Table 1 Translation of business model components

1a. Developing brand values

'Brand values' define what a 'brand 'is' and what it 'is not' - i.e. its 'personality'.

The 'brand' needs to convey clearly what a trial 'stands for'; what collaborators and participants can expect as being part of your study.

1b. Gaining legitimacy and prestige

Trials need legitimacy - they need to be positively 'tagged' by association with prestigious individuals and institutions.

At every stage in the trial demonstrate that the trial is being professionally managed. The support of respected funding bodies, Universities, clinical networks, academics and clinicians all contribute to this component.

1c. Signalling worthiness

It is vital to signal to collaborators and participants that this trial will create greater value than the costs (time and money) involved.

Demonstrate that the research question is extremely important. Can the trial be supported at recruiting sites by networks and/or research money? What benefits may participation and outcome bring to knowledge of the best treatments?

2a. Providing simple, complete processes

Trials require clinical staff to undertake work that is additional to their normal duties.

Getting a trial set-up, identifying, and recruiting participants, delivering the trial intervention and follow-up of participants all require effort. Data collection should be the minimum required and data entry/transfer processes should be as simple as possible. Clarity re roles and responsibilities is vital.

2b. Devising strategies for overcoming resistance

Potential participants frequently raise objections.

Recognise what anxieties collaborators are likely to have and develop accurate, standard responses. Ensure that the science of the trial is clear and unambiguous.

2c. Adopting an explicit marketing plan

The marketing of a trial is too important to be done informally. A formal marketing plan is required and should include a definition of target market segments (groups that need to buy in to the trial) and the trial's unique selling points (USPs).

Consider who the gatekeepers are and who should be approached to investigate participating in a study; consider why involvement in this trial is unique and the importance of answering the research question.

3a. Engaging active sponsors, champions and change agents

'Selling' a trial to prospective participants requires persuasion. This requires enrolling sponsors (public advocates), champions (activists) and change agents (facilitators).

Obtain and maintain the support of multiple groups such as disease specific networks, local experts in the disease area (e.g. local lead clinicians who can promote the study in their area), patient representatives and trial managers. Involve local investigators in promoting the study by giving presentations about the trial.

3b. Delivering a multi-audience, multi-level message

Trials need to convey sales messages through publicity, presentations, training materials, etc.

Communicate in the language of the persons being targeted (e.g. surgeons are more likely to be persuaded by different messages to administrators or nursing staff). Correct any misunderstandings by inviting feedback from audiences that the trial has been presented to and adapting the information as appropriate.

3c. Achieving buy-in (in public)

Public buy-in requires intended participants to announce their commitment to join the trial. When someone states, in public, that they are willing to undertake an action, then they are much more likely to do it.

Through websites, newsletters and other communication means, create and regularly update information on participating collaborators. Ensure that local teams are aware of research going on that may involve patients they deal with (e.g. ward staff). The local clinical leads should inform colleagues and team members of their participation in the trial enthusiastically and in person.

4a. Ensuring positive 'moments of truth'

People judge organisations on the basis of their experience at 'moments of truth'.

Have systems in place (e.g. dedicated email accounts, frequently asked questions on the trial website, prompt response by the trial manager to queries) to ensure all communications are handled efficiently and honestly. Providing competent and honest responses will increase loyalty to the trial and the research team and will result in a greater chance of ongoing successful collaborations.

4b. Providing frequent positive reinforcement

Positive reinforcement for existing participants should be an important part of a trial's 'participant retention strategy'. It is more 'expensive' to recruit new participants than to retain existing participants.

Provide regular updates of information and recognise successes. Keep participants informed e.g. through regular newsletters, website updates etc and sending small tokens of appreciation.

4c. Facilitating incorporation into routines

Activities that become embedded as routines are more likely to be done than 'one-offs'.

As far as possible, ensure the trial procedures are simple, in order that the participating sites can incorporate the study into their established routines. Flexibility may be required as processes can vary at different clinical sites.