EBMT - Newsletter - Clinical Trials report

Prospective Clinical Trials

The EBMT are committed to developing a wide ranging programme of prospective clinical trials and the last few years have seen the group take their first steps in achieving this goal. The programme is rapidly expanding and by the end of 2008 there will be around 20 Prospective Clinical Trials being conducted by the EBMT under the EU Directives.

Conducting academic studies to the standards mandated by the EU is undoubtedly a challenge and across the EU, such studies have decreased in number since the implementation of the Directives as academic groups struggle to find the necessary resources. Despite the trend, the EBMT has managed to increase the number of PCTs within their portfolio. This is largely due to the hard work of the participating institutions, the investment in the support infrastructure and last but not least the provision of some generous and realistic support grants from our partners in the Pharmaceutical Industry.

clinicaltrials

The EBMT is still very dependent on the commitment of the Investigators participating in each study. There is a considerable burden, in particular, placed on Country Lead Investigators and their teams. Given the limitations of language and the seemingly limitless variations in requirements both between and within the member states, we expect a lot from our Country Leads. They undertake a significant amount of work, including:

Translation of the study synopsis and the Patient Information Sheet/Consent Form.
Processing the paperwork and submission to the Competent Authorities and National Ethics, as well as the legion of other committees and regulators at a local or regional level.

The time commitment of these dedicated investigators is huge and is all in addition to the “day job”!

Our goal is to increase the level of support for these activities from within the Clinical Trial Offices and take the burden of the paperwork away from the Institutions, but this cannot happen overnight. Until then we will continue to rely on all our investigators and their teams, particularly those taking the lead in their country.

Many groups, including the EBMT, have made considerable progress identifying the rate limiting steps at a National/International level but we find that it is the local requirements that are difficult to identify. We also find ourselves repeatedly asking for the same items, so keeping electronic copies of such items as CVs, financial disclosures, lab norms would make everything much easier for both the EBMT and the participating centres.

I would encourage all sites to consider the following to help further improve our timelines in getting things approved and open.

Keep electronic copies of all CVs, scanning in the front page with a dated signature.
Keep lab norms electronically
Keep up to date information for financial disclosures for all your main investigators.
Send contact names and email addresses for the people who will complete the paperwork to the EBMT Clinical Trials Office when you agree to participate.
Let us know what additional approvals or registrations you will need to open your centre as soon as you receive the protocol, never assume we know, there are too many variations.
Start the contract process early, put the EBMT CTO staff in touch with the appropriate personnel in your institution.

If in doubt call us!

These are relatively simple suggestions but they could have an enormous impact on timelines, help us to be more efficient and improve our capability to open trials.

Zoë Doran
Clinical Trials Director