CLINICAL RESEARCH

Putting the focus on patient care

Jenny Hone

Peter’s story is not unique. He had been a solitary child and as he got older he became increasingly withdrawn. At the age of 16, when he left school, he shut himself away in his bedroom and for eight years he hid from the world, playing solitary computer games, or watching TV. Then his mother made a phone call that was to change his life.

His appointment was arranged for an evening, so he wouldn’t have to cope with a normally busy waiting room. Even so, he sat with his baseball cap pulled down over his eyes to hide his face, and his body language closed. Delyth Hague, the research nurse who interviewed Peter that evening, recalls how he was unable to make eye contact and blushed furiously when she spoke to him. He had to return the following day to meet the psychiatrist, but she didn’t think he’d come back.

However, Peter did return. He met the study criteria and, following the informed consent procedures, was enroled on the clinical trial. After two weeks on the study she could see a marked improvement in his behaviour, and within a month the change in Peter was dramatic. He was making eye contact with people and was initiating conversations. A few months further on, and the young man who previously had no friends and no social life had enroled in a college course, had a girlfriend, and had even booked a holiday with her to Greece. But Peter’s progress didn’t stop there: when he returned from his holiday he booked another one, and this time to go on his own. At the end of the trial Peter’s mother phoned Delyth and said: “You’ve given him his life back.”

Transforming lives

The lives of those suffering from debilitating illnesses – in this case social anxiety disorder – can be made miserable by their condition. Participating in a clinical trial has the potential to transform their lives. “Seeing a social anxiety patient gaining the courage to leave the house, an osteoporosis sufferer able to get in and out of a bath following years of immobility, or a lady with atopic dermatitis having the confidence to wear a skirt after 20 years of covering her legs is why I’m so passionate about what I do,” says Delyth Hague, research nurse for Quintiles. “But the good that’s being done by clinical trial research is often overlooked.”

While studies suggest that patients on clinical trials have better health outcomes than those who don’t participate, this information has yet to filter down to the general public. The industry is still hampered by low patient participation, even in therapy areas where you might expect more interest. In oncology, for example, less than 2% of patients in the US choose to take part in these studies. As Dr John Leonard, Professor of Medicine at Weill Cornell Medical College and attending physician at New York-Presbyterian Hospital/ Weill Cornell Medical Center, pointed out recently at the launch of the IMPACT (Improving Methods for Patient Accrual to Clinical Trials) study, in the area of cancer therapies “even a modest increase of two to three percentage points would mean the difference between completing a study in two years instead of three”. This reduction in study time, he noted, had the potential to provide more rapid improvement in the standard of care and result in “thousands of lives saved”.

The IMPACT study, which will be undertaken by Weill Cornell Medical College in New York City and the Cornell University College of Agriculture and Life Sciences in Ithaca, NY, and for which Dr Leonard is co-leader, will be the first to assess the barriers to enrolment from a socio-psychological perspective, using the specialised methods of risk communication. The pharmaceutical industry is also moving into new territory in its drive to improve patient accrual to clinical trials.

The problem of ‘time’

Increasing attention is now being focused on the patient and patient need. This patient-centred approach, along with dedicated trial awareness campaigns using mediums such as regional newspapers, the internet and, where appropriate, TV advertising, is the future for trial recruitment, retention and management, and many companies are now doing this to a lesser or greater extent. However, these initiatives generally don’t address the age-old problem of ‘time’.

Patients on clinical trials need time with healthcare professionals. Indeed, research shows that patients respond better to treatment and have better outcomes as a result of nurse attention. But hard-pressed physicians, practice nurses and other healthcare professionals must fit this work in around their healthcare role, and the time they can devote to trial set-up, management, and the patient is inevitably limited. One answer is for the sponsor or contract research organisation (CRO ) to deploy their own recruitment nurses dedicated solely to managing and overseeing individual clinical trials. Such an initiative can not only help to improve the outcome of a trial, but can result in improved enrolment rates and better trial management. In fact, where this strategy has been employed by a CRO recruitment rates have generally been twice the average, and in some cases these sites have performed up to 10 times better than average on speed of recruitment.

By forming close partnerships with trial sites the CRO can deploy recruitment nurses as and where they are needed, to work alongside the time-pressed physicians. At trial set-up, for example, the recruitment nurse can take on responsibility for: ensuring the correct documents are in place; that ethics approval has been granted; for organising the site initiation meeting; and for searching the physician databases and patient notes to identify suitable trial patients and ensure they meet the trial protocol. Once suitable patients have been identified the recruitment nurse can carry out all the procedures with the patient prior to the informed consent meeting with the doctor. This might include conducting the screening tests, providing the patient with details of the trial and, importantly, spending time answering any questions to help allay any concerns the patient might have.

Jo Harkness, policy and external affairs director of the International Alliance of Patients’ Organisations, suggests that a principle reason for patients deciding against enroling on a trial during this informed consent process is the complexity of the information they are given. “Clinical trial procedures are so regulated and strict that it is difficult to share sufficient information in a simple way. Patients decide against participating because they don’t feel they understand what is involved.” The extra time a dedicated recruitment nurse can spend with a patient at this stage, explaining all the issues and encouraging patients to ask questions on any areas they’re not clear about, is invaluable; and throughout the duration of the trial the nurse becomes the study patient’s first port of call.

“We are in quite a privileged position as we get to spend more time with patients, and we get to know them, and the patients love it,” says Delyth. “On the longer trials, in particular, patients will often look forward to their visit and will bring along photos of their holiday.” At the same time as providing patient support, the research nurse can also help to ensure flexibility of the trial process so that patients’ needs are fully accommodated. This might involve being available for early morning or late evening appointments if the patient can’t attend between the normal hours of 9am to 5pm – or even visiting the patient at home. Or it might involve maintaining phone contact to ensure the patient sticks with the trial. Indeed, the research nurse becomes so close to the patients that Delyth suggests trial design would benefit from bringing research nurses on board earlier as “we are in the best position to say what patients will or won’t do”, she says.

Positive outcomes

By forming a close partnership with investigative sites, and deploying recruitment nurses where required, CRO s can improve both the time to full patient recruitment and the experience of the patient during the trial. And having completed a trial, many patients are often favourably disposed towards enroling on another. US surveys show that in paediatric trials, for example, both the child and their parents are generally positive about the child’s involvement in the clinical research. In one 2003 survey, 72% of parents and 69% of participating children felt that the level of medical care received was better than they had expected, virtually all parents and patients said it met their expectations, and all the parents and about three quarters of the children said they would consider enrolment in another clinical study.

And of course there are people alive today because they came forward for a clinical trial – and not just those who met the study protocol. Only a small percentage of people who come forward for a trail are actually enroled. Many will not meet the protocol, but they receive preliminary health screening, and this has led to many incidents of previously unknown illnesses being diagnosed among the general public, particularly hypertension and cancers. In one prostate cancer prevention trial, which was looking for men at risk, the health screen identified a number of men with early stage cancer who were therefore able to get treatment. This is the flip side of the negative press that so often surrounds clinical trials.

Surprisingly, even those patients on placebo in a clinical trial have improved health outcomes to those who don’t participate. This is because the patient’s health is constantly reviewed by a nurse or doctor, and the patient also focuses on their own health, which is an important route to recovery or reduction in severity of symptoms. Two important reasons why patients don’t enter clinical trials are because they don’t know about them, or they don’t understand the process and the possible benefits. The industry, academics, patients groups and many other organisations are all helping to improve patient awareness and to get the message out there. There is still much to be done but in the meantime, focusing on meeting the needs of the patient at study start-up and throughout the duration of the trial has to be the priority. Deploying specialist study nurses to improve the patient experience throughout the clinical trial is proving a major step forward.

Jenny Hone

Jenny Hone is a freelance writer and editorial consultant.

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