3 million and rising: the secret to recruiting more patients to trials could lie in better training for doctors and nurses

3 million patients have been recruited to clinical trials over the past six years.

That was the impressive bit of news put out by the National Institute for Health Research (NIHR) Clinical Research Networks yesterday. You may have heard its Chief Executive, Jonathan Sheffield, on local radio talking about we have got here and the important part played by patients both as participants and in shaping clinical studies.

It would seem the networks have smashed all sorts of records in the last year (http://www.thepharmaletter.com/article/record-year-for-commercial-contract-clinical-research-in-england ) . Some of those by individual trusts – and you can see what your own NHS Trust has been up too here: http://www.theguardian.com/healthcare-network-nihr-clinical-research-zone/table/nhs-trust-research-activity-league-table-2013-14 It is a sign that the message is getting through to the wider NHS.

So how do we push on from here? How do we grow the numbers of patients in trials? The ongoing reconfiguration of national networks into local research networks will help by moving how we think and operate closer to the point of contact with patients.

As will campaigns like ‘Ok to ask.’ I would like to think that the bump in network performance during the 2nd Quarter of 2013/14 is down to our first ‘Ok to ask’ campaign that May. It is a thought that has no basis in fact of course, but allow me my fantasies please.

Another way may be by improving the training about research that our wider NHS workforce received. I would like to thank Sir Iain Chalmers for pointing me yesterday in the direction of an excellent paper by Professor Jennifer Donovan at Bristol University and recently published in Trials: http://www.trialsjournal.com/content/15/1/5

It makes fascinating reading. It looks at ‘clear’ and ‘hidden obstacles’ to recruiting patients based on interviews with doctors and nurses involved in recruiting to six Randomised Clinical Trials (RCTs). The most significant hidden hurdle is the degree to which – often very understandable – professional and personal anxieties among recruiters lead them to make judgements about patient eligibility and effectively deny patients from having a choice. In one instance where a training intervention was made, recruitment to the trial improved markedly. The paper goes on to argue the importance of training our workforce in such a way that the decision to join a trial is – my words – truly shared between patient and doctor.

I wonder whether a public involvement intervention would also have helped? In fact I think there’s something between the lines of this paper which is about professional understanding and appreciation of the patient experience.

I hope that brief summary does the paper justice and, more important, is fair and accurate.

Training issues are being actively addressed. I have been very impressed with the work being done by Susan Hamer at NIHR CRN and many others to put in place a programme to support the career development and progression of clinical research nurses.

Health Education England (HEE) recently finished consulting on their strategy for developing a research savvy health and social care workforce. And the Association of Medical Research Charities (AMRC) have been important in raising this issue across Westminster and Whitehall as part of their vision for the NHS.

Earlier this week I attended a most absorbing discussion hosted by the International Academy of Clinical Research. Launched in 2011 it had been agitating ever since for a competency and accreditation framework in clinical research. Dry stuff you may think. So did I. Until we began to do some group work looking at recent US Federal Drug Administration (FDA) warning letters to sponsors of clinical trials about poor and possibly fraudulent practice. From patients not being consented properly poor record keeping. It was quite an eye opener.

It’s then you realise that training is not just about ensuring patients have an informed choice but also that their safety is assured.

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