The role communications can play in clinical trial programmes

Consistent and integrated communication with all stakeholders involved in clinical trials can help progress the trial, and may improve the likelihood of success when a brand comes to market. The following is a discussion on how pharmaceutical companies can best utilize communications around their clinical programmes.    

Clinical trial programmes provide a continuum of communications opportunities and yet these are frequently missed by pharmaceutical companies.  From explaining the initial concept right through to announcing results and beyond, communications can help ensure that companies achieve both their clinical and commercial goals.  Key to this is ensuring that marketing and clinical teams work closely together.

Clinical and marketing teams must work together
Preliminary research among investigators and their site staff will help identify potential needs and concerns.  Based on this, the company can then help address any challenges and provide resources to help investigators and their staff with the study.  Opportunities include building relationships with opinion leaders, understanding the environment, developing appropriate brand messages, preparing the publications plan and identifying potential opportunities and threats. 

Plan communications strategies early
All aspects of communications around the study should be planned from an early stage.  This includes looking at how the use of communications can help engage and train investigators, recruit and motivate patients and make the most of the results of the study with all relevant audiences.

Central to this process is the publications plan which should be developed early.  Throughout the life of a clinical trial there are numerous opportunities for publications such as review papers on the area of science, protocol papers, interim analyses and of course results. 

Investigators can be your strongest brand advocates
There is significant competition to secure the right investigators for studies and doctors have to choose carefully which studies to be involved with and with which companies to work. 

Investigators who have been involved in a clinical trial and had a positive experience are likely to be supporters of the brand when it comes to market and prescribe it themselves.  This highlights the importance of nurturing the relationship with investigators so that they evolve to become active brand advocates over time.

It is important to make sure that the experience is as positive as possible for the investigator, that their role is clear and that they are provided with the support needed. 
Preliminary research among investigators will help identify potential concerns which can then be addressed by the company. 

The value of study branding
Branding a study makes it distinct, gives it personality and potentially strengthens the link to the brand over time.  The branding of a study, or a larger trial programme, should be approached as a proper branding exercise.  Combined clinical and marketing teams should seek to shape the branding based on the positioning and messages that they wish to communicate. 

Engaging and motivating investigators
The key opportunity for engaging investigators and study co-ordinators is the kick-off meeting.  Research conducted by Axon has demonstrated that investigators frequently find these meetings tedious and may leave them feeling unenthused and often unclear on specifics.  This may impact on the study in terms of data management, speed of recruitment and, ultimately, completion.

These meetings can provide an excellent opportunity for building relationships with and motivating investigators.  The meetings should be as interactive and exciting as possible and based around challenges which participants feel are important to overcome.

Engaging and motivating patients
Each study will have its own set of challenges when it comes to the patient.  In some cases it may be difficult to recruit patients due to the rarity of the condition, or the taboo nature of the topic.  In other studies, patient retention may be the key problem.  Whatever the need, investigators and their staff require support in this area.

Patient recruitment needs to be managed carefully as there are some potential pitfalls.  Recruitment approaches may vary from highly targeted, surgery-based communications to more broad-based communications including mass media such as radio and newspaper advertising.  Activities need to be approved by the relevant ethics boards and enquiries need to be channeled in a highly professional manner. 

Keeping patients on their treatment regimen is critical for the success of any study.  Regular communication with patients can be helpful; for example, information about their condition and its treatment through websites, newsletters with helpful tips and updates on the study.

Patient organizations or patient advisory groups can play a valuable role in shaping communications to patients. 

Closely co-ordinate the release of results
The communication of clinical trial results has become a real minefield in recent years.  The interests of investigators, patients and shareholders have to be balanced.  At the same time the requirements of congresses and publications are strict. 

Generally, as a result of regulatory requirements, companies are required to share top-line data with the stockmarket first, but do keep more detailed analysis until they can be presented to investigators and the broader medical community. 

The key point is that the clinical, marketing and corporate teams all need to work together to plan the release of data carefully in a co-ordinated manner so that all stakeholders – investors, physicians, patients and the company’s own staff feel that they have been informed of the results at the right time.

Of course, all opportunities for release of data through a variety of channels should be explored working closely in conjunction with the publications planning and public relations teams.

Be transparent
The clinical trial process - and in particular the sharing of results, whether positive, neutral or negative - is under considerable scrutiny from politicians, media and investors.  The pharmaceutical industry must now plan its clinical trial process in a transparent manner.  This is appreciated by the medical profession and encourages them to work with one company over another.

In conclusion, every step in the lifecycle of a clinical trial presents opportunities for forging relationships, educating stakeholders and seeding brand messages.  By working effectively together marketing and clinical can seize these opportunities and truly make a difference when bringing a brand to market.