Introduction

Clinical trials are a special type of research involving human participants, sometimes with healthy volunteers, but often with patients who agree to participate in trials as part of their treatment and medical care. Trials therefore carry particular responsibilities both to ensure the welfare of their participants and to be publicly accountable. In the quest to design, conduct and report the results of the 'perfect' trial, we must not lose sight of the fact that the whole purpose of trials is ultimately to benefit patients and the community at large. Clinical trials cannot be done without patients, and success depends upon establishing effective partnerships between researchers, clinicians and patients.

In the past, patients seldom played an active role in decisions about their treatments, but this is changing rapidly. Although many patients do still wish decisions to be taken entirely by their doctor, in general, people are better informed and want to be more involved in determining their individual health care. This has been facilitated by the availability and accessibility of information over the internet which has made it easier for individuals to learn in detail about their disease and treatment possibilities. It is not unusual for patients to arrive at consultations with downloaded information on the 'latest advances' in the treatment of their particular condition. However, they may need help in evaluating the information that they have found. In particular, because the internet provides health-care advice from a variety of contributors, including academic institutions, self-help organisations, commercial interests and downright cranks, they may need help in sorting the potentially worthwhile from the worthless.

New trials must therefore be planned in the context of an increasingly informed patient population. Historically, many doctors and researchers favoured a paternalistic approach and the public perspective was often neglected. However, this is changing and lay involvement is becoming established at all levels of clinical research. This includes helping to set research agendas, to design trials that are relevant and to ensure that the results of research are reported appropriately. These days trialists must be ready to accept wider responsibilities and to forge new kinds of relationships with the patients included in their trials, with community groups and with the general public.

The public consists of many different stakeholders, all of whom have differing needs for information about clinical trials. Central are those patients, doctors and nurses taking part in the trials. The wider audience includes the pool of all potential participants, others involved in healthcare provision and policy making, and the general public -including politicians and the media. Ultimately, we are all potential trial participants at some point in our lives, and we all need information concerning trials at some level.

If trials are to be successful and achieve their aim of improving public health, then they should be relevant and practical. The accrual rate must not be so slow that the results are overtaken by changing conditions or practice, and results should be disseminated and acted upon appropriately. All of these aspects require public support. This chapter can address only briefly some of the many issues involved. It deals mostly with communication relating to entry to trials. Where possible this is based on the results of empirical research. It differs from other parts of this book in that first-hand experience of lay involvement in the design and conduct of MRC cancer trials is less well developed than for other aspects of trial design, management and analysis. So far, trials in breast and prostate cancer have benefited from lay representation at all stages of trial development and it is an area that we believe to be essential to future progress. Important first steps have been taken and we plan to build on these over the coming years.

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