Legal and ethical issues associated with patient recruitment in clinical trials: the case of competitive enrolment.

• Author: Caulfield, Timothy A.

Introduction

The demand for patients for clinical trials continues to increase. There are more clinical trials being done (often involving patients with similar conditions), government regulators require an increasing amount of data for the drug approval process, and some within industry have speculated that patients are becoming less willing to participate.

These pressures have led to the development of a variety strategies to make the recruitment of patients more efficient and effective, such as the creation of research networks, the implementation of software to determine patient eligibility (1) and the use of email and the internet to find new patients. (2) Indeed, patient recruitment has become an industry.

Competitive enrolment has emerged as one of the most common patient recruitment practices. Despite being ubiquitous, there is surprisingly little literature on the nature and ethical implications of competitive enrolment. This paper briefly considers the issues associated with this recruitment scheme. I will argue that competitive enrolment creates significant ethical challenges that need to be addressed by both REBs and at the level of national research ethics policy.

Competitive Enrolment

From the perspective of industry, patient recruitment is seen as a critical issue. In a paper written by an industry consultant, it is claimed that "only 15% of clinical trials are completed on time, with over 50% of delays attributed to patient recruitment and 30% of investigator sites failing to recruit a single patient." (3) The authors also suggest that the "estimated cost of patient recruitment is $1.89 billion. These costs are subject to further increases with each day's delay in bringing the product to market." (4) In another industry document it is stated that "drug companies stand to lose between $600,000 and $8 million each day clinical trials delay a drug's development and launch." (5)

It shouldn't be forgotten how much the industry has invested in the research and development process. Though estimates vary considerably, one paper suggests that it "takes nearly eight years to develop a drug, almost twice as long as it took 20 years ago" and, quoting from a study by the Tufts Center for the Study of Drug Development, "$1 billion per drug, from concept to market." (6)

While such figures often come from industry sources, there is no doubt that increasing access to patients and promoting patient participation in clinical trials has become an industry priority. A lot of money is at stake. For sponsoring companies, encouraging patients to participate and to complete clinical trials has a direct relationship to profit and the success of a new drug product. As such, it is understandable that sponsoring companies would want to devise strategies to optimize recruitment.

One such strategy is competitive enrolment. Indeed, it is frequently viewed as an essential part of the overall patient recruitment plan. As noted by one recruitment consultant: "We strongly recommend the use of competitive enrolment together with the inclusion of backup sites so they can be brought on board should individual sites drop below their agreed target levels." (7)

Competitive enrolment is often part of the clinical trial agreement...