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Cytespace Research Pvt. Ltd.

Behind Every Clinical Trial - There are Thousands of Subjects Vulnerable Subjects in Clinical Trials

Volume 6, May 20, 2016

Thank you all for your continued support and guidance in publishing CyteXpression.

As we are celebrating “International Clinical Trials Day” on May 20th, there are numerous events, talks & pro-grams that are being arranged around the world emphasizing the need for Clinical Research, Regulatory envi-ronment, Paradigm shift in Clinical Research with RBM and newer technologies, thereby creating Quality Sites to generate best in class Data. However, my thoughts go for “Subjects”, who are participating in Clinical Trials. They are the real “Champions” and only they can advocate how important Clinical Research is for the society. Keeping this thought in mind, we are dedicating this edition of CyteXpression to “Subjects”. Sincere thanks to all subjects around the world, who have been taking part in Clinical Trials.

I would like to place my sincere thanks to all the Investigators, Ethics Committees and Sponsors, who are in-vesting their time this week in organizing & participating in events to celebrate “International Clinical Trials Day.”

We have been talking a lot about credible, ethical, and reliable data gen-eration in a clinical trial. However, the responsibility to ensure that these standards are met, is not solely of an investigator or a sponsor, in fact, the flip side of the coin is that the subject shares equal responsibil-ity with any other stakeholders involved in the trial. At one end, where the subject can voluntarily withdraw from a trial at any point in time, on the other, they shall carefully follow the instructions of the investigator.

When a drug or medical/diagnostic device is successful in a market, the credit may go to the sponsor, however, if you really ask them, they may praise the exceptional sites and the investigators they selected, and if someone really wants to dig deep into that to understand the success, the investigator may say it’s not because of us, instead, it is the subjects who made it successful. It would not be incorrect to quote that “Behind Every successful Clinical Trial there are Thousands of Subjects”

Though, we as investigators, sponsor/CRO, and Site Solutions Organiza-tion, understand the root of any successful Clinical Trial, this shall be sensitized equally in the participating subjects. Through this write up we are sharing solutions for two common challenges that sites face on usu-al or unusual basis with subjects retention or compliance:

The most common challenge that many sites witness is that the subjects often do not turn up on time during the clinic visits, or are reported lost to follow up. While some may say that at site level we could not control this, however, at the same time, we may need to check the relationship between subject and the site staff. The education of subject by the site team and any positive gesture to express how important and crucial they are to them, is of great importance.

Another set of deviation that is being reported often by sites is that sub-jects are not compliant with IP intake or completion of the subject diary. Though, the solution may require some extra efforts from us, it is also known that “nothing great comes without great efforts”. So we may need to re-assess the efforts we are investing, that is, are we installing reminder in subject’s cell phone, or, are we synchronising our calendar with subject’s reminder, or, are we connecting with subject until they are self-dependent in these activities.

Hence, along with education, training, and maintaining relationship, sensitization about the subject’s role and responsibilities is also re-quired. In this edition, we are sharing only few such challenges, howev-er, we would encourage you to write to us at Cytexpres-sion@Cytespace.com, about how you are managing the challenges at the site, and we would be happy to provide any available and possible solutions at our end.

Ms. Akanksha Jain Site Solutions Manager—Cytespace

Mr. Bhavesh Acharya Head-Site Solutions, India

Are we unknowingly ignoring Vul-

nerable Subjects to take part in

Clinical Trials?

I know this is quite a provocative

statement to make, especially

when we are celebrating Interna-

tional Clinical Trials Day this week.

As Bhavesh mentioned in his intro-

ductory note, my sincere gratitude too goes to all the

clinical trial subjects and when we talk of subjects in

India, we tend to divide it broadly into two, affluent

class and lower economic strata. There is a myth of ex-

ploiting people to participate in clinical trial from lower

economic strata. In my experience of clinical research in

India since almost last 2 decades, there is a sea shift and

we are seeing quite a good balance of subjects partici-

pating in Clinical Trial across all segments of society.

However, here, this is not something that we want to

talk. Here we want to focus on subjects, who come un-

der the definition of “Vulnerable Subject Population”.

Vulnerable Population is clearly defined by all regulatory bodies, be it ICH-GCP, Schedule Y or ICMR. We carefully consider group characteristics such as economic, social, physical and environmental conditions, to ensure that the research incorporates additional safeguards measures for vulnerable subjects. There is a clear guid-ance given by the regulatory bodies as well as Ethics Committees to handle such population to make them part of clinical trial. However, because such population requires us to create detailed documentation (both by the Investigator as well as Ethics Committee) to ensure that we are not exploiting them, we tend to not consid-er them from participation. I personally believe that all patients must be given option to choose their medical treatment by providing required information, be it the routine medical practice or a clinical trial. Looking forward to interacting with more investigators and sponsors, who will promote participation of sub-jects not only across all economic strata but vulnerable population too.

Prof. (Dr.) L SREENIVASAMURTHY Sr. Consultant Physician and

Diabetologist

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Cytespace Research Pvt. Ltd.

A South Indian film Actress experience

“I have been on an experimental immunotherapy for the last one year. There's an eligibility criteria to be part of the trial. You can be on it only if you fail everything else. That's how I got in. And I didn't go searching for it. It's a miracle. It found me while I was looking for something else. It's working for me. I haven't lost my hair; my ener-gy levels are at the peak. It works very different from chemotherapy. Right now my doctors are already working on what after this. We want to see the end of it.” - Courtesy Times of India

These are the words written by a famous South Indian film ac-tress – Mamta Mohandas, and who looked at cancer objectively until she was hit by it repeatedly. She battled Hodgkin's lympho-ma with positive energy and confidence. She had a relapse of Cancer later and underwent treatment, few of which failed. She decided to participate in a Clinical Trial conducted at the Univer-sity of California and is not shying away from sharing her experi-ence. During her study participation days, she enjoyed staying alone in Los Angels and even started acting in a film which was majorly shot in Canada and the other parts of US, which helped Mamta in continuing with her treatments.

In India, the awareness of Clinical Research and participation – pros and cons are still not known to many. Physicians are also at times are over cautious to inform their patients about partici-pating in a clinical trial, could be because of the scepticism was shown by the patients. People seems to be more interested in the media news highlighting the side effects and the unethical conduct of clinical research. However, Mamta’s attitude has to be more valued and is a motivation to cancer patients as well as to the Clinical Research participants. Without Clinical trial sub-jects participation, we would not be able to advance medical science/ research to the next level.

Ms. Asha Nair Site Solutions Manager—Cytespace

Clinical Research Awareness among Patients EC Re-Registration Process

It’s time for EC re-registration. As per the EC registrations pro-vided by DCGI in the year of 2013, it’s time to apply for re-registration. The process is simple and very identical to the ini-tial one, however, need to be very accurate in submitting these documents to have EC registration well in time.

Application - An application shall be prepared for a renewal of EC registration. The letter shall have existing EC registration number and shall be created in duplicate with original signa-tures (Office copy and acknowledgement/reference copy).

Preparation of EC dossier - The entire dossier shall be created same as was done earlier at the time of initial registration. Quick reference to the checklist and the process to be followed can be downloaded from the below-mentioned CDSCO link.

http://cdsco.nic.in/writereaddata/FINAL%20CHECKLIST%20FOR%20RE-REGISTRATION%20OF%20EC%201%20FEB%202016.pdf

Contents - The contents shall be in line with the checklist, and the entire dossier shall be arranged in the same sequence.

Additional Information - The checklist does not have provi-sion for renewal of registration, and hence apart from existing 19 points an additional 20th point shall be added for following details. Please Note - The below-mentioned information shall be submitted in the form of table ( A dummy table has been created for your easy reference)

Types of clinical research reviewed by the committee (e.g. pharmaceuticals, devices, epidemiological, retrospective, herb-als, etc.).

Documents reviewed for every clinical trial protocol includ-ing Informed Consent documents.

Information in respect to a number of meetings of the com-mittee and documentation of the minutes of meetings of these committees concerning clinical trials.

Information regarding review of serious adverse events reported during the conduct of the trial.

The dossier shall be spiral bounded with no loose pages.

Types of

clinical

research

reviewed

by the

com-

mittee

Docu-

ments

reviewed

No of EC

Meetings

MOM

s (Y/

N)

Information regarding

review of serious ad-

verse events

No. of

SAEs

No. of

Cases

Compensa-

tion appli-

cable

Pharma-

ceutical –

Phase III

Protocol,

ICF,

Patient

diary,

CTA,

Insur-

ance

3 Y 2 0

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Cytespace Research Pvt. Ltd.

Empowering Trial Sites

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Accelerated Clinical Trials Through

High Performance Sites

Enchanched Patient Safety,

Compliance and Data Quality

Reduced Spend, Increase Efficiency

at Trial Sites

With an objective of providing complete solutions to the sites for conduct of clinical trials. Cytespace has lately introduce Cytestream (www.cytestream.com), our proprietary 21 CFR Part 11 compliant Clinical Trial Management Software (CTMS). Subject Management is an integral part of the Cytestream. All Clinical Trial Sites can make use of this functionality:

Subject confidential data would only be visible to site.

Subjects could be added to create database at site

Quick subject search can be done

Details of demographic, medical history, medications, investigations and procedure could be added for easy reference.

Site personnel receives “Automated Emails” from the system for upcoming Subject Visits and for weekly updates.

Contact Us

Last quarter we have been involved in activities like Ethics Committee Training: Recently Cytespace Research Private Limited and Dr Nandini Kumar in collaboration with Lakeshore Hospital, Cochin conducted EC training on Febru-ary 14, 2016.

Proud to share that a total of 6 Ethics Committee personnel actively participated and was a good experience to conduct such training. Looking forward to having more such pro-grammes across India, as we get momentum with more Clin-ical Trials in India in 2016.

Quiz

1. Which one of the following person fits the definition of sub investigator in an Oncology study?

a. A colleague of the Investigator who can make decisions regard-ing the study or trial

b. A colleague of the Investigator who is an expert on type of can-cer being studied

c. A Laboratory director who oversees laboratory tests for cancer patients

d. A Radiologist who reviews and reports scans & films

2. Form 483 is a letter from the USFDA for

a. Notice for Inspection

b. Warning letter

c. Notifying the site of a major / critical findings

d. Investigator statement of declaration

You may send your answers to Cytexpression@cytespace.com