Posted on Thu, Feb 11, 2010
Mark Wade, Global Practice Leader of Lionbridge Life Sciences, recently wrote about language translation within the area of global clinical trials in the Life Science Leader "2010 Guide to Outsourcing Partners."
In addition to discussing the role translation plays in clinical trials, Mark also provides three best practices which will help ensure success in your clinical trial:
- Plan for Language
- Look for a Local Presence
- Audit the Managing Translation Site
Learn more using the following links:
Posted on Thu, Jan 07, 2010
Today Mark Wade is sharing his opinions on why Cognitive Debriefing subjects don't need to be in the specified trial disease state.
Recently I've had some discussions with a Sponsor about whether Cognitive Debriefing subjects need to be in the specified trial disease state. Can we use healthy, non-disease state interviewees in this process?
Cognitive Debriefing (CD), also known as Pilot Testing, is part of a translation process where people are invited to review a recently translated, validated Quality of Life (QoL) instrument - a questionnaire - that will be used in a clinical trial in their country. They review the questionnaire and are asked specific questions by a Debriefer as to whether the translation is both culturally and linguistically correct. They are specifically asked whether the verbiage in the questionnaire is clear and unambiguous. The review is carried out in a structured interview fashion.
It is well established that these subjects must be based in the country where the trial is taking place; they should represent the trial's characteristics in terms of race, gender and socio-economic backgrounds. A debate continues, however, as to whether these interviewees should also have the disease pathology specified by the trial.
In 2007, a paper submitted to ISPOR spoke to this very topic. Entitled Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation, the article concluded that, where possible, patients in the disease state should be used. The language was, I would respectfully suggest, deliberately open. Recruiting people in certain disease states is almost impossible. Chronic Obstructive Pulmonary Disease (COPD) is a good example. It is extremely difficult to recruit people in the chronic disease state, so authors and instrument developers have become creative and recruited patients with emphysema and other respiratory conditions. I am quite sure it has been considered that recruiting certain patients with advanced forms of cancer to review the translations is improper, given that their participation neither promises the prospect of therapy nor the promise of good health. It is just a linguistic validation exercise.
So, the real question is: If you use participants in the disease state, do you get better data from the group or not?
There is at least one relatively strong argument I have heard for using patients in the disease state: Patient experience is important for linguistic validation of the questionnaires. There are language-based differences in understanding expressions such as fatigue and lethargy that have different meanings to cancer and non-cancer patients.
The argument is that sufferers have a different understanding and concept of fatigue and lethargy than non-sufferers. I believe this to be true. I am sure there are many differences in the way sufferers perceive the world around them. I am sure that abstract and tangible concepts, such as time, hold different meaning for both groups of people.
But where I am at a loss is why that has anything to do with linguistically validating a QoL instrument. When we perform CD, we are looking to see whether the translation is culturally correct, linguistically correct, and clear about the information the instrument is trying to elicit from the patient. Given that the interviewees DO NOT actually ANSWER the questions in the instrument at the time of validation, I fail to see the advantage of solely recruiting people in a particular disease state. Taking up their time seems selfish to me. When we look to concepts such as fatigue or lethargy, we are asking whether the question is understood. I am sure that a healthy person and a sick person would answer it differently; but, we'll never know because we don't ask them to answer the question on the questionnaire. We only ask them if they understood the question.
Learn more about translation in the Life Sciences industry in the Lionbridge Knowledge Center:
Posted on Tue, Sep 08, 2009
Today, our guest blogger Mark Wade talks about what is important in clinical trials...
Finally empirical evidence that turnaround times and deadlines are mission critical in clinical trials. A staggering 19 out of 21 pharmaceutical companies surveyed by Cutting Edge Information ranked a contract research organization's ability to hit trial deadlines as either "extremely important" or very "important," making it the top quality identified by respondents.
The report, titled: "Clinical Outsourcing Strategy: Selecting Partners and Managing Relationships" gathered data from a cross section of Pharma companies.
- Six were large, global pharmaceutical or biotech companies with multiple approved products and earnings of over $10bn dollars
- Five were medium-size companies with at least one approved product and earnings of over $1bn
- Five participants were small pharmaceutical companies without an approved product on the market
While the report notes that Pharma companies understand that there are unavoidable unforeseen delays possible in trials, it is the CROs 'real world' experience and ability to deal with these issues that sets some apart from others.
So what does that mean in terms of translation? Well, consider that each of the necessary documentation needs to pass at least once through an Independent Review Board (IRB) before the documents become final. If you also consider that CROs often receive several versions of the final documents from the Sponsor before they become final with very little time to spare before sites are supposed to go live, then the challenge for language translation becomes clear.
With a Sponsor focused on working closely with their CRO to ensure that documents are signed off and CROs focused on having sites prepared for the first day of patient enrolment, it is very easy to push language translation down the priority list. The problem with that is that if you do not have the patient facing documents translated, you cannot enrol your first patient!!!
It appears to me that it is becoming more important everyday to work hand-in-hand with the CROs and Sponsors to ensure that any translation that can be done upfront. The risk of leaving all translations until the last few days has too much of a risk profile i.e. no first enrolment...significant increase in non-recoverable costs!
Posted on Tue, Aug 11, 2009
Today's Guest Blogger in our Life Sciences blog is Mark Wade, the Life Sciences Global Practice Leader at Lionbridge Life Sciences. He has more than 15 years of sales and operations management experience in the life sciences industry. Thanks for joining us, Mark - take it away!
Over the past few months there has been some unbelievable noise made about two large Pharmas outsourcing their respective R&D capabilities to CROs. There are no redundancies per se, but the CROs take on all of the R&D staff as their own and manage the whole discovery process, Phase I - IV etc.
Okay, I understand that; the old TCO model and all that, but isn't there a grey area around who owns the IP? On the premise that "you can't unlearn what you have already learned," can some of this IP cross-pollinate into other areas?
Wall Street values Pharma companies on what IP they have coming down the pipeline. If the CRO is effectively running this pipeline and the Pharma is paying for it, then is the 21st century Pharma just a brand and a sales channel?
The old cliché "Poacher turned Gamekeeper" springs to mind ... just a thought!
Posted on Thu, Jul 16, 2009
Our first Life Sciences post comes to you from Kaarin Gordon, the Lionbridge VP of Life Sciences. Meet Kaarin and the rest of the Lionbridge bloggers on our About page.
It is interesting to watch the Pfizer evolution. Why I find this intriguing is because Pfizer is a legacy, large Pharma who has now acquired Wyeth, a large Pharma also, but one that already transformed itself into a Pharma AND Biologics company. This is a fundamental change both Pfizer and for the industry at large.
Think about it...now we are talking about creating individual pharmacological products based on individual patient's physiology. These individual medicines are the next evolutionary step in pharma. So what? It means a significant number of additional trials will be needed = a significant number of patients will be needed = AN INCREASED NUMBER OF LANGUAGES required.
There's another piece to this. As individual medicines emerge, the amount of content in Labeling (Notifying Body clinical submission) will increase exponentially. This is the due to the single patient specific scenario of biologics and Labels will have to incorporate all scenarios of patient physiology. Again, this means an increased amount of content will need to be translated.
Pfizer acquires Wyeth. Roche acquires Genentech. This is only the beginning...