insite clinical research fall 2018

HR Solutions: Crucial Conversations in Clinical Research

Our success is dictated by the quality of our relationships. We don’t get what we deserve; we get what we negotiate. Those who excel at negotiating get what they want or negotiate a win-win for both parties. They engage with people rather than bulldozing them and create meaningful conversations and bonds that transform situations and relationships. Communicating clearly demonstrates personal accountability and respect and results in higher levels of trust. When we get an opportunity to communicate clearly and effectively but choose not to, our standards slip and we become less effective in the workplace.

Who are the people most responsible for your career? That would be you, you and, oh yeah, you! The quality and longevity of your career is in large part dependent upon your ability to form healthy, professional relationships with your boss, colleagues and collaborators. These are the people you need to learn to communicate with in a clear, direct and simple manner, The quality of professional relationships is of paramount importance in clinical research: the stakes are high, compliance is required, resources are stretched thin, and the protocols have never been more complex.

Clinical Research Application

According to Miseta, clinical trials have increased in complexity in the last 15 years.1 There are nearly double the number of procedures, eligibility criteria, endpoints, data entry requirements and amendments compared to fifteen years ago. Site operations have also increased in complexity. It is common for sites to juggle 20 different electronic systems daily among eSource, eRegulatory, electronic medical records, patient portals, questionnaires, IVRS, electronic data capture systems, and clinical trial management systems. To make matters worse, while protocol and clinical research operations have increased in complexity, clinical trial budgets have remained stagnant.2 The environment is rife with opportunities to make mistakes and mistrust key stakeholders. The solution is impeccable communication within and between the site, trial participants, sponsors and clinical research organizations (CRO).

 

Strategies for Crucial Conversations

  1. Set up the rules in advance: Have weekly site team meetings for non-urgent issues. Establish a set agenda for your monitoring visits, including time to discuss progress. What is the plan to escalate issues to the principal investigator (PI), sponsor and CRO?
  2. Assume good intentions from all parties: Ultimately, all of us want what is best for the participants and the science. Clinical research is the ultimate team sport. Approach situations with the goal of solving problems, rather than “one-upping” others.
  3. Investigate the situation: This means actively listening before doing. “Listen with the intent to understand, not the intent to reply,” says Stephen Covey.
  4. Do it in person: Due to the complexity of clinical trials, it is better to talk face to face to eliminate misunderstandings. At the very least, conduct the conversation by voice (never by text!). There’s a difference between a “making sure we are all on the same page” email versus a message that comes across as if you are trying to cover your tracks or throw shade at another colleague.
  5. Stick to the facts: Some conversations can get confrontational. Even a monitoring report can appear confrontational. Provide justifications (especially in negotiating budgets), supporting documents (referencing the protocol, source documents, or regulations), and/or a third party (another investigator confirming eligibility) to assist in the resolution.
  6. Document, document, document: Akin to the ALCOA principle, document your communication plan and share it with all applicable parties. This will ensure clarity and consistency across all channels.

Conclusion

Clear communication helps all key stakeholders understand the big picture and ensures that your team is set up for success. By utilizing these strategies, you are creating a culture of accountability and compassion, where people are open and honest when they make a mistake, others come to their aid, and the team focuses on resolving problems rather than on failure. When employees support one other, they are more motivated to do their best and be more engaged with their performance.

Note: This article originally appeared in the Fall, 2018 edition of SCRS Insite: The Global Journal for Clinical Research Sites.

References

Burgess, L.J. & Sulzer, N.U. (2010). The growing disparity between clinical trial complexity and investigator compensation. Cardiovascular Journal of Africa, 21(5), 249-250. August, 1979. Accessed July 6, 2018 from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3721298/.

Miseta, E. (2016). Getz: Site activations hurt by commodity mentality. Clinical Leader [online]. May 16, 2016. Accessed July 5, 2018 from https://www.clinicalleader.com/doc/getz-site-activations-hurt-by-commodity-mentality-0001.

About the Authors

Molly has over 18 years of health care experience with specialization in oncology, research and health care administration. Now, Molly shares her experience and expertise with sites as a Medix Clinical Research Strategy Executive. This article was co-authored by John R. Nocero, PhD, MBA, CCRP, GCP, CC, ACB, IPPCR.

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