Pharma Needs You!

Pharma firms are finding it increasingly difficult to rapidly recruit patients for clinical trials and many are turning to internet tools and patient resources abroad.

With estimates suggesting that it can now cost up to a billion dollars to take a drug from test tube to prescription bottle, pharmaceutical firms are in a greater rush than ever before to get their products to market and start making returns. Every extra day a drug spends in the pharmaceutical pipeline can cost a company hundreds of thousands of dollars. Yet increasingly strict clinical trial regulations are demanding longer-term monitoring, more trials and more patients. As such, the clinical trial testing costs of developing a new drug have risen a staggering 55 percent since 1999.

“Clinical trials is the largest cost centre and there are a number of trends why costs are spiralling, but number one is the larger patient population that the FDA is wanting for Phase 3,” says Michael Ferrante, a Director in the pharmaceutical research and development practice at PricewaterhouseCoopers. “The FDA wants to catch as many adverse events as it can in Phase 3 and that requires larger and larger patients populations in order to differentiate these events.”

Understandably, this has led to a renewed urgency to recruit appropriate and abundant numbers of patients for clinical trials. But with all businesses in the same boat, patient recruitment has emerged as a major headache. “There are now more trials competing for less patients in some therapeutic areas,” explains Ben Quartley, Head of Clinical Operations at Profiad. “And that really leads to delays in terms of the time it takes to recruit the patients into the study – which is one of the major cost factors that impact on the clinical development phase of the study. The length of time that it takes to recruit the patients into the study can be extended by anything up to six months in some studies, which means that the whole clinical program for that drug is extended by six months longer and then there are the huge associated costs of managing and monitoring those clinical trials.”

Traditionally, pharmaceutical firms have used media advertising to attract the interest of patients, although the most successful route has been to secure the cooperation of physicians. “Physicians are the ones who are most likely to have contact with patients who may be good candidates for clinical trial participation,” says Kimberly M. O'Malley, eHealth Analyst at Datamonitor. “They are the best decision-makers as to whether patients are appropriate for a study. In addition, as trusted sources of medical information, physicians can strongly influence their patients’ decisions. Patients are more likely to be comfortable taking part in a clinical trial if their doctor recommends participation. Therefore, the strongest recruitment tools for pharmaceutical firms are physicians with large populations of patients.”

Web-based tools

Nevertheless, an increasing number of firms are also leveraging other approaches to meet their patient recruitment needs. Profiad is one of many firms that is utilizing web-based tools for a study that it is presently undertaking, so that it can advertise direct to the patient. “It is something that we are seeing more and more of these days,” admits Quartley. “The traditional way of recruiting patients for a study is that you involve their clinician as an investigator in the study, and patients present to that investigator as part of their routine healthcare. Then when they have got the study they phone the patients up and tell them about it. But that is very limiting and very dependent on the investigator. So now we are moving more towards direct-to-patient access.

“For instance, we are advertising on the IBS website, telling them we have an IBS study being run at centers across the country, and providing a number to call. We are finding that is giving us access to many more patients than the traditional model of recruitment would have done because lots of those patients may never even present to their doctor or if they go to their doctor he may forget that they are taking part in a clinical trial and may not bother to ask the patient. So for some types of studies, web-based advertizing can be very effective. That is a tool that can be used to speed up what seems to be the very limiting step in the clinical program, which is the patient recruitment.”

O’Malley sees similar benefits for recruitment over the internet. “Datamonitor’s research has shown that one of the most significant problems in clinical trial recruitment is that people do not realize that there are clinical trials out there that they can qualify to participate in,” she explains. “Particularly, many people do no know there are opportunities for healthy participants, as well as for those who are ill. The Internet is making this information more widely available. Also, the internet is a useful medium through which to reach proactive consumers – the decision-makers who are more likely to take their health into their own hands and therefore may be more willing to consider participating in a clinical trial. Patients who have Internet access are highly likely to independently go online and research the treatment options that are available. In some cases, particularly when a patient has failed to respond to available treatment, these options include participation in clinical trials for novel therapies.”

Linda Horton, a Partner at International Law firm Hogan & Hartson, has had a long career in the FDA's legislative, legal and international policy offices, serving as the Director of International Policy for eight years. She has witnessed several trends in patient recruitment in the last few years – but ultimately believes that pharma firms will increasingly turn their attention away from our shores.

“If there is any way to plug into a hospital or university that has a whole lot of patients with a certain disease, that really helps,” she explains. “John Hopkins University and two or three others have set up in-house CROs to manage commercial research. But the competition for the attention of doctors and patients is major. There are a lot of challenges right now as far as interesting patients and doctors in clinical trials and this is one reason why trials have been moving to Central and Eastern Europe and South America and countries where there is very high interest by doctors and patients in participating in clinical trials.”

Recruiting abroad

Janet Jones, PhD, is Director of Patient Access and Retention for patient recruitment firm Kendle, a company that strongly believes in the merits of this shift of focus abroad. “We take a global approach to patient recruitment,” she says. “This involves looking to emerging regions such as Central and Eastern Europe and Latin America for difficult-to-recruit patients. For example, we’re increasingly seeing five times more patients from these regions than you would find in the United States for a similar protocol. There are lots of reasons for this: these regions offer different and often previously-untreated patient populations; the doctor-patient relationships are stronger, so patients are more likely to participate in a clinical trial if their doctor suggests it; and they provide more centralised healthcare. All of these factors contribute to more patients enrolling in clinical trials, which in turn enables us to get studies up and running more quickly for our customers.”

“If you want your trial populated quickly, you go to Central and Eastern Europe,” adds Horton. “Countries such as Poland and Russia have large populations, and there are high quality doctors that can get people enrolled quickly. US or Western European pharmaceutical companies are increasingly doing their clinical trials in this region. If you think about it, if you are in a country that has a really good national health service or a really good fee-for-service system where you can get state-of-the-art medicine, what is your motivation to be in a clinical trial? Maybe two-thirds of Americans have super healthcare and we’re not very motivated. But you go to central Europe and there are fewer people who have that kind of safety net and the doctors are very well trained but will work for less compensation. And that is where the motivation comes.”

With clinical trial costs spiralling and patient recruitment consuming around 30 percent of the overall clinical trial process according to estimates, pharma firms will increasingly be looking to streamline the recruitment process. The indications are that regulations regarding trials will only get stricter, erring on the side of caution to protect the consumer, and this will demand ever more trials and ever more patients. But while businesses can leverage the internet to recruit patients and look abroad to meet further requirements, there is no silver bullet solution.

Irrespective of how the patients are recruited, it is critical that pharma firms get the fundamentals in order – or else no effective recruitment campaign can save them from haemorrhaging even more time and money. “There is an increased sense of urgency around study start-up these days,” acknowledges Jones. “Recruiting patients as quickly as possible is a priority but it is also about getting it right. It is about planning with realistic expectations, setting your study correctly at the start, and putting the right approaches in at the beginning. Yes, you don’t want to delay the entire study, but if you set it up with too few sites, for instance, and then half way through you realize that you haven’t got enough or you haven’t got the right sites or the patients don’t exist, it will prove a lot more costly to bring in more sites and start again than it would have been to have done it at the beginning. We strongly advocate conducting a thorough feasibility analysis upfront – it might sound more expensive, but it is not in the long run.” And with margins as tight as they are in the clinical trial process at present, the pharma industry would do well to listen to that piece of advice.