Rapid Responses to:

EDUCATION AND DEBATE: Barbara Farrell Efficient management of randomised controlled trials: nature or nurture BMJ 1998; 317: 1236-1239 [Full text]

Rapid Responses: Submit a response to this article

Rapid Responses published:

Day-to-day management of clinical trials

Maxine Stead   (10 November 1998)

Paper is always a problem

Roberto Lede, Graciela Abriata   (11 December 1998)

Day-to-day management of clinical trials 10 November 1998
Maxine Stead Send response to journal: Re: Day-to-day management of clinical trials	EDITOR - We entirely agree with Farrell's article regarding the day- to-day management of clinical trials (1). There appears to be limited recognition by medical professionals and funding agencies of the importance of a trained, experienced, multi-disciplinary team in the setting up and co-ordination of a multi-centre clinical trial, and also of the role such teams play in maintaining enthusiasm amongst medical staff involved throughout the often lengthy periods of recruitment and follow- up. The cost of employing a dedicated trial team is also poorly recognised and appreciated. It is essential to train and maintain staff in order to provide the necessary expertise. However, whilst there is training available for statisticians and programmers, training facilities for trial co-ordination staff are very limited. Career plans for all staff are often unstructured, or even non-existent. In addition, the time taken to maintain enthusiasm across centres, to visit centres throughout the trial, and to monitor recruitment and identify methods to improve or help lagging recruitment is often underestimated. A well-run trial also involves significant data handling including the entry, chasing, checking and monitoring (both source data verification and statistical monitoring) of trial data to improve its accuracy and completeness. As Farrell points out, a customised computer programme is also an essential component of high quality validated data in clinical trials. However, the time and cost of developing trial-specific databases and purchasing computer hardware, software and systems support is also often underestimated. Employing staff on long-term contracts (as opposed to short-term contracts dependent on one trial's funding) ensures job security, motivation and the opportunity to build on the expertise and knowledge of existing staff. This however usually depends on the provision of core funding which is critical to maintaining a pool of experienced and trained employees. Thus, in support of Farrell we encourage the development of recognised training courses and career development for trial staff; we urge funding bodies to recognise the importance and necessity of funding experienced core staff who are critical components of the success of trial completion and data collection; and we encourage sharing the experience of data management and trial procedures using both current and new technologies. The importance of core funding to provide training and financial resources for experienced core staff in multi-centre trials units must be recognised as the only sensible way of providing cost- effective, high quality multi-centre research which will answer the nation's major health questions. Maxine Stead, Quality Assurance/Trials Manager Su Mason, Joint Head of Unit Trish Shevlin, Senior Medical Statistician Julia Brown, Joint Head of Unit Northern and Yorkshire Clinical Trials and Research Unit, Arthington House, Hospital Lane, Leeds, LS16 6QB. Tel: 0113 392 4411, fax: 0113 261 9006, e-mail: mls@yco.leeds.ac.uk 1 Farrell B. Efficient management of randomised controlled trials: nature or nurture. BMJ 1998;317:1236-39. (31 October.)
Paper is always a problem 11 December 1998
Roberto Lede, Director Aregentinen Institute for Evidence Based Medicine, Graciela Abriata Send response to journal: Re: Paper is always a problem	We agree with Barbara Farrell (1) that in multicentric clinical trials paper is always a problem. To the ways of communication used in those trials mentioned in her very interesting paper, we would like to add the one we have been using for a year. As the Latin-American co-ordinating centre for a large clinical trial based in Leicester (UK), large quantity of forms are filled. To deal with this issue we scan each form in a “bmp” file format and send them attached to an email to the central co- ordinating centre. Once received, the files are printed or seen onto the PC monitor using the available software provided by the most common informatic enviroment. The whole procedure is easy to perform and it only requires usual hardware. Also, transfer paper in electronic files permit storage in diskettes or CD saving space and gaining in security. Up to now, more than 1000 forms were successfully delivered in this way and we encourage other centres to try this way of communication in order to save time and money. Roberto Lede, MD, PhD Ma. Graciela Abriata, MD Argentinean Institute for Evidence Based Medicine Reference: 1. Farrell B. Efficient management of randomised controlled trials: nature or nurture. BMJ 1998; 317: 1236-9