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Viagra volunteer shortage effect is delaying clinical trial completions

Datamonitor : 22 July, 2008  (Special Report)
Viagra, Avastin or Lipitor were all required to complete clinical drug trials before they could be released on the market and the trials for these types of drugs and their next generation equivalents are showing signs of taking longer than expected to be completed.
CLINICAL TRIAL RECRUITMENT A Prohealthservicezone Special Report

The reality is that about ninety percent of trials are delayed. The majority of these delays are attributed to patient recruitment problems. Patient recruitment takes longer than any other step of a clinical trial and the public perception of the clinical trial process and pharmaceutical industry on the whole is largely very negative.

Every extra day spent in clinical trials dents the pharmaceutical company’s profits from $600,000 to $8 million. Patient recruitment and retention remains a challenge for any pharmaceutical company who wants to prevent costly bottlenecks in drug development.

A new report by independent market analyst Datamonitor entitled 'eHealthInsight Series: Online Patient Recruitment Strategies - Optimizing the clinical trial process' describes how the internet is proving to be a useful tool to streamline the patient selection process.

The patient recruitment hurdle is a two-fold problem: on the one hand the public has a poor perception of the clinical trial process, and on the other, clinical trials are becoming more and more complex. Ultimately, the combination can only discourage potential patients from participating in research.

The increasing number and size of trials in the last decade has affected recruitment numbers. The growing complexity of protocols has reduced the rates of patient recruitment and retention. Like a domino effect, this translates into delays, increases in costs for the study and can even mean losing a first-to-market position for a drug candidate, which can in turn cost a drug manufacturer millions in revenue over the lifecycle of the drug. Considering thousands of patients are needed for just one study, this is a costly stage and one which is extremely prone to delays.

Overall, the pharma industry does not enjoy a good reputation in the eyes of the general public. Extensive media coverage of drug withdrawals and deaths of study volunteers have left the public sceptical about the pharma industry as a whole. Controversial books on the subject have been widely publicized and volunteers have been routinely labelled as 'guinea pigs'.

This perception fails to acknowledge that the study volunteers have given their consent to participate and are free to withdraw at any time. Datamonitor pharmaceutical analyst ,Maura Musciacco said: 'Due to this ill-informed portrayal, patients are reluctant to participate in clinical trials. It is concerning that $500m is spent annually on mass media patient recruitment advertising and promotion, yet less than 15 percent of the public have a basic understanding of clinical research' (Ref 1).

'If the general awareness and education are improved, more people are likely to participate in trials,' Musciacco explained.

In order to tackle the public's distrust, a radical change is needed one that would target the masses. Advertising has proved successful with many brands and campaigns, and now this has been applied to 'rebrand' clinical trials. Since 2006, a large-scale educational campaign called 'Everyday Heroes' was launched in the USA. This was done to send the message that participating in clinical trials is a good and noble thing to do, in addition to changing the image of the people who volunteer from 'guinea pig' to 'hero'. Although the purpose of this campaign is not to recruit patients directly, Eli Lilly has found that running this advert together with its recruitment adverts has generated more than 35 percent improvement in monthly enrolees (Ref 2).

In order to overcome delays, an increasing number of pharmaceutical companies are using the internet at all stages of the clinical trial process, including for patient recruitment and retention.

Traditionally patients are recruited through their doctor, who can advise patients and can influence their decision thanks to the rapport they have built with the patient. Recruitment through media is common as well, whether television, radio, billboards or newspapers. However, this is the most expensive route and one which can provide limited educational material.

This is where online recruitment shines. As it has minimal costs, the internet can provide substantial cost savings. With internet penetration booming, websites can reach populations all over the world at a remarkable rate. The point of web-based tools is that it offers a targeted and on-demand service. Research has shown that surfers tend to be more interested in clinical trials than those viewing posters in the clinic.

Musciacco said: 'We can probably all identify with this. How many times have we searched for symptoms of our latest itch, or even for family and friends? The Googling phenomenon is spreading like an epidemic and it is certainly even more utilized by patients with chronic diseases who may have exhausted all treatment options.'

'Websites can also provide more information, so as to educate the patients and allow them to make a more informed decision, and whether they decide to participate or not, they have learned about the new treatment.'

The main barrier in utilizing the internet for recruitment is that often patients do not know where to look for information. This can confuse and frustrate the patient, leading them to give up their search. To overcome this, websites must be user-friendly, with complete and up-to-date information that can be understood by the general public.

Specialists in the field of patient recruitment talk about a more 'patient-centric' approach for the attraction and recruitment of volunteers. This is the Holy Grail said Musciacco. 'By placing the patient first, they will feel a valued member of the study, thus preventing them from dropping out before the trial is completed. Patient retention is the very last phase of the recruitment process, one which is often overlooked, but if more focus is placed on it, it will save companies a lot of money.'

To make sure patients stick to the protocol until the end of the study, it is necessary to motivate them. When designing an online recruitment strategy it is crucial to take into consideration the patients' needs, maintain a two-way communication, ensure the transparency of the project even after it has finished, and keep pushing for awareness and education. Last but not least; keep patients informed to foster commitment and compliance to a trial.

As the scope and size of clinical trials increase, demand for patients rises and competition for volunteers becomes tougher. It is not only important to recruit and retain enough patients, it is equally important to target the right ones. This is where online recruitment comes in handy thanks to its targeted approach, Musciacco said: 'However, it must be kept in mind that it is the synergy of all methods (doctor, media and internet) which will ultimately increase patient enrolment.'

'Although only 20 percent of patients are currently recruited through the internet, online recruitment will escalate as patients are becoming more proactive and the increasing internet penetration aids in spreading information. Nevertheless, pharmaceutical companies should start their recruitment as early as possible and must increase their promotion in order to boost patient awareness.'

Ref 1 - Getz, K A Sergeant, E Kremidas, J 2007

Ref 2 - Getz, K A Sergeant, E Kremidas, J 2008
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