Friday, April 15, 2011

EC chairperson can serve as legal expert during the meeting

Please clarify re: patient reported outcome (PRO) instruments:
1) Post translations whose responsibility is it to validate the translated version of the questionnaire?
2) Could the translated version be submitted to the regulatory authority without validation?
3) Whose responsibility is it to submit the translated questionnaire post validation?
4) If any modification is done in the validated translated version then is there a requirement to validate the modified version and then submit the same to the regulatory authority?
5) What if a translated questionnaire is used without validation considering a situation where only English document has been submitted to the regulatory authorities and the translated version have only been submitted to the respective Ethics Committees?
Garima Singh
For 1) & 3) - FDA has released a guidance on PRO in Dec 2009. It is addressed to sponsors. Hence, they are responsible for validation of the PRO instrument - both English as well as translations.
For 2) - The FDA expects the sponsor to submit validated translations (see below appendix to the FDA guidance).
VIII. Language Translation and Cultural Adaptation
  • Process used to translate and culturally adapt the instrument for populations that will use them in the trial
  • Description of patient testing, language- or culture-specific concerns, and rationale for decisions made to create new versions.
  • Copies of translated or adapted versions
  • Evidence that content validity and other measurement properties are comparable between the original and new instruments
For 4) - If there is a modification, following documents are required.

Monday, April 11, 2011

Good Clinical Practices

Clinical research is the key to the discovery of latest diagnostic methods and to develop modern drugs for treatment of diseases. Good Clinical Practices (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. Compliance with this standard provides assurance to public that the rights, safety and well being of trial subjects are protected, consistent with the principles enshrined in the Declaration of Helsinki and ensures that clinical trial data are credible.  

It has been widely recognized that India offers unique opportunities for conducting clinical trials in view of the large patient pool, well- trained and enthusiastic investigators and premiere medical institutes available in the country along with considerable low per patient trial cost, as compared to developed countries.

A need was, however, felt to develop our own Indian Guidelines to ensure uniform quality of clinical research throughout the country and to generate data for registration for new drugs before use in the Indian population. An Expert Committee set up by Central Drugs Standard Control Organisation (CDSCO) in consultation with clinical expert has formulated this GCP guideline for generation of clinical data on drugs. 

The Drug Technical Advisory Board (DTAB), the highest technical body under D&C, Act, has endorsed adoption of this GCP guideline for streamlining the clinical studies in India.