Assessing and managing issues around clinical trials: a multi-stakeholder approach


Many companies are facing challenging decisions on whether to proceed with clinical trials in the coming months as countries experience varying degrees of lockdown.

Questions need to be asked: is it practical to conduct a study at the current time? Can patients and healthcare professionals be kept safe? Will the data be robust? Could the varying conditions in different countries and study centers harm data integrity? Delaying clinical trials can have significant financial implications for a company, but so too can a study that fails because it could not be conducted in line with the protocol.

Health authorities such as the FDA and EMA are providing guidance on the conduct of clinical trials, including managing protocol deviations, but the decision to proceed or postpone should not simply be an operational one. There are also issues of reputation. Although a study may be possible operationally, will moving ahead at this time lead to questions over whether the company is putting its self-interest ahead of patients and healthcare professionals? Or will halting an existing study or not commencing a new one also harm the organization’s reputation? Delaying studies means patients need to wait longer for potentially life-saving treatments. There are no easy answers.

What is important is that organizations consider all the stakeholders involved and are prepared for communicating about their decision clearly and consistently.

Stakeholders may include:

  • Investigators and study coordinators directly involved in a study
  • Ethics review boards
  • Independent Safety Monitoring Committee members
  • Patients and their carers
  • Patient advocacy organizations
  • Opinion leaders in the therapy area and the broader prescribing community
  • Health authorities
  • Politicians
  • Investors
  • Media
  • Contract and Academic Research organizations

And within an organization:

  • Senior management
  • Clinical operations
  • Brand teams and their different functions, including medical, regulatory, commercial
  • MSLs and other customer-facing staff
  • Supply chain
  • Investor relations
  • Communications

Organizations should think from the outside in. How will each of these stakeholders react to your decision, depending on the scenario, and how will they influence other stakeholders? By mapping out the stakeholders, the decision-makers in the team can better understand how an issue might be triggered, how it may evolve and how bad could it get. Then companies need to establish their narratives around their decisions and agree the right order of communicating.

Right now, companies are concerned about being seen to do or say the wrong thing. The first important step should be to take a comprehensive, multi-stakeholder approach and map out who you need to consider – both internally and externally. Shaping a clear, consistent communications cascade to reach all of those individuals and groups could help to limit the potential for an issue to arise that could harm the company’s reputation for the long term. For more information on the types of messages and other considerations in communicating with key audiences, please see Best practices for communicating clinical trial changes and delays.

Do you feel like your issues preparation or management could use a fresh perspective? Please contact us.

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