Characterizing the Real Cost of Site Regulatory Compliance

It is widely acknowledged by professionals involved with conducting clinical studies, as well as by those who oversee and manage clinical trials, that investigative sites face a heavy regulatory compliance burden. Yet, until recently, only anecdotal evidence existed to support this belief.

CenterWatch, in collaboration with Complion-a Cleveland-based firm that develops regulatory documentation solutions for investigative sites-have completed a new study that begins to quantify this regulatory compliance burden.  

Kenneth A. Getz

The study was conducted online between October and December 2014. A total of 164 U.S. sites completed the survey questionnaire. The majority of respondents (60%) are study coordinators; 20% are principal investigators. The remainder of respondents includes administrative support and regulatory staff, among other site personnel.

Nearly four out of 10 (38%) of the respondents work in independent, dedicated, and part-time community based sites. One-third (35%) are based within academic medical centers (AMCs) and 27% are within community hospitals.

The results suggest that investigative sites are dedicating substantial capacity, infrastructure, and resources to manage regulatory compliance. And the expense to do so dramatically reduces site operating profit. Most sites are handling regulatory compliance tasks in a relatively unsophisticated manner, using a combination of paper and electronic solutions. And sites expect the regulatory burden to increase. What follows are highlights from this recent study.

Perceived burden and its causes

The majority (85%) of investigative sites perceive that the burden and cost associated with regulatory compliance has increased “significantly” (41%) or “somewhat” (44%) during the past two years.  

None of the respondents from independent investigative sites and community hospitals perceive that their regulatory compliance burden has diminished compared to two years ago. Less than 10% of respondents from clinical research functions within academic medical centers perceive that their regulatory burden has decreased.

Investigative sites mention a variety of factors that are contributing to increased compliance burden. Top factors include increased regulatory requirements (73% mention) and more complex protocols (66% mention). Increased reporting requirements for adverse events and protocol deviations are mentioned by 53% of investigative sites. 

Staffing and capacity

Independent investigative sites report that two staff members are typically involved in managing regulatory compliance tasks. Each member manages a mix of clerical, regulatory, and sponsor/CRO related compliance tasks for an average of six studies at any given time. AMCs and community hospitals report that an average of three staff is involved with regulatory compliance tasks. But whereas each dedicated staff member manages tasks for an average of seven studies at community hospitals, within AMCs, each staff member

manages regulatory compliance tasks for an average of 3.3 studies. Compliance burden per study is likely higher within academic centers, given additional institutional reporting and compliance requirements.

Half of investigative sites report that study coordinators are typically the primary individuals involved with managing regulatory compliance tasks.  Less than 20% of sites indicate that the principal investigator primarily handles these tasks. Approximately 30% of sites report that a dedicated regulatory specialist is primarily involved with managing compliance tasks.

In all, respondents provided workload-as measured by hours of time-for 25 regulatory compliance tasks on the survey. Clerical tasks assessed include handling study compliance documentation and correspondences, obtaining signatures, and general communication and reporting. Regulatory tasks include good clinical practice and protocol-specific training and document creation and editing. Sponsor/CRO tasks assessed include preparing for audit and monitoring visits, reviewing material with the study monitor or auditor and post visit follow-up.

The most time-consuming regulatory compliance tasks are associated with learning sponsor/CRO’s investigator or regulatory web portals and protocol-specific training. Sites report that 20 hours per study is devoted to these specific tasks. Reviewing regulatory documentation with the study monitor or auditor, following up with monitors and auditors after visits, reviewing correspondences and documentation, and filing staff credentials are also cited as the most time-consuming tasks. On a weekly basis, half of a staff member’s time is devoted to preparing for, meeting with, following up with, and reviewing correspondences with study monitors and auditors. 

Staff involved with managing regulatory compliance tasks appears overloaded. Less than half-46%-of investigative sites report that they are on schedule with their management of regulatory compliance tasks. One-quarter (28%) are approximately one week behind and 26% report being at least two weeks behind on their compliance-related tasks.

Space and storage

Regulatory compliance requires sites to physically store records and absorb most of the archiving costs, often for 11 years or longer. The predominant storage format across all types of clinical study documentation is a combination of paper and electronic. Of all respondents (i.e., combined independent, AMCs, and community hospitals), eight out of 10 report storing their regulatory and clinical data documents using a combination of paper and electronic formats. An eye-opening 25% of independent investigative sites stores their documents in paper format only.

Half of respondents indicate that their research center dedicates approximately 20% of their physical office space or more to store paper regulatory documents, including printouts of emails and electronic file attachments.  About half (54%) of respondents report that four or more binders are used to store regulatory documents for a single study  and most said that each document typically exceeded 250 pages in length. A majority of sites indicate that they contract with outside companies to augment their limited in-house storage space. 

Four out of 10 (44%) respondents exchange ethical review submission documents with their institutional review board (IRB) using electronic formats, compared to about half (48%) that use a combination of paper and electronic formats. The most commonly used method for the exchange of regulatory documents is email, followed by a sponsor/CRO web portal and fax. 

Estimated and actual cost

The majority (79%) of investigative sites report that sponsors are not sufficiently compensating sites for all of their regulatory compliance expenses. The results of this study support this claim.

Respondents were asked to estimate total site-operating costs-staff time plus infrastructure required-to cover regulatory compliance tasks associated with a single study. The median estimate came to $6,550. Based on itemized costs (including paper, folders, binders, storage boxes, document storage, and regulatory software) and specific staff hours per regulatory compliance task per study, the total average aggregate cost is $13,901, more than double the median per study estimate from sites.

Sites are reimbursed a median $3,000 per study, about 80% of the median estimated regulatory start-up cost of $3,750 but less than 50% of the estimated regulatory compliance cost and only one-quarter of the actual per-study cost burden. Given the average number of active studies conducted annually, overall site operating profits would nearly triple if sites were remunerated 80% of their total actual study-specific regulatory compliance cost.

Engagement through easing burden 

Investigative site regulatory compliance is mission critical. Still, the results of this new study suggest that this burden may be requiring an inordinate amount of staff capacity and infrastructure that is significantly diminishing site operating profit, and may be harming operating efficiency and performance.

For less established and less sophisticated investigative sites, the burden of regulatory compliance may be hurting their long-term viability. Indeed, nearly 60% of novice investigators drop out of the clinical research enterprise, choosing not to conduct another FDA-regulated clinical trial. The No. 1 reason given: the heavy burden of regulatory compliance.

The results of this study help quantify how sites are managing regulatory compliance. The results suggest opportunities for electronic technology solutions to help streamline regulatory document storage and exchange capabilities and to reduce infrastructure requirements. The results also suggest the need for regulatory professionals, sponsors, and CROs to scrutinize regulatory compliance tasks and identify ways to simplify the compliance burden. Focusing attention and implementing steps to ease the regulatory compliance burden may go far in helping to improve site performance and sponsor-site and CRO-site relationship quality.

Kenneth A. Getz, MBA, is the Director of Sponsored Research at the Tufts CSDD and Chairman of CISCRP, both in Boston, MA, e-mail: kenneth.getz@tufts.edu.