Oh No Not Again...

ICH GCP, the backbone of clinical research in the ICH regions has been in place for more than 15 years. Repeated training on this standard has been conducted as we have no other way of recognizing whether the investigators who work on our studies are suitably qualified. Despite all this training the same findings keep occurring. The pharma industry needs to re-think its approach as our previous efforts have clearly not been effective.

Development of investigator training on aspects of GCP by an independent body that regulates the courses and provides tangible evidence of achievement as defined by the accrediting body is the way forward. We need to ensure that investigator attendance is not just passive, and that learning outcomes are clearly defined and are fit for purpose. Investigator training should not be a "one-off" session at the start of clinical trial, but a continual assessment with repeated re-certification at clearly defined time points.

Nicky Dodsworth

When we think about the requirements of the "independent body" it is important that they have a suitable infrastructure with trainers who have the knowledge and expertise to deliver education. The GCP course should cover the required elements as "bite-sized learning" or a modular approach, so topics can be studied at convenient times. The nuances of GCP using real-life experience along with conducting testing at the beginning and at the end of each module will make this more applicable to investigators in their daily activities and will help to focus the investigator on the training being delivered.

Training will need to fulfill set requirements and be recognized by the pharma industry. Undoubtedly this is a cultural shift in the way the industry currently works, but there are several companies that are now starting to work together in this direction.

If this type of training is established we must ensure that this is not just to benefit the pharma industry. Training such as this will have mutual benefits to the investigator and their site staff and also increase public confidence in the way clinical research is conducted. When clinical research professionals attend training that provides them with a recognized accreditation this will also support the development of their career. Accreditations will need to be recognized by their employers and be transferable.

The pharma industry has been reticent about sharing best practices in the past and has been reluctant to work together on such projects. The involvement of "independent bodies" acting as an intermediary could be the way forward, the issue may be the fact that there are several of these organizations currently starting to be involved in this process which could be counterproductive. It may take a government or national body or a more global "independent" organization to finally make this work.

The spirit of harmonization has never been greater, so now is the time to work together to standardize investigator GCP training and establish mutually recognized certified courses that can deliver effective understanding of the requirements, enhancing the quality of data and patient safety. Industry support is vital in helping define and establish such training. It is to our advantage that we support this initiative as this has significant time and cost implications—the previous way we have worked has not been successful. Now is the time for change and we are the ones that can make it happen.

Nicky Dodsworth Vice President, Global Quality Assurance, Premier Research Group E-mail: Nicky.Dodsworth@premier-research.com