Question & Answer Responses:
Is NIH prepared to support genomic studies specific to SJS? (Asked by James Chodosh)
Yes, assuming they are scientifically meritorious and score well in peer review. Applying in response to our program announcements, PA-16-274, ‘Serious Adverse Drug Reaction Research (R21)’ https://grants.nih.gov/grants/guide/pa-files/PAR-16-274.html and PA-16-275, ‘Serious Adverse Drug Reaction Research (R01)’ https://grants.nih.gov/grants/guide/pa-files/PAR-16-275.html would be the most effective route.
(Answered by Teri Manolio)
How do you evaluate the ocular findings? On your case report form, there seemed to be only presence or absence of Mucous membrane involvement.
There are a couple of ways the trial evaluates or addresses ocular involvement
- The supportive care protocol predefines acute ocular findings for which a specific intervention should be given. The specific ocular findings are evaluated based on this construct. The case report form is binary for acute ocular findings overall (Yes/No), but the final version that is uploaded to our database provides the ability to comment on the specific findings. We are aware there may be important differences in ocular outcomes between arms. This will be addressed in the trial analysis.
- The follow-up (3 and 12 months) visits more specifically address the chronic ocular complications and what has occurred. This is tracked again the treatment arms to see if we can make a difference in the long term (eg. synblepharon or blindness)
(Answered by Brandon Worley)