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Putting Intriguing Ideas to Work

At a time when more and more clinical operations managers are saying ‘Yes!’ to daring new ideas for improving study efficiencies, the industry is learning that successfully operationalising and distributing those great ideas often presents the greatest challenge

The pharmaceutical and healthcare industry is endlessly fascinating. It has been responsible for some of humanity’s most astonishing and important breakthroughs, and continues to offer new possibilities with even greater promise just beyond the horizon. It is filled with some of the world’s brightest minds that have dedicated themselves to finding new solutions to previously unsolved health problems – to achieving what others may have thought impossible (or at the very least, quite maddeningly difficult).

It is an industry driven by innovation. Years of meticulous planning and testing. Trial and error. Success and failure. As a patient recruitment and retention specialist, this roadmap to innovation is one that is very familiar to me. However, until very recently, the application of innovative ideas in patient recruitment was often underappreciated throughout the industry.

For years, sponsors and clinical operations managers were hesitant to explore new ways of reaching out to patients about clinical trial participation. New platforms for patient engagement, such as direct-to-patient advertising or dedicated study websites, were viewed as impractical or unnecessary. Today, the industry increasingly finds itself involved in fierce internal battles to quickly find more and more of the ‘right’ patients. This has led to an increased desire to develop bold innovations, efficiencies and pilot programmes that can benefit not just patients, but all parties in the clinical trial experience. Yet what is frequently forgotten in the afterglow of racing to bring these new ideas to light is often the most critical and challenging piece of the puzzle: creating a platform to successfully operationalise and distribute these innovations.

Expect the Unexpected

Introducing a new patient recruitment initiative is a complex and delicate process. Sharing your vision of the programme with the study community is bound to generate a number of questions and comments from just about everyone involved – from senior management to site personnel. Although not every question will have an immediate and satisfying answer, understanding the types of questions being asked can help you identify and address potential programme deficiencies in advance.

Several years ago, while supporting a clinical trial for head and neck cancers, the sponsor was interested in establishing an integrated social media study awareness campaign on Facebook, a completely new idea at the time. The campaign also presented a unique challenge: the possibility of study participants visiting the website and unblinding themselves through online postings.

If patients could unblind themselves, what else might they share on the site? Every possible outcome spawned half a dozen more. Quickly, we came to understand the larger issue and its solution: the need to limit communication functionalities. So the question became: how do you promote study awareness on a social media website when you can’t risk the patients communicating with each other?

The answer was to lock down the page to comments and populate it with ethics committee-approved (EC) messaging that rotated on a weekly basis. The content provided patients with information about cancers in the head and neck region, online support groups, motivational messaging, and links to the official study website. It required planning out nearly a year’s worth of messaging in advance of its launch, and a detailed action plan in the event of future core functionality changes to the website that could affect our ability to control it.

This required close cooperation with ECs as there were no established guidelines for advertising through social media. Rather than base our strategy and tactics around what we thought an EC would or would not allow, we proactively engaged the EC over several weeks to explain the programme in detail, including our rationale based on best recruitment practices. The result was a programme without precedent – but one that helped to establish social media best practices within the regulatory community.

Getting the Word Out

From the outset, effective communication with study personnel about the implementation of such a programme will be critical to its adoption and future success:

  • Define the purpose, benefits, and goals of the programme
  • Clearly communicate why this new programme is necessary for recruitment success
  • Identify the recruitment challenges that it is specifically meant to address
  • Share why you believe the programme will ultimately make the process easier and more efficient
  • Identify roles and responsibilities within the programme
  • Assign personnel/departments who will help oversee key programme infrastructures (for example, technology, communications, logistics)
  • Be clear as to what you expect from each user from a programme implementation and proficiency standpoint
  • Create a contingency plan that will address user non-compliance
  • Offer programme assistance
  • Create comprehensive training materials and programme support services that are readily accessible on-site
  • Schedule programme refresher sessions to review the programme to date and update users on any recent changes/upgrades
  • Appoint dedicated programme personnel who will be responsible for training new personnel
  • Proactively seek feedback
  • Reach out frequently to evaluate how the programme is working
  • Ask questions that identify and address not only current programme functionalities, but also additional functionalities that could be implemented
  • Never stop improving: schedule regular meetings with managing departments to discuss timelines for implementing programme upgrades

Incremental Improvements

Innovation doesn’t always have to mean coming up with a shiny new idea. In fact, the best innovations often involve minor improvements to established practices that have the ability to yield greater efficiencies. It is about incremental improvements, and as clinical research professionals, we all know this. Incremental improvements are the foundation of advancements in the healthcare industry. So where can we apply the practice of incremental improvement in order to benefit study enrolment?

Since the beginning of clinical research, getting study participants to attend all of their scheduled study visits has been a source of frustration. Study participants who lack transportation, experience chronic mobility issues, or suffer from cognitive impairment are far more likely to miss a study visit. To compensate, study sites may offer cash or vouchers for patients to secure their own transportation services. However, this places an increased burden on site staff to maintain, track and distribute these funds. This system can also negatively affect patients who may be forced to make inconvenient travel plans based on public or private transportation schedules.

One way in which clinical trial companies can overcome this retention barrier for sponsors is to allow study staff to schedule and manage reliable, private transportation for study participants who are unable or prefer not to drive themselves to and from study visits. Through a pre-arranged payment system linking individual participants and study visits, it is possible to eliminate the need for sites to commit their own funds for patient travel services. By improving the study visit experience through programmes like this, companies can make a significant impact on those studies where patient retention is of paramount importance.

Ask the Experts

One of the best ways to operationalise a new process or programme is by tapping into existing resources, including those outside the clinical research community. One method of doing this is through working with patient advocacy groups.

Patients think of these groups as ‘experts’ because they are often formed and led by actual patients who live each day with the condition. These groups are dedicated to improving the patient experience. They keep up with and share the latest news and information about treatment options, have a unique understanding of the daily challenges that patients face in managing their condition, and have no shortage of opinions on ways to improve treatment.

Clinical research studies can greatly benefit from the insights and abilities of these advocacy groups. Not only are they a great resource for gaining insights into the patient mind frame when developing a new protocol, but they also have an established infrastructure of online tools and resource materials for patient recruitment purposes.

Let’s consider another example: a clinical trial for Tourette’s syndrome in a paediatric population. Rather than try to build an entirely new platform of recruitment materials to educate parents and children about the condition, it was suggested that study staff enlist the advice and assistance of a large Tourette’s advocacy group. This group understood the importance of clinical research and the need to develop new treatment options. They were willing to supply large amounts of educational content to study participants and their parents throughout their study participation. This content included blogs from parents, video interviews with other patients, as well as games and activities that children could perform while waiting for upcoming study visits.

Resources of this type can expand the study participation process beyond patients simply showing up to each visit and taking their study drugs. Using them demonstrates a deeper level of commitment to parents and study participants – one that rewards their time and effort with resources that enhance their overall study experience and, in turn, will have a positive effect on study compliance.

Every single thing which works began with a point at which it did not work. New medications, breakthrough surgical techniques and technological advancements are all accomplished through a varying mix of persistence, luck, setbacks and ultimate triumph.

I mention this because there is always the possibility that no matter how wonderful your patient recruitment idea, how perfect the planning and execution, things may fall short of your expectations. Call me a blister pack half-full guy, but I believe in looking at the experience in its entirety. We need to change our way of thinking about what is, and what is not, ‘successful.’ There is value in the journey.

Examining Success

In an industry where study data is carefully scrubbed and analysed for any type of perceptible trend, we frequently fail to do the same when evaluating the processes involved in patient recruitment beyond the overly simplistic: did the study enrol on time or not? Like any good analysis, equal time should be dedicated to examining those parts of the programme that yielded positive or unexpected results. This includes asking questions such as:

  • Which sites were most successful in implementing the programme? Was this due to their clinical trial experience or due to their expressed desire for such a programme?
  • Could the programme or its planning be modified to address some of its deficits? Where can the process be augmented/ scaled back to maximise return on investment?
  • Did budgetary and/or time constrictions limit the effectiveness of the programme? Did the programme have the proper levels of support it needed to be successful?
  • How did the programme respond to unforeseen challenges and obstacles? Was there a clear process for addressing problems as they arose? Were these problems accurately documented and resolved?
  • Would a smaller- or larger-scale pilot programme have been more appropriate to implement? Did you collect enough data to properly inform your decision to move forward with this programme in the future?
  • Did your colleagues excel at handling new responsibilities? Who could you entrust to run and expand upon this programme for future clinical trials?
  • Were too many people involved in making important and/or timely decisions? Were the ‘right’ people involved? New programmes often require quick, necessary changes. Was this process difficult to achieve? Did the people making these decisions fully understand the programme and the implications of the changes they were being asked to make?
  • How could this new technology be incorporated into existing or future products? What are some ways that it could be used in other areas of patient recruitment, across multiple studies, or to support recruitment in other countries?

As clinical research professionals, we’re all in the business of innovation. Some things will work out; others will fall by the wayside. It’s the operationalisation of these programmes and distribution of learning that will provide the firm foundation necessary to accomplish the next big breakthroughs in patient recruitment and retention.

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Justin Jones is a Senior Copywriter and Creative Strategist at BBK Worldwide, a marketing consultancy specialising in patient recruitment for the clinical R&D segments of the pharmaceutical, biotechnology and medical device industries. Throughout his five years of experience, he has contributed to numerous innovations in global patient recruitment, including print, electronic, and broadcast marketing initiatives, as well as mobile device app development and implementation.  

Justin Jones
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