Research Involvement Network opportunity: Become a patient/carer member of Precision-Panc PRIMUS Trial Management Groups (TMGs)

Advisory roles for people affected by pancreatic cancer to help shape the trials in the Precision-Panc platform. 

About the opportunities:

The Precision-Panc team are looking for several people with lived experience of pancreatic cancer (patients/carers) to join Trial Management Groups (TMGs) for each PRIMUS (Pancreatic canceR Individualised Multi-arm Umbrella Studies) associated with the Precision-Panc programme of research as well as for the Precision-Panc Master Protocol. 

This involves taking part in the group that works on the day to day running of each PRIMUS clinical trial and helping shape the study as it progresses.  The team includes everyone involved in running the study; doctors, statisticians, project manager, trial coordinator, IT developers, pharmacists and trial sponsors.  We are seeking patient advocates to join these groups to ensure that every trial in Precision-Panc is centred around the needs of people with pancreatic cancer. 

In joining a PRIMUS Trial Management Group, there is the opportunity to join the wider Precision-Panc Patient Advisory Group (PPAG). Therefore, occasional ad hoc opportunities may also come up e.g. reviewing proposed research studies and patient facing information but these consultations will be entirely optional. 

The PPAG has been established since 2017 and has provided patient advocacy for Precision-Panc since its inception. As the number of trials has significantly increased, the team would like to expand the opportunities for more patients and advocates to join the PPAG via these TMG opportunities 

About the Study

To improve treatment for people with pancreatic cancer, we need to be able to identify the specific type of pancreatic cancer a person has, based on the genetic make-up of the cancer itself, and give them a treatment tailored to that type. This approach needs to be tested in clinical trials. 

Precision-Panc is a precision medicine programme which takes a two-tier form. Firstly, there is a Master Protocol where patients consent for their tissue (biopsy) and blood tests to be tested for genetic analysis. Secondly, there are a number of clinical trials aiming to determine the best cancer treatment based on the results of the genetic analysis. This is also known as an ‘umbrella study’. It is being run at multiple centres throughout the UK where patients will be able to provide samples. 

What types of activities would I be doing in the role? 

The role of the TMG is to review the ongoing status of the trial and to ensure the trial is running to target, to review any issues and discuss how these can be overcome and implement changes. This might include reviewing progress made through recruitment, site opening and other aims against any targets that have been set.  You may be involved in helping to review study documents that require updates or be asked for your input/opinion on progress reports that are required by the funders and regulatory bodies. You will be asked for your opinions on how the study is being run and any advice from a patient/carer perspective on how to improve the study during the meetings.  

There are multiple umbrella studies within the programme of research and each has its own TMG which has open positions for patient/carer representatives. The areas of work are as below: 

Precision-Panc Master Protocol:  All patients wishing to enter a PRIMUS study must first enter and be registered to the Master Protocol.  The Master Protocol allows for the patient’s tissue to be transferred to Glasgow and for molecular testing to be performed. 

PRIMUS 001 is a trial for patient who have metastatic* pancreatic cancer and is looking at two different chemotherapy regimens (FOLFOX-A [which involved chemotherapy drugs called 5-fluorouracil, oxaliplatin and nab-paclitaxel] and AG [nab-paclitaxel and gemcitabine]). The trial treatment offered would be the first line of treatment for the patient’s metastatic cancer. 

*Metastatic = cancer that has spread to other parts of the body.   

PRIMUS 002 is looking at the same two chemotherapy regimens (FOLFOX-A and AG), but on this occasion for patients whose cancer is suitable or potentially suitable for surgery, so earlier in the stage of pancreas cancer.  

PRIMUS 003 is closed to recruitment. 

PRIMUS 004 is going to be a platform study looking at different treatments for patients who already have had one treatment for their metastatic cancer. 

PRIMUS 005 will be looking at using ATRA** to target the stroma*** of the pancreatic cancer in patients that have locally advanced disease. 

** all trans retinoic acid (ATRA) and its brand name is Vesanoid. It belongs to a group of drugs called retinoids, these are similar to vitamin A. 

*** Pancreatic cancer is surrounded by thick scar tissue called stroma. This can block chemotherapy drugs from reaching the cancer. 

PRIMUS 006 is a clinical trial for patients with metastatic* pancreatic cancer who may not be fit enough for the PRIMUS -001 study option. This is a combination of drugs including chemotherapy, immunotherapy and something called a mycobacterium that is thought to help prime the microenvironment around the tumour to make the other drugs work better.  

*Metastatic = cancer that has spread to other parts of the body. 

PRIMUS 007 is a trial for patients with pancreatic cancer who are found to have a specific gene mutation† and whose cancer has progressed following initial treatment. This study is looking at whether an investigational new drug RXC004 is effective for this very specific patient group.. 

†RNF43 Loss of Function mutation positive pancreatic ductal adenocarcinoma (PDAC) 

Who can take up this opportunity?  

The team are looking for people who have…

  • Experience of pancreatic cancer, either personally or through the experience of a loved one. 
  • A keen interest in pancreatic cancer research and precision medicine.  
  • Are comfortable and willing to share their experience and opinions  
  • Have good communication skills and the ability to share their thoughts constructively 
  • Are confident in offering their opinion in meetings attended by very senior clinicians and researchers 
  • Take a solutions-based approach to problems 
  • The ability to represent the needs of a broad range of people 
  • The ability to think objectively and consider the needs and concerns of all people affected by pancreatic cancer.  
  • The ability to maintain confidentiality, where required. 
  • Experience of formal meetings is desirable, but not essential.   
  • Experience of patient and public involvement in research is desirable, but not essential. 

Time commitment

A one hour meeting will be held every 6-8 weeks.  Paperwork and minutes will be circulated prior to each meeting the day before and can take approx. 15-30 minutes to review. Attendance is not compulsory for every meeting although they are always keen to involve patients and advocates in their work. 

There may also be some occasional ad hoc opportunities to be involved with other Precision-Panc studies too, however these will be entirely optional. 

How much paperwork will I need to read/review?

The group is provided with: 

TMG Agenda 

Study overview documents (2-4 pages) 

Previous meeting minutes 

Any other feedback documents that may need to be reviewed by the group from time to time   

These will be provided to the TMG 24 hours prior to the meeting for review via email. 

How long would I be a member of the TMG?

The term is voluntary, depending on how long you want to stay involved, however we would encourage anyone applying to try to commit to being involved for at least 6 months if possible. The TMGs will run until the studies are complete.  

Next steps

If you would be interested in joining the PRIMUS TMGs and representing the PRECISION-Panc Advisory Group, please contact Pancreatic Cancer UK’s Research Team with an expression of interest briefly outlining your connection to pancreatic cancer and an indication of whether you have a preference for which PRIMUS TMG you would be interested in joining. 

You will then be invited for an informal chat to find out more and answer any questions you have before committing to the role.