Many years ago we worked successfully with local pharmacies helping us with recruitment of asthmatics for a phase 1 clinical trial at our phase 1 unit in Sydney. Patients on average visit their pharmacist more often than they see their GP or specialist, which provides plenty of patient interactions opportunities for the pharmacist and their staff. Recently Kenneth Getz from CISCRP reported data from one of their studies where they evaluated the impact of in-pharmacy education on patient’s knowledge, interest and willingness to participate in clinical trials. They engaged and trained independent community pharmacies and equipped them with educational material to display and distribute. The results indicated that outreach through the pharmacy educational channel indeed improved patient’s knowledge of and interest in participating in clinical trials.

Pharmacies represent a powerful outreach and education opportunity because of their accessibility and closeness to patients. They are especially valuable for remote areas where patients are very difficult to reach otherwise. Furthermore, pharmacists are one of the most trusted sources for health related information. Involving pharmacies to raise general and specific clinical trial awareness will help patients to learn about and participate in clinical trials.

Read more in Kenneth Getz original article here.

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It is great to see this initiative out there and to have the opportunity to provide input. Reading through the paper though I struggled with the overall scope and objective of the proposed initiative and I welcome other peoples’ view on it.

The paper refers to the ‘recognition of clinical sites’ and is listing general basic criteria which should apply to all investigational sites currently recruiting for studies. The ‘similar UK initiative’ quoted in the consultation paper, however, refers to registration of specialised clinical trial units with proven evidence of their ability to coordinate and lead multi-centre studies – there is an impressive list of criteria tick boxes listed on their website (http://www.ukcrc-ctu.org.uk/?page=CTURole).
The UK model also separates the rather later clinical phase clinical trial units (CTU)/investigational sites from ‘experimental medicine and early phase clinical trial’. This separation is necessary because  ‘phase 1 units’ or ‘experimental medicines units’ will have different criteria to meet; especially dedicated phase 1 unit should have a more comprehensive accreditation scheme applied to.
I appreciate this new initiative kicking off, because we need more clinical trials coming our way and we need to boost clinical research activities in Australia. We should, however, take the opportunity to create a robust and selective registration scheme that covers all categories of clinical trial sites, a scheme that goes beyond ‘recognition’. We need to provide a valid register to international (and national) Sponsors where they can find top clinical trial centres that meet global standards and that deliver high quality data on time and target.

The post NHMRC Consultation Paper – Clinical Trials Ready appeared first on Wahoo Clinical.

Watch this space for news and discussion topics related to clinical research and development.

I will attend the 2015 ARCS Scientific Congress May 5-7 in Randwick, Sydney (www.arcsconference.com). If you would like to organize a time to meet during the conference please get in touch here.

See you soon

Franziska Loehrer PhD
Director at Wahoo Clinical

Wahoo picture: copyright Ashton Howard

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