Rules for engagement

It is recognised that the success and worth of CHaRT rests heavily on the quality of the randomised controlled trials (RCT) that CHaRT will engage in. Considerable care is taken in the choice of new trials based on the following criteria:

• Addresses an important question. The RCT must address a question that is clinically important such that, if the trial is successful, there will be a reasonable expectation of the findings resulting in a worthwhile change in clinical practice.
• Necessary. A proper review of the evidence base (including a formal overview of relevant RCTs) should indicate that an RCT is needed.
• Multicentre clinical network trials. CHaRT is particularly keen to be involved in trials that are multicentre trials supported by a clinical network.
• Feasible. Many RCTs fail to proceed in line with expectations, in particular failing to recruit and retain the required number of participants. The assumptions behind the study would be critically reviewed, with evidence sought up-front that these assumptions are reasonable. If no such reassurance is possible, then it will be sought from a pilot study or early returns as the study commences. The study should be led by a Chief Investigator with the correct blend of experience and clinical credibility.
• Methodologically sound. CHaRT engages with leads of individual trials at the planning stage to ensure the optimal scientific design, with the best and most appropriate analysis and suitable methods of managing and conducting the trial.
• Financially viable. CHaRT’s involvement with a study must be appropriately financed, with a minimum expectation that CHaRT recovers the true cost of its engagement in the study (in terms of its expense of staff costs and consumables).
• Attractive to CHaRT, HSRU, and the IAHS. CHaRT will carefully assess its engagement in a trial on the basis that the trial should enhance and confirm CHaRT’s reputation as the delivery of high quality, clinically relevant, methodologically excellent RCTs. CHaRT will consider each trial on it’s merits but particular attention will be paid to studies which are likely to:
  • Contribute a step change in the clinical management of a condition i.e. be of ‘landmark’ status.
  • Further the ability of HSRU to meet its remit, for example, by widening its support of Scottish researchers and mounting multicentre trials on a Scotland-wide basis.
  • Enhance the strategic plan of the IAHS, for example by facilitating trials in clinical areas recognised to be the University of Aberdeen’s strengths.
  • Provide CHaRT with access to a network of clinical collaborators eg through a national professional group.
  • Give the opportunity to explore methodological advances in RCT design, analysis, conduct and reporting (for example, trials involving novel IT applications, trials in difficult settings, e.g. ICU studies).
  • Add coherence to the portfolio; ‘in-house’ HSRU trials in particular would be expected to develop within the themes of the Unit’s Health Care Assessment programme.