According to some studies, 85% of clinical trials fail to enroll enough patients by the deadline. Even though a third of their budget is typically allocated to patient recruitment and retention, trials still fail to meet their target dates — and without the necessary patients, even the most well-planned clinical trial will fail.
Approximately 50% of study sites enroll one or no patients. For example, statistics show that only 3% of people with cancer are aware they can participate in clinical trials. As a result, recruiting and retaining the necessary number of patients has become a growing challenge for sponsors and clinical research organizations. The result is more expensive clinical trials, lower staff satisfaction, and a weaker statistical power for the study.
But why is the business of conducting clinical trials becoming more complex? Market researchers found that the primary reasons for low recruitment rates are nonresponse, respondent fatigue, and sampling snags. However, dealing with humans seems to be at the top of the list.
In addition, there is a problem with outsourcing. Namely, as a solution to these challenges, many companies entrust clinical trial recruitment to clinical development outsourcers. These companies handle some of the more essential clinical trial functions (such as patient recruitment) to make the program more efficient and effective. They try to pass through the top recruitment barriers to screen a larger pool of potential patients.
The ISR surveys hundreds of clinical development outsourcers each year to learn more about their experience and gain insight into two time-consuming and challenging processes: CRO selection and performance evaluation.
Importance of Outsourcing in Clinical Trials
Pharmaceutical companies outsource research to Contract Research Organizations (CROs) when developing new drugs. Most CROs provide clinical study and trial support for drugs or medical devices. This allows drug sponsors to move new medical products from conception to the FDA or EMA marketing authorization without maintaining a dedicated staff. Some CROs can generate revenues as high as 4.3 billion dollars annually, and over 1,000 of them worldwide.
However, choosing the right CRO can be crucial to the success of a clinical trial. Still, many companies find selecting the best organization to conduct their trials stressful due to the number of decisions they have to make. Plus, with so many criteria to choose from, the question arises — which ones should be used to evaluate different CROs?
A vital factor to consider when assessing a CRO is the company’s experience — or, more importantly, its expertise in the therapeutic area of your study. Companies must look at each organization’s track records and check how consistently they have delivered for their clients.
Additionally, a clinical trial can be cancelled at any time for various reasons, so choosing a CRO that has the financial stability to weather industry uncertainties without negatively impacting your project is crucial.
Outsourcing clinical trials to a CRO may be beneficial because, unlike your company, this organization may have access to investigator sites or unique patient populations. One of the most important factors is the organization’s expertise in the field when obtaining productive sites (or the sites that have gained valuable patients and provided high-quality data on them).
Most sponsors assume their CROs will provide complete insight into study progress and milestones, only to discover that transparency is not a priority. However, it needs to be actively communicated and pursued during the negotiation phase, which is why it should be high on your list of selection criteria. Complete transparency can be especially valuable when sponsors use multiple CROs and need insights across different systems.
Results of the ISR Survey
The Industry Standard Research (ISR), a full-service market research provider, has been overseeing the selection and performance of CROs for nearly 15 years. These experts have witnessed industry growth, expansion of service offerings, and provider consolidation.
The ISR’s annual CRO benchmarking survey explores the impact of preferred provider agreements. During their interviews, clinical development outsourcers were expected to answer to what extent they could relate to these three different scenarios:
Using preferred provider agreements
Going outside of preferred provider agreements
Not using preferred provider agreements
Although they differ significantly, all three scenarios share some common shortcomings, and the one that particularly stands out is related to the diversity of patients, which remains a major challenge.
Moreover, ISR has interviewed more than 300 outsourcers to learn more about their future plans and the extent to which they agree with the statements related to their clinical development programs. Approximately two-thirds and three-quarters of respondents stated they expect the enrollment of diverse populations and the use of more specialized patient recruitment processes in the future. Big pharma companies responded that they have even greater expectations regarding their future patient recruitment plans.
It seems the use of specialized patient recruitment companies will increase in the near future. Only 17% of respondents at large firms disagree with the claim that specialized patient recruitment companies will become more prevalent over the next two years, compared with 31% at non-large pharma businesses.
Large pharma companies seem to be more aware that the enrollment of diverse populations is a significant issue. We can confirm this by looking at the numbers — 85% of respondents at large pharmaceutical companies plan to enroll a diverse population group in their clinical trials, compared to 60% of non-large pharmaceutical respondents.
When it comes to the increased usage of specialized site identification companies, large pharma organizations are more likely to put it into practice (70%) than non-large ones (60%). Large companies see the benefits of this strategy — by identifying and qualifying clinical centers, these companies can access high-recruitment academic sites with special patient populations.
Naturally, patient recruitment is a challenge both sponsors and providers have faced for a long time. In addition, there is no doubt that businesses will need more assistance from providers in getting used to the altered post-COVID world of interpersonal relationships.
Conclusion
Sponsored CRO partnerships seem to be the future. An ideal CRO partner should be able to accommodate the type of product the pharmaceutical company is developing. In addition, its infrastructure must allow the project to be completed on schedule. Finally, it should be able to improve patient recruitment and retention.
With the right CRO that has a proven track record, a clear organization model, and measurable performance indicators, drug companies can create long-term relationships that will become even more efficient with time. Plus, partnerships with special CROs could prove beneficial as these organizations operate globally and have experience handling regional issues.
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