In the past decade there have been huge advances in medicine, and the pharmaceutical industry is bursting with potential blockbuster drugs to treat or cure many medical conditions. Yet there is one stumbling block: not enough human volunteers to try them.
To obtain approval from the Food and Drug Administration, a drug must undergo extensive clinical trials involving hundreds, if not thousands, of patients who must be both eligible for the study and willing to participate. Almost 80 percent of clinical trials fail to enroll the required number of patients in the time published by investigators, and the scarcity could worsen. IMS Health Inc, Westport, CT, estimates 1,900 drugs are in human trials worldwide. Close to 400 new drugs will advance to Phase III – the final and longest phase – which will require a million new qualified volunteers.
Time is money. In the hotly contested races to bring innovative therapies to market, the first drug approved garners huge advantages in terms of market exclusivity, leadership positioning or even thought leader and advocacy relationships. These advantages, even for only a few months, can make or break the potential of a critical new product.
A speedy drug approval process benefits the pharmaceutical manufacturer and patients. Clinical trials are so important to public health and the progression of medical research that recently the Clinton administration issued an executive memorandum to address the crisis in volunteer shortages. It directs the Health Care Financing Administration to revise its payment policy and immediately begin to reimburse providers for any Medicare patients who participate in clinical trials.
Intense pressure. As the urgency for faster trial completion increases, so does the urgency to recruit patients – which is not an easy task. Traditionally, volunteers have been recruited by doctors who are compensated for their work. If recruitment is lagging, drug companies often institute aggressive public advertising to attract potential study patients.
While not the norm, investigators of clinical trial recruitment have found instances where patients are enrolled simply because the doctor is getting compensated for the number of his enrollees.
Patient-centered alternatives. Can recruitment be accelerated while avoiding such ethically murky waters? There is reason to be optimistic. Many drug companies and specialized marketing firms are seeking volunteers through advertisements in major newspapers, television, radio and the Internet. While traditional broadcast and print media are appropriate for recruiting patients in prevalent disease states, they are inefficient for finding most patients needed for today’s clinical trials. The Internet offers the promise of more targeted advertising, but early initiatives have shown limited success.
Forging the final link. Two problems confront the efforts of recruiting through the Internet. First, most patients expressing interest in trials over the Internet are not close enough to a trial site. Second, even for consumers who are ideally located, the logistics of handling them have proved daunting. Potential volunteers need to be carefully handled through the process of properly qualifying them, scheduling the necessary preliminary examinations and ensuring they are assigned to the desired trial.
To set up these programs, pharmaceutical companies must work with agencies that have the capabilities to field high volumes of interested consumers and guide them through the process of enrolling, if appropriate. Internet sites responding to clinical trial responses should maintain a national network of clinical research sites and be highly experienced in managing patients and investigators. It is this capability that can ensure a consumer’s interest in volunteering is converted to enrollment.
As the average number of clinical trials for each new drug application grows and as the number of patients in each clinical trial climbs, it will be important that pharmaceutical manufacturers use targeted marketing practices for their recruitment.
By selectively targeting their potential trial volunteers, drug makers can ensure they are reaching the right patient, in the right location and with a willingness to participate. By cutting down the recruitment time, more clinical trials will be completed sooner, and more breakthroughs in medicine can be achieved, benefiting the pharmaceutical manufacturers and public health.