Luis A. Rojas, PhD

The recent evolution within the pharmaceutical industry to the use of technologies associated with clinical trial data collection and storage is quite impressive. Even the risk-averse clinical trial sites are now comfortable departing from recording clinical trial data on pieces of paper to the use of technology-driven data collection solutions. As a result, new requirements must be put in place to ensure data quality and integrity (DQI). At the same time we must avoid adding new complexities to the clinical trial paradigm that attempt to solve problems that do not exist. We suggest referencing an article entitled "When Should the Audit Trail Begin? co-authored by the eClinical Forum, published in 2021, as a particularly good start.

 The article addresses issues such as evaluating software that has the capability to track keystrokes prior to hitting “submit” in an electronic data capture (EDC) system. The authors concluded that if companies or regulators would recommend this as a requirement, it would add additional workflow data for analysis without any proof of value to DQI, or the ability to address any perceived malfeasance. What all this means is that we have be cautious when instituting any new quality associated technology so as not to add requirements/features just because we can. The pharmaceutical industry and regulators must also not use paper-based processes as gold standards as they critically review the root reasons behind any new rules. Any new rules must be clearly documented why they are indeed necessary and how they add to DQI.

The historical record of writing things down started around 3100 BCE when people started to write on clay tablets.

 Around 3000 BCE, the Egyptians begin writing and painting on papyrus, a material prepared from the stem of the water plant Cyperus papyrus. Ordinary leather in the form of parchment began to be used for writing around 2500 BCE. During the second century BCE, a better form of parchment was introduced such that both sides could be written on, but it was not until 400 years later that parchment rivaled papyrus. According to Chinese tradition, paper as we know it today was invented in the year 105 CE by Cai Lun, a eunuch who resided at the imperial court. Fragments of this paper product, made from rags and the fibers of mulberry, laurel and Chinese grass, are currently available in museums. Nevertheless, parchment was the standard writing surface for European scribes up and until the 15th century. Historically, for the Jewish bible, a Torah or biblical scroll could only be written on parchment from the skin of a kosher animal, and the five pages of the U.S. Constitution as well as the Declaration of Independence, the Bill of Rights, and the Articles of Confederation were all written on parchment.

A detailed summary of clinical trials that were conducted between 562 BCE and 1537 was published in 2010.

 It should be noted that during these early times there were no regulators other than kings and curious researchers, and no papyrus or parchment records were being checked by clinical research associates (CRAs). According to the article, the world's first clinical trial is recorded in the Bible’s “Book of Daniel.” This experiment was conducted by King Nebuchadnezzar of Babylon who conquered Jerusalem in 586 BCE and destroyed the Jewish Temple. During his rule, there was a time when all subjects were ordered to eat only meat and drink only wine to keep them in sound physical condition. However, when several of the king’s relatives who preferred to eat vegetables objected, the king allowed them just to eat legumes and drink water for 10 days. When the experiment ended and those eating vegetables appeared better nourished than the “meat-eating controls,” the king graciously permitted the vegetarians to continue on their diet. According to the article, this may have been the first time in the evolution of humans that an open-label clinical trial guided a public health decision.

More recently, the first “controlled” clinical trial was performed by Dr. James Lind (1716-1794), who while working as a ship’s surgeon, was appalled by the high incidence and mortality of scurvy amongst sailors. As a result, he planned and executed a comparative trial of the most promising cures for scurvy. His insightful and vivid description of the trial covers the essential elements of a controlled clinical trial. Dr James Lind's “Treatise on Scurvy” was published in Edinburgh, Scotland in 1753.

Early computers had a type of disk storage composed of a thin and flexible disk using magnetic technology. The original “floppies” stored 384K of data. Later, 720K (double-density) and 1.44MB (high-density) disks were developed. In the mid-80’s, Dr. Fred Wolfe’s rheumatology clinical research unit in Wichita, Kansas had electronic records stored on a computer with backups on floppy disks. Dr. Wolfe had a plan to ship the floppy disks directly to the data management department for processing at the pharmaceutical company where the senior author of this article was running the clinical trial. This could have been the beginning of direct data capture and the elimination of source data verification (SDV). Unfortunately, the idea did not gain acceptance and was abandoned.

Evolution of paper-based data collection in clinical trials

Until the onset of the use of EDC systems in the 1990’s, clinical trial case report forms (CRFs) were composed of three-part NCR (no carbon required) paper with the original copy remaining at the site, and the other copies submitted to the sponsoring pharmaceutical company. The capture of clinical trial data directly onto the paper CRFs was not permitted. Instead, an independent original source record was to be maintained at the clinical research site and the basic function of the CRAs at the “site visit” was to compare the precision and accuracy of the CRF data transcribed from a source record onto a paper CRF, a process defined as source data verification (SDV). In order to complete the data validation process, the paper CRFs were then sent to the pharmaceutical company for data entry into the study database by two separate individuals, a process known as double-key data entry. These data were then compared and any inconsistencies resolved.

Once EDC systems were introduced, paper CRFs were eliminated, and data entry into the study database was shifted to the clinical research sites. This process did not change the SDV workflow as it was still no longer certain that site staff always entered the data accurately into the EDC system. While the data within the databases of the EDC systems could have been used as source data, it was not initially accepted that data entered directly into EDC systems could replace the “source” and “transcribed copy procedures” adopted during the use of paper CRFs.

Figure 1: EDC data workflow when paper source records are used

The transition to direct data capture and eSource technologies

In 2011, a study evaluated the effects of SDV on the mean and standard deviation values of five variables when using an EDC system together with paper-based source records.

 The protocol was for a new treatment in men with lower urinary tract symptoms associated with benign prostatic hyperplasia. Data were collected from 566 subjects who signed informed consent and from 492 of these same subjects who were subsequently randomized. Results showed that post data validation, there were virtually no differences in mean values of the five key variables and a very minor decrease in the standard deviations.

In 2012, in lieu of initially capturing all source data using paper records, a US-based clinical trial evaluating the pharmacokinetics of a topically applied drug product allowed the clinical site to use direct data entry (DDE) into an EDC system at the time of the clinic visit.

 The clinical research team also implemented a risk-based monitoring (RBM) plan which defined the scope of SDV 1) if paper records were used, 2) the frequency and scope of online data review, 3) the role of centralized statistical monitoring (CSM) and 4) the criteria for when to perform in-person monitoring at the clinical research site. As a result of this novel approach to clinical research operations, there were1) no protocol violations as screening errors were identified prior to randomization, 2) minimal transcription errors as very few paper source records were used, and 3) major reductions in onsite monitoring tasks compared to comparable studies that used paper as source records. As needed, EDC edit checks were modified early in the course of the clinical trial, and compliance issues were identified in real time and corrected. From the safety perspective, there was rapid transparency and detection of safety issues. The clinical research site estimated that just in terms of data entry, it was able to save 70 hours of labor by eliminating paper as the original source records. The article concluded that when DDE and RBM are properly implemented, there could be major increases in productivity for both sponsors, clinical sites, and CROs, as well as reduced times to database lock and the statistical analyses.

Figure 2: Direct data entry/eSource workflow

In terms of the impact on query generation, an article published in 2014 reported the results of study that evaluated the use DDE at the time of the patient encounter on the effect of the query effectiveness ratio (QER), defined as the ratio of the number of queries leading to change divided by the total number of queries issued.

 The study looked at 38,207 forms in a phase 2 study for the treatment of migraine. Results showed that of the 1,397 (3.7%) of forms that were queried, only 782 (2.0%) forms required changes to the database. Of these changes, 294 (37.6%) were in the concomitant medication forms and none of the changes had any impact on the study results.

Traditionally, the major roles of the CRAs were to train the clinical sites on the steps needed to execute the clinical trial and then to assess, via SDV, how the clinical sites could accurately transcribe data from paper source records onto paper CRFs. Data management wrote programs to look at logical errors and inconsistencies among and between forms, and communicated these issues directly to the CRAs or via a query directly to the clinical research site. The number of data entry errors was often used as the main metric to see how well a site was executing the study. As a result, this approach focused more on process conformance rather than on protocol compliance. Unfortunately, due to this manual effort, by the time an error was identified by the CRAs or data management, the same error could have been repeated multiple times due to the time between data entry by the site and monitoring by the CRAs.

Currently with the application of DDE in various software solutions including EDC, Electronic Patient Reported Outcomes (ePRO), Electronic Clinical Outcome Assessment (eCOA), Electronic Informed Consent (eICF), Mobile Medical Devices, etc., there is no need to question the data as the system validation efforts at the time of data capture assure the data integrity. Real-time remote monitoring by CRAs and data managers can now focus on 1) protocol compliance, 2) illogical results/outliers, 3) high risk issues related to safety and efficacy endpoints, and 4) evaluation of potential protocol deviations and violations. As a result, DDE logic errors that are systemic and not user specific can be corrected rapidly and communicated to those performing data entry. It is also now possible to evaluate the performance of the CRAs in detecting issues.

However, if debunking “accuracy” is no longer highly critical in the data validation process as one usually assumes, then what is? The recently published ICH E8(R1) emphases the need for “completeness (lack of missing information)” and “consistency (uniformity of ascertainment over time).”

 Thus, it is reasonable to expect that narrow-focused / accuracy-specific edit checks will play a lesser role over time, while at the same time, the part of aggregate (“across subject”) and complex statistical checks will expand. Data management and clinical operations professionals should not only be ready for this paradigm shift, but lead the transition. This advancement will demand a shift in perception and processes and equally importantly, the development of new skills. Let us now recognize that “Data Science” is no longer exclusively the domain of statisticians, but is now associated with all clinical research operations dealing with data collection, validation, and monitoring.

It is now time to follow the new definition of Data Quality documented by the Clinical Trials Transformation Initiative (CTTI), and redesign the data validation processes from eliminating all errors to the elimination of errors that matter to decision making. It is also time to focus on potential errors which have a meaningful impact on the safety of trial participants, the credibility of the results and the potential impact on the future care of patients.

Technology is providing major contributions to the execution of clinical trials and has assisted in the improvement of DQI. However, there are still major challenges ahead to increase efficiencies, avoid redundancies, and ensure compliance with all aspects associated with data capture, data transfer and final reporting. The creation of lean documented processes and procedures will enable technology and human interactions to expedite clinical development, while at the same time protect the data and the basic principles that govern quality as documented in existing regulations.

With the implementation of DDE, RBM and technology solutions, we can now early in a clinical trial identify potential risks to the patients and to the study itself. Real time risk mitigation strategies must address those risks that are most critical for the evaluation of the safety and efficacy profile of the drug or device under study. Regulators can now shift their focus from how well a data point is transcribed from one medium to another, to issues that could put patients/study participants at risk and compromise the clinical trial outcome, such as lack of protocol compliance, incompetent or unscrupulous investigators and biased sponsors. It is now time to also avoid the profound effects on patients and sponsoring companies where studies fail due to lack of quality rather than lack of efficacy.

., is the President and CEO of THI Pharma Services Inc.

, BS, is the President and CEO of Fasor Technical Services, Inc.

, BE, is the Regulatory Affairs Manager for Videoc Technologies.

, MS., is the Faculty / Program Coordinator / Senior Lecturer, MS in Regulatory Science & Food Safety Regulation Programs, at Johns Hopkins University.

Sr. Director, Data Quality Science and Programming, at BioMarin Pharmaceuticals, Inc.

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Articles

New requirements must be put in place to ensure data quality and integrity.

The Transformation of Clinical Trials from Writing on Papyrus to the World of Technology

At the October 2021 DIA conference on Digital Technologies in Clinical Trials, Pfizer reported the following timeline for the Pfizer-BioNTech COVID-19 vaccine
clinical program:

On May 4, 2020, the Phase I study was initiated, followed by initiation of the Phase II/III program on July 27, 2020. Positive interim results were reported on November 18, 2020 followed by the Emergency Use Authorization (EUA) submission request on November 20, 2020. The first Food and Drug Administration (FDA) EUA clearance occurred on December 2, 2020. The program, which evaluated over 46,000 subjects at approximately 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina, took just 8 months from first patient first visit (FPFV) to FDA clearance.

This major achievement by Pfizer, as well as the rapid development of products to prevent and treat the novel coronavirus disease 2019 (COVID-19) by others in the pharmaceutical industry and academic centers, are to be commended. Similarly, the FDA must also be commended on the speed that products have received EUA and full marketing approvals during the COVID-19 pandemic.

While clinical trials are costly and time consuming, they are necessary to assure that safe and effective products reach patients. As it is well known, the steps of drug development to approval involve multiple factors that could be improved in order to accelerate the process. The processes, resources and strategies to maximize efficiencies need to be revisited in order to continue exploring innovative study designs and methodologies that could result in reducing timelines and costs to product approval. On this topic, a recent article addresses the value of randomized clinical trials as well as the value of real world evidence together with novel approaches to statistical methodologies.

 Another recent article addresses the suitability of registries for embedding clinical trials.

Going forward, efforts need to be magnified to encourage biotech and pharmaceutical companies to continue promoting solutions to benefit of patients who are expecting solutions for their unmet medical needs. With this premise in mind, the current article first describes recent approaches to accelerate the marketing approval process, followed by a proposition of alternative strategies to accelerate the regulatory review approval process once it is concluded that an investigational product has passed the initial threshold of demonstrating safety and effectiveness in one or more clinical trials.

Current FDA programs to accelerate access

In order to accelerate the product approval process, four regulatory programs currently exist to reduce development and review times for products that address unmet medical needs for the treatment of serious or life-threatening conditions. In May 2014, FDA issued a Final Guidance for Industry entitled, “Expedited Programs for Serious Conditions–Drugs and Biologics” which addresses fast track designation, breakthrough therapy designation, priority review designation and accelerated approval.

In addition to this guidance document, under section 564 of the FD&C Act, 21 U.S.C. 360bbb-3, in a situation where the Secretary of Health and Human Services (HHS) issues a declaration of emergency or threat justifying authorization of emergency use for a product caused by chemical, biological, radiological or nuclear (CBRN) agents, as well as an infectious disease, the Commissioner of the FDA may authorize an EUA of an unapproved product or an unapproved use of an approved product. In 2004, the EUA authority was incorporated in the Project BioShield Act of 2004, which amended the FD&C Act. In January 2017, the “Emergency Use Authorization of Medical Products and Related Authorities” guidance was finalized.

Section 112 of the Food and Drug Administration Modernization Act of 1997 (FDAMA), entitled “Expediting Study and Approval of Fast Track Drugs,” mandates the facilitation of the development and processes to expedite review of therapeutics intended to treat serious or life-threatening conditions presenting with unmet medical needs. Fast Track designation, which also allows for the possibility of a “rolling review” of New Drug Applications (NDA) and Biologics License Applications (BLA), can be requested early in the development process at the time of Investigational New Drug (IND) filing or completion of Phase I studies. When a product receives a Fast Track designation, there is a strong emphasis on the importance of continuous communication with FDA so that questions and issues can be resolved quickly. Examples of diseases/therapeutic areas considered to be serious conditions include AIDS, Alzheimer’s disease, heart failure, cancer, epilepsy, depression, and diabetes, among others.

In contrast to Fast Track designation, a Breakthrough Therapy designation is assigned to an investigational product that is intended alone or in combination with one or more other products to treat a serious or life-threatening condition, and where there is preliminary clinical evidence that indicates that the investigation product may demonstrate substantial clinical benefit over existing therapies. Breakthrough Therapy designation requests usually occur at the end of Phase II. A drug that receives Breakthrough Therapy designation is eligible for all of the features of Fast Track designation.

The Accelerated Approval Program supports the concept that a treatment may be conditionally approved based on a validated surrogate biomarker or an intermediate clinical endpoint that strongly support the possibility of clinical benefit. Accelerated Approval agreements with FDA occurs close to the NDA or BLA submission. The regulation also requires that upon receiving Accelerated Approval, sponsors must perform a confirmatory study to demonstrate clinical benefit. If data from the confirmatory study does not demonstrate a clinical benefit, the product will be withdrawn from the market for use in that indication.

Under the 1992 Prescription Drug User Act (PDUFA), FDA committed to specific goals for improving drug review times. As a result, a two-tiered system of review times, Standard Review and Priority Review was created. A Priority Review designation means that the goal is for the FDA to act on a marketing application within 6 months of receipt, rather than a Standard Review of 10 months, as long as the investigational product can be shown to provide significant advantages such as:

Evidence of increased treatment effectiveness

Elimination or substantial reduction of a treatment-limiting adverse drug reactions

Documented enhancement of patient
compliance

Evidence of safety and effectiveness in a novel subpopulation of a disease

FDA informs the applicant the status of a Priority Review designation within 60 days of the receipt of the original BLA, NDA, or efficacy supplement.

Current FDA approaches to accelerate clearance of medical devices

In 1997, in order to improve the efficiency and timeliness of the 510(k) process of certain low-to-moderate risk new medical devices, the Accredited Persons Program was included in FDAMA. In 2018, a slide deck was published by FDA that describes how it is updating its 510(k) Third Party (3P) Review Program in order to avoid the routine re-review of 510(k) submissions already reviewed by a 3P Review Organization.

 As a follow-up, a March 12, 2020 final guidance document was issued entitled “510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations.”

 This guidance document provides medical device manufacturers with a voluntary process where FDA-authorized Third Party Review Organizations (3P510k Review Organizations) are permitted to evaluate and recommend approval or rejection of new devices. The guidance also delineates how decisions are made if certain medical devices are eligible for review under the Third Party Review Program. This new authority had been codified in the FDA Reauthorization Act of 2017 (FDARA) and allows discretion as to which devices are eligible for third party review. Approximately 50% of 510(k) applications now fall under this program.

The following section addresses proposed changes to existing FDA rules and regulations using a parallel format of the four phases of clinical trials during drug development. However, before moving forward, the are questions of special interest that should be addressed:

Under whose authority would it be to propose and implement these changes?

Would these proposed changes all fall within the jurisdiction of FDA rules and regulations, or would some require legislative action such as modifying the FD&C Act?

Based on lessons learned from the product approval process during COVID-19, and as previously published over 20 years ago, it is critical that sponsors continue to interact with FDA to discuss their development plans.

 In addition, FDA should expand the scope of exempt studies falling under IND and Investigational Device Exemption (IDE) regulations, and thus allow sponsors, with FDA concurrence, to proceed to clinical trials without FDA clearance of an IND or IDE. However, in order to control this process, each sponsor would be certified through an independent audit, that it complies with all relevant FDA rules and regulations, and training procedures are in place to guarantee that experienced staff manage all aspects of Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). The auditors will be certified by FDA based on their curriculum vitae and experience, and there will be an agreed upon fee across the industry, which will be paid by the company being audited. Each company will do yearly internal audits to assure continued compliance, and at the time of a marketing application, this process will be subject to regulatory review during preapproval inspections.

In addition, as is current practice, a clinical trial cannot be initiated without: 1) review and approval of the protocol and informed consent by an IRB or Ethics Committee; 2) review and signoff by an independent study Principal Investigator; and 3) review and signoff by each clinical site. Some academic organizations also have separate protocol review committees that must approve all new protocols.

From the data analysis perspective, the regulatory guidance ICH-E9 R1 is a key instrument to ensure more robustness and consistency during protocol development and statistical analysis planning. In order to minimize bias and increase the precision around the interpretation of the estimates associated with the clinical trial, the guidance forces trialists to provide more details about how the research questions, objectives, endpoints, and statistical analysis should be codified.

In terms of study designs, the discrepancies between the requirements and magnitude of the thresholds to demonstrate clinically significant safety differences, in most cases, is usually higher than the expectations for the efficacy profile. Thus, to have confidence that a study design is adequate to establish that an investigational product shows success both in terms of efficacy and safety in relationship with a comparator arm, the following issues must be addressed in all applicable phases of clinical development:

Clearly define the research question and hypothesis

Definition of the estimand and its attributes for the evaluation of all endpoints, including:

The endpoints and variables to be evaluated, and the validated instruments to be used for each case

Intercurrent events (ICE) that could impact the evaluation and interpretation of all endpoints, and the approaches to be used for each ICE

Population level summary for the evaluation of endpoints including the analysis dataset that will be used for each case

Sensitivity and supplemental analyses, for example:

Using the per protocol population or completers

Considering other missing data mechanisms different to the assumptions to the one used in the evaluation of the primary endpoint

Tipping point analysis under different scenarios

Supplemental analysis using different statistical models/methods

Testing strategies to control the familywise type I error

Assessments to capture the data associated with all endpoints using validated instruments

Description of the evaluation of the safety profile of drugs and devices including:

Treatment Emergent Adverse Events (TEAEs)

Treatment Emergent Serious Adverse Events (TESAEs)

Adverse Events of Special Interest (AESI)

Serious Unexpected Serious Adverse Reactions (SUSARs)

A general framework currently exists when FDA requests product approval recommendations from Scientific Advisory Boards for drugs and biologics and Third Party Review Organizations for devices. Thus, in order to expedite the review of marketing applications and reduce the time for a final marketing decision, in lieu of a detailed FDA review of all marketing applications, it is proposed that a framework be established for drugs, biologics and high risk new medical devices such that external expert committees, comprised of individuals certified by FDA, also be able to review the marketing applications and make product approval or rejection recommendations to the FDA review divisions responsible for final decision-making. However, in the event there are disagreements or basic questions that need to be resolved during the committee review, a process must be put in place for FDA, the expert review committee and sponsor to rapidly reconcile any and all issues.

For drugs and devices approved outside of the United States, the same processes should be followed by the expert committees, while taking under consideration any significant differences in regional differences in study designs and/or the population(s) studied.

Phase 3 - Post marketing safety monitoring

Currently, companies with FDA-regulated marketed products are required to track and report post marketing safety events either as expedited reports or as part of required annual reporting. Examples of the sources of these safety events include ongoing clinical trials, direct reports to companies of adverse events, data from electronic medical records, foreign data reports, the literature and data from patient registries and professional societies. Patient advocacy groups like the Cystic Fibrosis Foundation and professional societies like the Society for Thoracic Surgeons maintain patient registries.

 The Cystic Fibrosis Foundation registry tracks adverse events for all marketed and off label use of drugs for the treatment of patients with cystic fibrosis. In 1989, the Society for Thoracic Surgeons established the STS National Database to support the quality of patient care and to track safety events occurring during surgical procedures performed by their members. While some patient registries are being mandated by FDA to be used for safety monitoring, the use of patient registries should be expanded especially in rare diseases and in special patient population where there are active registries. However, if registries are mandated as a source of safety monitoring, the cost associated with this requirement should be reasonable and transparent so as remove any burdens, especially on smaller companies.

In the Food and Drug Administration Amendments Act (FDAAA; H.R. 3580) of 2007, Congress mandated that FDA track safety signals of marketed products. Subsequently, the Sentinel System was established in 2009 that uses electronic health data to assess post‐market medical product safety.

 The full Sentinel System was officially launched in February 2016. Through Sentinel, FDA assesses the safety of approved medical products including drugs, biologics, and medical devices. Sentinel’s data are based primarily on administrative claims and electronic health records (EHRs). The core Data Partner organizations include national and regional health plans partners, integrated delivery systems, and Medicare‐fee‐for service data. Sentinel partnerships also include EHR‐based organizations and networks, including CA Healthcare, the National Patient‐Centered Clinical Research Network (PCORnet), and several EHR data aggregators (TriNetX, Veradigm, IBM Explorys) who contribute data on a case‐by‐case basis.

There are currently over 70 million patients actively providing data to Sentinel. However, since there is a reported lag of 6-9 months from the date of health care and the data are only refreshed quarterly,

 we are pleased that FDA’s FY 2022 budget includes $82.9 million for an agency-wide data modernization and enhanced technologies initiative that supports medical product safety programs. These investments will modernize FDA’s data infrastructure by using current technology innovations that will allow FDA to more efficiently to gather data; identify, analyze, and respond to potential problems more quickly; and further improve review times for medical products.

Data from large national pharmacy chains can also be used to rapidly capture and report adverse events immediately upon product launch. For example, on May 20, 2021 CVS announced that their “CVS Health Clinical Trial Services is working with key stakeholders in the biopharmaceutical industry and across the clinical trial ecosystem to design and deliver innovative approaches to research and real-world evidence generation.”

While COVID-19 and previous pandemics have brought terrible devastation throughout the planet, government and societal reactions to COVID-19, for the most part, have demonstrated that it is possible to develop and release vaccines and other therapeutics in record times, and that humans have the ability and capability to collaborate for the common good. Regulators have also demonstrated that it is possible to accelerate the approval of much needed therapeutics in novel ways, and that if the proper resources are allocated both within and outside of governments, it becomes a win-win for citizens today and for all future generations.

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President, CEO, THI Pharma Services Inc., 

Faculty, Program Coordinator, Senior Lecturer, MS in Regulatory Science & Food Safety Regulation Programs, Johns Hopkins University

Lessons learned from FDA’s current process and proposed alternative review strategies.

Luis A. Rojas, PhD

Articles

The Transformation of Clinical Trials from Writing on Papyrus to the World of Technology

Analysis: FDA’s COVID-19 Accelerated Pathways