blockbuster drug. Unfortunately, the scientific rationale for the study was weak and the study faced multiple regulatory delays. Despite this, the oversight director was confident that the enrollment goal could be met within the required timeline.

However, the client became nervous due to the importance of the study and the regulatory delays, and the client-CRO relationship started to become tense. The client insisted that the CRO open a new country for this study six months before enrollment was due to be completed and wanted the CRO to assume the additional cost of this rescue scenario.

After internal discussions with senior management, the CRO oversight director suggested a shared responsibility proposal to the client: If the CRO missed the recruitment deadline, the CRO would pay for the cost of the additional country and any additional delay. However, if recruitment was completed in the original timeline, the client would assume the cost of the additional country.

The purpose of the CRO’s shared responsibility proposal was to demonstrate that the CRO was a real partner of the client and to rebuild their team’s credibility. The client agreed to the CRO’s proposal. The CRO met the recruitment goal in the allocated time, and the additional country did not need to be added.

Comprehensiveness describes the range and depth of the team’s decision-making process. In clinical research, this could be the study team or the team managing the study deliverables. Understanding each role in a single, comprehensive organizational system and understanding the parameters that guide the scope of the work and range of responsibilities are essential to comprehensiveness.

Example: A client wanted to run a compassionate use study in an expanded access program as part of a large development program executed by a CRO. Upon review of the compassionate use study, the CRO discovered a serious issue that would have prevented the study from succeeding: The study design would not generate the data necessary to support the drug safety and efficacy requirements in multiple countries. The CRO recommended a more effective way to develop the product, which the client (gratefully) implemented.

Circumspection is critical in evaluating clinical research for potential risks because protecting patient safety is crucial. Qualities of circumspection include caution, alertness, care, wariness, and watchfulness.

Example: A pediatric study was in the start-up phase. It looked like there were no issues with the study design or the protocol, and the study start-up department had begun to prepare the documents for the regulatory and ethics submissions.

Meanwhile, the CRO allocated a new project leader to run the study. Their first activity was to carefully review the protocol and all study materials. This review uncovered several items which would have led to an unsuccessful regulatory outcome if not addressed. For example, the volume of laboratory samples to be drawn from babies was unacceptably high, and the tablet was too large for children to swallow.

After escalating these findings internally, the new CRO project leader notified the client and recommended implementing several corrective actions. The client was glad that these issues had been identified early enough to rectify prior to submitting the study for regulatory and ethics reviews.

Some team members may feel that they are not confident enough to lead sophisticated negotiations in a diplomatic way. This is especially true the first time an individual leads negotiations. It is critical to remember that thorough preparation helps build confidence. A consistent approach where consistency results in meeting expectations builds trust. Trust is critical to successful negotiations, and receiving trust from others builds the leader’s confidence and enables them to project more confidence.

Example: A CRO project leader was giving a presentation to a client in a bid defense meeting. Everything went well, even though the client thought that this project leader did not have the required therapeutic experience. Eventually, the client asked the CRO why they should be awarded this study when the project leader did not have this specific expertise.

The project leader smiled and quietly explained that while they had not had a chance to work on a study exactly like this, they had extensive experience in managing many complex and challenging studies in similar indications. The leader further explained that they knew how to lead the study to success, had a team of high-quality professionals supporting them, and that the medical director was an expert in the disease. The study was awarded to this CRO team with no further questions.

Confident communicators are assertive (subtle and respectful) but not aggressive (abrupt and disrespectful). It is important to consider assertiveness in communications. Avoid aggressiveness, which will immediately thwart if not reverse any progress made. Displaying knowledge and understanding is key.

Perceptiveness means noticing and understanding things that others may not notice. Paying attention to every detail helps one make fully informed decisions and prevent potential challenges. Simply asking questions also helps avoid misunderstandings.

Example: A CRO project leader was involved in the preparation of a proposal for a new study. While reviewing the materials provided to prepare the proposal, the project leader spotted a real concern for the client hidden in the materials and ensured that their proposal proactively addressed this concern.

This resulted in a CRO-client meeting to discuss the study. This was the only CRO to identify and proactively address this concern, and the client engaged this CRO for this study.

Understanding helps develop and implement realistic plans. Understanding considers how people may react in certain circumstances or if they need to accept a specific compromise in negotiation. Understanding also creates a positive environment for collaboration, which facilitates compromise and accelerates the process of negotiating an agreement.

It is critical for all stakeholders to check the initial negotiated agreement prior to implementation. Identify all stakeholders who should review the agreement, share it with them, and if the review returns even one “no,” redistribute and refine the agreement until every reviewer agrees.

Example: In one study, the client wanted to accelerate site initiation to occur earlier in the process, and the CRO project leader agreed. However, when the CRO clinical team was informed, they determined that it was impossible to initiate these sites early. This difficult situation forced the CRO project leader to explain and renegotiate the agreement with the client.

Conclusion

We hope that these examples have given new practical meaning to clarity, credibility, comprehensiveness, circumspection, confidence-building, perceptiveness, and understanding in the context of diplomacy in clinical research leadership. Applying diplomacy in clinical research in these examples resulted in:

Early risk assessment
Streamlined communication
Proactive, rational issue escalation
Clearly defined roles and responsibilities
In-depth review of study plans and trackers
Team empowerment
Regular task review
Engaged, proactive mindset
Clarity through discussion before implementing client requests
Eliminating overlapping meetings
Eliminating micromanagement
Encouraging constructive feedback

The outcome from implementing principles of diplomacy for this CRO project team was beyond their expectations. Even though they had extra work to do, they saw “light at the end of the tunnel” as the client-CRO relationship started improving. The CRO project team also gained more satisfaction and confidence in their work.

The authors thank Jodie Block, Eleni Vanden Eede, Tomasz Lipiec, Yolande Paraiso, and Dirk Sneyers for sharing examples and contributing to this article. The content of this article does not necessarily reflect the views or policies of Thermo Fisher Scientific (TFS). Examples shared in the article represent authors’ collective experience gained throughout their careers and are not limited to TFS only.

Resources Related to Diplomacy

Appendix:

Definitions Related to Diplomatic Principles
Definitions of “diplomacy” from popular sources:

Although this definition mentions foreign governments and people, it can also be applied to groups of people, including those working in clinical research.

Not upsetting people is very important in most endeavors, including clinical research. Consequently, every study considers the risks and builds contingency plans to avoid or mitigate them. However, most teams will face issues and challenges and must determine how to mitigate them as a team as a study progresses. It is essential that team members are aware of how to approach these problems in a diplomatic way.

Clinical research groups can also use diplomacy, because

Table 1: The Main Functions of Diplomacy in Clinical Research

  • Diplomacy is about:
    • Influencing decisions and behavior through dialogue and negotiation
    • Maintaining friendly relationships between groups or individuals
    • Controlling a difficult situation without causing resentment
    • Strengthening organizations
  • Need for diplomacy in management: Guide people through difficult complex situations and fragile relationships to success
  • Adopt and apply: Use diplomatic principles and approaches in these critical functions of clinical research leadership.
    • Representation: The leader in any situation is the individual representing the project team or organization. The leader’s image—their personality, style, values, and capabilities—is crucial. This leader must have high emotional intelligence and the ability to adjust their management style to changing situations and different individuals. They must be able to find common ground in order to achieve a satisfactory outcome for all parties without acting in isolation but by seeking input from others. The leader should listen to and hear others and analyze their input while working effectively with peers and senior management. The leader must make good decisions and remain strong, demonstrating decisiveness and perseverance.
      • Adjust management style to changing situations
      • Find common ground
      • Be open to the input of others
      • Work effectively with peers and higher management
      • Make good decisions
      • Be firm and stay strong
    • Protection of interests: In protecting the interests of the organization, the leader must keep in mind that the other party wants to protect their interests, too. Try to understand others’ point of view by listening and asking questions to avoid clashes and achieve a win-win outcome through wise compromise that benefits the project or organization. If neither party gets everything it wants, then the ability to compromise is key.
      • Listen and ask questions to understand others’ point of view
      • Avoid clashes
      • Compromise to benefit your group
      • Achieve a win-win outcome
    • Negotiation: Each negotiation situation is unique. Consider what the other party is likely to need along with your own goals to formulate your strategy before negotiations begin. During negotiations, it is essential to employ common sense and consider your timing: aim to make the right statement at the best moment to achieve the optimal outcome. All parties want to complete the negotiation with the feeling that they have gained something that is valuable to them. Compromise is necessary, even when compromise is difficult. It is good practice to consider in advance the specific compromises that your team is willing to make.
      • Thoroughly prepare
      • Optimize the strategy when negotiations begin
      • Use good timing and common sense
      • Compromise even when compromise is difficult
      • Keep calm and do not burn any bridges
      • Find common ground
    • Observation and reporting: Observation and reporting keeps careful watch for potential difficulties or threats. Proactively reporting relevant status or changes helps ensure the communication that is essential to success. Sharing information also helps overcome the silo effect and gives people the opportunity to see the big picture.
      • Be proactive
      • Actively report the relevant status or changes
      • Share information
      • Avoid the silo effect
    • Promote friendly relationships:
      • Increase knowledge sharing
      • Increase team spirit and morale
      • Reduce stress
      • Improve mental health
      • Create a positive environment
      • Increase external (customer) and internal (staff) satisfaction

Table 2: Principles of Diplomacy

  • Clarity: Planning must be clear so that both sides understand it. Unclear planning can lead to the risk of taking inappropriate actions that may distort or impede progress. Lack of clarity in communication or intent may lead to speculations, unnecessary concerns, wrong assumptions that result in wrong decisions, or incorrect planning and actions, all of which make it unlikely that either party will achieve their objectives.
  • Credibility: Being trusted is the most important quality of people who have credibility; other important qualities are integrity, reliability, and believability. Credibility demonstrates to our team members and partners that we are honest and do the right thing, and that we have the authority to negotiate and implement agreed-upon decisions:
    • Be knowledgeable and professional
    • Use good communication skills
    • Be confident
    • Use teamwork and collaborate
    • Think logically
  • Comprehensiveness: Consider the big picture, work cohesively with others, and remain aware of other influences that could impact decision-making to achieve the best outcome for all parties.
  • Circumspection: Be curious and critical and do not assume or take things for granted. Leaders who constantly evaluate the situation, ask as many questions as necessary, and survey possible consequences before acting can make prudent and timely decisions.
  • Confidence-building: Thorough preparation helps build confidence, and consistently meeting expectations builds trust. Receiving trust from others also builds the leader’s confidence and enables them to project more confidence.
    • Build trust with consistency: Consistently deliver and meet expectations
    • Project and show confidence
    • Use assertiveness in communication
    • Be knowledgeable and understanding
  • Perceptiveness: The ability to identify or interpret your stakeholders’ needs and expectations is an asset, whether you have worked with this person for some time or this is your first meeting.
    • Be aware and look for things that are not easy to spot
    • Pay attention to detail
    • Ask questions to avoid misunderstandings
  • Understanding: Sensing what the client wants to achieve and responding to their unsaid requests demonstrates understanding and facilitates the environment of trust that is essential in clinical research.
    • Predict what people might feel
    • Understand how people react
    • Create a positive environment for collaboration
    • Facilitate compromise
    • Accelerate the process of reaching agreement
    • Facilitate the negotiation process.
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