Having a Patient discuss an Adverse Event in a Forum is one of the major concerns (nightmare ?) within Bio-Pharmaceutical companies against using a Patient Forum. And of course, it is the Regulatory and Legal people which dictate this concern. Let’s try to place it in a context. We will do this in a 3-step process.
Step 1: The Clinical Study Portal is a secured environment, which requires user authorization before Users can logon. So it is like a gated community. Everything said within this ‘trial community’ will only be ‘heard’ by other group members. So this limits your problem to a ‘known’ group of people.
Step 2: Having said that, we still have our question “Do we, as a Bio-Pharmaceutical (or Medical Device) company, carry responsibility for anything said by a Patient on ‘our’ Forum as made available within a clinical trial setting?” The answer is ‘No’ and ‘Yes’.
‘No’ to the extent that it should be made perfectly clear to all participants that the intent of the Forum is to create a platform which allows more ‘openness’ and sharing of ideas and opinions within all trial participants. And that you, as a Sponsor, carry no responsibility for anything said or listed. In fact, Patients should feel free to discuss anything they want on a Forum.
‘Yes’ to the extent that this doesn’t alleviate you from your legal responsibility to report Adverse Events to FDA or EMEA. So does this imply that you as, as a Bio-Pharmaceutical company, should monitor all what’s being said on a Forum? Time for a next Step.
Step 3: So where do the previous two Frameworks lead us? We know we are dealing with a ‘known’ group of users, we have stated that patients participating in a Trial Forum should feel free to discuss anything they want, and we have confirmed that you, as a Bio-Pharmaceutical company, have a legal responsibility to report any Adverse Event.
The solution then, is to set a couple of simple ‘rules of engagement’ before you allow Patients access to the Forum or other Social Media tool. These rules can be simple and straightforward:
- All Patients should feel free to discuss anything they want on the Forum, including any side-effects or other complaints they might experience.
- You, as a Bio-Pharmaceutical company, have a legal responsibility to report any Adverse Event.
- You don’t want to review everything what is being said on the Forum to check if there is any reference to an Adverse Event.
- Patients are free to discuss any side-effect or complaints, as long as they have also reported that side-effect or complaints to the responsible trial investigator.
In other words, the responsibility for proper reporting of any Adverse Event rests at the patient. Is this new? No, because even without the additional communication tool of using a clinical trial Forum, it is the patient’s decision whether or not to report a side-effect to an investigator.
