Clinical trials contribute greatly to improving the knowledge on diseases, treatment, and overall quality of life. However, in order to obtain valid and reliable results, such trials depend on the successful enrollment of participants. Although investigations into new cancer treatments have grown, researchers lack finding patients to participant in cancer trials. On average, phase I, II, and III trials take 30% longer to conduct due to low patient enrollment and retention. This is partly due to the nature of the treatments, which may be effective only in specific patients and also partly due to companies rushing to push potential new cancer drugs on the market.
Currently, there are more than 1,000 ongoing immunotherapy trials and the number keeps growing by day. For this reason, ample patient enrollment is important for patient retention, resulting in a conclusive patient data. However, patients cannot be retained without the help of researchers, physicians, and planned strategies. Increasing patient enrollment and retention rates is key to successful clinical trials in the future, as well as healthcare advancements. This being said, what are the greatest challenges that both researchers and physicians, such as you, face?
- Not being well prepared
Every clinical trial needs a proper patient enrollment plan that fits well within the researchers’ budget and duration. It is not enough to simply create and submit templates. Recruitment materials must be prepared in advance, reviewed thoroughly, and most important, they must be customizable. Moreover, promotion of these materials is paramount. Establishing an online presence will help patients to find answers to their questions and concerns. In turn, they will be more open to enrollment.
- Poor recruitment materials
Patients will always fear being “guinea pigs”. This is a result of a lack of patient awareness. As researchers, knowing why patients do and do not enroll in clinical trials is important to understand. Recruitment materials must reflect the actual intent of the study in order for patients to be motivated to participate. In fact, reports show that most patients who choose to participate in clinical trials do so to help advance medicine. This being said, recruitment materials must be presented in an honest way and one that is easy to understand. Furthermore, the tone should target the right individual using the right channel.
- Complicated rules and regulations
Regardless of how well designed and colorful recruitment materials may be, if the rules and regulations related to the procedure prove to be complex, the study will lack in patient population. With numerous requirements, most patients often give up because they do not fit the criteria – or at least, they think they don’t. Two significant aspects must be put into order: first and foremost, recruitment materials must be presented in a clear and concise way and secondly, a screening process should be established. By incorporating patients’ perspective, researchers are most likely to reach out to available patient population and anticipate enrollment.
- Lack of new methods of recruitment
Nowadays, advancement in technology has made a tremendous impact on several sectors, including healthcare. In an industry that is constantly looking to grow in research and findings, knowing what methods of recruitment to use is likely to grow potential for patient enrollment. The fact is that what was effective several years ago may not be as effective today. For this reason, being on top of new channels and modern approaches raises new opportunities to reach out to patients.
So how can researchers and physicians improve recruitment and target the patient population?
- Establishing an online presence
Establishing an online presence will not only help provide more detailed information about clinical trials in general, but it will also provide specific details on particular studies being conducted. By using the internet and several social media channels, standards of patient care are clarified and patient enrollment is improved.
- Promoting the benefits of participating in a clinical trial
By establishing marketing initiatives, participation can be encouraged. Patients need to understand the benefits of participating in a clinical trial, whether it is to help advance medicine or better their own conditions. By understanding their role in healthcare, they are likely to contribute to medical research and probable advancements.
- Increasing physician and patient awareness
Currently, one of the main challenges in current clinical trials is lack of patient awareness. In a recent study, over 80% of patients felt entirely oblivious to the fact that they could participate in a clinical trial as part of their treatment plan. Therefore, increasing both patient and physician awareness needs to be done through constant communication, open access, and collaboration.
Deciding to take part in a clinical trial is a rather complex and uneasy decision to make. For most patients, a clinical trial may be the best treatment option available, while for others, it is a chance to volunteer and progress studies that may benefit future patients with cancer. This helps a lot of individuals feel that they are making a difference in the world. Nowadays, every cancer treatment available, for both children and adults, is a direct result of clinical research. As a physician, you rely on clinical trials and so it is your job to help patients decide if they want to participate in them. You can do so by:
- Informing your patients what types of clinical trials are being conducted and how they are performed;
- Talking with your patients about which clinical trials are right for them;
- Discussing with your patients the risks and benefits associated with a particular clinical trial;
- Answering any questions or concerns your patients may have
Furthermore, participating in a clinical trial always has its benefits and risk. Some patients may feel there are too many risks involved, while others may feel that the benefits outweigh the risks. It is imperative that you discuss with your patients how participating in a clinical trial can help them to:
- Contribute to medical research and advancements;
- Improve knowledge of early detection, screening, diagnosis, treatment, and prevention of cancer;
- Gain access to new treatments that have not yet been made publicly available;
- Receive high quality medical care at leading health care facilities;
- Receive treatment that may be free or at low cost;
- Take on an active role in their own care;
- Continue check-ups on a regular basis, thus leading to better health
And the potential risks involved:
- Some medications and treatments may trigger side effects;
- The clinical trial may require longer duration, hospital stay, and doctor visits;
- The clinical trial may require undergoing addition treatments;
- The treatment may prove to be ineffective;
- The treatment may not be available right away following the end of the clinical trial;
- Some health insurances may not cover all costs related to clinical trial participation
Patient enrollment is one of the greatest challenges facing clinical trials today. Lack of patient population adds to costly and prolonged delays that can be seen in all phases of clinical research. Each clinical trial goes through several phases, mainly three, and each in its own way presents different hardships. In phase I, clinical trials find it difficult to recruit patients who are healthy and determined to make an immense impact on medical advancements. In phase II, clinical trials face similar recruitment issues but more relating to patient retention, due to unexpected or additional treatments. In phase III, the challenge lies in recruiting ill patients. Most ill patients have a hard enough time dealing with their conditions that they would rather focus on getting better than participating in an unpredictable research study.
Clinical trials are paramount to the healthcare industry. They help to move it forward and advancement in clinical trial participation has the potential to improve the lives of millions of patients. It is imperative that patient enrollment and retention strategies are created and put into practice so that clinical trial participation can grow. With such growth, new treatments can be developed and the future of medicine can be enhanced.