Patient recruitment is mandatory for all phases of clinical trials, yet it’s often treated like a distant afterthought. Patient recruitment delays are the main reason why clinical trials fail to complete on time. CW Weekly cited results from research conducted by Cutting Edge Information that an estimated 80% of trials fail to meet enrollment timelines, with as many as 50% of research trial sites enrolling one or no patients. These factors can cause a trial sponsor to lose millions of dollars by having to extend study timelines—subsequently delaying the drug’s regulatory clearance and greatly impacting sales.
The top barriers: communication and regulatory affairs
With dozens of clinical trials behind us, the top factors that we see contributing to patient recruitment challenges are communication and regulatory affairs.
Communicating with hundreds and sometimes thousands of stakeholders and patients on a global scale is time consuming and very detailed. It is an ongoing effort with demanding deadlines and requirements. Study Sites— approved research centers responsible for implementing the trial’s study protocol—retain the responsibility to communicate not only with their current patient population, but also with potential study participants. Site personnel who are tasked with overseeing patient recruitment communication make use of a variety of online and offline materials to create awareness, open dialogues, and build a sense of commitment with potential and existing trial participants. However, usage issues can arise with patient recruitment materials because the materials may have not been created by individuals with life sciences expertise. With that, they fall short on impact and relevance and will not be used, negatively impacting enrollment. Life science training and expertise is truly needed to fully engage the patient population on a global scale. For example, the graphic design of recruitment materials may not resonate with all potential patients. What seems appropriate and acceptable in North America may offend or alienate potential patients in China or Africa, for instance. In addition, text created for patient recruitment materials is often developed in English and subsequently translated for in-country use. When the text is improperly translated, the intended meaning can be lost and the recruitment materials become ineffective.
To further illustrate the impact of poor communications, a recent poll cited that patients were never made aware of a clinical trial which would have been an ideal match for their particular condition, despite the fact that their primary physician was serving as the Principal Investigator. How could well-developed patient communications have turned this scenario around and have supported stronger patient recruitment outcomes?
Poor communication between the CROs, Sites, and Sponsors can also lead to poor recruitment results. Oftentimes, desirable sites indicate that they are involved in too many clinical trials. This impacts the time and attention they can spend recruiting study participants for any given protocol. Poor communication leads to time wasted, money lost, and ineffective patient recruitment. Developing a well-thought-out global communication plan which includes a global patient recruitment strategy at the outset is imperative to the overall success of a global clinical trial.
Each country has varying regulatory requirements and approval timelines that determine how quickly a Site can be activated and start enrolling study participants. Historically, Sites in different countries don’t start patient recruitment activities at the same time. CROs are typically entrusted with facilitating regulatory affairs activities on behalf of the Sponsor. This is challenging because in a global clinical trial, a CRO is responsible for facilitating regulatory approvals and site activations in multiple countries for 30, 50, or sometimes over 100 sites. In an ever-changing regulatory environment, it is very challenging to be fully aware of each country’s regulatory requirement, especially when most CROs do not have in-country regulatory affairs professionals with in-depth knowledge of the country’s regulations. If a regulatory submission is not done correctly and is subsequently rejected by the local Ethics Committee or Regulatory Authority, the overall study recruitment timeline can be adversely affected. The longer a Site is inactive, the less likely they will be able to recruit a single patient into the clinical trial. Being aware of and communicating each country’s regulatory requirements at the onset of a clinical trial is important to streamlining Site activations and ultimately improving patient recruitment activities.
A better way to overcoming global recruitment challenges
Lionbridge Life Sciences has a dedicated network of in-country experts who are knowledgeable in all phases of clinical research, particularly patient communication and regulatory affairs requirements. These in-country experts include:
- Clinical translators
- Medical reviewers
- Regulatory affairs experts
Partnering with Lionbridge Life Sciences can quickly alleviate many of the challenges associated with patient recruitment, helping you achieve efficient and strong study enrollment. To learn more, download our webinar on Global Patient Recruitment and Retention Strategies.