25. December 2009 by harshit.

We are in the process of organising a workshop on ICH-GCP guidelines, clinical conduct of the trial and its mangement, ethical and regulatory issues, role of quality and pharmacovigilance in India.

Our expert panel includes industry veterans like Mr. P.K. Rastogi (Ex Deputy controller general of India), a well known Investigator Dr. Naresh Gupta and several other to present their views on recent trends in clinical research with a deep insight on future of clinical research in
India.

The workshop will be held in Delhi for two days. It will cover several topics on basic principles, practical aspects of conducting trials. All doctors (MBBS, BHMS, BAMS), Life sciences graduates (Msc., Bsc.) and those who want to pursue a carrier in clinical research are cordially invited.

All the attendees will be provided with certificate of attendance.

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17. December 2009 by harshit.

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Sponsors know that clinical trials are one of the most expensive endeavors for their company. Many sponsors would like to manage their trials in-house, but lack the needed infrastructure. Yet, sponsors have reservations outsourcing clinical research due to problems experienced working with CROs. These difficulties include lack of pricing clarity, poor communication, and inconsistent commitment to projects. In our experience, sponsors can better manage these issues by improving the processes they use when selecting CROs.

Sponsors typically select CROs in a competitive bid process. Sponsors issue a request for proposal (RFP) to a number of CROs. The RFP describes the project the winning CRO will perform. In addition, it instructs CROs to provide information the sponsor requires to identify the vendor that best meets its needs.

CROs then bid on the project by preparing a proposal. The sponsor reviews all proposals and awards the contract to one of the bidders.

The winning CROs proposal, premised on the RFP, establishes the foundation of the project plan. An inadequate RFP leads to inadequate proposals, which leads to an inadequate project plan. This, in turn, leads to budget creep, insufficient resources to complete the project, and the potential collapse of the relationship between sponsor and CRO

We have written proposals for CROs bidding on clinical projects valued at more than $10 million. Through this experience, we have seen poor RFPs as well as excellent ones. This article distils our experience and presents the five biggest mistakes sponsors make when preparing RFPs. Readers will learn what these mistakes are and gain insight into how to avoid these pitfalls. These mistakes include:

• Lack of proper preparation
• Omitting vital information
• Not verifying CRO qualifications
• Over reliance on bid grids
• Failure to properly evaluate pricing.
• Lack of proper preparation

Many sponsors issue RFPs before they have a sufficient understanding of their outsourcing needs. In some cases, this is okay if the sponsor is using a CRO to help finalize certain details of its clinical plan. However, if too much of the clinical plan is undeveloped, the sponsor gives the CRO power to design a plan they want, not the one the sponsor needs. The plan the CRO wants is the one that will win the contract.

CROs have learnt that, on average, a low price wins contracts. Moreover, they know that many sponsors will choose a proposal with a low price even if the proposed project plan does not reflect their needs.

Sponsors allow this to happen when they do not take the time to educate themselves on what their needs are. Thus, CROs will design a bare-bones project plan with a low price. Only once the project starts does the sponsor learn the extent of the services it actually needs, and the project’s scope and budget inflate. So, before issuing the RFP, sponsors should have a solid clinical plan.

Perhaps the sponsor will leave some details for the CRO to finalize. But the more the sponsor can tell the CRO, the more it retains the power to ensure the project plan and budget developed by the CRO are realistic. To do this, the sponsor must put in effort before issuing the RFP. It must thoughtfully map out its clinical program. If the company lacks the expertise to do this in-house, it should acquire expert help.

Omitting vital information

There is information CROs must have to develop a budget and work plan. In the absence of this information, CROs must make budget assumptions. Different CROs will choose different assumptions, undermining your ability to compare the costs from one CRO to another. Moreover, when CROs get to choose their budget assumptions, they tend to choose ones that make their costs look good.

It is true that in many cases sponsors may not know the details the CRO needs. Indeed, you may not know certain details, such as the number of queries per subject, until the study begins. In these cases, the sponsor should provide the budget assumptions in its RFP. If this is not possible—say, because you are asking the CRO to suggest the monitoring frequency—the RFP should clearly ask the CRO to state its assumptions, justify those assumptions, and provide a unit cost for the activity.
To help the CRO write a proposal, the RFP should provide:

The number and location of clinical sites
The number of subjects
Dates when enrollment starts and ends
Duration of follow-up
Proposed case report forms (CRFs) or a list of required CRFs
A schedule of assessments
An assumption of the number of queries per subject
An assumption of the number of serious adverse events per subject
Monitoring frequency
This list is far from complete. Given the range of services a sponsor might require, providing a complete list of the information needed by the CRO is beyond this article’s scope. There are, however, a number of resources available to sponsors, such as RFP manuals and templates. If you are unsure what information the CRO needs, ask them prior to submitting your RFP.

Not verifying CRO qualifications

A clinical trial is one of the most costly activities sponsors perform. Moreover, the future success of the sponsor is dependant on the trial’s results. Is it not worth some effort to ensure the CRO you hire is up to the task?

Sponsors should perform proper due diligence of the CRO they hire. This includes reference checks, review of financial information, study of staff turnover, and a site visit.

Reference check. The RFP should instruct the CRO to provide at least three references from customers who have had projects similar to yours run by the CRO. This is critical to ensuring the CRO is capable of delivering the work you are contracting out at the level of quality you need.

Financial check. The CRO industry is becoming more competitive. As a result, the number of CROs in the
United States is decreasing through attrition and consolidation. Should your CRO experience financial distress, this can jeopardize your project. Sponsors can assess this risk by asking the CRO to provide at least three years of financial statements. Someone with financial training at the sponsor should review this data to assess the CROs financial strength.

Staff turnover. High staff turnover at the CRO can be disruptive to your study. The RFP should instruct the CRO to provide turnover data. The sponsor can then compare the turnover data among bidding CROs. Note that you can define turnover in several ways. Thus, the RFP should define how to make this calculation. We recommend the method presented in Figure 1.

Site visit. A site visit allows you to verify with your own eyes the CRO’s abilities. In addition, when you hire a CRO their project team becomes a part of yours. Therefore, the compatibility of the two project teams is important. The site visit allows you to assess this compatibility.

Over reliance on bid grids

Unless instructed otherwise, each CRO will present its budget in its own format. To control for this, some sponsors present a bid grid in their RFP that instructs CROs how they want the budget presented.

In theory, this makes sense, as you can easily see where differences between CROs lie. In practice, though, there are shortcomings of relying too heavily on a bid grid. This stems from the fact that there are many ways a CRO can organize its workforce to perform a clinical trial. Each CRO organizes its budget to reflect its unique workflow. When you present it with a bid grid, it must now translate its budget into your grid. This requires discretion.
Consider the following: Where should a CRO allocate the cost for overseeing copying and shipment of paper CRFs from global sites to your data center? One CRO may file it under data management because they assign a data manager to oversee this task. In another, the monitor performs this function, so they allocate it to monitoring.

Once the CRO has allocated its expenses across your bid grid, it will review each category to see if any item seems too big or too small. It will then readjust how it allocated costs until the bid grid “looks about right.”

If the sponsor does provide a bid grid in its RFP, keep the details to a minimum. The bid grids provided from sponsors containing over 100 budget line items that contain minutia such as “Prepare Investigator Notebooks.” Imagine the effort required to compare the bids from three to five CROs across 100+ line items. Given the latitude CROs have in translating their budget to your bid grid, are differences across line items such as “Prepare Investigator Notebooks” very meaningful?

Dividing your bid grid into major categories, such as project management, data management, and so on is sufficient. Moreover, we recommend that sponsors not read too much into differences observed across categories in their grids. If the total budget of the most and least expensive CRO is within 25% of each other, then differences observed across the bid grid are probably not important.

Failure to properly evaluate pricing

Because of rising costs, sponsors obsessively search for the cheapest solution to their needs. To achieve this, they mercilessly drive down CRO rates and cut corners on their clinical plan. Unfortunately, many companies incur long-term costs in their search for short-term savings.

We have observed sponsors approach CROs they have short-listed and ask them to find ways to cut their price. CROs often respond by scaling back the services offered in their initial proposal, for example, by reducing monitoring frequency. Justifications for this will often include wording like, “Now that we understand your project better, we feel some of our earlier assumptions were too conservative.”

However, if the sponsor needs extra monitoring visits later, the CRO will bill this as an extra service. We have often observed that services removed from the proposal to lower costs end up being required. Many CROs bill for these “extra services” at a higher rate than activities scheduled in the proposal. Thus, not only do sponsors not get the savings they were expecting, they end up paying more than the CRO’s original plan. To reduce overall costs, companies need to stop looking for the cheapest solution and start looking for the best value.

Sponsors should do two things in their search for value. First, as stated, they must put effort into identifying their needs before issuing an RFP. Continuing with the earlier example, the sponsor should know the appropriate monitoring frequency for its study. Then, rather than allowing CROs to cut visits to reduce costs, sponsors should look for CROs that can deliver those visits for the best cost. If a CRO suggests a lower monitoring frequency, the sponsor should press them to justify their recommendation.

Secondly, once the sponsor has received proposals, it should select CROs based on value obtained per dollar, rather than the raw dollar amount of the proposal. To achieve this, sponsors can design a point system to grade proposals received—say, for instance, a score out of 100 total points. Dividing this score by the price quoted by the CRO yields a “value ratio.” This is the number of points the CRO scores per dollar. The higher the value ratio, the more value you are getting for your dollar

Improving CRO selection

Sponsors cannot abdicate the design of their clinical program to a CRO while grinding the CRO’s rates down and then expect they will get the study they need with a realistic budget. By improving processes to select CROs, sponsors can reduce overall costs and improve the quality of their program.

However, to achieve this, sponsors must educate themselves on their needs for the project. They must then translate these needs into an RFP that will lead CROs to develop a realistic project plan and budget. To reduce long-term project costs, sponsors must then evaluate each proposal and select the CRO that will provide the best value.

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14. December 2009 by rahul.

Clinical trials involve subjects as well as patients. Recruitment and retention of patients are central to the exercise. Great care has to be exercised at every stage of patient induction. Availability of large patient population for enrolment in a proposed Clinical Trial is a Myth. Most of these patients vanish as the trial begins. Internationally, recruitment and retention of clinical trial patients are a big challenge. More than 80% of global trials fail to enroll on time, with 52% delayed by 1‐6 month .Failure to recruit patients on time leads to loss of over 85‐95% of days in a clinical trial. India has become an attractive country due to its potential for rapid recruitment of patients. Many optimistic estimates suggest that patient enrolment rates in India could be 3‐4 times faster than Western countries. However, the number of patients who complete the trial decides the success of a global trial.
More and more drugs on trial have been designed to attack very specific biological targets. This necessitates the need to identify, recruit and retain patients that fit an increasingly narrower medical profile. Therefore, pharmaceutical companies and clinical research organizations (CRO) are seeking new ways to optimize recruiting operations and gain a competitive edge. Operational delays in clinical trials reduce patent exclusivity time and shorten the most commercially productive phase of a product’s life cycle. This results in financial loss and missed market opportunities for potential blockbusters. The primary source of such delays is the recruitment and retention of patients that fit the trials ‘requirements.

Slow patient enrollment…reasons
1) Too rigid inclusion/exclusion criteria.
2) Poor motivation for Clinical Trial site personnel
3) Clinical Trial monitors not proactive
4) Competition for enrollment (financial Incentive greater from other sponsor)
5) Unrealistic enrollment expectations
6) Inaction against site specific reports by Clinical Trial Monitors

Recruitment tactics…..
1) Increase the accessible pt. population (increase time frame and CT sites)
2) Relax inclusion/exclusion criteria (progressively from phase 2 to phase 4, not to disturb pre‐set randomization)
3) Wider publicity (advertisement, internet). The Internet is an important tool to recruit both patients and physicians, but remains under‐utilized.
4) Clinical Trial sites and/or Clinical Investigators pressurized to increase patient enrollment, also inducing own patients to enroll.
5) Payments to other Investigators for enrolling their patients (Referrals)
6) Financial inducement to exceed targets
7) Penalties for sites not meeting targets.

Retention of enrolled patients/subjects…
1) Make patient partner in treatment
2) Explain to him/her the commitment to CT
3) Provide good quality professional care(minimize waiting period, listen patiently to complaints about treatment or ADRs, explain all queries regarding CTs)
4) Explain dosage schedule in detail and consequences of non‐adherence to schedule
5) Explain likely ADRs, and action if occurs
6) Financial package for enrollment in Clinical Trials
7) Incentive for completing Clinical Trial

In Non therapeutic trials, adequacy of Financial Package determines the size of your “Volunteer Bank”. In therapeutic trials, undisclosed personal financial incentives to Clinical Investigators are often used to increase patient recruitment rate or to exceed the target. For increasing recruitment, patient participation has to be increased. Protection of rights, well being and Confidentiality of patients has to be increased. All concerns of the patients for lack of efficacy or ADRs should be carefully attended to and assessed. It has to be remembered that “a satisfied patient is the best ambassador for patient enrolment in future C.T.’s by persuading the fence sitters “

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13. December 2009 by harshit.

The act by a regulatory authority of conducting an official review of documents, facilities and any other resources that are deemed to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s or CRO facilities or at other establishment deemed appropriate by the regulatory authority. 

A) Purpose: The rights and well being of the trial subjects are well protected The trial data credible, complete and verifiable from the source documents The conduct of the trial is in compliance with the current approved protocol/amendments and GCP and the regulatory requirement

B) Types: Routine: Inspections assigned for NDA’s Directed: Problems identified at
IND stage, complaints to DSIPre Approval Clinical Investigator Inspection Sponsor/CRO/Monitor Inspection  

C) Process: Scheduling of Inspection Site selection Inspection review of sponsor files Inspector arrives and presents credentials and FDA-482Opening meeting Review of study conduct Request copies of documents and/or samples Discussion with the Investigator and site staff Presents the deficiencies and corrective actions Written report sent to Sponsor/Investigator 483 and follow up inspections

D) Criteria for selection: Insufficient domestic data Only foreign data submitted to support an application Conflicting data between domestic and foreign data Serious issues: Suspecting fraud, scientific/ethical misconduct, human subject protection violation      

E) Review: Trial related documentation Interview with clinical trial staff Facility tour Review records and record keeping Source data verification Review of other resources related to the trial Site to be prepared for:FDA form 1572IRB communication Informed consent Process SAE notification Patient logs Medication dispensing logs Inclusion/Exclusion criteria issues       Source document issues role in the study

F) Inspection Outcomes:

NAI: No action indicated Firm in compliance No actions/ response necessary: Voluntary action indicated Violative practices noted requires corrective actions Responses required and follow up inspection expected OAI: Official action indicates Violation are severe enough to warrant immediate administration actions , Reinspection likely Warning letter 

G) Common findings at Inspections Record keeping deficiencies (34%)Protocol deviations (25%)Test article accountability (5%)Adverse event reporting (2%)Informed consent (2%)

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8. December 2009 by rahul.

Phthalates are chemicals that soften plastic. That new toy and new shower curtain smell is phthalates off gassing. They’re also found in medical supplies such as IV tubes and drip bags, plastic food wrapping and containers, and most ubiquitously in fragrances of every description, from scented candles and (so-called) air fresheners, to fabric softeners and perfumes. Phthalates block androgens, or male hormones, and can interfere with normal genital development in boys. Guys, if you want to make a baby, leave the cologne in the medicine cabinet, blow out the scented candles, Stop nuking your food in plastic and toss the hair gel. Phthalates literally block androgen receptors, so that male hormones can’t plug in and give their male hormone messages to cells. At this moment in human history, those of us who live in industrialized countries can’t get away from phthalates — they’re literally everywhere. But we can minimize our exposure by reading labels and opting for cleaner, greener products.

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8. December 2009 by harshit.

The central government in India is planning to mandate biometric identification for clinical trial volunteers in the country to bring in global standards and to weed out unethical practices in the industry, which is less than a decade old.Clinical trials are essentially research studies to test the safety and efficacy of a new drug by administering it on healthy human volunteers and patients. Unlike other forms of identification, biometric identification — which relies on the unique physical characteristics of a person, like the iris of the eye or a fingerprint — is almost impossible to fudge.The Ministry of Health and Family Welfare plans to ask all clinical research organisations (CROs) to enforce biometric identification for the volunteers they recruit for their clinical trials, according to officials at the ministry. Data from the trials will then have to be made available for scrutiny by regulators, civil society groups and the clinical trial industry.
The biometric system, which is present in developed countries, will also help the Indian clinical research industry generate more credible data and ensure better care for the human volunteers

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8. December 2009 by rahul.

Confidentiality has become a growing concern. In the healthcare industry HIPAA regulations try to ensure an individual’s privacy by limiting access to medical records.HIPAA was enacted by Congress and signed into law by President William Clinton on August 21, 1996. The goal of HIPAA is to ensure that healthcare providers secure electronic records about patients in the same manner that hard copy records are secured. By securing the records, the healthcare industry can improve their level of services since improved security will lead to greater adoption of electronic transactions. One of the reasons that HIPAA was enacted was because the U.S. Federal Government wants all Medicare transactions to occur electronically by October 16, 2003. Before Congress could mandate patient records surrounding Medicare occur electronically, the security and privacy of patient records needed to be guaranteed.

Congress enacted HIPAA in response to the growing use of the Internet and electronic transactions. HIPAA is a privacy law to protect consumers from having their personal health information exploited by insurance companies, employers, and anyone else who may try to exploit, disclose, or publish their personal health information. In the Federal Register, HIPAA is more informally known as the Privacy Rule. Except in certain circumstances, individuals have the right to inspect, review and receive a copy of their medical and billing records that are held by health plans and healthcare providers. There are, however, some circumstances in which a patient would not be permitted to access his medical record. If a health care professional feels that the information requested could cause potential harm to either the patient or another individual, access could be denied. Other restricted health care information may include: psychotherapy notes, information gathered for legal proceedings, and laboratory results kept confidential by some research institutes.

Personal Health Information can be used for the following purposes, unrelated to health care:

1. As required by Law. Covered entities may use and disclose protected health information without individual authorization as required by law (including by statute, regulation, or court orders.

2. For Public Health Activities. Covered entities may disclose protected health information to: public health authorities authorized by law to collect or receive such information for preventing or controlling disease, injury, or disability and to public health or other government authorities authorized to receive reports of child abuse and neglect; entities subject to FDA regulation regarding FDA regulated products or activities for purposes such as adverse event reporting, tracking of products, product recalls, and post-marketing surveillance.

3. Victims of Abuse, Neglect or Domestic Violence. In certain circumstances, covered entities may disclose protected health information to appropriate government authorities regarding victims of abuse, neglect, or domestic violence.

4. Health Oversight Activities. Covered entities may disclose protected health information to health oversight agencies (as defined in the Rule) for purposes of legally authorized health oversight activities, such as audits and investigations necessary for oversight of the health care system and government benefit programs.

5. Judicial and Administrative Proceedings. Covered entities may disclose protected health information in a judicial or administrative proceeding if the request for the information is through an order from a court or administrative tribunal.

6. Decedents. Covered entities may disclose protected health information to funeral directors as needed, and to coroners or medical examiners to identify a deceased person, determine the cause of death, and perform other functions authorized by law.

7. Cadaveric Organ, Eye, or Tissue Donation. Covered entities may use or disclose protected health information to facilitate the donation and transplantation of cadaveric organs, eyes, and tissue.

8. Serious Threat to Health or Safety. Covered entities may disclose protected health information that they believe is necessary to prevent or lessen a serious and imminent threat to a person or the public, when such disclosure is made to someone they believe can prevent or lessen the threat (including the target of the threat). Covered entities may also disclose to law enforcement if the information is needed to identify or apprehend an escapee or violent criminal.

9. Workers’ Compensation. Covered entities may disclose protected health information as authorized by, and to comply with, workers’ compensation laws and other similar programs providing benefits for work-related injuries or illnesses.

HIPAA is far more complex than the Year 2000 date problem that information technology administrators faced in 1999, and that is why there are few guidelines available and few organizations providing compliancy services.

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4. December 2009 by rahul.

A medical device is a product which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals. Examples: include tongue depressors, medical thermometers, blood sugar meters, and X-ray machines.

Classification of Medical Devices
The regulatory authorities in recognize different classes of medical devices, based on their design complexity, their use characteristics, and their potential for harm if misused. Approximately 1,700 types of medical devices are regulated by FDA.Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.
The three classes and the requirements which apply to them are:
 Class I - General Controls
 Class II - Special Controls
 Class III - Premarket Approval

Class I - General Controls: Class I devices are subject to the least regulatory control as present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples: elastic bandages, examination gloves, and hand-held surgical instruments.

Class II - Special Controls: Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness.. Examples: powered wheelchairs, infusion pumps, and surgical drapes

Class III - Premarket Approval: Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Premarket approval is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Examples: replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators.

The basic regulatory requirements that manufacturers of medical devices must comply with :

1. Establishment registration 21 CFR Part 807: Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA.

2. 2.Premarket Notification 510 (k)- 21 CFR Part 807 :A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. Most Class I devices are exempt from the premarket notification and/or good manufacturing practices regulation.

3. Premarket Approval (PMA) - 21 CFR Part 814: Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

4. Investigational Device Exemption (IDE) - 21CFR Part 812: An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to FDA.

5. Good Manufacturing Practices (GMP) - 21 CFR Part 820: GMP includes requirements related to the methods used in: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices.

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2. December 2009 by rahul.

The 1572 is a federal form and is the statement of the investigator that he will abide by the federal guidelines set forth in the Code of Federal Regulations for the use of drugs in an investigational setting.
An investigator that is involved in drug or biologic research under Investigative New Drug (IND) regulations is obligated to sign a FDA form 1572. The PI signs a contract with the FDA which documents his or her agreement to follow the protocol and study obligations in conducting the trial. The investigator makes this contractual commitment when the FDA form 1572 (drug/biologic studies) or Investigator’s Agreement (device studies) is signed; the PI serves as the communication link between the sponsor and the FDA.
A new FDA 1572 Form must be submitted to the Program Management Board (PMB) whenever a change in any of the required information, such as the name or address of the PI or a change in the site IRB, occurs within the current year.
Regulation/Reference: 21 CFR 312
Purpose:
1. Document that the Investigator of Record (IoR) (i.e., Principal Investigator or PI)
agrees to conduct the trial according to the obligations stated in the form.
2. Update as study personnel and/or other data on the form changes.
3. The original version and any updated form must be retained as per regulatory
requirements.
4. The Investigator in box 1 of Form FDA 1572 is the individual who must sign and
date the signature box
5. Only laboratories specified in the protocol need to be listed in Section 4 to address
the following:
• Research /academic labs do not need to be listed on Form FDA 1572
• Research /academic labs should be listed in the protocol
• Central lab should be listed in the protocol for multi-center study protocol
• List individual clinical labs as in the protocol, unless it is a large multi-center
study and it would be impractical to list labs for every site.
1572 itself declares that, “No investigator may participate in an investigation until he/she provides the sponsor with a completed, signed Statement of Investigator, Form FDA 1572.” And FDA regulations at 21 CFR 312.53(c)(1) add that, “Before permitting an investigator to begin participation in an investigation, the sponsor shall obtain the following: (1) A signed investigator statement (Form FDA-1572)….” Therefore, the Form 1572 is a document that an investigator must submit to the study sponsor.
Through the 1572 Form and the attachments typically sent with it, an investigator provides a sponsor with, among other things, information on his or her education, training, and experience (CV or other statement of qualifications) that qualifies him or her to undertake the clinical investigation, information on the relevant facility, IRB, and sub investigators, protocol information, and the investigator’s commitment to conduct the study in accordance with the protocol and FDA regulations.

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