In the previous posts on barriers to recruiting patients for clinical trials, I addressed some of the problems that patients and clinicians face. In this final post, I will discuss some of the difficulties faced from a healthcare systems perspective, and ways in which these might be tackled.
Funding and coordination
Undoubtedly, the major barrier to healthcare organizations taking a more active role in clinical trials and recruitment of patients is funding and available human resources. This includes both limited resources at the level of healthcare facilities themselves, and a lack of funding for clinical trial research, especially from national research organizations.
Clinical trials often require a minimum number of patients to effectively assess the success of a treatment and therefore have to remain open and actively recruiting for long periods of time. This can be extremely expensive. Also, where funding is available, it still may not be sufficient to carry out clinical trials with designs that best test particular treatment modalities.
Another issue, connected to that of limited funding, is lack of resources for study coordination. It can be very difficult for healthcare organizations to identify patients that are eligible for clinical trials. Getting healthcare professionals working together to achieve patient recruitment targets is also a challenge. These issues are compounded if the facility has only a minimal infrastructure for clinical trials, or does not have a funded clinical trials coordinator.
In OncLive’s recent article, “Tackling Patient Recruitment Challenges in Clinical Trials”, Dr. Timothy Mullet, Chief, Section of General Thoracic Surgery at University of Kentucky College of Medicine, summarized the concerns, “Those in the ivory tower want us to take care of patients efficiently, and bill for it . . . there is just no way to justify the costs, so there has to be a commitment from the enterprise that they are willing to take a loss on it.”
Issues regarding insurance can be another major hurdle for healthcare systems to overcome when recruiting patients for clinical trials. While some insurers may provide adequate coverage for standard care, many may be unwilling to cover care outside of their facilities, even if they do not have appropriate treatment options available to patients. Where patients are uninsured this can also be a barrier to participation in clinical trials. It is sometimes possible to find resources to support uninsured patients care, but this will often delay their treatment for several months.
Strategies for tackling funding
So, how can these barriers to recruitment be overcome? The experts interviewed by OncLive had a number of recommendations. One point that was emphasized was the necessity to hardwire clinical trials awareness and recruitment into healthcare systems.
In terms of tackling funding issues, the experts suggested that healthcare organizations approached legislative bodies for additional funding, as well as private foundations that might be interested in supporting clinical trials. In addition to this, organizations should consider supporting different types of clinical trials, from those supported by industry, which have sufficient funding of their own, to cooperative and investigator initiated ones.
Strategies for tackling coordination
As well as tackling questions of funding, it is essential for healthcare organizations to recognize the importance of clinical trials, by providing appropriate support, personnel, office space and resources, and thus enabling them to achieve their goals. Organizations should consider the support that their clinicians can provide and the systems capacity that they have, and only carry out trials which will be both cost effective, and can be conducted responsibly and with good clinical practice.
In terms of strategies for overcoming coordination challenges, OncLive’s panel of experts had a range of long-term practices that would hugely improve healthcare systems’ ability to effectively run clinical trials. For example, healthcare leaders can encourage recruitment by initiating a dialogue with patients and communities about clinical trials, leading to positive publicity and increased awareness.
Other suggestions included adopting new technologies such as electronic medical records, combining practices to create large networks, and devising methods of monitoring performance to assess whether trial targets are being met. One recommendation that met with universal support from OncLive’s experts was the designation of a dedicated clinical trials coordinator: someone who knows which trials are available and can explain to patients how participation in trials could be of benefit to them, acting to coordinate the whole process.
At Clinical Accelerator we believe that patient enrolment organizations can effectively intervene in situations when investigative sites experience lack of resources. Assisting sites with screening efforts, patient recruitment and retention, even embedding into sites’ structure external dedicated study co-ordinators directly employed by a patient enrolment organization can lead to significant improvement in site performance.
Clinical trials are good for patients
In this series of blog posts, I have discussed some of the major barriers to successful recruitment of patients to clinical trials. There are many potential approaches to overcoming these obstacles. However, communication has been demonstrated to be of paramount importance. The ultimate goal of clinical trials is to help patients and improve treatments. Getting this message across to everyone involved is key to improving recruitment.
Tackling Patient Recruitment Challenges in Clinical Trials – http://www.onclive.com/publications/oncology-live/2014/march-2014/tackling-patient-recruitment-challenges-in-clinical-trials/