by Jennifer Landis
Clinical trials offer patients the opportunity to contribute to the development and approval of new therapies, drugs, treatments and medical devices. This research has the potential to improve the participating patient’s quality of life. In fact, recent advancements in the health care field over the past few decades can be attributed to clinical trial testing.
The vast patient benefits of participating in clinical trials include contributing to new research, access to the latest medical developments and positive effects on patient well-being. Despite this, clinical trials have struggled to recruit their target number of participants, with many recent studies failing to reach 33 percent of their original recruitment goal.
Patients decline to participate in clinical trials due to personal inconvenience and concerns with protocol, including using treatment methods unapproved by the FDA and conflicts with the research process. The development of programs that are focused more on patients rather than on statistical outcomes could increase the success of future programs.
Program Improvements
Clinical trials aren’t without fault. Improper reporting, misinterpreted outcomes, misleading reports and lost data are several of the items that skew trial results and occasionally render them unusable. Researchers can minimize these pitfalls by paying careful attention to detail, performing objective data analysis and reporting all trial results.
To encourage additional patient participation, trial administrators can work to develop programs specific to the outcomes relevant to patients in addition to clinician-reported outcomes. In the past, outcomes important to patients, such as death or outcomes, were considered to be of little value to completed studies or not reported at all.
Patient outcomes of interest include life expectancy, how they feel and how they function on a daily basis. Studies that share these metrics, as well as the symptoms and side effects experienced by participants, will garner more interest and be of more value to individuals suffering from the disease.
For successful trials to continue, qualified patients of all ages and backgrounds need to participate. A diverse trial group stands the best chance at representing the population that will be using the tested treatment options or devices.
Reduce Failure Rates
Approximately 50 percent of Phase III clinical trials fail by not exhibiting effective treatment outcomes, having severe or unexpected side effects or by not proving to be financially beneficial. Nearly 70 percent of Phase II clinical trials fail, though this is expected as these trials are in a more preliminary stage.
Patients who participate in Phase III trials are typically in late-stage conditions. These patients may have exhausted other treatments or have limited time available to find a successful option. Failed trials put them at risk for emotional distress and decreased quality of life.
The failure rate for Phase III trials can be reduced by defining specific protocol earlier on in the testing process, before beginning Phase II trials. A clear path forward during testing will reduce the number of treatment options that move to Phase III trials. This may increase the success rate of clinical trials and increase patient interest and involvement.
Future Possibilities
Remote clinical trials offer patients and clinicians a flexible option for participating in and conducting new research. Patients living in rural communities or patients that have difficulty commuting to a research facility have the option of participating in studies that otherwise might not have been available to them. Remote trials can solve the problem of patient participation as a larger audience can be reached.
Clinicians can ensure the integrity of trials by directing patients to one central location where specific protocols can be followed. Researchers can then work together to analyze and track the patient data being provided in one area. This reduces the potential for lost data or information being left out of analysis.
New apps have been developed that enable communications between patients and physicians directly. Patients can also track and record their progress through these apps and share this information with physicians through the app. This lessens the financial burden on patients as the number of visits to the clinical trial center and travel costs are reduced.
Registered reports are a new method to ensure clinical trial information is shared regardless of the outcome. In the first stage, the clinical trial process is peer-reviewed and sent back for revisions, if necessary. Once the protocol is accepted, the journal agrees to publish the results of the study regardless of the outcomes. This removes pressure for clinicians to leave out negative results and promotes trust among participants, since reviewed and defined processes will be followed.
Clinical trials are necessary to continue to make advancements in medical treatments. Reviewed, established protocol before beginning trials can ensure a higher success rate. This, along with a more patient-centric approach and remote trial options, can increase the number of participants.
Jennifer Landis is a freelance writer and healthy living blogger. She drinks tea in excess, has a collection of peanut butters, and is a super nerd at heart. Read more from Jennifer on her blog, Mindfulness Mama.
Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.