How to handle a clinical trial crisis

By Kirsty Barnes

- Last updated on GMT

Related tags: Clinical trial, Tgn1412

Are you ready to handle a clinical trial crisis if it lands on your
doorstep tomorrow?

Many biopharma firms, trial sponsors and clinical research organisations (CROs) are not, Aafke Huininga of Burson-Marsteller warned delegates at the Association of Clinical Research Professionals (ACRP) conference in Brussels.

After the recent media circus surrounding the clinical trial crisis involving Parexel and Tegenero, companies can never be too careful, Huininga pointed out.

The most important piece of advice companies should follow when facing a crisis is "don't adopt a siege mentality,"​ she said.

Companies must fight the urge to remain silent - according to Huininga: "This is the worst thing you can do."

Many firms still do not understand this and yet it is fundamental, she added.

"If you do not speak about the issue the public will naturally assume you are guilty. Journalists will also be forced to go elsewhere for their information sources and will be unable to present your side of the story,"​ Huininga explained.

"This is far more dangerous than if you were to willingly offer journalists the basic facts."

Furthermore, Huininga stressed that in the event of a crisis, "time is your worst enemy. The first 20 minutes are particularly crucial."

When a crisis hits, the situation may escalate very quickly - the media will start asking questions and the authorities will want to know what has happened - there is no time to think and plan and no time to address all issues, she said.

"This is why all companies conducting clinical trials must have a competent crisis plan in place that is ready to swing into action without any notice."

However, simply having a plan is not enough, regular simulations of this plan are then needed to maintain an adequate level of alertness and contact details of the individuals who are responsible during a crisis should always be kept readily available in a centralised company database.

It is also important to pre-train a crisis team as well as any members of staff who are considered "experts" who could be used as a company media spokesperson in a crisis situation.

"In a crisis, sending a corporate/PR spokesperson to talk to the media is simply not sufficient,"​ said Huininga.

These experts should be well enough trained to be able to make statements that strike a balance between the company's legal obligations and its public obligations, she said.

"Mistakes are costly and often irreversible."

Moving on, if a crisis does occur, firms should immediately isolate the crisis team from daily concerns so that they can define the real problem - in both the short and long term - and assume a "worst case scenario" planning position.

It is then important to centralise and control the information flow coming in and out of the firm, while still understanding the demand for information from external audiences such as the media.

"Always be nice to people, if you can't answer questions on the spot, write them down and be sure to get back to them as soon as possible with a follow up,"​ said Huininga.

When preparing a company statement, Huininga had some further advice.

"All audiences have basically the same questions and in the interest of minimizing enquiries it is important to answer the key questions from the outset,"​ she said.

These include: Why did it happen?; Who is to blame?; Who are the victims?; What is their condition?; Did you follow all the protocols?; What are you doing now?; and Can this happen again?

It is also wise to show a human face during a crisis and address the emotion/fear concerns that the public will have, as well as giving whatever reassurance is possible and demonstrate a company commitment/perspective on the issue, she said.

And most importantly - at all times tell the truth. "If you do not you will inevitably be found out and this will always do far more damage to reputation than coming clean in the first place."

Related topics: Clinical Development

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