Winning the race

Sponsor companies need to get creative with communications programmes if they want to solve the patient recruitment dilemma

Competitive processes and the need for greater transparency of the pharmaceutical industry are forcing companies to streamline practices in clinical development more than ever before.

Every additional day spent in clinical development equates to one less day of patent-protected commercial life (figure 1).

To stay ahead of the competition pharmaceutical companies must realise the importance and benefits of optimising clinical development.

Scenario a: Clinical development completed on time: Greater time-to-patent-end maximises revenues.

Scenario b: Delays in clinical development: Reduced time-to-patent-end means less revenues.

Indeed, a CentreWatch Europe survey revealed that in 40 per cent of clinical studies, missing patient recruitment and retention targets was the most frequent cause for delays. This led to additional study costs as well as lost revenue. So what techniques can be used to help prevent companies from incurring such costs and delays with patient recruitment and retention?

Lagging behind

Pharma fully understands the role of marketing communications and advertising in the post-launch phase to raise awareness and educate consumers about their product. However, when translating this role to the clinical development arena, European and other markets lag some way behind their American counterparts.

Patient recruitment communications campaigns have been implemented at a late stage if at all outside the US. However, it is becoming more usual for pharma companies to recognise the value of implementing these campaigns earlier.

This change follows the launch, and gradual implementation of the EU Directive (Directive 2001/20/EC), which was effective from May 2004. It was designed to provide guidance on good clinical practice and harmonisation in the conduct of clinical trials. It also has implications for those involved in the patient recruitment process. The guidelines have provided a platform for progressive clinical teams on which to base their recruitment plans. They also provide an opportunity to consider marketing tools as an effective and legal method of patient recruitment within Europe and beyond.

Solving the dilemma

Trends in clinical development are moving towards centralised, global studies, enabling a consistent communications message in all countries. However, this approach to recruitment may not suit everyone, so it is important to consider the opinions and expertise of the study sites. These can often be empowered with responsibility for meeting 100 per cent of the recruitment target, but to achieve this target it is necessary to understand more than the clinical development environment.

Selecting the appropriate tactics is more than just guesswork, and a vital part of ensuring the success of a campaign. It takes experience and understanding of patient communications, as well as the clinical development environment.

There is also the ever-changing regulatory environment to consider if you want to devise an appropriate, approvable and successful campaign. Time is needed to gain understanding of the dynamics of the target population; typical patient presentation, demographics and psychographics, motivating factors and cultural sensitivities, are all vital. Taking all of these factors into account, the most appropriate country-led approach can be devised.

Raising the profile

A communications campaign may consist of all parts of the marketing mix or a combination of tactics. The materials may not only be directed to the patient, but also to family, friends, carers and healthcare professionals, to help raise the profile of the study among the referral network. Media relations activities and liaison with patient support groups is also important here, whilst also improving awareness and understanding of the condition. A successful media relations campaign can dramatically reduce the cost of recruitment efforts, replacing premium media spend with the cost of establishing and coordinating media visibility and interviews.

Patient education is vital and can often tie in with the use of the Internet in patient recruitment and retention. Proactive information seekers can be informed about the study through a study-specific website. Such websites can be useful as they are a relatively private medium for patients wishing to find out more information about their condition.

Experienced communications professionals will also recognise the role of the investigator in the overall recruitment campaign. Communications strategies are designed to complement and not replace site-led recruitment efforts. Clinical trial recruitment can significantly benefit from activities to improve site relations. Keeping the study in the front of the investigator's mind is especially important for studies of long duration or if there is a considerable time lapse between site visits and activities. Improving site relations and coordinator motivation can go a long way to improving site efficiencies and ensuring work is carried out to Good Clinical Practice.

Changing tactics

With a combination of these tactics, patient recruitment targets stand a significantly higher chance of being met. Tactics have moved on from blanket advertising in major publications to a more sophisticated approach. Communications service providers must now provide evidence of the theory behind the proposed strategy, with accurate modelling of patient responses versus recruitment targets. Not only does this provide justification of the approach and also the required budget, it also gives study teams a clearer idea of resources required to implement the strategy.

Besides this, the communications strategy can be optimised in a relatively short time with real-time analysis of recruitment rates, site performance and media efficiencies. This will maximise the effectiveness of the campaign and minimise the cost per patient.

The role of communications campaigns in patient recruitment and retention has moved a long way from the 'single-club' approaches. There are many tactics to consider, liaison with study sites, additional science as well as more expertise. If sponsor companies want to reap the benefits of such an approach, they will need to consider pushing their boundaries and be creative in their thinking to win the clinical study race.

Author
Penny Westmacott, Defacto Communications