Specialty Groups
The West Yorkshire local specialty groups are CLRN priority areas identified as those research areas where we have the:
- commitment
- capability and
- capacity to support Portfolio studies
In addition to supporting growth, CLRNs have also identified priorities within developmental areas. Our local specialty groups:
- Provide a local focus for activity in that particular topic
- Advise the CLRN on the topic aspects of the local portfolio, including infrastructure
- Provide requirements and oversight of the management and delivery of portfolio studies in that topic area
- Provide a forum to bring together all researchers (clinical academics, university researchers, nurses, allied health professionals etc.) interested in that topic from across the CLRN
- Support the CLRN to provide detailed “Level 2” feasibility required for commercial studies
- Provide a strategic overview of the local infrastructure required to support the topic with an emphasis on identifying blocks and then working with the CLRN team and/or the national Specialty Groups to find suitable solutions
- Contact and involve local TCRN LRNs or PCRN clinical leads as appropriate
Here are some examples of the help they have provided to researchers:
Cardiovascular – We had a site that did not make it to the list of final sites following site assessment visits, as the Sponsor stated they did not have sufficient clinical trial experience in that area. After discussing this with the Specialty Group Lead, we found out that, the investigator in question was already in possession of an honorary contract with another participating Trust. We were able to add them on as a co-investigator for another site, and any patients they were able to refer to this site would start the process of building up recruitment history for additional studies.
Diabetes/Endocrinology/Obesity – As we are not covered by the Diabetes Research Network, we have linked in closely with the North West Diabetes Research Network; which means our investigators and research nurses can attend operational and other meetings, as well as training days held by the network. It also means that West Yorkshire will receive Industry expressions of interest to give our investigators a fair chance of participating in adopted commercial studies in this area.
Gastroenterology – We had an investigator who was keen to participate in a study, however, they did not have research nurse support. After discussing this with the Specialty Group Lead, the CLRN agreed to underwrite a research nurse post on the basis of full cost recovery from the Sponsor if the site is selected.
Infection and Microbiology – We had a researcher who was new to commercial research and had recently expressed interest in a study. The researcher wanted to make sure that they were completing the Sponsor’s forms with the appropriate information. The Industry Manager was able to go through the forms together with the researcher to ensure all the necessary information had been included.
Mental Health – As we are not covered by the Mental Health Research Network, we are in the process of developing closer links with this network. We have appointed a local Mental Health lead for West Yorkshire to assist with facilitating mental health research. This resulted in an increase in expressions of interest for this area.
Neurology – As West Yorkshire does not have a specialty group for this clinical area we are in the process of setting up close links with Dendron, which will see us gain access to more studies that are of interest to our investigators. A full time post has also been recruited to support research in this area.
Paediatric Studies – As we are not covered by the Medicines for Children Research Network, we have linked closely with this MCRN Coordinating Centre, who do send expressions of interest for paediatric studies.
Renal – An investigator was approached by non-EU sponsor regarding setting up a programme of studies, however there were concerns regarding whether the study would be eligible for adoption. The CLRN have taken this on and we are working closely with the NIHR CC to make sure the study is eligible for adoption.
Renal - One of our investigators recently expressed their interest in an Industry study (Renal) and following the site assessment visit, the company did not select them for inclusion onto the study. The CLRN requested feedback as to why this site was not selected, and the Sponsor cited two main issues. The first was the recruitment potential in comparison with other UK sites; the second was related to capacity within the Pharmacy department. The Trust in question is now in the process of securing additional financial support for their Pharmacy department, which should mean they will not get turned down on the basis of capacity in Pharmacy.
Surgery – One of our investigators recently expressed their interest in an Industry study and following the first site assessment visit, the company decided to have cancer patients as their eligibility criteria. This triggered processes which resulted in the study being allocated to the Topic Specific Network despite the recruitment and study procedures being undertaken by Surgery. In addition, the company and our Local Surgery Group Lead were not entirely happy with this allocation and they contacted the West Yorkshire CLRN to resolve this issue. Following a series of discussions with the NIHR Coordinating Centre, the study was able to remain within the Comprehensive (Surgery) with Cancer providing support where appropriate. As a number of you cited the adoption allocation methods as being one of the barriers to clinical research, this is one of a number of ways we can help to increase fair access to commercial clinical trial for clinicians and patients.
Last updated: 4 June 2010