Using technology to address recruitment issues in the clinical trial process.

It takes nearly ten years to get a drug through the discovery and development pipeline and onto the market; most of this time is spent in the clinical phase. Clinical development times vary widely from drug to drug, but a drug typically spends just over 6 years going through clinical trials and regulatory processes. At least 3 years of this time is spent recruiting patients. Every month by which the development process can be shortened is worth US $25 million in additional income for the average drug. Can the recruitment time be shortened?

[1]  N. Geller,et al.  Identifying high yield sources of patients with coronary artery disease for clinical trials: Lessons from the asymptomatic cardiac ischemia pilot (ACIP) experience , 1998, Clinical cardiology.

[2]  K. McPherson,et al.  Cancer patients' information needs and information seeking behaviour: in depth interview study , 2000, BMJ : British Medical Journal.

[3]  E. Frank,et al.  Effect of different recruitment sources on the composition of a bipolar disorder case registry , 2000, Social Psychiatry and Psychiatric Epidemiology.

[4]  F. Nieman,et al.  Determinants of patient participation in clinical studies requiring informed consent: why patients enter a clinical trial. , 1998, Patient education and counseling.

[5]  G. Swanson,et al.  Recruiting minorities into clinical trials: toward a participant-friendly system. , 1995, Journal of the National Cancer Institute.

[6]  D. Hunninghake,et al.  Recruitment experience in clinical trials: literature summary and annotated bibliography. , 1987, Controlled clinical trials.

[7]  M. Drury,et al.  Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners , 1996, BMJ.

[8]  R. Foy,et al.  Clinical trials in primary care , 1998, BMJ.

[9]  A. Buist,et al.  Monitoring recruitment effectiveness and cost in a clinical trial. , 1993, Controlled clinical trials.

[10]  J. Ioannidis,et al.  Patterns of patient enrollment in randomized controlled trials. , 2001, Journal of clinical epidemiology.

[11]  A. Glass,et al.  Mailing strategies and costs of recruiting heavy smokers in CARET, a large chemoprevention trial. , 1998, Controlled clinical trials.

[12]  M. Sinclair,et al.  Methods used to maintain a high level of participant involvement in a clinical trial , 2001, Journal of epidemiology and community health.

[13]  D. Hunninghake,et al.  Recruitment for controlled clinical trials: literature summary and annotated bibliography. , 1997, Controlled clinical trials.

[14]  S. Keith Evaluating characteristics of patient selection and dropout rates. , 2001, Journal of Clinical Psychiatry.

[15]  R. Prescott,et al.  Barriers to participation in randomised controlled trials: a systematic review. , 1999, Journal of clinical epidemiology.