The road to success is never smooth nor easy, and the same can be said in conducting clinical trials. Before announcing that a drug or a treatment is safe for public use, the biotech and pharmaceutical industries must first overcome countless barriers. For most clinical operations, these barriers are frontiers of the study, ensuring failure before having a shot at accomplishing a clinical project’s ultimate goal–a medical breakthrough.
If good intentions are followed by bad execution, the plan is doomed from the start. In delivering clinical operations, it isn’t a question of why one operates, it is a question of how one operates. Clinical operations management is the determinant factor of whether a clinical project succeeds or fails, and for the most part, they fail. As stated by Dr. Duxin Sun, a professor of Pharmaceutical Sciences at the University of Michigan, only 1 out of 10 clinical trials pass testing and government approval [1]. This can only mean that the barriers, even with an astronomical amount of funds and ultramodern technology, are far more complex than they seem.
Underrepresentation
As explained by Alemayehu, Mitchell, and Nikles in Barriers for Conducting Clinical Trials in Developing Countries - A Systematic Review (2018), barriers in clinical operations vary from one country to another [2]. Furthermore, they stated that developing countries are underrepresented in clinical research around the world. In the aforementioned paper, it says that more than 80% of clinical trials that are listed on clinicaltrials.gov are performed in developed countries. The world’s total population is dominated by developing countries and they are home to almost 90% of diseases that are mostly preventable infectious diseases. The lack of population representation from developing countries may cause an imbalance of relevant information available for delivering clinical operations in terms of geographical location and demographics.
Lack of Funds
Funding for the pharma and biotech industries in developing countries are primarily derived from Western countries and the firms that reside there. According to Alemayehu et.al (2018), research is a luxury for developing countries [2]. In most LMIC or Low- and Medium-Income Countries, economic constraints and priorities are the culprit for the lack of knowledge surrounding the Clinical Science field.
Poorly Trained Professionals
Alemayehu et. al (2018) also pointed out that medical schools and teaching hospitals in LMIC or Low- and Medium-Income Countries are purely unprepared and inexperienced in delivering clinical operations and clinical operations management [2]. The authors of the previously mentioned paper cited India as an example where there are only 50-60 physicians per 100,000 people there. To make matters worse, only fewer than 200 medical professionals have been trained in Good Clinical Practice (GCP). The lack of clinical operations expertise and clinical operations training in developing countries can result in poor implementation of study protocols, poor handling of patients, poor data management, and ultimately the failure of a clinical trial.
Outsourcing and globalization of clinical operations prove to be beneficial for LMIC. However, funding local-driven research and educating the locals about the benefits of clinical trials can prove to be a long but powerful solution to address the underrepresentation barrier.
Patient Participation
According to an article published by BioPharma Dive on January 29, 2019, 85% of clinical trials fail to have a sufficient number of participants [3]. Moreover, 80% are delayed due to various recruitment issues. In addition to this challenge, the rate of dropouts is high. These figures are the resulting factor of many different socio-economic barriers such as geography, finance, and education. Whatever the case may be, a low participation rate can cause a number of problems.
According to an article published by Fred Hutchinson Cancer Research Center in 2019, 56% of patients don’t have access to clinical trials in their local vicinity or institutions [4]. As a result, most patients lack the opportunity to participate in trials or clinical projects. Patients may become discouraged to participate in a clinical trial if there is a level of hassle involved. Considering the proximity of the trial combined with the cost of transportation may be helpful to increase patient recruitment.
Geography
As emphasized in the article published by MD Group on November 25, 2020, clinical operations need to be more considerate around patient recruitment [5]. A patient should not need to travel more than 25 miles to access a research center. This could pose a challenge for clinical trial enrollment, especially for those individuals with low incomes.
Delivering clinical operations repeatedly in large hospitals is also a barrier. Not only does this avenue attract the same patient population, but also the same clinical project managers, clinical project staff, and sponsors. Hence, the research population would fail to reflect the accuracy and diversity of population demographics that a clinical study should have.
Finance
According to a study conducted by Nipp, Hong, and Paskett, Overcoming Barriers to Clinical Trial Enrollment (2019), financial issues represent a barrier to the participation of patients in clinical trials [6]. People of higher socioeconomic status enroll frequently. Such disparity can be caused by routine care costs, time away from work for clinical visits, lodging & meal expenses, and treatment for adverse effects. These financial considerations can be considered too much and perceived as an excess expense for the low-to-middle income population.
To ease the burden for other potential patients seeking to participate in a clinical trial, replacing site visits with home visits is an ideal and simple solution. Additionally, offering variable financial assistance and swift reimbursements of incurred costs could somehow alleviate the reluctance of those individuals who are eager to participate in a clinical trial.
Conclusion
To conquer such barriers, Clinical Operations requires a new kind of approach to conducting clinical trials. Aside from trained clinical project managers, clinical operations experts, and clinical operations consultants, third-party services that offer strategic solutions have also proven to be helpful in achieving the end goal of achieving a medical breakthrough.
References
- Sun D. 90% of drugs fail clinical trials – here’s one way researchers can select better drug candidates. The Conversation [Internet]. 2022 Feb 23 [cited 2022 Sep 23]; Available from: http://theconversation.com/90-of-drugs-fail-clinical-trials-heres-one-way-researchers-can-select-better-drug-candidates-174152
- Alemayehu C, Mitchell G, Nikles J. Barriers for conducting clinical trials in developing countries- a systematic review. Int J Equity Health [Internet]. 2018 [cited 2022 Sep 23];17(1). Available from: http://dx.doi.org/10.1186/s12939-018-0748-6
- Decentralized clinical trials: Are we ready to make the leap? [Internet]. BioPharma Dive. 2019 [cited 2022 Sep 23]. Available from: https://www.biopharmadive.com/spons/decentralized-clinical-trials-are-we-ready-to-make-the-leap/546591/
- Fred Hutchinson Cancer Research Center. Structural barriers are the biggest reason for low participation in clinical trials, research shows. Science Daily [Internet]. 2019 Feb 19 [cited 2022 Sep 23]; Available from: https://www.sciencedaily.com/releases/2019/02/190219111739.htm
- How we can address barriers to clinical trial accessibility [Internet]. mdgroup. 2020 [cited 2022 Sep 23]. Available from: https://mdgroup.com/blog/how-we-can-address-barriers-to-clinical-trial-accessibility/
- Nipp RD, Hong K, Paskett ED. Overcoming barriers to clinical trial enrollment. Am Soc Clin Oncol Educ Book [Internet]. 2019;39(39):105–14. Available from: http://dx.doi.org/10.1200/EDBK_243729
