A Comparative, Multi Centric, Cross-sectional Study

Of

Perception and Awareness of Clinical Research

In

Trial Participants and General Public of AP

INTRODUCTION

Clinical research helps us determine the safety and efficacy of medications, devices, diagnostic products intended for human use.

The design and conduct of the trial is dictated by the protocol & approved by regulatory authorities

The data thus collected is scientifically analyzed to reach a valid inference

The most challenging area in Clinical Research is :

finding eligible and compliant subjects for willful participation .

NEED TO CREATE AWARENESS

Important steps in clinical research

Public should know

Public should understand

Public should participate

PREVIOUS STUDIES AND RESULTS

WHAT IS NEWSWORTHY? LONGITUDINAL STUDY OF THE REPORTING OF MEDICAL RESEARCH IN TWO BRITISH NEWSPAPERS. BMJ Current public understanding of

clinical research is poor and media

coverage of clinical research trials is often

negative

  Bartlett C, Sterne J, Egger M

PROMOTING PUBLIC AWARENESS OF RANDOMISED CLINICAL TRIALS USING THE MEDIA: THE ‘GET RANDOMISED’ CAMPAIGN

There is agreement in the

literature that one of the major

barriers to recruitment and

enrollment of patients in clinical

trials is patients' lack of awareness

about clinical trials.

Isla S Mackenzie, Li Wei, Daniel Rutherford et al

ATTITUDES TOWARD CLINICAL TRIALS AMONG PATIENTS AND THE PUBLIC

Responses differed neither by subgroup nor

by demographic variables.

{104 cancer pts, 84 cardiology pts, and 107 general public}

Most respondents (71%) believed that patients should serve as research subjects

Cassileth BR, LuskEJ, Miller DS, Hurwitz S

PARTAKE STUDY Results suggest the Indian public is aware

of some key features of clinical research like:

purpose/ value/ voluntariness and supports clinical research in general

But is unaware of other key features like:

Compensation/confidentiality/protection of human participants &

Exhibits some distrust in the conduct and reporting of clinical trials

PARTAKE Survey of Public Knowledge and Perceptions of Clinical Research in India (Delhi)

ATTITUDES TOWARDS CLINICAL RESEARCH AMONGST PARTICIPANTS AND NONPARTICIPANTS. J INTERN MED 

Trial participants were, as compared with nonparticipating respondents, more positive towards both participation of self and others.

Both personal and altruistic motives for participation were highly rated.

Primary reasons for nonparticipation were *fear of ‘the unknown’ and/or *unease with randomization

Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P (Copenhagen University )

RESULTS OF HARRIS INTERACTIVE SURVEY :

1)Awareness changes attitude toward clinical research

2) Helps participant make an informed decision

3) Improves overall trust in the clinical research

OBJECTIVES OF OUR STUDY :

To determine the areas in which there is LACK of

perception & awareness of clinical trial in both groups (TP) & (NTP)

To determine the areas in which there is GAP of perception & awareness of clinical trial between both groups (TP) & (NTP)

To determine ways and means for bringing about better awareness in both groups

{{TP—trial participants, NTP----non trial participants}}

MATERIALS & METHODS Protocol was designed and an approval from

Institutional Ethics Committee was taken Sample size was calculated and found to be 165 in

each group. {Assuming 70% of awareness with 95% of confidence interval (C.I), 20% relative precision with a design effect of 2}.

Designed a Questionnaire and EC approval taken Recruitment process discussed for TPs and NTPs Data collection procedure finalised Statistical Analysis discussed

RESULTS

LITERACY

TP NTP

Illiterate 9% 9%

1-12 class 61% 61%

Graduate 30% 30%

COMPARABLE GROUPS

PURPOSE AND SOURCE OF INFORMATION ABOUT CLINICAL RESEARCH

Purpose TP NTP

Help in Research 74% 57%

Financial Benefit 21% 32%

Others 5% 11%

Source of Information TP NTP

Friends/ Relatives/ Participated subject

81% 53%

Advertisements 5% 16%

Others (Doctors etc…) 13% 28%

Awareness TP NTPMedicines using today were part of clinical trials earlier 85% 60%

Clinical research an essential step for developing new treatment

of diseases

86% 62%

Trials conducted globally for better treatment of diseases 88% 60%

Many people participating in clinical trials all over the world 89% 54%

Confidentiality of the participants personal information will be

maintained

97% 47%

Drugs tested thoroughly for its safety before using it 97% 62%

Leaflet that comes with medicine prepared based on clinical trial

results

89% 53%

Pharmaceutical companies spend billions of rupees on clinical

research

91% 53%

Take years for a drug to come into market 81% 61%

Surveillance by regulatory bodies even after the drug approval 74% 42%

Awareness on Clinical Research

Awareness on Elements of Consent Form

Participation se with Audio-Video Consenting TP- 56% Believe NTP- 73% Don’t believe

98% 98%64% 79%

98% 98%

20% 27%52%

27%53% 41%

TP NTP

TP=Trial Participants; NTP=Non-Trial Participants (General public).

Ethics Committee

TP=Trial Participants; NTP=Non-Trial Participants (General public)

0%30%60%90%

TPNTP

Financial transaction

TP (%) NTP(%)

Food and transport 34 37

Reward for participation 33 41

Transport, food and reward for

participation

12 -

Transport, food and others 14 -

Others 7 22

Awareness on Risks Vs Benefits

TP=Trial Participants; NTP=Non-Trial Participants (General public)

93% 90% 98% 97%73%

49% 47% 51%

TP NTP

Knowledge on who will be the beneficiary in Clinical Trials

Beneficiary TP NTP

Participants7% 13%

Pharmaceutical company12% 36%

Society70% 49%

Society and Pharmaceutical company6% 2%

Society and participants5% -

PUNE VS HYDERABAD STUDY Source of Information:

Awareness on Risks and Benefits

Need to create awareness:

Pune: 97%; Hyderabad: 81%

Hyderabad

Pune

Friends/ Relatives/ participated subjects

81% 28%

Doctors / Clinics 13% 72%

Hyderabad

Pune

Risks involved in clinical Research

93% 60%

Benefits in clinical Research 95% 75%

CONCLUSION

According to our survey it was concluded that the awareness on

clinical research is low in our society especially in the areas of:

1) elements of consent form and consenting process,

2) Confidentiality in Clinical Research

3) Regulatory machinery of the clinical research.