This article has been published by the International Biopharmaceutical Associationwww.ibpassociation.org
The project is sponsored by KRC CRO and training services ( www.kriger.com ) and ClinQua CRO (www.clinqua.com )
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Over the last ten years, getting patients and doctors into clinical trials has become the most delay-ridden aspect of the drug discovery and development process. When implemented effectively, clinical trial recruitment (CTR) initiatives can be highly successful. Time lines can be dramatically reduced and recruitment targets can be met ahead of schedule; every day saved in the progression to marketing authorization can equate to millions of pounds made in patent-protected sales revenue.
However, great care is needed in the development of a CTR program. Considerable ethical scrutiny is applied to all patient recruitment materials and initiatives. For example, in 2002 the European Commission issued guidelines for consultation which require patient advertising and details of recruitment initiatives to be submitted to appropriate ethics committees.
Unfortunately, there is no simple code of practice established and no unified regulatory body and no recourse to appeal. If an ethics committee doesn't like what a CRO has planned, the CRO can't use it. In Europe, this aspect has yet to be effectively addressed.
Enhancing CTR is obviously an area in which great caution is required. Some investigating doctors, for example, question the need for extra activities as, they claim, there are sufficient numbers of suitable patients among those already attending their clinics. However, practical experience has shown that this is an over-estimation of the number of patients physicians will be able to recruit and it is estimated that only about 10% of a physician’s patients will actually wish to enroll in a clinical trial.
Perhaps more importantly, there are also objections raised from within the industry. These usually centre on a highly cautious approach to the ethics and legitimacy of patient-facing initiatives. Some nervousness is understandable given the strict controls that govern DTC marketing but for clinical research there is a critical need for increased patient understanding and education. The signs are that the caution of the industry is slowly giving way to a new openness and confidence.
A review of recent press coverage also highlights a deep skepticism of industry involvement in clinical research. If not approached ethically, a firm’s CTR campaign can leave them wide open to aggressive media criticism and adverse advocacy relationships. The key point to remember is that the objective of all this work is ultimately to improve care for the patient. A strenuous effort to maintain this focus throughout clinical development will ultimately allow pharma companies to reap considerable rewards.
Over the past several years these problems have been addressed in the US, where clinical research receives more and more active support of government bodies, advocacy groups, charities and patient groups. This provides a collaborative environment and ensures that there is always an independent counterpoint when the integrity of industry-sponsored studies is attacked.
The American public sees a vast amount of government-sponsored education, designed to maximize understanding of clinical trials. A quick look at Cancer.gov and ClinicalTrials.gov, both run by the National Institutes for Health, illustrates just how much work is being done. This in turn is supported by private efforts such as Centerwatch.com, which is currently offers a 300-page book on informed consent for patients.
The nature of American healthcare provision no doubt motivates patients to seek free or subsidized medication, but the investment, approach and partnerships in the US are demystifying clinical trials and generating considerable goodwill toward industry-driven research.
A recently announced US public/private partnership designed to improve trial recruitment demonstrates how support for industry research can be broadened. The initiative created a $6m fund, which the contributing pharma companies and National Cancer Institute will use to accelerate patient recruitment for Phase I and II cancer studies. Naturally, the credibility of the public bodies involved enhances the effectiveness of the scheme.