Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 7 Issue 2 (May 2000).

Copies of back issues and individual articles are available direct from the publisher � please contact us for further information.

"Editorial"
by Anna Bingham

Abstract
Reform within the NHS and other significant factors that have promoted change (eg, the introduction of MRECs, NICE and PCGs) pose new challenges to carrying out clinical research in the UK. In conjunction with an increase in regulatory demands and developments within the Far East, South America and Eastern Europe, the pharmaceutical industry is looking beyond Western Europe towards these increasingly viable and economical research options. In my previous Opinion column I expressed my fear that guidelines may fog the essence of GCP and fuel process-led practice � a sentiment supported by Dr Gordon McInnes of Merck Sharp & Dohme who spoke at the ACRPI meeting last month. The essence of his message was antagonistic � understandably so, given his personal perspective as a UK investigator. McInnes questioned whether GCP really could ensure good clinical practice, claiming that its implementation denies investigators the time to care for their patients. Investigators justify their gripe with bureaucracy, believing that management of clinical research should focus on ethical rather than legal considerations. Who's to say that this is misguided? � nobody I hope. But in short we all know that GCP alone cannot subsist such an arduous task. If we wish to retain our clinical excellence we need to be flexible and adaptable in finding new ways of working within this changing environment. Hence, we should regard these guidelines as a framework within which to develop our own best practice, as opposed to regarding them as "bureaucratic nonsense" that serves no honourable tool with which to harness our collective knowledge and experience, and to fashion it to trials reviewed systematically; ethics committees, whose role it is to protect patients' rights, safety and wellbeing, are empowered adequately; and to safeguard data integrity. One suggestion is that we should implement meticulous, auditable processes for procedures earlier in clinical development as a matter of course � to be a little more creative and innovative in the workplace. We should be rewarded for using the right side of our head to foresee clinical need(s) and respond to it/them prior to legitimised enforcement. After all, it is human nature not to like being told what to do and when to do it, so it would be in our best interest to complement legislation in this way.

Perhaps I am in danger of upsetting those overworked investigators who are too busy to do what they must do, let alone what they should� especially as the volume of paperwork associated with clinical research is off-putting to potential practitioners. However, if we implement these changes from the beginning and focus on the startpoints rather than endpoints of research, we may help ourselves further. It is no great surprise then that the new EU Clinical Trials Directive proposes change within academic research in an attempt to bring it in line with clinical trial analysis and procedures. Although I heartily agree with Dr Innes that the current state of play gets in the way of GCP, I believe that the single most important role of GCP is to act as a catalyst for the dissemination of information which, in turn, should help to prevent duplication of product development- related research and enable more efficient use of resources. Audits, for example, have traditionally been identified as a major "bug bear" for investigators, who have been quoted as saying that "trials are dominated by GCP police intent on identifying trivial deviations (from protocol)" and GCP appears not to be patient care but bureaucracy within. European Union directives are likely to make matters worse". However, the flip side of this argument is that old problems surface time and time again, suggesting that lessons are not being learnt for one reason or another. In his article, Nigel Crossland, an independent auditor for many years, suggests that this is largely due to a lack of communication post-audit and proposes procedures to help correct this shortfall. The two articles herein by Suzanne Wampler and Jean-Pierre Tassignon, which address protocol complexity and clinical development planning, respectively, are a step in the right direction. They discuss how we could have the best of both worlds with a little creative thinking and reorganisation, with a shift in focus towards minimising the paperwork through maximising the sharing of information and decreasing repetition of work. Both articles build solutions around the mountains of paperwork by ensuring that clinicians and investigators are equipped with the information necessary to enable them to perform fewer procedures per patient on the minimal number of patients. In conclusion, we live in a blame culture that, by its very nature, suppresses innovation and creativity. Investigators are dismayed by the paperwork that the industry requires. The industry implements these rules because they are audited and the auditors are there to enforce GCP compliance in accordance with the regulatory authorities. These bodies enforce the guidelines because they support legislation, which is imposed by the government, who must conform to European regulations that must comply with world standards. The point is that the regulatory authorities are currently proposing to legislate EU member state GCP inspections later this findings regarding inadequate consent and understanding of responsibilities, inappropriate delegation of duties and violation of protocol eligibility data. Therefore, it is in the interest of investigators and pharmaceutical companies alike, to be one step ahead of the game to protect our privileged position at the forefront of research excellence. We should all strive to ensure that we are the instigators of legislation and ensure the continued involvement of worthy legislation such as the data protection directive (The European Data Privacy Directive (95/46/EC)), which is discussed in Franklin Kimbimbi Mingo's article. Whether you agree or disagree with the point(s) that I have raised, I invite you to reply. I look forward to your contribution for discussion.

"Compliance with GCP at the investigator site � are the lessons being learnt?"
by Nigel Crossland

Abstract
Standards for the performance of clinical trials within the EU are on the threshold of becoming law through the implementation of the European Directive on Good Clinical Practice (GCP) in Clinical Trials. Various guidelines on GCP have, however, been in place for many years. Despite differences in detail, they all stress the importance of ensuring that clinical trials on human subjects should only be performed under circumstances that ensure that the rights, safety and well-being of trial subjects are not compromised and that the integrity of the trial remains intact.

"Computerised medical information: a patient's perspective"
by Franklin Kimbimbi Mingo

Abstract
Nowadays, it is trivial to refer to modern society as an "information society". Advances in telecommunication and information technology have fuelled our dependence on items such as the internet and mobile phones to go about our business and daily lives. The recent Forum at Davos (January 2000), where major leaders of the economic and political world convened, sanctified the apparition of the "new economy" based on the Internet. From the proceedings of this meeting, one can predict that this new medium will generate $2 800 billion by the year 2003 � 7% of the world's gross domestic product!

"Preparing a clinical development plan"
by Jean-Pierre Tassignon

Abstract
Delegates at the European Forum for Good Clinical Practice Year 2000 conference considered the preparation of clinical development plans in a workshop that recognised the need for written development plans.

"Tackling a protocol complexity"
by Suzanne Wampler

Abstract
The complexity of trial protocols is fast being identified as a problem that must be overcome if trials are to meet the timelines demanded by both industry and patients. The rise in the number of procedures per patient and excessive inclusion and exclusion criteria are two of the main offenders and, thus, a measure of protocol complexity � which we know to increase cost and impart increased demands on healthcare resources. If we listen to current debate, one might also conclude that it is a factor in determining an investigator's willingness to conduct clinical research; it is certainly linked to the dropout rate of trial participants. Further, the impact of protocol complexity introduces delays in data entry and query resolution, which has a knock-on effect that results in a significant delay in time to market for the trial drug. This in turn is a financial disaster to the sponsor companies and delays the availability of new treatments to patients.