The clinical trial process is most successful when all of the stakeholders involved work together toward a common good. Yet too often, individual experts become so acutely focused on their own tasks that they lose sight of the broader goals. This can ultimately add time, cost and risk to the trial process.
In honor of International Clinical Trials Day on May 20, we as an industry should take a more holistic look at the entire clinical trial lifecycle and how it positively or negatively impacts stakeholders. When researchers engage the broader stakeholder community in clinical trials from the beginning, they can speed the trial process and ensure it is a positive experience for all of those involved. By breaking down some of the barriers in a clinical trial, they can conduct a more effective study while minimizing the risk of patient attrition and lost recruitment opportunities.
Consider these recommendations to drive stronger connections and create a more effective study:
- When designing your trial, think about how you can minimize negative impact on the patients’ productivity and quality of life. Consider if the time commitment will affect their job and family life, whether treatment steps will cause undue suffering and if the trial could have financial implications related to missed work, or increased costs related to childcare or travel. To gain this perspective, you will need to talk to the patients themselves, as well as their families, physicians, social workers and anyone else who can offer a unique view of target population or the care cycle for this disease.
- Support patient advocacy groups. Patient advocacy groups are important constituents in the clinical trial stakeholder community because they can determine whether the community pays attention to your scientific efforts. To make the most of these groups, researchers should engage with advocacy groups well before the trial starts to build awareness of their efforts, get their input on the best way to connect with patients and provide them with information and resources to educate their members about your research. The more connected you are with these groups, the more likely you are to find the right recruits for your trial.
- Consider how you can incorporate the general practitioner into your clinical trial. One of the main reasons practicing physicians don’t want to get involved in recruiting for other clinical trials is the fear that they will lose those patients – and, as a result, the revenue that they generate. This is a counterproductive move, as these practicing physicians are one of the best resources for identifying clinical trial candidates at precisely the right time in their disease cycle. Consider bringing them on as a sub-investigator and other approaches that would incorporate them into the trial process. For example, you might have patients do all of their follow-up visits with their local doctor as part of the treatment protocol. This gives the physician confidence that the patient will stay engaged with their practice, and can make it easier for the patient and the clinical trial staff to complete these treatment tasks.
- Build social networks for physicians. These networks give physicians an opportunity to connect with treating physicians and other experts in their field where they can share ideas and best practices, and build long-term relationships that can lead to recruiting benefits later on. At Quintiles, we recently launched a LinkedIn group called Physician2Physician, which provides a forum for clinical researchers to discuss successes, challenges, and ideas as it relates to conducting clinical trials. Our hope is that this forum will generate ideas and conversations to help change the way clinical trials are conducted and foster new relationships with fellow Investigators.
If researchers want to reduce the time and cost of their trials and improve the patient experience, they need to break down barriers and ensure everyone involved is focused on achieving common goals. Such efforts will help them eliminate risks and improve outcomes.