Diane Wild is a colleague that I have the privilege of working with closely. She is at the leading edge of what’s new with ePRO in terms of best practices and current industry guidelines regarding instrument migration, usability testing and linguistic validation. She is one of the founders of Oxford Outcomes, a leading international health outcomes consultancy that was recently acquired by ICON. Not only is Diane a well respected professional, but she is also a wonderful person much liked by myself as well as many of her colleagues at Oxford Outcomes.
I had an opportunity to pick her brain and conduct an interview at the ISPOR Annual European Congress in Madrid, Spain.
Me: The FDA PRO guidance came out in 2009. How has it been received and adopted during the last two years?
Diane: There was a lot of uncertainty once the draft guidance came out and nobody knew quite how the final guidance would turn out. It was finally released in 2009 and since then, many companies have conducted webinars to help the industry understand the implications of the final guidance. Now after two years, there is a general feeling of acceptance of the guidance and deeper understanding of it amongst vendors as well as Sponsors. For example, in the beginning, nobody quite knew what the PRO evidence dossier should look like, but now many people know how to put them together. However, there are still some specific questions. For example, there is some ambiguity regarding the use of mixed modes of delivery, such as paper and electronic PROs in clinical studies as well as how to show evidence of content validity when doing linguistic validation.
Me: What about the EMA? How has the FDA guidance affected the way things are done in Europe?
Diane: There is a general acceptance that the FDA documentation will be acceptable for EMA submissions as well. We also have more experience now in submitting to the EMA and there is a greater emphasis looking for evidence of psychometric properties of measures rather than focusing so much on content validity. The EMA also has a more pragmatic approach, especially when considering the use of widely used measures.
Me: Doesn’t the EMA differentiate between ‘simple’ measures, such as a symptom scale and more complex QoL instruments?
Diane: Yes that is right. The EMA currently differentiate between PROs that are well established and measure symptoms such as pain or itch in psoriasis, and multidimensional measures of health-related quality of life. Different levels of evidence are required by the EMA as a result of this distinction.
Me: Having worked in this field for such a long time, what do you see as the top trends or hot topics in the PRO / ePRO space right now?
Diane: At least from my perspective, one of the most important areas regarding PRO and the FDA is the expansion of the PRO final guidance to cover other endpoints under SEALD’s consideration – observed outcomes (ObsRO) and clinician reported outcomes (ClinROs). This is going to have an impact on how we work in terms of needing to demonstrate content validity and measurement properties for these clinical outcome assessments moving beyond the current PRO focus.
From the ePRO perspective, it has now been 2 years since the ISPOR ePRO Task Force Report by Coons et. al. regarding paper to ePRO migration. Technology has moved fast in this area and this is now forcing us to think about how things have changed since the publishing of this paper. For example, we might now need to consider migrating from one ePRO platform to another and consider the differences between different ePRO modalities and not just paper vs. ePRO. There is now the ePRO Consortium organized by the C-Path institute and there are six ePRO vendors who are members and are now working together collaboratively to create standards and to provide updates and guidance in this area.
Me: So there is much more cross-vendor collaboration than in the past? Do we have a chance to come up with meaningful standards?
Diane: Absolutely. I think you can compare ePRO migration to the world of translations and linguistic validation. We are not constantly re-inventing the wheel as translations are re-usable between Sponsors and vendors. This is where we want to get to with ePRO migration as well, so that we are not constantly re-evaluating the same instruments and that they are effectively shared.
Me: My next question is more on the personal level. You founded Oxford Outcomes 14 years ago and it has now been acquired by ICON. Your colleagues have said very nice things about working with you and you are clearly still inspired and motivated to work in this space. What is your secret?
Diane: Well, we have always been about organic growth and over the period of 14 years, we have grown from just two of us to about 80 people at the time we were acquired. The key really has been about recruiting and working with the right people as well as being passionate about the work.
Me: I think it’s a job really well done. There is a very positive atmosphere around Oxford Outcomes and I have certainly enjoyed working with all of you. Thank you very much for the interview.
Senior Director, Technical Support, CRF Health