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Connecting with patients

Published on 08/02/05 at 09:02am

In order for a clinical trial to be viable, it needs patients. Sounds obvious, but despite the fact that patients involved in clinical trials benefit from their treatment, recruiting them is still a major challenge. Failure to find sufficient numbers of patients costs companies precious time and money.

In fact drug companies stand to lose between $600,000 and $8 million each day clinical trials delay a drug's development and launch. Inefficient patient recruitment processes are already formidable barriers to successful product launches and may become even more detrimental as trial complexity grows.

So why is patient recruitment such a challenge and what can companies do to ensure they get the patients they need?

Forward planning

In 1999, a Health Technology Assessment Report published guidance regarding recruitment of patients to randomised controlled trials (RCTs). It indicated that multiple recruitment strategies should be used with the aim of screening at least twice the planned sample size and that there should be contingency plans for fewer patients being randomised than expected.

It also advised that staggering recruitment at centres may help to prevent falling recruitment over time and that before starting most RCTs, pilot studies should refine important aspects of their design and conduct, and to check that recruitment strategies are adequate. Wise advice - indeed many would agree that in order to ensure successful patient recruitment, it should be one of the first considerations of trial design.

It has been argued that starting out with the right clinical trial protocol can dictate the subsequent level of success in patient recruitment. Often, most of the emphasis is focused on getting the scientific basis of the protocol correct. However, many pharmaceutical companies rarely have the patient in mind at this stage of the game. Simply put - patient recruitment is almost always the least planned aspect of a trial.

Dr Fahti Khosrow, an executive in clinical development practice at Campbell Alliance, a management consulting firm serving the pharmaceutical and biotech industries, believes that successful patient enrolment not only requires a solid strategy but requires a strategy that is aligned with a strong operational plan.

"Most sponsors initiate studies following a purely tactical approach without developing a well-thought out plan early in the process to guide enrolment. The result of this tactical execution is that often, sponsors set recruitment goals and timelines based (at least in part) on the recruitment predictions/estimates of the potential investigator sites," says Khosrow.

Dr Rob Davie, vice president of clinical service delivery at the Clinical Research Organisation, Covance, believes that a further cause of delayed patient recruitment lies in setting out unrealistic expectations at the outset.

"Study sponsors often massively overestimate the likelihood of recruitment, and often doctors at the study sites will say they can get patients even when they know they can't," says Davie.

Dr Janet Jones, director, global feasibility and patient access at global CRO Kendle, believes the ability to assess the protocol and its requirements from the perspective of potential patients and investigative sites is critical to a successful patient recruitment plan.

"Identification of enrolment barriers and the impact that they will have on trial completion must be established and shared with pharmaceutical companies upfront to avoid obstacles later on in the process," she says.

Careful site planning is also a crucial factor in successful patient recruitment, not only in terms of ensuring the necessary number of patients are recruited but also to give the study sponsors the best chance of accruing patients with the target disease for the drug under examination.

"In Central and Eastern Europe, there are specialised units where people suffering from a particular disease will go. In Western Europe it isn't like that - patients are dispersed, hence the site has to be motivated to get the patients it needs," says Davie.

Khosrow agrees with this statement, saying: "Many companies don't think about where they want to commercialise a drug, but it is crucial that they study where their market is going to be as this will determine where trials should be carried out. Certain regions will give companies the best chance of recruiting the patients they need. For example, colorectal cancer has a high incidence in Nordic countries, therefore it would make sense to undertake a trial for a colorectal cancer drug in that region."

Ignorance is bliss?

Despite the various methods available for finding recruits, such as public information campaigns, raising patient groups, collaboration with patient groups, information leaflets in GP surgeries, press announcements and listing on the appropriate websites, people still appear not to be receiving information as to how to get involved even though they may very much want to.

"Patients are often desperate to get involved in trials, especially those who are suffering from a life-threatening illness," says Khosrow.

However, it's only people suffering from critical illnesses that are keen to get involved. Many patients who participate feel that they are contributing to research in helping to find a treatment that may not benefit them directly but may lead to improved treatments down the line.

"Patients are very altruistic and very keen on seeing something good come out of their participation; however, often, they aren't aware of which trials are going on. This may change though with increasing use of the internet," says Davie.

A 2001 Harris Interactive survey supports these comments, finding that 85% of cancer patients were either unaware or unsure that participation in a clinical trial was an option. The study revealed that a large number of patients were never told about enrolling in a clinical trial. Had they known, 75% said they would have enrolled, indicating there is potential to increase patients' participation in new research.

Technological tactics

Using the internet as an aid to boost patient participation in trials is a relatively new idea, but is increasingly being recognised as a valuable tool. Given that more and more patients are now turning to the internet to look for health and medical information, it would seem logical to assume that patients wishing to enter a clinical trial may look there for relevant information.

Robert Tufel, executive director of The National Brain Tumor Foundation, a non-profit US organisation, believes the internet could be a valuable educational and recruitment tool.

"The internet can help alert patients when clinical trials are looking to recruit patients and help educate them about the clinical trial process. It can also be used by patients as a way to locate clinical trials and find out if they are eligible," he says.

An added benefit is that patients can peruse information at their leisure without having to worry about having to absorb everything their doctors tell them before they leave the consulting room. The internet offers the opportunity of reaching a greater number and variety of patients than is currently being reached by SMOs, individual consultants and their practices.

"The informed component of informed consent is key to successful patient recruitment," says Dr Jones.

"Using the internet and other technologies, such as interactive CDs, the patient can listen, see pictures, seek information, ask questions and be fully informed about their participation in the trial. Higher levels of understanding create greater trust and commitment, which ultimately leads to trial success."

The web can also be used by patients as a way to locate clinical trials and find out if they are eligible. An additional advantage of web-based patient recruitment is that websites have more freedom to discuss a clinical trial than traditional avenues and often there are forums where patients can discuss concerns and issues with other patients.

The use of the internet to support patient recruitment into trials is not yet a reality in Europe. Ultimately, internet recruitment will probably become a routine part of the clinical research tool kit and there are already a number of websites in the UK designed to recruit patients.

According to IBM Business Solutions, the internet could have a further role to play in improving the timeliness of patient recruitment. Pharmaceutical companies are currently experimenting with disease specific websites that enable people suffering from a disease to register their interest in trial participation.

Additionally, competitive recruitment with tables posted on a website is ensuring that investigators are motivated to recruit patients to a deadline, or miss out on the opportunity as others run more successful recruitment programmes.

Despite a clear role for the internet and its ability to reach a wide number of people, for older patients it is often inaccessible. This is one reason why internet recruitment hasn't taken off as quickly as it might have - older age groups (who form the largest proportion of the population for most clinical trials) do not have access to it. Although this is gradually changing, it remains to be seen whether the internet will be used as a recruitment tool or simply as a means of educating patients about clinical trials and what they involve.

Providing reassurance

A lack of awareness of clinical trials is not the only reason limiting patient recruitment. A study published in Health Technology Assessment in 1999, set out to identify factors that limit the quality, number and progress of randomised controlled trials.

When the authors investigated the factors inhibiting patient recruitment, they found that barriers to patient participation included:  

  • High numbers of appointments necessary
  • Time constraints
  • Hospital stays
  • Concern about the discomfort of treatment
  • Fear of experimentation

The 2001 Harris Interactive Study found that 16% of cancer patients interviewed knew about clinical trials for their illness, but were scared to participate in them. The reasons they gave suggest they may have been misinformed about what might happen to them during the trial.

Tufel believes that a major factor inhibiting patient recruitment is fear of the unknown.

"There is a fear of being an experimental test subject, especially if the patient lacks knowledge about the specifics of the drug or the clinical trial process. They also fear that they will be receiving a placebo. Although this does not occur with brain tumour clinical trials, it may happen in trials dealing with non life-threatening diseases," he says.

Addressing patient fears and providing support is incumbent on doctors but Khosrow believes that pharmaceutical companies have a responsibility to provide information. "Companies can help in the recruitment process by providing information, for example, in the form of booklets and brochures, especially important when a patient has fears," she says.

Sharing information

A need for information in order to reassure and educate potential clinical trial candidates has prompted consumers in NHS Research to commission the Health Services Research Unit to assess the types of information that are important to potential trial participants and appraise the ways in which that information could be provided.

This will help develop a publicly available resource containing information about ongoing clinical trials designed for use by potential participants.

The study revealed that when considering information about trials, people want to know about:  

  • the quality of the trials     
  • interventions being compared  
  • what participation would mean for them personally

People also revealed that they would prefer to have access to someone to discuss their potential involvement in a particular trial. There was also widespread desire for a guide to help people self appraise aspects of a clinical trial.

It appears that patients not only want information before a trial, but also once the trial is completed.

Speaking at a seminar, Current Issues in Clinical Trials, held by the ABPI, Dr Robert Meadowcroft, director of policy, research and information at the Parkinson's Disease Society, said that lack of feedback could put some patients off.

"A lack of feedback to participants about trials is a frequent issue - they want to know what the end date is, where the results will be published, what the outcomes were, etc," said Meadowcroft.

Led by moves at Bayer and GlaxoSmithKline last year, it seems that the industry is at last responding to this need and planning to place more information about clinical trials in the public domain.

Creative solutions

Despite the depressing statistics associated with patient recruitment, the finding that patients are at least motivated to get involved and are likely to become more aware of potential trials thanks to the internet, means that clinical trial sponsors can afford to be more optimistic. However, creative efforts to boost patient recruitment are still needed.

"I believe it is incumbent upon both medical institutions and patient organizations to find creative ways to increase participation in clinical trials so that we can see real advances in cancer treatment.

"Also, clinical trial sponsors should take a tip from paediatric trials, which have a much better participation rate than adult clinical trials. This can serve as a model for medical professionals looking to increase adult participation," says Tufel.

 

 

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