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Pragmatic Clinical Trials Unit

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FAQs

About Us

What is a Clinical Trials Unit?

See our ‘About Us’ pages for an explanation of how a Clinical Trial’s Unit is defined.

What is a Pragmatic Clinical Trial?

Information about what a Pragmatic Trial is can be found here

What is UKCRC registration and does PCTU have it?

The PCTU has full registration with UK Clinical Research Collaboration (UKCRC).  UKCRC registration is intended to help improve the quality and quantity of expertise involved in implementing clinical trials.  In order to achieve UKCRC registration PCTU has demonstrated a proven track record in coordinating multi-centre trials, expert staff to develop studies, robust quality assurance systems and evidence of long-term viability of capacity for trials coordination. 

What areas of research does the PCTU cover?

The PCTU collaborates in studies across many clinical areas but our five strengths are in Colorectal Surgery, Mental Health, Primary Care, Women's Health and Critical Care. We focus on Pragmatic Trials but will consider many other types of trial and other well-designed studies. We have particular methodological strengths in cluster-randomised trials including stepped wedge designs, and pilot and feasibility studies. Further information can be found on our Clinical Strengths and Studies pages and Methodological Strengths and Research pages. 

What studies does the PCTU currently collaborate on?

Our Current Studies pages list all the studies and projects we are currently collaborating on. These pages have links to further information about the study and the study teams.

Collaborating with us

What types of studies do the PCTU collaborate on?  

Please see our Explore a New Collaboration pages for details of the types of projects we collaborate on.

What should I do if I would like PCTU to collaborate on my project?

Detailed guidance on enquiries process, including how to contact us and when can be found on our Explore a New Collaboration pages.

Timelines 

At what point should I collaborate with the PCTU?

Detailed guidance on the enquiries process, including how and when to contact us can be found on our Explore a New Collaboration pages.

How should I calculate my study timelines and milestones?

The PCTU, in particular the Senior Trials Manager, will help you to do this. Study timelines vary and are dependent on a number of factors such as complexity, study type, population, sample size and follow-up time.

We advise that our collaborators create and maintain a project Gantt chart which should be shared regularly with the PCTU. We have found that this practice best ensures vital milestones are met to time, whilst also helping communicate developments in key tasks which are being shared between the PCTU and our collaborators. A template Gantt chart is available to the research team upon request from the PCTU which can be tailored to your project’s needs.

How long does it take to build a database?

The length of time to design and develop a database depends on a number of factors such as study complexity, integration with other datasets, number of fields and use of standardised measures vs bespoke measures. The PCTU will advise each study on specific timelines. The following stages will need to be completed before a database goes live:

  • Case Report Form (CRF) development
  • Database specification, review and sign off
  • Database build
  • UAT (User Acceptance Testing)
  • Data Management Plan (DMP) development and sign-off

These processes and documents are explained in more detail in the Data Management FAQs below.

What considerations does the PCTU factor in when calculating a feasible time schedule for analyses?

The PCTU is a leader and a collaborator in a large number of multi-centre trials/studies. Our statisticians therefore work on multiple projects at the same time. When calculating a feasible time schedule for analyses we must consider the expected time to complete the analyses within the context of the statistician’s workload.

In addition to the analysis itself, an important factor to consider is the time scheduled for quality control of the analyses, which is undertaken by an independent Statistician (within the PCTU team) whose workload must also be considered. The incorporation of quality control is necessary to ensure the high standard of analyses produced by the PCTU.

Based on experience, we also factor in the possibility of unexpected delays in the study and unforeseen difficulties when analysing data which could impact the time allocated to analyses. Analyses usually take place at the end of the study so it is wise to assign a generous length of analysis time to allow for any potential delays earlier in the study.  

At what stage of the clinical study should I consider an economic evaluation?

An economic evaluation should be considered at the design stage of the clinical study to allow important aspects of the economic study, such as additional data collection from study participants and sites, to be appropriately integrated in the study. 

Costing PCTU Collaboration

How is PCTU collaboration costed?

If the PCTU collaborates on your study, the staff involved will be a Senior Statistician, Statistician, Senior Data Manager, Data Manager, Senior Trial Manager and Quality Assurance Manager. Depending on your study, a Senior Health Economist, Health Economist, Trial Manager/Coordinator and Trial Monitor may also be involved. As part of our unit’s function, all studies will have a small amount costed for PCTU Administration.

Prior to grant submission, the PCTU collaborates with you to develop your study before funding. We will use the information gathered about your study to calculate the % of PCTU staff resources and some consumables (See below: why have PCTU consumable costs been added to my budget and what do they include?) that your study requires. The PCTU will liaise with Queen Mary Joint Research Management office to calculate staff salaries.

The PCTU will provide you with costs for our staff time in a form which we call Collaboration And Financial Form (CAFF). The Collaboration And Financial Form will also have more detailed breakdown about the activity of each staff member collaborating on your study.

Will the PCTU cost my whole study?

The PCTU will only provide costs for the PCTU staff that will be working on your study. You should contact your sponsors R&D office as soon as possible to discuss other costs such as equipment, travel, subsistence and patient costs.

Why have PCTU consumable costs been added to my budget and what do they include?

The PCTU incorporate 10% of staff salaries towards consumables including specialised software, required PCTU staff training, some IT equipment, stationary and printing.

Why do you have to re-cost an application from an outline to full application?

Due to the time elapsed between outline and full application it is essential that the costs are reviewed. Dependent on the feedback you receive from funders, there may also be a need to make changes to costs from outline to full.

CTIMPs and PCTU Collaboration

What is a CTIMP and how do I know whether my study is a CTIMP?

A CTIMP is a Clinical Trial of an Investigational Medicinal Product. These typically involve trials of new and experimental drugs but may also include testing existing drugs in patient groups or for alternative indications outside of their approved use. These trials are regulated and approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in addition to your sponsor and the HRA.

Medical device studies that involves CE marked devices that are being used outside their intended purpose or Non-CE marked devices must apply to MHRA for approval which is the UK competent authority for medical devices.

To find out if your trial is a CTIMP study use the MHRA algorithm.

In addition, it is advisable to contact the MHRA to confirm whether your trial is indeed a CTIMP or non-CTIMP trial.

You should also speak with your study sponsor in advance so that may advise you on any specific requirements they may have and to discuss their capacity to support a CTIMP trial.

Does PCTU collaboration in a CTIMP/Device cost more than PCTU collaboration in a non-CTIMP?

The cost of collaborating with the PCTU is calculated individually for each trial. A CTIMP/device trial will require a full time Trial Manager (please see below: Why do I need a full time PCTU-based Trial Manager for my MHRA regulated study?) and additional rigorous auditing and monitoring to ensure safety of participants and compliance to stricter regulations. All these factors may involve additional costs for the PCTU to support the trial. The PCTU makes a fair costing proposal with the study team and sponsor. 

Trial Management

What does a Trial Manager/Coordinator do?

The titles of ‘Trial Manager’ and ‘Trial Coordinator’ are used differently by different studies and organisations. In some cases ‘Trial Managers’ are more senior to ‘Trial Coordinators’ but for the most part, the two titles are interchangeable.

Trial Managers/Coordinators are responsible for the day to day management of one or more studies, which are run in accordance with the Good Clinical Practice guidelines. The main responsibilities include:

  • Acting as the main point of contact for the study, communicating with investigators, clinicians, stakeholders, sites, funders, ethics and the sponsor
  • Coordinating the preparation, collection, review and tracking of essential study documents
  • Setting up sites for recruitment activities
  • Arranging Trial Management Group (TMG), Trial Steering Committee (TSC) and Data Monitoring Ethics Committee (DMEC) meetings
  • Monitoring and reporting on study progress (recruitment, budget, timelines etc.)
  • Coordinating any amendment applications
  • Creating and maintaining the Trial Master File (TMF)
  • Closing the study down and archiving 

What does a Programme Manager do?

Programmes consist of a coordinated and coherent group of related projects/studies, focused on a coherent theme, requiring multidisciplinary approaches. Programme grants provide larger, longer term (for example, usually five years for NIHR Programme Grants for Applied Research) and, sometimes, renewable funding.

A Programme Manager oversees the overall efficient day-to-day management of the programme, ensuring co-ordination and joint working across the different projects/studies.

Often, a programme will be also staffed by a Trial Manager/Coordinator and/or Research Assistants who might work on one or more of the projects/studies within the programme. The Programme Manager may supervise these staff.

What does the PCTU Senior Trials Manager Do?

The PCTU Senior Trials Manager has a dual role.

Firstly, they provide operational and specialist support for Trial Managers/Coordinators, providing training and advice as needed. When the Trial Manager/Trial Coordinator is not physically based within the PCTU, the Senior Trials Manager is the main operational liaison between the Trial Manager/Coordinator and the PCTU. The PCTU Senior Trial Manager also monitors the progress of all studies in the PCTU and reports back to the Management and Operational Teams.

Secondly, the PCTU Senior Trials Manager undertakes responsibilities on individual studies.  The main responsibilities of the PCTU Senior Trials Manager for each individual study include:

  • Collaborating with the study team to develop study materials
  • Contributing to the multidisciplinary risk assessment
  • Contributing to the development of study management tools (e.g. Gantt charts)
  • Advising the study team when key decisions are made during the running of the study e.g. changing timelines
  • Troubleshooting recruitment and other study management issues
  • Overseeing the work of the trial coordinator, if based at the PCTU
  • Attending Trial Management Group (TMG) meetings as required

How does the Trial Manager/Coordinator interact with the study team and the other teams at PCTU?

The study team comprises all those who work on a study. The Trial Manager/Coordinator provides a link between study team staff in the core PCTU team and the rest of the study team. The Trial Manager/Coordinator will usually coordinate and facilitate the Trial Management Group (TMG) meetings which allow core PCTU staff to have regular input into the management of a study. For some processes, the Trial Manager/Coordinator will liaise with an individual within the PCTU over a period of time. For example, when the database is being developed the Trial Manager/Coordinator will be in regular (sometimes daily) contact with the Database Developer and Database Manager to develop the database requirements and to test the database.

The Trial Manager/Coordinator is expected to keep the PCTU up-to-date on study progress and issues. This can be done via the PCTU Senior Trial Manager, or in Trial Management Group (TMG) meetings.

The PCTU also run regular Trial Management Forums, which consist of workshops, presentations and group work. The Forums also provide an opportunity to network and troubleshoot issues. The Forums are open to anyone involved in the management of a PCTU linked study. For more information, please contact the PCTU Senior Trial Manager (PCTU Staff List)

Should I cost a whole-time or part-time Trial Manager/Coordinator into my study?

This depends on a number of factors, including but not limited to; study complexity, study risk, study type (e.g. Clinical Trial of an Investigational Medicinal Product (CTIMP) or non-CTIMP, randomised or observational) study size (i.e. sample size), study duration and number of recruiting sites.

The PCTU has considerable experience of the amount of time needed for study management in different studies and can advise about the management resources that are needed in your study at the pre-submission stage (i.e. before the study is funded).

Where will Trial Managers/Coordinators be based?

This depends on the study, your location, expertise and team. If your study is not being run from Queen Mary University of London (QMUL), or Barts NHS Health Trust, then the trial management will often be based at the sponsoring organisation.

If your study is being run within QMUL or Barts NHS Health Trust, there are advantages in having the Trial Manager/Coordinator directly line managed and mentored by the PCTU Senior Trials Manager, in terms of their interaction and learning from other experienced trial staff and better communication links with the others in the core PCTU teams.

For Clinical Trials of an Investigational Medicinal Product (CTIMPs) it is PCTU policy that a full time Trial Manager/Coordinator  is line managed by the PCTU Senior Trials Manager(please see ‘Why do I need a full time PCTU-based Trial Manager for my MHRA regulated study?’)

All PCTU supported studies require a small amount of PCTU Senior Trials Manager time. For more info please read ‘What does the PCTU Senior Trials Manager Do?’.

Why do I need a full time PCTU-based Trial Manager for my MHRA regulated study?

CTIMP and other MHRA governed studies are usually higher risk, they require more procedural management to ensure that they are in line with all regulations and are also subject to intensive inspections by the MHRA. They therefore require an experienced, full-time Trial Manager who can work very closely with the PCTU QA team.  Thus the PCTU has a policy that all such studies require a full-time Trial Manager/Coordinator line managed by a PCTU Senior Trials Manager.

This does not mean that non-CTIMPs will never require a full time Trial Manager/Coordinator; some non-CTIMP studies can be just as complex (in terms of management) as non-CTIMPs. Furthermore, the PCTU aims to conduct all studies to the highest quality, not just CTIMPs.

What is a TMF and why do I need one?

A Trial Master File (TMF) is a standard filing system of essential study documents kept at the coordinating centre/site. A TMF will help with efficient study management and is needed to facilitate the reconstruction of the conduct of the study during the audit/inspection process.

For more information please read: http://www.ct-toolkit.ac.uk/routemap/trial-master-file 

Quality Assurance, Auditing and Monitoring

Why will my trial be monitored and audited?

It is important that all clinical studies are appropriately monitored and audited in line with regulations and sponsor requirements. Monitoring and auditing allows us to ensure trials are being performed accurately and safely to ethical and legal requirements. In conducting monitoring and auditing processes we ensure that are patients are safe during trials and that their rights are being upheld, it also offers reassurance to trial teams that their trial is being conducted as planned and spots any issues which could hold back the progress of your project. The frequency of monitoring will depend on the risk of the study, but all trials will be audited annually regardless of their risk.

How will the PCTU decide how to monitor and audit my study?

All trials supported by the PCTU undergo a risk assessment. Our risk assessment takes into consideration a number of factors including the experience of the team, the type of patients being considered, any drugs or procedures being used in the trial, the trial design and the proposed data collection methods. Depending on the outcome of the risk assessment, we will agree on a Monitoring Plan for the study with the study team and sponsor.

The Monitoring Plan will outline the plan for study start-up and site initiation, level and frequency of monitoring for the study, detail all relevant contacts and outline the procedure for trial close out. 

Data Management

How do I estimate how many databases I need?

You should consult with a member of the PCTU before you get funding. There are a number of factors to consider when estimating the number of databases required for a study, for example:

  • Types of participants – if the study was collecting data from participants and also professionals e.g. therapists, these would be classed as two different groups of participants and may require multiple databases.
  • Method of randomisation – if online randomisation is necessary this will require a PCTU Online Randomisation System.
  • Collecting Participant Identifiable Data (PID) – where possible PID data should be kept separate from study data and therefore multiple databases may be needed.

What are the stages of database development?

  • Case Report Form (CRF) development, review and sign off – Case Report Forms (CRFs) are printed, optical or electronic documents designed to record all of the information required for a study, as outlined in the protocol. There are many individuals within the PCTU who have expertise in CRF development. The Data Management team will review your CRF in relation to database development, the Statisticians will look at the CRFs to ensure they will provide the relevant data to address the study’s aims, and the Quality Assurance team will review to ensure that the CRFs are in line with good practice and regulations. To ensure CRF design is as efficient as possible we will give you a checklist prior to starting CRF design.  The CRFs will need to be signed off by Data Management, the Senior Statistician, a Quality Assurance Manager and (where relevant) a Health Economist.
  • Database specification, review and sign off – The Requirements Specification Document (RSD) will be initiated by the Data Management team. It outlines how each data item will be set up in the front end and back end of the database. It defines the events, forms, variables and rules that will be used to develop the database. To avoid multiple iterations and potential errors the specification development will not start until the CRFs are signed off.
  • Building of the database – a PCTU Data Manager will build the database according to the agreed specification.
  • UAT (User Acceptance Training) – users (such as Trial Coordinators or site staff) will be asked to test the database against the agreed specification. It is important to plan this stage carefully; we will need a specific window of time in which the users of the database will be available to test the system. It is important that this window is adhered to as delays will affect the final ‘go-live’ of the database.
  • Documentation – The Data Management Plan (DMP) documents everything about the data collected throughout the entire study and fulfils an important Good Clinical Practice (GCP) requirement of accurately documenting all study procedures. The Data Management Plan (DMP) is developed jointly by the Trial Manager/Coordinator, Data Management and Statistics teams. All data to be collected/extracted or linked to the study must be defined in the DMP. This is the case even if there is data collected which will not be entered into a database developed by, or worked on by the PCTU.
  • Database go live – a go live date will be agreed when the CRFs are signed off, however any delay in any stage prior to this may delay this date.

My study will be using routine data from external sources. I do not think I need a database. Why do I need data management input?

It is important to discuss the study with a data manager early on to make sure that you really do not need a database. Please see ‘How do I estimate how many databases I need?’

In addition to database development activities, the PCTU Data Management team provide support for most data management (DM), IT and Information Governance (IG) related activities within the study. These include:

  • Ensuring compliance to Information Governance procedures
  • Help with troubleshooting IT/Data Management issues
  • Expertise in data sharing agreements
  • Secure transfer of data to/from external sources
  • Secure storage of data
  • Setting up and managing user accounts for various systems
  • Data integration between systems and management of all other data activities

We only need a randomisation system – can the PCTU help?

Yes, we do provide a randomisation system if that is all that is required, though we would discuss with you to confirm this before agreeing to provide the system. A service level agreement (SLA) that describes the service that will be provided by PCTU will need to be agreed and signed off.

What is the difference between a data manager and a database developer?

A data manager provides support to the study team on data management (DM) activities. These activities are study specific and can include: general DM & IG advice, CRF review, help with gathering information required to build, test and validate the database, user training, query management, data transfer, data extract and database lock. The PCTU Data Manager is also involved in building databases using electronic data capture systems (EDCs) such as OpenClinica and REDCap.

A Database Developer mainly builds, deploys and maintains databases. At the PCTU the role focuses on custom-built databases. A Database Developer will have specific expertise and training in complex programming to develop custom databases, such as the randomisation system.

Who should I contact if I need help with a data management issue during my study?

The PCTU Data Management team are unable to answer queries from site and data entry staff (also referred to as end users). Some studies have over 100 sites and the volume of queries would be unmanageable. Therefore there is a two-step process for data management issues:

  • For site and data entry staff (or end users), all queries should be directed to the Trial Manager/Coordinator who is trained and generally able to help or advise on regular study-specific queries (e.g. confirming existence of accounts, resending login details, advising on password resets, best course of action, etc.). The Trial Manager/Coordinator can escalate issues to the PCTU Data Management team where necessary.
  • Trial Managers/Coordinators, can contact the Data Management helpdesk (pctu-dm-helpdesk@qmul.ac.uk) and an appropriate member of the team will respond.

Who is responsible for training study sites on the data management systems?

The PCTU Data Management team work on a ‘Train the Trainers’ model where the Data Manager will train the Trial Manager/Coordinator. It is then the responsibility of the Trial Manager/Coordinator to provide training to site and data entry staff (also referred to as end users) and to produce a User Guide using the PCTU template.

What are the main factors to consider for integrating multiple datasets?

  • Study teams need to plan the integration (sometimes referred to as ‘linking’) of datasets at the start of the study, so that all teams can advise on the suitability and availability of the datasets
  • Study teams need to provide the PCTU Statistics and Data Management team with information about the structure, format and content of all existing datasets, to ensure that they can be linked
  • The Data Management team will pilot the integration/linkage early on in the study to help identify problems as soon as possible.

The database(s) for my study were agreed and signed off and are being used. Now I want to make some changes. What should I do? 

You need to contact the DM helpdesk (pctu-dm-helpdesk@qmul.ac.uk) where a member of the Data Management team will be assigned to deal with changes or amendments. Some amendments will need to be approved by an ethics committee and/or the PCTU Senior Statistician. The Data Management team will then assess the complexity of the changes requested and if they have been approved will include these in the next version of the database release. For approved changes, the specification document will need to be updated and all changes tested before the new version of the database can be released. 

Statistics

How many Statisticians will work on my study?

The PCTU will allocate a Senior Statistician and a Statistician to every study. The Senior Statistician provides an experienced perspective on study design, methodology and analysis. The Statistician will perform the analysis under supervision from the Senior Statistician. Studies are also allocated an independent Statistician to perform any un-blinded analysis and quality checks.

What will the PCTU Statistics team do?

The PCTU guarantees that your analysis will be undertaken by highly skilled and professionally trained Statisticians. All Statisticians that work within the PCTU have extensive statistical experience and undergo rigorous training to adhere to the PCTU Standard Operating Procedures (SOPs) which include Information Governance (IG). We instil a strict Quality Control (QC) process, which involves thoroughly checking statistical code and output by an independent Statistician, for all analyses produced by the PCTU and provide a safe and secure system for data. The PCTU also has an integrated functionality across the Statistics, Data Management, Health Economists, Quality Assurance and Trial Management teams to ensure a successful project

We provide analysis support in a range of statistical software and check the validation of statistical methods. We also implement rigorous Standard Operating Procedures (SOPs) in all analyses to ensure robustness against bias. Within the PCTU we have a secure data server which meets information governance standards. This assures the security of your data.

I would welcome senior statistical input from PCTU but I have a Statistician who works with me who I would like to work on my study. Is this possible?

Experience suggests that there are almost always problems with having a non-PCTU Statistician working with a PCTU Senior Statistician (e.g. the Statistician leaves and you find it hard to appoint another; long distance liaison between the Senior and Junior Statistician doesn’t work very well; the Statistician finds it harder to work to PCTU processes and procedures than they would do if they were on site at PCTU) and we therefore do not offer this model of working.

What can I do if the PCTU does not agree to collaborate in my study?

Information and guidance on finding a Statistician is available from the Research Design Service (RDS), the UK Clinical Research Collaboration (UKCRC) and the Search for Oversight Statisticians website. You may also wish to contact other Clinical Trials Units (CTUs) to see if they have statistical capacity to support your trial.  

Health Economics

What is the purpose of economic evaluations in clinical studies?

Economic analyses (or economic evaluations) are widely used to inform healthcare implementation decisions in the UK (e.g. National Institute for Health and Care Excellence (NICE)) and many other countries. The economic analysis assesses intervention’s efficiency or whether it is a good use of healthcare and/or other societal resources. This analysis compares and reports the net costs of providing the intervention relative to intervention’s net overall health benefits and intervention’s cost-effectiveness.

In a clinical study, the effectiveness and safety of an intervention compared to usual care or best available alternative treatment are assessed. Clinical studies provide a good opportunity to efficiently collect further data on resource use, costs and health outcomes required to assess interventions’ effects on costs, health-related quality of life, and ultimately their cost-effectiveness. Funders often require that economic evaluations are integrated in clinical studies in an effort to shorten the time for intervention’s implementation in clinical practice and increase study impact.

Can the clinical study provide all information required for the development of the economic analysis?

Not necessarily. To reliably inform implementation decisions, economic analyses should consider all relevant evidence. For example, this could include evidence synthesis beyond the respective study such as meta-analysis of interventions effects on health outcomes from a number of studies; extrapolation of interventions’ effects beyond the duration of the study and/or to a more typical target patient population. Decision analytic modelling is often used to frame the decision problem and the economic analysis.

Can I identify support for the Health Economic analysis in my study outside PCTU?

Yes, you could consider alternative arrangements for the development of the economic analysis in your study (e.g. Health Economist/s in your organisation or elsewhere). We strongly recommend that you seek collaboration with an experienced Health Economist.

What approach does PCTU take in supporting economic analysis in clinical studies?

In studies in which PCTU supports the economic analyses, our standard approach is to involve one or more experienced Health Economists to lead the development, analysis and dissemination of the economic analysis. Health Economists contribute throughout the different stages of development of the clinical study and develop their analyses in consideration of overall clinical study design and statistical analysis.  

Other

I am interested in working at the PCTU, do you have any job vacancies?

Job vacancies are advertised on our Careers and Development pages. Check back here regularly for new job vacancies.

What short courses and events do PCTU run?

We runs some short courses and events throughout the year.  Further information about our courses and events can be found on our Courses and Events home page.  Link?

How can I find a trial to take part in?

The PCTU are not involved directly in recruiting patients to trials.  However, the following links to databases allow you to search for trials in the UK and abroad.

http://www.isrctn.com

https://clinicaltrials.gov

https://www.ukctg.nihr.ac.uk 

Glossary of terms:

  • BCC – Barts Cancer Centre
  • CRF – Case Report Form
  • DM – Data Management
  • IG – Information Governance
  • PCTU – Pragmatic Clinical Trials Unit
  • Sponsor – for more information on the definition of sponsors please go to http://www.ct-toolkit.ac.uk/routemap/sponsorship/

If you have any questions that have not been answered in the FAQs, please email: pctu-enquiries@qmul.ac.uk

 

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